Clinical trial NCT00093145: Study of Albumin-bound Paclitaxel (Abraxane) in Combination With Carboplatin and Herceptin in Patients With Advanced Breast Cancer
Official title: A Phase II Study of Weekly Dose-Dense Nanoparticle Paclitaxel (ABI-007), Carboplatin With Herceptin® As First-Line Therapy of Advanced HER-2 Positive Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Breast Cancer
Keywords: Advanced Breast Cancer
Lead sponsor: Celgene
Sponsor class: INDUSTRY
First posted: 2004-10-05
Enrollment: 32
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This trial will treat patients with advanced breast cancer with a new anti-cancer medicine used in combination with two existing anti-cancer medications: Albumin-bound paclitaxel (ABI-007), Carboplatin and Herceptin. Participants will be given the combination therapy on a weekly basis and may continue on therapy as long as their condition improves and drug toxicity is tolerated.


Eligibility criteria: Inclusion Criteria:

* Confirmed adenocarcinoma of the breast
* Tumor shows 3+ overexpression of the human epidermal growth factor receptor 2 (HER-2)/proto-oncogene by immunohistochemistry assay, or is fluorescence in situ hybridization (FISH)+
* Stage IV disease
* Measurable disease
* At least 3 weeks since prior cytotoxic chemotherapy
* At least 4 weeks since radiotherapy with full recovery
* At least 4 weeks since major surgery with full recovery
* Eastern Cooperative Oncology Group (ECOG) performance status 0-2
* At least 18 years old
* Absolute neutrophil count (ANC) at least 1.5 x 10\^9 cells/L
* Platelets at least 100 x 10\^9 cells/L
* Hemoglobin at least 9 g/dL
* Aspartame aminotransferase (AST), alanine aminotransferase (ALT) less than 2.5X upper limit normal
* Alkaline Phosphatase less than 1.5X upper limit normal
* Creatinine less than 1.5 gm/dL
* Normal left ventricular ejection fraction
* Negative pregnancy test
* Agree to use method to avoid pregnancy
* Informed Consent is obtained

Exclusion Criteria:

* Up to one regimen of prior neo-adjuvant or adjuvant chemotherapy is allowed. One year since Taxane and Herceptin treatment.
* Cumulative life-time dose of doxorubicin is greater than 360 mg/m\^2
* Concurrent immunotherapy or hormonal therapy
* Parenchymal brain metastases, if present, must be documented to be clinically and radiographically stable for at least 6 months after treatment
* Serious intercurrent medical or psychiatric illness, including serious active infection
* History of congestive heart failure
* History of other malignancy within the last 5 years which could affect the diagnosis or assessment of breast cancer
* Patients who have received an investigational drug within the previous 3 weeks
* Patient is currently enrolled in another clinical study receiving investigational therapies
* Pregnant or nursing women

Primary outcomes:
measure: Percentage of Participants Who Achieved an Objective Confirmed Complete or Partial Overall Response
timeFrame: Objective response was evaluated every 2 cycles, up to a maximum of 39 cycles (approximately 39 months)
Secondary outcomes:
measure: Percentage of Participants With a Total Response
timeFrame: Evaluated every 2 cycles, up to a maximum of 39 cycles.
measure: Time to Disease Progression
timeFrame: Assessed every 2 cycles, up to a maximum of 39 cycles.
measure: Duration of Response
timeFrame: Assessed every 2 cycles, up to a maximum of 39 cycles.
measure: Overall Patient Survival
timeFrame: From Day 1 until approximately 44 months.
measure: Number of Participants With Adverse Events (AEs)
timeFrame: Day 1 up to 39 cycles
Other outcomes:
Locations:
city: Long Beach
country: United States
facility: Breastlink Med Group
state: California
city: Stamford
country: United States
facility: Hematology/Oncology P.C. Carl & Dorothy Bennet Cancer Center
state: Connecticut
city: Washington
country: United States
facility: Washington Hospital Center
state: District of Columbia
city: Washington
country: United States
facility: Lombardi Cancer Center Georgetown University Hospital
state: District of Columbia
city: Hudson
country: United States
facility: Florida Cancer Institute
state: Florida
city: Saint Petersburg
country: United States
facility: Gulf Coast Oncology Associates
state: Florida
city: West Palm Beach
country: United States
facility: Palm Beach Cancer Institute
state: Florida
city: Atlanta
country: United States
facility: Gerogia Cancer Specialist
state: Georgia
city: Scarborough
country: United States
facility: Maine Center for Cancer Medicine and Blood Disorders
state: Maine
city: New York
country: United States
facility: Memorial Sloan-Kettering Cancer Center
state: New York
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center Magee Womens Hospital
state: Pennsylvania
city: Providence
country: United States
facility: Rhode Island Hospital
state: Rhode Island
city: Austin
country: United States
facility: Southwest Regional Cancer Center
state: Texas
city: Seattle
country: United States
facility: Swedish Medical Center Cancer Institute Research
state: Washington
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Andrew Seidman, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Conlin AK, Seidman AD, Bach A, Lake D, Dickler M, D'Andrea G, Traina T, Danso M, Brufsky AM, Saleh M, Clawson A, Hudis CA. Phase II trial of weekly nanoparticle albumin-bound paclitaxel with carboplatin and trastuzumab as first-line therapy for women with HER2-overexpressing metastatic breast cancer. Clin Breast Cancer. 2010 Aug 1;10(4):281-7. doi: 10.3816/CBC.2010.n.036.