Clinical trial NCT03281954: Clinical Trial of Neoadjuvant Chemotherapy With Atezolizumab or Placebo in Patients With Triple-Negative Breast Cancer Followed After Surgery by Atezolizumab or Placebo
Official title: A Randomized, Double-Blind, Phase III Clinical Trial of Neoadjuvant Chemotherapy With Atezolizumab or Placebo in Patients With Triple-Negative Breast Cancer Followed by Adjuvant Continuation of Atezolizumab or Placebo
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Triple Negative Breast Cancer
Keywords: anti-PD-L1 antibody
TNBC
Lead sponsor: NSABP Foundation Inc
Sponsor class: NETWORK
Collaborators: name: Genentech, Inc.
name: Hoffmann-La Roche
First posted: 2017-09-13
Enrollment: 1550
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The main purpose of this study is to learn if the usual chemotherapy given before surgery (neoadjuvant therapy) for breast cancer plus the experimental drug, atezolizumab, is better than the usual chemotherapy plus a placebo. (A placebo is a drug that looks like the study drug but contains no medication.) The usual chemotherapy in this study is paclitaxel (WP) and carboplatin followed by doxorubicin and cyclophosphamide (AC) or epirubicin and cyclophosphamide (EC). Usually, after neoadjuvant therapy and surgery for triple negative breast cancer, no additional treatment is given unless the cancer returns. This study will also look at continuing treatment after surgery with atezolizumab or the placebo. To be better, atezolizumab given with the neoadjuvant therapy should be better at: 1) decreasing the amount of tumor in the breast than the placebo given with the usual chemotherapy and 2) decreasing the chance of the cancer from returning after surgery.

Another purpose of this study is to test the good and bad effects of atezolizumab when added to the usual chemotherapy. Atezolizumab may keep your cancer from growing but it can also cause side effects.

Detailed description: NSABP B-59/GBG 96-GeparDouze is a prospective, randomized, double-blind, Phase III clinical trial. This is a collaborative study being conducted by NSABP Foundation, Inc. in partnership with the German Breast Group (GBG), and supported by funding by Genentech, a Member of the Roche Group, and F. Hoffmann-La Roche, Ltd.

In this clinical trial of neoadjuvant and adjuvant administration of atezolizumab/placebo in patients with high risk triple-negative breast cancer, the potential incremental efficacy and safety of neoadjuvant administration of atezolizumab/placebo with a sequential regimen of weekly paclitaxel with every-3-week carboplatin followed immediately by neoadjuvant administration of atezolizumab/placebo with AC/EC will be evaluated. Patients will then undergo surgery. Following recovery from surgery, patients will initiate approximately 6 months of adjuvant therapy with atezolizumab/placebo and receive the same investigational agent they received pre-operatively. Administration of radiation therapy will be based on local standards at the discretion of patients and investigators, but if administered, atezolizumab/placebo will be administered concurrently. Adjuvant atezolizumab/placebo may be delayed until after completion of radiation therapy per investigator discretion. Patients with residual invasive cancer at the time of surgery may receive capecitabine concurrently with atezolizumab/placebo in the adjuvant setting per investigator discretion and local guidelines. Patients with germline BRCA1 or BRCA2 mutations with residual invasive cancer at the time of surgery may receive olaparib in the adjuvant setting per investigator discretion and local guidelines. Patients receiving olaparib must discontinue atezolizumab/placebo.

The primary aims of the study are 1) to determine value of atezolizumab in improving pathologic complete response in the breast and post-therapy lymph nodes evaluated histologically (pCR breast and nodes \[(ypT0/Tis ypN0)\]), and 2) to determine the value of atezolizumab in improving event-free survival (EFS). Secondary aims include: pathologic complete response in the breast (ypT0/Tis); pathologic complete response in the breast and lymph nodes (ypT0 ypN0); positive nodal status conversion rate; overall survival; recurrence-free interval: distant disease-free survival; brain metastases free survival; and toxicity. The stratification factors for the study are: 1) clinical size of the primary tumor (1.1-3.0 cm; \> 3.0 cm); 2) nodal status as determined by protocol-specified criteria (negative, positive); 3) AC/EC (every 2 weeks; every 3 weeks); and 4) Region (North America; Europe).

For patient eligibility, local testing on the diagnostic core must have determined the patient's tumor to be ER-negative, PgR-negative, and HER2-negative by current ASCO/CAP guidelines. Material from either the diagnostic core biopsy or the research biopsy must be sent for central testing for confirmation of ER, PgR, and HER2 to confirm eligibility. If local testing has determined a tumor to be HER2 equivocal or to have a borderline ER/PgR status (% IHC staining \< 10% for both), material may be submitted for central testing to determine eligibility.

In order to proactively identify and further assess any cardiac toxicity that may occur with the combination of anthracyclines and atezolizumab, this study includes a cardiac safety lead-in for the first 60 patients who initiate AC/EC. The safety lead-in will consist of assessment of ECG and serum troponin-T obtained just prior to administration of the first dose of AC/EC, following completion of the administration of the 1st and 3rd cycle of AC/EC prior to initiation of the atezolizumab/placebo. An additional assessment of LVEF with echocardiogram or MUGA scan will also be obtained prior to the 3rd dose of AC/EC. In order to provide an early assessment of cardiac safety, results of the troponin-T assessments, ECGs, LVEF assessment, and cardiac safety data will be evaluated by the Data Safety Monitoring Board (DSMB) when the last of the initial 20 patients who initiate AC/EC undergo their scheduled post-surgery LVEF assessment. When the last of the first 60 patients to initiate AC/EC undergo their scheduled post-surgery LVEF assessment, results of the troponin assessments, ECGs, LVEF assessments, and cardiac safety data from all 60 patients will be evaluated by the DSMB.

Research core biopsies of breast primary at baseline and 1-4 days prior to the second dose of atezolizumab/placebo are a study requirement for all patients. One to three representative blocks of residual primary tumor containing the maximum amount of tumor and node with the largest focus of metastasis is required from the definitive breast surgery if gross residual disease is greater than or equal to 1.0 cm. If gross residual disease is less than 1.0 cm, tissue should be submitted, if possible. Blood specimens will be collected on all patients at baseline for exploratory biomarker analysis and to support future correlative studies.

Accrual to NSABP B-59/GBG 96-GeparDouze began in December 2017 and was completed in May 2021 with a total of 1550 patients randomized. Based on actual accrual and the decision to eliminate pCR as a co-primary endpoint, we recalculated the power to detect a hazard ratio of 0.70 attributed to the addition of atezolizumab, assuming a lost-to-follow-up rate of 0.00083 per month, using the actual accrual pattern for the power calculation. With 1550 patients accrued in 42 months, an additional 22 months follow up will allow us to obtain 252 events under the assumptions stated above, which will provide 80% power to detect a HR of 0.7 between the atezolizumab and the placebo arm at an overall 2-sided alpha level of 0.05.

Eligibility criteria: Inclusion Criteria:

* The patient must have consented to participate and, prior to beginning specific study procedures, must have signed and dated an appropriate IRB-approved consent form that conforms to federal and institutional guidelines for study treatment and for submission of tumor samples from a research biospy as required by NSABP B-59/GBG 96-GeparDouze for baseline correlative science studies.
* The diagnosis of invasive adenocarcinoma of the breast must have been made by core needle biopsy.
* Local testing on the diagnostic core must have determined the tumor to be ER-negative, PgR-negative, and HER2-negative by current ASCO/CAP guidelines. (If local testing has determined a tumor to be HER2 equivocal or to have a borderline ER/PgR status (% IHC staining \< 10% for both) and other eligibility criteria are met, material may be submitted for central testing to determine eligibility.)
* Central testing for ER, PgR, and HER2 will be performed, and the tumor must be determined to be ER-negative, PgR-negative, and HER2-negative by current ASCO/CAP Guidelines Recommendations.
* The tumor specimen used for central ER, PgR, and HER2 testing must also be used for central testing of PD-L1 status using the Ventana PD-L1 testing result including PD-L1 indeterminate Patients will be classifies as positive, negative, or indeterminate for stratification purposes.
* Patients must be ≥ 18 years old.
* Patient may be female or male.
* The ECOG performance status must be 0-1.
* The primary tumor can be clinical stage T2 or T3, if clinically node negative according to AJCC 7th Edition. If the regional lymph nodes are cN1 and cytologically or histologically positive or cN2-N3 with or without a biopsy, the primary breast tumor can be clinically T1c, T2, or T3.
* Ipsilateral axillary lymph nodes must be evaluated by imaging (mammogram, ultrasound, and/or MRI) within 84 days prior to study entry. If suspicious or abnormal, FNA or core biopsy is recommended. Findings of these evaluations will be used to define the nodal status prior to study entry according to the following criteria:

  * Nodal status - negative (Imaging of the axilla is negative; Imaging is suspicious or abnormal but the FNA or core biopsy of the questionable node\[s\] on imaging is negative)
  * Nodal status - positive (FNA or core biopsy of the node\[s\] is cytologically or histologically suspicious or positive; Imaging is suspicious or abnormal but FNA or core biopsy was not performed.)
* Patients with synchronous bilateral or multicentric HER2-negative breast cancer are eligible as long as the highest risk tumor is ER-negative and PgR-negative and meets stage eligibility criteria. All of the other invasive tumors must also be HER2-negative by ASCO/CAP Guidelines based on local testing. Central testing to confirm TNBC status is only required for the highest risk tumor.
* Blood counts performed within 28 days prior to randomization must meet the following criteria:

  * ANC must be ≥ 1500/mm3;
  * platelet count must be ≥ 100,000/mm3; and
  * hemoglobin must be ≥10 g/dL.
* The following criteria for evidence of adequate hepatic function performed within 28 days prior to randomization must be met:

  * total bilirubin must be ≤ ULN for the lab unless the patient has a bilirubin elevation \> ULN to 1.5 x ULN due to Gilbert's disease or similar syndrome involving slow conjugation of bilirubin; and
  * alkaline phosphatase must be ≤ 2.5 x ULN for the lab; and
  * AST and ALT must be ≤ 1.5 x ULN for the lab.
* Patients with AST or ALT or alkaline phosphatase \> ULN are eligible for inclusion in the study if liver imaging (CT, MRI, abdominal ultrasound, PET-CT, or PET scan) performed within 28 days prior to randomization does not demonstrate metastatic disease and the requirements in criterion (just above) are met.
* Patients with alkaline phosphatase that is \> ULN but less than or equal to 2.5 x ULN or with unexplained bone pain are eligible for inclusion in the study if bone imaging (bone scan, PET-CT scan, or PET scan) supported by additional studies when indicated (CT, x-ray, MRI) performed within 28 days prior to randomization does not demonstrate metastatic disease.
* Patients with N2 or N3 nodal disease or T3 primary disease must undergo liver and bone imaging (as described in 4.1.13 and 4.1.14) within 28 days prior to randomization, irrespective of baseline lab results, and studies must not demonstrate metastatic disease. Chest imaging with chest x-ray PA and Lateral, CT of the chest, or PET-CT must also be performed.
* Creatinine clearance ≥ 50 mL/min (see Section 7.2.1 for instructions regarding calculation of creatinine clearance) performed within 28 days prior to randomization.
* PT/INR ≤ ULN within 28 days of randomization. Patients receiving therapeutic anti-coagulants are not eligible.
* A serum TSH and AM (morning) cortisol performed within 28 days prior to randomization to obtain a baseline value. Patients with abnormal TSH or AM cortisol baseline levels should be further evaluated and managed per institutional standards. Asymptomatic patients who require initiation or adjustment of medication or are followed without initiating treatment based on endocrinologist's recommendations are eligible.
* LVEF assessment must be performed within 42 days prior to randomization. (LVEF assessment performed by echocardiogram is preferred; however, MUGA scan may be substituted based on institutional preferences.) The LVEF must be ≥ 55% regardless of the cardiac imaging facility's lower limit of normal.
* For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods that result in a failure rate of \< 1% per year during the treatment period and for at least 5 months after the last dose of atezolizumab/placebo or 12 months after the last dose of chemotherapy.

  * A woman is considered to be of childbearing potential if she is not postmenopausal, has not reached a postmenopausal state (≥ 12 continuous months of amenorrhea with no identified cause other than menopause), and has not undergone surgical sterilization (removal of ovaries and/or uterus).
  * Examples of contraceptive methods with a failure rate of \< 1% per year include: bilateral tubal ligation; male partner sterilization; hormonal contraceptives that inhibit ovulation; hormone-releasing intrauterine devices; copper intrauterine devices.
  * The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical study and the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not acceptable methods of contraception.
* Patient must be willing and able to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures.

Exclusion Criteria:

* Excisional biopsy or lumpectomy performed prior to study entry.
* FNA alone to diagnose the breast cancer.
* Surgical axillary staging procedure prior to randomization. Exception: FNA or core biopsy of an axillary node is permitted for any patient. A pre-neoadjuvant therapy sentinel lymph node biopsy for patients with clinically negative axillary nodes is prohibited.
* Definitive clinical or radiologic evidence of metastatic disease.
* Previous history of contralateral invasive breast cancer. (Patients with synchronous and/or previous contralateral DCIS or LCIS are eligible.)
* Previous history of ipsilateral invasive breast cancer or ipsilateral DCIS. (Patients with synchronous or previous ipsilateral LCIS are eligible.)
* History of non-breast malignancies (except for in situ cancers treated only by local excision and basal cell and squamous cell carcinomas of the skin) within 5 years prior to study entry.
* Treatment including radiation therapy, chemotherapy, or targeted therapy, for the currently diagnosed breast cancer prior to randomization.
* Previous therapy with anthracyclines or taxanes for any malignancy.
* Cardiac disease (history of and/or active disease) that would preclude the use of the drugs included in the treatment regimens. This includes but is not confined to:

  * Active cardiac disease: angina pectoris that requires the use of anti-anginal medication; ventricular arrhythmias except for benign premature ventricular contractions; supraventricular and nodal arrhythmias requiring a pacemaker or not controlled with medication; conduction abnormality requiring a pacemaker; valvular disease with documented compromise in cardiac function; or symptomatic pericarditis.
  * History of cardiac disease: myocardial infarction documented by elevated cardiac enzymes or persistent regional wall abnormalities on assessment of left ventricular function within 6 months prior to randomization; history of documented CHF; or documented cardiomyopathy.
* Uncontrolled hypertension defined as sustained systolic BP \> 150 mmHg or diastolic BP \> 90 mmHg. (Patients with initial BP elevations are eligible if initiation or adjustment of BP medication lowers pressure to meet entry criteria.) Patients requiring ≥ 3 BP medications are not eligible.
* History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins.
* Known hypersensitivity to biopharmaceuticals produced in Chinese hamster ovary cells.
* Known allergy or hypersensitivity to the components of the atezolizumab formulation.
* Known allergy or hypersensitivity to the components of the doxorubicin, epirubicin, cyclophosphamide, carboplatin, or paclitaxel formulations.
* Known allergy or hypersensitivity to liposomal or pegylated G-CSF formulations.
* Active or history of autoimmune disease or immune deficiency, including but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, antiphospholipid syndrome, Wegener granulomatosis, Sjögren syndrome, Guillain-Barré syndrome, or multiple sclerosis for a more comprehensive list of autoimmune diseases and immune deficiencies) with the following exceptions:

  * Patients with a history of autoimmune-related hypothyroidism on a stable dose of thyroid replacement hormone may be eligible for this study.
  * Patients with controlled Type 1 diabetes mellitus on a stable dose of insulin regimen may be eligible for this study.
  * Patients with eczema, psoriasis, lichen simplex chronicus, or vitiligo with dermatologic manifestations only (e.g., patients with psoriatic arthritis are excluded) are permitted provided all of following conditions are met: Rash must cover \< 10% of body surface area; Disease is well controlled at baseline and requires only low-potency topical corticosteroids; No occurrence of acute exacerbations of the underlying condition requiring psoralen plus ultraviolet A radiation, methotrexate, retinoids, biologic agents, oral calcineurin inhibitors, or high-potency or oral corticosteroids within the previous 12 months.
* History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan.
* Patients known to be HIV positive.
* Active hepatitis B virus (HBV) infection, defined as having a positive hepatitis B surface antigen (HBsAg) test at screening. Patients with a past or resolved HBV infection, defined as having a negative HBsAg test and a positive total hepatitis B core antibody (HBcAb) test at screening, are eligible for the study if active HBV infection is ruled out on the basis of HBV DNA viral load per local guidelines.
* Active hepatitis C virus (HCV) infection, defined as having a positive HCV antibody test at screening confirmed by a polymerase chain reaction (PCR) positive for HCV RNA.
* Patients with clinically active tuberculosis.
* Severe infection within 28 days prior to randomization, including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia.
* Prior allogeneic stem cell or solid organ transplantation.
* Administration of a live, attenuated vaccine within 28 days prior to randomization or anticipation that such vaccine will be required during the study. Patients must agree not to receive live, attenuated influenza vaccine (e.g., FluMist) within 28 days prior to randomization, during treatment or within 5 months following the last dose of atezolizumab/placebo.
* Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or render the patient at high risk from treatment complications.
* Prior treatment with CD137 agonists or immune checkpoint-blockade therapies, including anti-CD40, anti-CTLA-4, anti-PD-1, and anti-PD-L1 therapeutic antibodies.
* Treatment with systemic immunosuppressive medications (including but not limited to interferons, IL-2) within 28 days or 5 half-lives of the drug, whichever is longer, prior to randomization.
* Treatment with systemic immunosuppressive medications (including but not limited to prednisone, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis \[anti-TNF\] factor agents) within 14 days prior to randomization or anticipation of need for systemic immunosuppressive medications during the study.
* Nervous system disorder (paresthesias, peripheral motor neuropathy, or peripheral sensory neuropathy) ≥ Grade 2, per the CTCAE v4.0.
* Symptomatic peripheral ischemia.
* Pregnancy or lactation at the time of randomization or intention to become pregnant during the study. (Note: Negative serum pregnancy test must be obtained within 14 days prior to randomization).
* Use of any investigational agent within 28 days prior to randomization.

Primary outcomes:
measure: Event-free survival (EFS)
timeFrame: From randomization until event, through study follow up to the time target number of events is obtained, up to 5 years
Secondary outcomes:
measure: Overall survival (OS)
timeFrame: From date of randomization through study follow-up, to the time the target number of events is obtained, up to 5 years
measure: Pathologic complete response in the breast and lymph nodes (ypT0/Tis ypN0)
timeFrame: Following completion of neoadjuvant therapy (ypT0/Tis ypN0)
measure: Distant disease-free survival (DDFS)
timeFrame: From date of randomization through study follow-up, to the time the target number of events is obtained, up to 5 years
measure: Disease-free survival (DFS)
timeFrame: From the first breast surgical procedure to the first disease recurrence or death from any cause
measure: Frequency of Adverse Events
timeFrame: From beginning of study therapy to 90 days after last dose of study therapy
measure: Frequency of immune Adverse Events of Special Interest
timeFrame: From beginning of study therapy to 90 days after last dose of study therapy
measure: Cardiac safety lead-in (Troponin-T)
timeFrame: prior to initial dose of AC/EC following completion of carboplatin/paclitaxel co-administered with atezolizumab/placebo, approximately 12 weeks
measure: Cardiac safety lead-in (Troponin-T)
timeFrame: After administration of the 1st dose of AC/EC prior to administration of atezolizumab/placebo, approximately 1 hour after beginning the 1st dose of AC/EC
measure: Cardiac safety lead-in (Troponin-T)
timeFrame: After administration of the 3rd dose (Cycle 3; each cycle is 21 days) of AC/EC prior to administration of atezolizumab/placebo, approximately 1 hour after beginning the 3rd dose of AC/EC
measure: Cardiac safety lead-in (Left ventricular ejection fraction; LVEF)
timeFrame: Prior to initiation of carboplatin/paclitaxel and atezolizumab/placebo, at baseline
measure: Cardiac safety lead-in (Left ventricular ejection fraction; LVEF)
timeFrame: Prior to the 3rd cycle (each cycle is every 21 days) of AC/EC, approximately 6 weeks after initiation of AC/EC
measure: Cardiac safety lead-in (Left ventricular ejection fraction; LVEF)
timeFrame: Four to 6 weeks after surgery
Other outcomes:
Locations:
city: Mobile
country: United States
facility: University of South Alabama Mitchell Cancer Institute
state: Alabama
city: Anchorage
country: United States
facility: Katmai Oncology Group
state: Alaska
city: Jonesboro
country: United States
facility: St. Bernard's Medical Center
state: Arkansas
city: Paragould
country: United States
facility: St. Bernard's Medical Center
state: Arkansas
city: Anaheim
country: United States
facility: Kaiser Permanente-Anaheim
state: California
city: Baldwin Park
country: United States
facility: Kaiser Permanente-Baldwin Park
state: California
city: Bellflower
country: United States
facility: Kaiser Permanente-Bellflower
state: California
city: Colton
country: United States
facility: Arrowhead Regional Medical Center
state: California
city: Duarte
country: United States
facility: City of Hope
state: California
city: Fontana
country: United States
facility: Kaiser Permanente-Fontana
state: California
city: Harbor City
country: United States
facility: Kaiser Permanente-Harbor City
state: California
city: Irvine
country: United States
facility: Kaiser Permanente-Irvine
state: California
city: Los Alamitos
country: United States
facility: Cancer and Blood Specialty Clinic
state: California
city: Los Angeles
country: United States
facility: Kaiser Permanente-Sunset
state: California
city: Los Angeles
country: United States
facility: Kaiser Permanente-West Los Angeles
state: California
city: Panorama City
country: United States
facility: Kaiser Permanente-Panorama City
state: California
city: Riverside
country: United States
facility: Kaiser Permanente-Riverside
state: California
city: San Diego
country: United States
facility: Kaiser Permanente Medical Group
state: California
city: San Diego
country: United States
facility: Kaiser Permanente-Zion
state: California
city: San Diego
country: United States
facility: Kaiser Permanente - Otay
state: California
city: San Marcos
country: United States
facility: Kaiser Permanente- San Marcos
state: California
city: South Pasadena
country: United States
facility: City of Hope - South Pasadena
state: California
city: Torrance
country: United States
facility: Torrance Memorial Physician Network
state: California
city: Upland
country: United States
facility: City of Hope - Upland
state: California
city: Whittier
country: United States
facility: PIH Health
state: California
city: Woodland Hills
country: United States
facility: Kaiser Permanente-Woodland Hills
state: California
city: Aventura
country: United States
facility: Mount Sinai Comprehensive Cancer Center Aventura
state: Florida
city: Hollywood
country: United States
facility: Memorial Healthcare System Office of Human Research
state: Florida
city: Miami Beach
country: United States
facility: Mount Sinai Comprehensive Cancer Center
state: Florida
city: Orlando
country: United States
facility: UF Health Cancer Center at Orlando Health
state: Florida
city: Duluth
country: United States
facility: Gwinnett Hospital System Center for Cancer Care
state: Georgia
city: Lawrenceville
country: United States
facility: Gwinnett Hospital System Center for Cancer Care
state: Georgia
city: Snellville
country: United States
facility: Gwinnett Hospital System Center for Cancer Care
state: Georgia
city: Bloomington
country: United States
facility: Illinois Cancer Care-Bloomington
state: Illinois
city: Chicago Ridge
country: United States
facility: Affiliated Oncologists
state: Illinois
city: Chicago
country: United States
facility: John H. Stroger, Jr. Hospital of Cook County
state: Illinois
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Decatur
country: United States
facility: Cancer Care Specialists of Central Illinois
state: Illinois
city: Decatur
country: United States
facility: Decatur Memorial Hospital
state: Illinois
city: Effingham
country: United States
facility: Crossroads Cancer Center
state: Illinois
city: Elmhurst
country: United States
facility: Emhurst Memorial Nancy W. Knowles Cancer Center
state: Illinois
city: Galesburg
country: United States
facility: Illinois Cancer Care-Galesburg
state: Illinois
city: Naperville
country: United States
facility: Edward Cancer Center
state: Illinois
city: Ottawa
country: United States
facility: Illinois Cancer Care-Ottawa
state: Illinois
city: Peoria
country: United States
facility: Illinois Cancer Care PC
state: Illinois
city: Peru
country: United States
facility: Illinois Cancer Care-Peru
state: Illinois
city: Plainfield
country: United States
facility: Edward Cancer Center Plainfield
state: Illinois
city: Swansea
country: United States
facility: Cancer Care Specialists of Central Illinois-Swansea
state: Illinois
city: Fort Wayne
country: United States
facility: Fort Wayne Medical Oncology and Hematology Inc (W. Jefferson Blvd)
state: Indiana
city: Fort Wayne
country: United States
facility: Fort Wayne Medical Oncology and Hematology Inc (Parkview Plaza)
state: Indiana
city: Cedar Rapids
country: United States
facility: Mercy Medical Center Hall-Perrine Cancer Center
state: Iowa
city: Chanute
country: United States
facility: Cancer Center of Kansas - Chanute
state: Kansas
city: Dodge City
country: United States
facility: Cancer Center of Kansas - Dodge City
state: Kansas
city: El Dorado
country: United States
facility: Susan B. Allen Memorial Hosptial
state: Kansas
city: Independence
country: United States
facility: Cancer Center at Mercy - W. Laurel
state: Kansas
city: Kingman
country: United States
facility: Kingman Community Hospital
state: Kansas
city: Liberal
country: United States
facility: Southwest Medical Center
state: Kansas
city: McPherson
country: United States
facility: McPherson Center for Health
state: Kansas
city: Newton
country: United States
facility: Newton Medical Center
state: Kansas
city: Parsons
country: United States
facility: Labette Health
state: Kansas
city: Pratt
country: United States
facility: Pratt Regional Medical Center
state: Kansas
city: Salina
country: United States
facility: Cancer Center of Kansas - Salina
state: Kansas
city: Wichita
country: United States
facility: Cancer Center of Kansas - Wichita
state: Kansas
city: Wichita
country: United States
facility: Cancer Center of Kansas
state: Kansas
city: Winfield
country: United States
facility: Winfield Healthcare Center
state: Kansas
city: Louisville
country: United States
facility: Norton Cancer Institute-Downtown
state: Kentucky
city: Louisville
country: United States
facility: Norton Cancer Institute-Norton Healthcare Pavilion
state: Kentucky
city: Louisville
country: United States
facility: University of Louisville-James Graham Brown Cancer Center
state: Kentucky
city: Louisville
country: United States
facility: Baptist Health Louisville; Consultants in Blood Disorders and Cancer
state: Kentucky
city: Louisville
country: United States
facility: Norton Cancer Institute-St Matthews
state: Kentucky
city: Louisville
country: United States
facility: Norton Cancer Institute-Brownsboro
state: Kentucky
city: Kenner
country: United States
facility: Ochsner Medical Center-Kenner
state: Louisiana
city: Marrero
country: United States
facility: West Jefferson Medical Center Cancer Center
state: Louisiana
city: New Orleans
country: United States
facility: University Medical Center New Orleans
state: Louisiana
city: New Orleans
country: United States
facility: Ochsner Medical Center
state: Louisiana
city: Baltimore
country: United States
facility: Greater Baltimore Medical Center
state: Maryland
city: Baltimore
country: United States
facility: Medstar Union Memorial Hospital
state: Maryland
city: Baltimore
country: United States
facility: Harry and Jeanette Weinberg Cancer Center at Franklin Square
state: Maryland
city: Bethesda
country: United States
facility: Maryland Oncology Hematology
state: Maryland
city: Brandywine
country: United States
facility: Maryland Oncology - Hematology Brandywine
state: Maryland
city: Columbia
country: United States
facility: Maryland Oncology - Hematology PA
state: Maryland
city: Frederick
country: United States
facility: Maryland Oncology - Hematology Frederick
state: Maryland
city: Hagerstown
country: United States
facility: Meritus Center for Clinical Research
state: Maryland
city: Lanham
country: United States
facility: Maryland Oncology - Hematology PA
state: Maryland
city: Rockville
country: United States
facility: Maryland Oncology Hematology
state: Maryland
city: Silver Spring
country: United States
facility: Capital Hematology Oncology Associates
state: Maryland
city: Silver Spring
country: United States
facility: Holy Cross Hospital
state: Maryland
city: Towson
country: United States
facility: University of Maryland, St. Joseph Medical Center
state: Maryland
city: Wheaton
country: United States
facility: Maryland Oncology Hematology
state: Maryland
city: Pittsfield
country: United States
facility: Berkshire Hematology Oncology Services at Berkshire Medical Center Cancer and Infusion Center
state: Massachusetts
city: Brownstown
country: United States
facility: Henry Ford Cancer Institute Brownstown
state: Michigan
city: Clinton Township
country: United States
facility: Henry Ford Cancer Institute Macomb Hospital
state: Michigan
city: Dearborn
country: United States
facility: Henry Ford Medical Center Fairlane
state: Michigan
city: Detroit
country: United States
facility: Henry Ford Hospital
state: Michigan
city: East Lansing
country: United States
facility: Michigan State University
state: Michigan
city: Jackson
country: United States
facility: Henry Ford Allegiance Health
state: Michigan
city: Lansing
country: United States
facility: Michigan State University-Breslin Cancer Center
state: Michigan
city: Novi
country: United States
facility: Henry Ford Medical Center Columbus
state: Michigan
city: West Bloomfield
country: United States
facility: Henry Ford Hospital W Bloomfield
state: Michigan
city: Wyandotte
country: United States
facility: Henry Ford Cancer Institute Wyandotte Hospital
state: Michigan
city: Columbia
country: United States
facility: University of Missouri-Ellis Fischel Cancer Center
state: Missouri
city: Newark
country: United States
facility: Newark Beth Israel Medical Center
state: New Jersey
city: Voorhees
country: United States
facility: MD Anderson Cancer Center at Cooper
state: New Jersey
city: Albany
country: United States
facility: New York Oncology Hematology PC
state: New York
city: Binghamton
country: United States
facility: Broome Oncolgy
state: New York
city: Johnson City
country: United States
facility: Broome Oncology
state: New York
city: Poughkeepsie
country: United States
facility: Health Quest Medical Practice
state: New York
city: Poughkeepsie
country: United States
facility: Vassar Brothers Medical Center
state: New York
city: Cary
country: United States
facility: RHOA of Cary
state: North Carolina
city: Cary
country: United States
facility: Waverly Hematology Oncology
state: North Carolina
city: Charlotte
country: United States
facility: Carolinas Medical Center-Levine Cancer Insitute
state: North Carolina
city: Charlotte
country: United States
facility: Levine Cancer Center Institute Pineville
state: North Carolina
city: Garner
country: United States
facility: RHOA of Garner
state: North Carolina
city: High Point
country: United States
facility: UNC Regional Physicians Hematology and Oncolgoy
state: North Carolina
city: Pinehurst
country: United States
facility: FirstHealth of the Carolinas FirstHealth Outpatient Cancer Center
state: North Carolina
city: Raleigh
country: United States
facility: Rex Cancer Center
state: North Carolina
city: Raleigh
country: United States
facility: RHOA of Blue Ridge
state: North Carolina
city: Raleigh
country: United States
facility: RCC of Wakefield
state: North Carolina
city: Rocky Mount
country: United States
facility: Nash UNC Health Care - Danny Talbott Cancer Center
state: North Carolina
city: Fargo
country: United States
facility: Sanford Roger Maris Cancer Center
state: North Dakota
city: Alliance
country: United States
facility: Aultman Alliance Cancer Center
state: Ohio
city: Canton
country: United States
facility: Aultman Hospital
state: Ohio
city: Canton
country: United States
facility: Aultman Medical Group Hematology and Oncology
state: Ohio
city: Columbus
country: United States
facility: The Ohio State University Wexner Medical Center-Investigational Drug Service Oncology
state: Ohio
city: Columbus
country: United States
facility: The Stephanie Speilman Comprehensive Breast Center
state: Ohio
city: Eugene
country: United States
facility: Willamette Valley Cancer Institute and Research Center
state: Oregon
city: Portland
country: United States
facility: Kaiser Permanente Northwest-Oncology/Hematology
state: Oregon
city: Tigard
country: United States
facility: Northwest Cancer Specialists
state: Oregon
city: Beaver
country: United States
facility: UPMC Hillman Cancer Center-Beaver
state: Pennsylvania
city: Cranberry Township
country: United States
facility: UPMC Hillman Cancer Center - Passavant North
state: Pennsylvania
city: Ephrata
country: United States
facility: Ephrata Cancer Center
state: Pennsylvania
city: Erie
country: United States
facility: Allegheny Cancer Institute St. Vincent
state: Pennsylvania
city: Erie
country: United States
facility: St. Vincent Hospital
state: Pennsylvania
city: Farrell
country: United States
facility: UPMC Cancer Center Horizon
state: Pennsylvania
city: Gettysburg
country: United States
facility: Wellspan Medical Oncology
state: Pennsylvania
city: Greensburg
country: United States
facility: UPMC Hillman Cancer Center- Mountain View
state: Pennsylvania
city: Greenville
country: United States
facility: UPMC Cancer Center Greenville
state: Pennsylvania
city: Jefferson Hills
country: United States
facility: AHN Cancer Institute at Jefferson
state: Pennsylvania
city: Lebanon
country: United States
facility: Seechler Family Cancer Center
state: Pennsylvania
city: Monroeville
country: United States
facility: Forbes Regional Hospital
state: Pennsylvania
city: Monroeville
country: United States
facility: UPMC Hillman Cancer Center UPMC East-Monroeville
state: Pennsylvania
city: N. Huntingdon
country: United States
facility: UPMC Hillman Cancer Center Norwin
state: Pennsylvania
city: New Castle
country: United States
facility: UPMC Hillman Cancer Center New Castle
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Allegheny General Hospital
state: Pennsylvania
city: Pittsburgh
country: United States
facility: WPAON at AGH
state: Pennsylvania
city: Pittsburgh
country: United States
facility: WPAON at WPH
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Magee-Women's Hospital of Pittsburgh
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Western Pennsylvania Hospital
state: Pennsylvania
city: Pittsburgh
country: United States
facility: UPCI Investigational Drug Services
state: Pennsylvania
city: Pittsburgh
country: United States
facility: UPMC Hillman Cancer Center @ Passavant - HOA
state: Pennsylvania
city: Pittsburgh
country: United States
facility: UPMC Hillman Cancer Center @ Passavant - OHA
state: Pennsylvania
city: Pittsburgh
country: United States
facility: UPMC Hillman Cancer Center-Upper Saint Clair
state: Pennsylvania
city: Seneca
country: United States
facility: UPMC Cancer Center Northwest
state: Pennsylvania
city: Uniontown
country: United States
facility: UPMC Hillman Cancer Center - Uniontown
state: Pennsylvania
city: Washington
country: United States
facility: UPMC Hillman Cancer Center-Washington
state: Pennsylvania
city: Wexford
country: United States
facility: Wexford Health & Wellness Pavilion
state: Pennsylvania
city: York
country: United States
facility: Cancer Care Associates of York
state: Pennsylvania
city: York
country: United States
facility: Wellspan Health-York Cancer Center Oncology Research
state: Pennsylvania
city: Providence
country: United States
facility: Women's and Infants Hospital
state: Rhode Island
city: Greer
country: United States
facility: Gibbs Cancer Center and Research Institute - Pelham
state: South Carolina
city: Spartanburg
country: United States
facility: Spartanburg Medical Center
state: South Carolina
city: Sioux Falls
country: United States
facility: Sanford Cancer Center Oncology Clinic
state: South Dakota
city: Sioux Falls
country: United States
facility: Avera Cancer Institute-Sioux Falls
state: South Dakota
city: Sioux Falls
country: United States
facility: Avera Cancer Institute
state: South Dakota
city: Johnson City
country: United States
facility: Wellmont Cancer Institute
state: Tennessee
city: Kingsport
country: United States
facility: Wellmont Cancer Institute
state: Tennessee
city: Austin
country: United States
facility: Dell Seton Medical Center at the University of Texas-Seton Infusion Center
state: Texas
city: Bedford
country: United States
facility: Texas Oncology Bedford
state: Texas
city: Carrollton
country: United States
facility: Texas Oncology Carrollton
state: Texas
city: Dallas
country: United States
facility: Texas Oncology - Methodist Dallas Cancer Center
state: Texas
city: Dallas
country: United States
facility: Texas Oncology - Medical City Dallas
state: Texas
city: Dallas
country: United States
facility: Texas Oncology Dallas Presbyterian Hospital
state: Texas
city: Denton
country: United States
facility: Texas Oncology Denton
state: Texas
city: Flower Mound
country: United States
facility: Texas Oncology Flower Mound
state: Texas
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
city: Houston
country: United States
facility: Houston Methodist Cancer Center
state: Texas
city: Houston
country: United States
facility: Harris Health System-Smith Clinic
state: Texas
city: McAllen
country: United States
facility: Texas Oncology - McAllen South Second
state: Texas
city: Midland
country: United States
facility: Texas Oncology Midland Allison Cancer Center
state: Texas
city: Plano
country: United States
facility: Texas Oncology Plano
state: Texas
city: The Woodlands
country: United States
facility: Texas Oncology - The Woodlands
state: Texas
city: Bristol
country: United States
facility: Wellmont Medical Associates-Oncology and Hematology
state: Virginia
city: Leesburg
country: United States
facility: Virginia Cancer Care Specialist
state: Virginia
city: Lynchburg
country: United States
facility: Centra Lynchburg Hematology Oncology
state: Virginia
city: Mechanicsville
country: United States
facility: Bon Secours Richmond Community Hospital Medical Oncology Associates at Memorial Regional Medical Center
state: Virginia
city: Midlothian
country: United States
facility: Bon Secours St Francis Medical Center
state: Virginia
city: Norton
country: United States
facility: Southwest Virginia Regional Cancer Center
state: Virginia
city: Richmond
country: United States
facility: Bon Secours Richmond Community Hospital Oncology Associates at St. Mary's Hospital
state: Virginia
city: Auburn
country: United States
facility: MRCC Auburn
state: Washington
city: Gig Harbor
country: United States
facility: MRCC Gig Harbor
state: Washington
city: Puyallup
country: United States
facility: MRCC Puyallup
state: Washington
city: Tacoma
country: United States
facility: MultiCare Health System
state: Washington
city: Tacoma
country: United States
facility: MultiCare Institute for Research & Innovation
state: Washington
city: Charleston
country: United States
facility: CAMC Health Education and Research Institute
state: West Virginia
city: Morgantown
country: United States
facility: West Virginia University
state: West Virginia
city: Burlington
country: United States
facility: Aurora Cancer Care-Southern Lakes
state: Wisconsin
city: Fond Du Lac
country: United States
facility: Aurora Health Center Fond du Lac
state: Wisconsin
city: Germantown
country: United States
facility: Aurora Cancer Care-Germantown Health Center
state: Wisconsin
city: Grafton
country: United States
facility: Aurora Cancer Care-Grafton
state: Wisconsin
city: Green Bay
country: United States
facility: Aurora BayCare Medical Center
state: Wisconsin
city: Kenosha
country: United States
facility: Aurora Cancer Care-Kenosha South
state: Wisconsin
city: Milwaukee
country: United States
facility: Aurora Cancer Care
state: Wisconsin
city: Milwaukee
country: United States
facility: Aurora Cancer Care-Milwaukee South
state: Wisconsin
city: Milwaukee
country: United States
facility: Aurora St. Lukes Medical Center-Pharmacy Only
state: Wisconsin
city: Milwaukee
country: United States
facility: Aurora West Allis Medical Center
state: Wisconsin
city: Milwaukee
country: United States
facility: Aurora Sinai Medical Center
state: Wisconsin
city: Oshkosh
country: United States
facility: Vince Lombardi Cancer Clinic Oshkosh
state: Wisconsin
city: Racine
country: United States
facility: Aurora Cancer Care-Racine
state: Wisconsin
city: Sheboygan
country: United States
facility: Vince Lombardi Cancer Clinic Sheboygan
state: Wisconsin
city: Summit
country: United States
facility: Aurora Medical Center in Summit
state: Wisconsin
city: Two Rivers
country: United States
facility: Vince Lombardi Cancer Clinic-Two Rivers
state: Wisconsin
city: Wauwatosa
country: United States
facility: Aurora Cancer Care
state: Wisconsin
city: Montréal
country: Canada
facility: CIUSSS de l'Est-de-l'Ile-de-Montreal-Hopital-Maisonneuve-Rosemont
state: Quebec
city: Montréal
country: Canada
facility: Centre Hospitalier d'Universite de Montreal CHUM-Hotel Dieu
state: Quebec
city: Montréal
country: Canada
facility: SMBD-Jewish General Hospital (MPSG)
state: Quebec
city: Montréal
country: Canada
facility: McGill University Health Centre-Cedars Cancer Centre
state: Quebec
city: Quebec City
country: Canada
facility: CHU de Quebec-Hospital du Saint-Sacrement
state: Quebec
Study officials:
affiliation: NSBP Foundation, Inc.
name: Norman Wolmark, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Perez-Garcia J, Soberino J, Racca F, Gion M, Stradella A, Cortes J. Atezolizumab in the treatment of metastatic triple-negative breast cancer. Expert Opin Biol Ther. 2020 Sep;20(9):981-989. doi: 10.1080/14712598.2020.1769063. Epub 2020 May 25.