Clinical trial NCT03499353: Talazoparib For Neoadjuvant Treatment Of Germline BRCA1/2 Mutation Patients With Early Human Epidermal Growth Factor Receptor 2 Negative Breast Cancer
Official title: A PHASE 2, NON RANDOMIZED, OPEN LABEL, SINGLE ARM, MULTI CENTER STUDY OF TALAZOPARIB FOR NEOADJUVANT TREATMENT OF GERMLINE BRCA1/2 MUTATION PATIENTS WITH EARLY HUMAN EPIDERMAL GROWTH FACTOR RECEPTOR 2 NEGATIVE BREAST CANCER
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Early Breast Cancer
Keywords: Neoadjuvant Therapy, HUMAN EPIDERMAL GROWTH FACTOR RECEPTOR 2 NEGATIVE Breast Cancer, BRCA Positive
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2018-04-17
Enrollment: 61
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: THIS IS AN OPEN LABEL SINGLE ARM STUDY
Primary purpose: TREATMENT

Brief summary: A PHASE 2, NON RANDOMIZED, OPEN LABEL, SINGLE ARM, MULTI CENTER STUDY OF TALAZOPARIB FOR NEOADJUVANT TREATMENT OF GERMLINE BRCA1/2 MUTATION PATIENTS WITH EARLY HUMAN EPIDERMAL GROWTH FACTOR RECEPTOR 2 NEGATIVE BREAST CANCER

Detailed description: TALAZOPARIB (PARP INHIBITOR) FOR NEOADJUVANT TREATMENT OF GERMLINE BRCA1/2 MUTATION PATIENTS WITH EARLY HUMAN EPIDERMAL GROWTH FACTOR RECEPTOR 2 NEGATIVE BREAST CANCER. THIS IS A MONOTHERAPY TREATMENT FOR 24 WKS FOLLOWED BY SURGERY TO EVALUATE PATHOLOGICAL COMPLETE RESPONSE.

Eligibility criteria: Inclusion Criteria:

* Germline BRCA 1/2 Mutation Positive
* Women and men at least 18 years of age or older.
* Histologically confirmed invasive adenocarcinoma of the breast
* HER2 negative breast cancer as defined by ASCO-CAP criteria
* Tumor greater than or equal toT1, N0-3
* No evidence of distant metastasis
* Adequate bone marrow, hepatic, and renal function
* ECOG performance status 0 or 1

Exclusion Criteria:

* Any other previous antitumor therapies for the current cancer event. Treatment for ductal carcinoma in situ (DCIS) is allowed; ie, surgery, hormonal therapy and radiation.
* Evidence of distant metastasis apparent prior to randomization
* Patients with inflammatory breast carcinoma
* Malignancy within the last 3 years, except: Stage 1 melanoma which does not require any further treatment after adequate surgical excision; adequately treated non melanoma skin cancer; Curatively treated in situ cancer of the cervix; Stage 1, Grade 1 endometrial carcinoma; or Adequately treated contralateral breast carcinoma which has been disease free for a year; Other solid tumors including lymphomas (without bone marrow involvement) curatively treated with no evidence of disease for 5 years.
* Previous or concomitant systemic anti cancer therapies used for the treatment of cancer in the last 3 years.
* Prior treatment with a PARP inhibitor in any disease setting
* Concomitant use of Strong P gp inhibitors or inducers or BCRP inhibitors
* Patients who are unwilling or unable to use a highly effective method of contraception as outlined in this protocol
* Major surgery within 14 days prior to study entry
* Known history of cardiac disease, for example : Myocardial infarction or symptomatic cardiac ischemia within 24 weeks before screening; Congestive heart failure New York Heart Association Class III or IV; History of clinically significant ventricular arrhythmias within one year prior to randomization; History of Mobitz II second degree or third degree heart block, uncontrolled hypertension.
* Active clinically significant infection
* Clinically significant bleeding diathesis or coagulopathy
* Non healing wound, ulcer or bone fracture
* Known hypersensitivity to any of the components of talazoparib
* Patients with myelodysplastic syndrome/acute myeloid leukemia
* Patients with uncontrolled seizures.
* Any evidence of other disease or any concomitant medical or psychiatric problems which in the opinion of the Investigator would prevent completion of treatment

Primary outcomes:
measure: Percentage of Participants Achieving Pathological Complete Response (pCR) as Per Independent Central Review (ICR) in Evaluable Analysis Set as Per ICR With 80% Confidence Interval (CI)
timeFrame: Date of surgery (maximum of approximately 8 months post-baseline) (assessed within a maximum of 6 weeks of last dose of talazoparib)
measure: Percentage of Participants Achieving pCR as Per ICR in Evaluable Analysis Set as Per ICR With 95% CI
timeFrame: Date of surgery (maximum of approximately 8 months post-baseline) (assessed within a maximum of 6 weeks of last dose of talazoparib)
Secondary outcomes:
measure: Percentage of Participants Achieving pCR as Per ICR in Intention-to-Treat (ITT) Analysis Set With 80% CI
timeFrame: Date of surgery (maximum of approximately 8 months post-baseline) (assessed within a maximum of 6 weeks of last dose of talazoparib)
measure: Percentage of Participants Achieving pCR as Per ICR in ITT Analysis Set With 95% CI
timeFrame: Date of surgery (maximum of approximately 8 months post-baseline) (assessed within a maximum of 6 weeks of last dose of talazoparib)
measure: Percentage of Participants Achieving pCR as Per Investigator in Evaluable Analysis Set as Per Investigator
timeFrame: Date of surgery (maximum of approximately 8 months post-baseline) (assessed within a maximum of 6 weeks of last dose of talazoparib)
measure: Percentage of Participants Achieving pCR as Per Investigator in ITT Analysis Set
timeFrame: Date of surgery (maximum of approximately 8 months post-baseline) (assessed within a maximum of 6 weeks of last dose of talazoparib)
measure: Percentage of Participants Achieving pCR in Breast Only as Per Investigator in Evaluable Analysis Set as Per Investigator
timeFrame: Date of surgery (maximum of approximately 8 months post-baseline) (assessed within a maximum of 6 weeks of last dose of talazoparib)
measure: Percentage of Participants Achieving pCR in Breast Only as Per Investigator in ITT Analysis Set
timeFrame: Date of surgery (maximum of approximately 8 months post-baseline) (assessed within a maximum of 6 weeks of last dose of talazoparib)
measure: Percentage of Participants Achieving pCR in Breast Only as Per ICR in Evaluable Analysis Set as Per ICR
timeFrame: Date of surgery (maximum of approximately 8 months post-baseline) (assessed within a maximum of 6 weeks of last dose of talazoparib)
measure: Percentage of Participants Achieving pCR in Breast Only as Per ICR in ITT Analysis Set
timeFrame: Date of surgery (maximum of approximately 8 months post-baseline) (assessed within a maximum of 6 weeks of last dose of talazoparib)
measure: Percentage of Participants With Residual Cander Burden (RCB) as Per ICR in Evaluable Analysis Set as Per ICR
timeFrame: Date of surgery (maximum of approximately 8 months post-baseline) (assessed within a maximum of 6 weeks of last dose of talazoparib)
measure: Percentage of Participants With RCB as Per ICR in ITT Analysis Set
timeFrame: Date of surgery (maximum of approximately 8 months post-baseline) (assessed within a maximum of 6 weeks of last dose of talazoparib)
measure: Probability of Being Event-Free at 3 Years in Evaluable Analysis Set
timeFrame: 3 years after surgery
measure: Probability of Being Alive at 3 Years in Evaluable Analysis Set
timeFrame: 3 years after first dose of talazoparib
measure: Probability of Being Alive at 3 Years in ITT Analysis Set
timeFrame: 3 years after first dose of talazoparib
measure: Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
timeFrame: Baseline to 28 days after the last dose of talazoparib (maximum of approximately 8 months)
measure: Number of Participants With Serious Adverse Events (SAEs)
timeFrame: Baseline to 28 days after the last dose of talazoparib (maximum of approximately 8 months)
measure: Number of Participants With TEAEs Leading to Permanent Discontinuation of Study Drug
timeFrame: Baseline to 28 days after the last dose of talazoparib (maximum of approximately 8 months)
measure: Number of Participants With TEAEs Leading to Temporary Discontinuation of Study Drug
timeFrame: Baseline to 28 days after the last dose of talazoparib (maximum of approximately 8 months)
measure: Number of Participants With TEAEs Leading to Dose Reduction of Study Drug
timeFrame: Baseline to 28 days after the last dose of talazoparib (maximum of approximately 8 months)
measure: Number of Participants With Laboratory Abnormalities
timeFrame: Baseline to 28 days after the last dose of talazoparib (maximum of approximately 8 months)
measure: Number of Participants With Hematology Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-Baseline
timeFrame: Baseline to 28 days after the last dose of talazoparib (maximum of approximately 8 months)
measure: Number of Participants With Chemistry Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-Baseline
timeFrame: Baseline to 28 days after the last dose of talazoparib (maximum of approximately 8 months)
measure: Trough Plasma Concentration (Ctrough) of Talazoparib in Cycles 2, 3 and 4 in PK Analysis Set
timeFrame: Pre-dose on Day 1 of Cycles 2, 3, 4
measure: Within-Participant Average Ctrough of Talazoparib at Steady State in PK Analysis Set
timeFrame: Pre-dose on Day 1 of Cycles 2, 3, 4
measure: Ctrough of Talazoparib in Cycles 2, 3 and 4 in Dose-Compliant PK Analysis Set
timeFrame: Pre-dose on Day 1 of Cycles 2, 3, 4
measure: Within-Participant Average Ctrough of Talazoparib at Steady State in Dose-Compliant PK Analysis Set
timeFrame: Pre-dosing on Day 1 of Cycles 2, 3, 4
measure: Number of Participants Who Achieved Definitive Deterioration in Global Health Status (GHS)/Quality of Life (QoL) Per European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire (EORTC QLQ-30)
timeFrame: Baseline to End of Treatment visit (assessed for maximum of 33 weeks)
measure: Kaplan-Meier Estimate of Time to Definitive Deterioration in GHS/QoL Per EORTC QLQ-30
timeFrame: Baseline to End of Treatment visit (assessed for maximum of 33 weeks)
measure: Probability of Not Achieving Definitive Deterioration in GHS/QoL Per EORTC QLQ-C30 at 3 and 6 Months
timeFrame: 3 months and 6 months post-baseline
measure: Number of Participants Who Achieved Definitive Deterioration in Nausea and Vomiting Symptoms Per EORTC QLQ-C30
timeFrame: Baseline to End of Treatment visit (assessed for maximum of 33 weeks)
measure: Kaplan-Meier Estimate of Time to Definitive Deterioration in Nausea and Vomiting Symptoms Per EORTC QLQ-C30
timeFrame: Baseline to End of Treatment visit (assessed for maximum of 33 weeks)
measure: Probability of Not Achieving Definitive Deterioration in Nausea and Vomiting Symptoms Per EORTC QLQ-C30 at 3 and 6 Months
timeFrame: 3 months and 6 months post-baseline
measure: Change From Baseline in Global QoL Per EORTC QLQ-C30
timeFrame: Baseline, Cycle 1 Day 15, Cycle 2 Day 1, Cycle 2 Day 15, Day 1 of Cycles 3-6, End of Treatment visit (maximum of 33 weeks) and Post-surgical follow-up visit (maximum of 41 weeks)
measure: Change From Baseline in Physical Functioning Per EORTC QLQ-C30
timeFrame: Baseline, Cycle 1 Day 15, Cycle 2 Day 1, Cycle 2 Day 15, Day 1 of Cycles 3-6, End of Treatment visit (maximum of 33 weeks) and Post-surgical follow-up visit (maximum of 41 weeks)
measure: Change From Baseline in Role Functioning Per EORTC QLQ-C30
timeFrame: Baseline, Cycle 1 Day 15, Cycle 2 Day 1, Cycle 2 Day 15, Day 1 of Cycles 3-6, End of Treatment visit (maximum of 33 weeks) and Post-surgical follow-up visit (maximum of 41 weeks)
measure: Change From Baseline in Emotional Functioning Per EORTC QLQ-C30
timeFrame: Baseline, Cycle 1 Day 15, Cycle 2 Day 1, Cycle 2 Day 15, Day 1 of Cycles 3-6, End of Treatment visit (maximum of 33 weeks) and Post-surgical follow-up visit (maximum of 41 weeks)
measure: Change From Baseline in Cognitive Functioning Per EORTC QLQ-C30
timeFrame: Baseline, Cycle 1 Day 15, Cycle 2 Day 1, Cycle 2 Day 15, Day 1 of Cycles 3-6, End of Treatment visit (maximum of 33 weeks) and Post-surgical follow-up visit (maximum of 41 weeks)
measure: Change From Baseline in Social Functioning Per EORTC QLQ-C30
timeFrame: Baseline, Cycle 1 Day 15, Cycle 2 Day 1, Cycle 2 Day 15, Day 1 of Cycles 3-6, End of Treatment visit (maximum of 33 weeks) and Post-surgical follow-up visit (maximum of 41 weeks)
measure: Change From Baseline in Fatigue Symptoms Per EORTC QLQ-C30
timeFrame: Baseline, Cycle 1 Day 15, Cycle 2 Day 1, Cycle 2 Day 15, Day 1 of Cycles 3-6, End of Treatment visit (maximum of 33 weeks) and Post-surgical follow-up visit (maximum of 41 weeks)
measure: Change From Baseline in Nausea and Vomiting Symptoms Per EORTC QLQ-C30
timeFrame: Baseline, Cycle 1 Day 15, Cycle 2 Day 1, Cycle 2 Day 15, Day 1 of Cycles 3-6, End of Treatment visit (maximum of 33 weeks) and Post-surgical follow-up visit (maximum of 41 weeks)
measure: Change From Baseline in Pain Symptoms Per EORTC QLQ-C30
timeFrame: Baseline, Cycle 1 Day 15, Cycle 2 Day 1, Cycle 2 Day 15, Day 1 of Cycles 3-6, End of Treatment visit (maximum of 33 weeks) and Post-surgical follow-up visit (maximum of 41 weeks)
measure: Change From Baseline in Dyspnoea Symptoms Per EORTC QLQ-C30
timeFrame: Baseline, Cycle 1 Day 15, Cycle 2 Day 1, Cycle 2 Day 15, Day 1 of Cycles 3-6, End of Treatment visit (maximum of 33 weeks) and Post-surgical follow-up visit (maximum of 41 weeks)
measure: Change From Baseline in Insomnia Symptoms Per EORTC QLQ-C30
timeFrame: Baseline, Cycle 1 Day 15, Cycle 2 Day 1, Cycle 2 Day 15, Day 1 of Cycles 3-6, End of Treatment visit (maximum of 33 weeks) and Post-surgical follow-up visit (maximum of 41 weeks)
measure: Change From Baseline in Appetite Loss Symptoms Per EORTC QLQ-C30
timeFrame: Baseline, Cycle 1 Day 15, Cycle 2 Day 1, Cycle 2 Day 15, Day 1 of Cycles 3-6, End of Treatment visit (maximum of 33 weeks) and Post-surgical follow-up visit (maximum of 41 weeks)
measure: Change From Baseline in Constipation Symptoms Per EORTC QLQ-C30
timeFrame: Baseline, Cycle 1 Day 15, Cycle 2 Day 1, Cycle 2 Day 15, Day 1 of Cycles 3-6, End of Treatment visit (maximum of 33 weeks) and Post-surgical follow-up visit (maximum of 41 weeks)
measure: Change From Baseline in Diarrhea Symptoms Per EORTC QLQ-C30
timeFrame: Baseline, Cycle 1 Day 15, Cycle 2 Day 1, Cycle 2 Day 15, Day 1 of Cycles 3-6, End of Treatment visit (maximum of 33 weeks) and Post-surgical follow-up visit (maximum of 41 weeks)
measure: Change From Baseline in Financial Difficulties Per EORTC QLQ-C30
timeFrame: Baseline, Cycle 1 Day 15, Cycle 2 Day 1, Cycle 2 Day 15, Day 1 of Cycles 3-6, End of Treatment visit (maximum of 33 weeks) and Post-surgical follow-up visit (maximum of 41 weeks)
measure: Change From Baseline in Body Image Per EORTC QLQ Breast Cancer Quality of Life Questionnaire (EORTC QLQ-BR23)
timeFrame: Baseline, Cycle 1 Day 15, Cycle 2 Day 1, Cycle 2 Day 15, Day 1 of Cycles 3-6, End of Treatment visit (maximum of 33 weeks) and Post-surgical follow-up visit (maximum of 41 weeks)
measure: Change From Baseline in Sexual Functioning Per EORTC QLQ-BR23
timeFrame: Baseline, Cycle 1 Day 15, Cycle 2 Day 1, Cycle 2 Day 15, Day 1 of Cycles 3-6, End of Treatment visit (maximum of 33 weeks) and Post-surgical follow-up visit (maximum of 41 weeks)
measure: Change From Baseline in Sexual Enjoyment Per EORTC QLQ-BR23
timeFrame: Baseline, Cycle 1 Day 15, Cycle 2 Day 1, Cycle 2 Day 15, Day 1 of Cycles 3-6, End of Treatment visit (maximum of 33 weeks) and Post-surgical follow-up visit (maximum of 41 weeks)
measure: Change From Baseline in Future Perspective Per EORTC QLQ-BR23
timeFrame: Baseline, Cycle 1 Day 15, Cycle 2 Day 1, Cycle 2 Day 15, Day 1 of Cycles 3-6, End of Treatment visit (maximum of 33 weeks) and Post-surgical follow-up visit (maximum of 41 weeks)
measure: Change From Baseline in Systemic Therapy Side Effects Per EORTC QLQ-BR23
timeFrame: Baseline, Cycle 1 Day 15, Cycle 2 Day 1, Cycle 2 Day 15, Day 1 of Cycles 3-6, End of Treatment visit (maximum of 33 weeks) and Post-surgical follow-up visit (maximum of 41 weeks)
measure: Change From Baseline in Breast Symptoms Per EORTC QLQ-BR23
timeFrame: Baseline, Cycle 1 Day 15, Cycle 2 Day 1, Cycle 2 Day 15, Day 1 of Cycles 3-6, End of Treatment visit (maximum of 33 weeks) and Post-surgical follow-up visit (maximum of 41 weeks)
measure: Change From Baseline in Arm Symptoms Per EORTC QLQ-BR23
timeFrame: Baseline, Cycle 1 Day 15, Cycle 2 Day 1, Cycle 2 Day 15, Day 1 of Cycles 3-6, End of Treatment visit (maximum of 33 weeks) and Post-surgical follow-up visit (maximum of 41 weeks)
measure: Change From Baseline in Upset by Hair Loss Per EORTC QLQ-BR23
timeFrame: Baseline, Cycle 1 Day 15, Cycle 2 Day 1, Cycle 2 Day 15, Day 1 of Cycles 3-6, End of Treatment visit (maximum of 33 weeks) and Post-surgical follow-up visit (maximum of 41 weeks)
measure: Number of Participants With Deterioration in Nausea/Vomiting Symptoms
timeFrame: Baseline, Cycle 1 Day 15, Cycle 2 Day 1, Cycle 2 Day 15, Day 1 of Cycles 3-6, End of Treatment visit (maximum of 33 weeks) and Post-surgical follow-up visit (maximum of 41 weeks)
measure: Number of Participants With Improvement in Nausea/Vomiting Symptoms
timeFrame: Baseline, Cycle 1 Day 15, Cycle 2 Day 1, Cycle 2 Day 15, Day 1 of Cycles 3-6, End of Treatment visit (maximum of 33 weeks) and Post-surgical follow-up visit (maximum of 41 weeks)
measure: Number of Participants With No Change in Nausea/Vomiting Symptoms
timeFrame: Baseline, Cycle 1 Day 15, Cycle 2 Day 1, Cycle 2 Day 15, Day 1 of Cycles 3-6, End of Treatment visit (maximum of 33 weeks) and Post-surgical follow-up visit (maximum of 41 weeks)
measure: Number of Participants With Missed Expected Menstrual Periods Per Patient Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
timeFrame: Baseline, Cycle 1 Day 15, Cycle 2 Day 1, Cycle 2 Day 15, Day 1 of Cycles 3-6, End of Treatment visit (maximum of 33 weeks) and Post-surgical follow-up visit (maximum of 41 weeks)
Other outcomes:
Locations:
city: Gilbert
country: United States
facility: Banner Gateway Medical Center
state: Arizona
city: Gilbert
country: United States
facility: Banner MD Anderson Cancer Center
state: Arizona
city: Fayetteville
country: United States
facility: Highlands Oncology Group
state: Arkansas
city: Rogers
country: United States
facility: Highlands Oncology Group
state: Arkansas
city: Camarillo
country: United States
facility: PMK Medical Group Inc., dba Ventura County Hematology Oncology Specialists
state: California
city: Duarte
country: United States
facility: City of Hope (City of Hope National Medical Center, City of Hope Medical Center)
state: California
city: Duarte
country: United States
facility: City of Hope Investigational Drug Services (IDS)
state: California
city: Glendale
country: United States
facility: The Oncology Institute of Hope & Innovation
state: California
city: Glendale
country: United States
facility: Glendale Adventist Medical Center
state: California
city: Long Beach
country: United States
facility: The Oncology Institute of Hope & Innovation
state: California
city: Orange
country: United States
facility: UC Irvine Health
state: California
city: Orange
country: United States
facility: UC Irvine Medical Center
state: California
city: Oxnard
country: United States
facility: PMK Medical Group Inc., dba Ventura County Hematology Oncology Specialists
state: California
city: Redlands
country: United States
facility: Emad Ibrahim, MD, INC.
state: California
city: Santa Ana
country: United States
facility: The Oncology Institute of Hope & Innovation
state: California
city: Stanford
country: United States
facility: Stanford Cancer Institute
state: California
city: Stanford
country: United States
facility: Stanford Hospital and Clinics
state: California
city: Stanford
country: United States
facility: Stanford Women's Cancer Center
state: California
city: Ventura
country: United States
facility: PMK Medical Group Inc., dba Ventura County Hematology Oncology Specialists
state: California
city: West Covina
country: United States
facility: The Oncology Institute of Hope & Innovation
state: California
city: Whittier
country: United States
facility: The Oncology Institute of Hope & Innovation
state: California
city: Whittier
country: United States
facility: ICRI
state: California
city: Aurora
country: United States
facility: Rocky Mountain Cancer Centers
state: Colorado
city: Boulder
country: United States
facility: Rocky Mountain Cancer Centers
state: Colorado
city: Colorado Springs
country: United States
facility: Rocky Mountain Cancer Centers
state: Colorado
city: Denver
country: United States
facility: Rocky Mountain Cancer Centers
state: Colorado
city: Denver
country: United States
facility: Rocky Mountain Cancer Centers
state: Colorado
city: Englewood
country: United States
facility: Rocky Mountain Cancer Centers
state: Colorado
city: Lakewood
country: United States
facility: Rocky Mountain Cancer Centers
state: Colorado
city: Littleton
country: United States
facility: Rocky Mountain Cancer Centers
state: Colorado
city: Lone Tree
country: United States
facility: Rocky Mountain Cancer Centers
state: Colorado
city: Longmont
country: United States
facility: Rocky Mountain Cancer Centers
state: Colorado
city: Parker
country: United States
facility: Rocky Mountain Cancer Centers
state: Colorado
city: Pueblo
country: United States
facility: Rocky Mountain Cancer Centers
state: Colorado
city: Thornton
country: United States
facility: Rocky Mountain Cancer Centers
state: Colorado
city: Aventura
country: United States
facility: Innovative Medical Research of South Florida, Inc
state: Florida
city: Atlanta
country: United States
facility: Grady Health System
state: Georgia
city: Atlanta
country: United States
facility: Emory University Hospital Midtown
state: Georgia
city: Atlanta
country: United States
facility: Emory University Hospital
state: Georgia
city: Atlanta
country: United States
facility: The Emory Clinic
state: Georgia
city: Atlanta
country: United States
facility: Winship Cancer Institute
state: Georgia
city: Atlanta
country: United States
facility: Emory Saint Joseph's Hospital
state: Georgia
city: Chicago
country: United States
facility: Rush University Medical Center, Professional Office Building Infusion Pharmacy
state: Illinois
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Oak Park
country: United States
facility: Rush Oak Park Hospital
state: Illinois
city: Jackson
country: United States
facility: University of Mississippi Medical Center
state: Mississippi
city: Berkeley Heights
country: United States
facility: Summit Medical Group
state: New Jersey
city: Florham Park
country: United States
facility: Summit Medical Group PA
state: New Jersey
city: Phillipsburg
country: United States
facility: St. Luke's Hospital - Warren Campus
state: New Jersey
city: Phillipsburg
country: United States
facility: St. Luke's Warren Physician Group
state: New Jersey
city: Portland
country: United States
facility: Northwest Cancer Specialists, P.C.
state: Oregon
city: Portland
country: United States
facility: Northwest Cancer Specialists, P.C.
state: Oregon
city: Tigard
country: United States
facility: Northwest Cancer Specialists, P.C.
state: Oregon
city: Allentown
country: United States
facility: St. Luke's Hematology Oncology Specialists
state: Pennsylvania
city: Allentown
country: United States
facility: St. Luke's Hospital - Allentown Campus
state: Pennsylvania
city: Bethlehem
country: United States
facility: St. Luke's Hematology Oncology Specialists
state: Pennsylvania
city: Bethlehem
country: United States
facility: St. Luke's Hospital - Bethlehem Campus
state: Pennsylvania
city: Coaldale
country: United States
facility: St. Luke's Hospital - Miners Campus
state: Pennsylvania
city: Easton
country: United States
facility: St Luke's Hospital - Anderson Campus
state: Pennsylvania
city: Easton
country: United States
facility: St. Luke's Hospital - Anderson Campus
state: Pennsylvania
city: Greensburg
country: United States
facility: UPMC Hillman Cancer Center Mountainview Arnold Palmer Pavilion
state: Pennsylvania
city: Monroeville
country: United States
facility: UPMC Cancer Centers East Oxford Drive
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Magee-Womens Hospital of UPMC
state: Pennsylvania
city: Pittsburgh
country: United States
facility: UPMC Hillman Cancer Center
state: Pennsylvania
city: Pittsburgh
country: United States
facility: UPMC Hillman Cancer Center North Hills at Passavant
state: Pennsylvania
city: Pittsburgh
country: United States
facility: UPMC Hillman Cancer Center UPMC Passavant
state: Pennsylvania
city: Quakertown
country: United States
facility: St. Luke's Hospital - Quakertown Campus
state: Pennsylvania
city: Stroudsburg
country: United States
facility: St. Luke's Hospital - Monroe Campus
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: Charleston
country: United States
facility: Charleston Hematology Oncology Associates, PA
state: South Carolina
city: Sioux Falls
country: United States
facility: Avera Cancer Institute
state: South Dakota
city: Sioux Falls
country: United States
facility: Avera Specialty Hospital
state: South Dakota
city: Knoxville
country: United States
facility: Brig Center for Cancer Care and Survivorship
state: Tennessee
city: Memphis
country: United States
facility: Baptist Cancer Center
state: Tennessee
city: Allen
country: United States
facility: Texas Oncology - Allen
state: Texas
city: Austin
country: United States
facility: Texas Oncology - Austin Midtown
state: Texas
city: Austin
country: United States
facility: Texas Oncology-Austin Central
state: Texas
city: Austin
country: United States
facility: Texas Oncology - South Austin
state: Texas
city: Dallas
country: United States
facility: Texas Oncology-Baylor Charles A. Sammons Cancer Center
state: Texas
city: Denton
country: United States
facility: Texas Oncology-Denton South
state: Texas
city: Houston
country: United States
facility: The University of Texas MD Anderson Cancer Center
state: Texas
city: Houston
country: United States
facility: The University of Texas MD Anderson Cancer Center
state: Texas
city: Houston
country: United States
facility: U.T. MD Anderson Cancer Center, Investigational Pharmacy Services - Unit 376
state: Texas
city: Houston
country: United States
facility: U.T. MD Anderson Cancer Center
state: Texas
city: Irving
country: United States
facility: US Oncology Investigational Products Center (IPC)
state: Texas
city: McKinney
country: United States
facility: Texas Oncology - McKinney
state: Texas
city: Round Rock
country: United States
facility: Texas Oncology - Round Rock
state: Texas
city: Chesapeake
country: United States
facility: Virginia Oncology Associates
state: Virginia
city: Hampton
country: United States
facility: Virginia Oncology Associates
state: Virginia
city: Newport News
country: United States
facility: Virginia Oncology Associates
state: Virginia
city: Norfolk
country: United States
facility: Virginia Oncology Associates
state: Virginia
city: Virginia Beach
country: United States
facility: Virginia Oncology Associates
state: Virginia
city: Vancouver
country: United States
facility: Northwest Cancer Specialists, P.C.
state: Washington
city: Vancouver
country: United States
facility: Northwest Cancer Specialists, P.C.
state: Washington
city: Madison
country: United States
facility: University of Wisconsin Clinical Science Center
state: Wisconsin
city: Madison
country: United States
facility: UW Health University Hospital - Pharmaceutical Research Center
state: Wisconsin
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: Litton JK, Scoggins ME, Hess KR, Adrada BE, Murthy RK, Damodaran S, DeSnyder SM, Brewster AM, Barcenas CH, Valero V, Whitman GJ, Schwartz-Gomez J, Mittendorf EA, Thompson AM, Helgason T, Ibrahim N, Piwnica-Worms H, Moulder SL, Arun BK. Neoadjuvant Talazoparib for Patients With Operable Breast Cancer With a Germline BRCA Pathogenic Variant. J Clin Oncol. 2020 Feb 10;38(5):388-394. doi: 10.1200/JCO.19.01304. Epub 2019 Aug 28.