Study of Albumin-bound Paclitaxel (Abraxane) in Combination With Carboplatin and Herceptin in Patients With Advanced Breast Cancer
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
1 other identifier
interventional
32
1 country
14
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2 breast-cancer
Started Jun 2004
Typical duration for phase_2 breast-cancer
14 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2004
CompletedFirst Submitted
Initial submission to the registry
October 4, 2004
CompletedFirst Posted
Study publicly available on registry
October 5, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2008
CompletedResults Posted
Study results publicly available
July 17, 2013
CompletedNovember 25, 2019
November 1, 2019
4.3 years
October 4, 2004
May 7, 2013
November 13, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of Participants Who Achieved an Objective Confirmed Complete or Partial Overall Response
Percentage of participants who achieved an objective confirmed complete or partial overall response based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0. A complete response (CR) is the disappearance of all known disease and no new sites or disease related symptoms confirmed at least 4 weeks after initial documentation. A partial response (PR) is at least a 30% decrease in the sum of the longest diameters of target lesions, taking as a reference the baseline sum of the longest diameters confirmed at least 4 weeks after initial documentation. PR is also recorded when all measurable disease has completely disappeared, but a non-measurable component (i.e., ascites) is still present but not progressing, or with the persistence of one or more non-target lesions and/or the maintenance of tumor marker level above the normal limits.
Objective response was evaluated every 2 cycles, up to a maximum of 39 cycles (approximately 39 months)
Secondary Outcomes (5)
Percentage of Participants With a Total Response
Evaluated every 2 cycles, up to a maximum of 39 cycles.
Time to Disease Progression
Assessed every 2 cycles, up to a maximum of 39 cycles.
Duration of Response
Assessed every 2 cycles, up to a maximum of 39 cycles.
Overall Patient Survival
From Day 1 until approximately 44 months.
Number of Participants With Adverse Events (AEs)
Day 1 up to 39 cycles
Study Arms (1)
Albumin-bound paclitaxel, Carboplatin + Herceptin
EXPERIMENTALParticipants received albumin-bound paclitaxel, 100 mg/m\^2 weekly every 3 out of 4 weeks, carboplatin at an area under the curve (AUC) = 6 every 4 weeks and Herceptin weekly, 4 mg/kg the first week and 2 mg/kg on all subsequent weeks by intravenous (IV) infusion for up to 6 cycles in the absence of disease progression or intolerable toxicity. Participants could continue treatment with chemotherapy beyond 6 cycles at the discretion of the investigator, but Herceptin therapy was to continue to be administered weekly (2 mg/kg) until intercurrent illness, disease progression, unacceptable toxicity, patient withdrawal or administration of any non-protocol anti-cancer treatment.
Interventions
Administered by intravenous infusion.
Carboplatin dose was calculated using a modified Calvert formula (creatinine clearance was substituted for GFR): Total dose (mg) = (target AUC) x (creatinine clearance + 25). Note: AUC = 6 was initially targeted, but could be decreased due to toxicity.
Administered by IV infusion
Eligibility Criteria
You may qualify if:
- 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
- +4 more criteria
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Celgenelead
Study Sites (14)
Breastlink Med Group
Long Beach, California, 90806, United States
Hematology/Oncology P.C. Carl & Dorothy Bennet Cancer Center
Stamford, Connecticut, 06902, United States
Washington Hospital Center
Washington D.C., District of Columbia, 20010, United States
Lombardi Cancer Center Georgetown University Hospital
Washington D.C., District of Columbia, 2007, United States
Florida Cancer Institute
Hudson, Florida, 34667, United States
Gulf Coast Oncology Associates
St. Petersburg, Florida, 33705, United States
Palm Beach Cancer Institute
West Palm Beach, Florida, 33401, United States
Gerogia Cancer Specialist
Atlanta, Georgia, 30341, United States
Maine Center for Cancer Medicine and Blood Disorders
Scarborough, Maine, 04074, United States
Memorial Sloan-Kettering Cancer Center
New York, New York, 10021, United States
University of Pittsburgh Medical Center Magee Womens Hospital
Pittsburgh, Pennsylvania, 15213, United States
Rhode Island Hospital
Providence, Rhode Island, 02903, United States
Southwest Regional Cancer Center
Austin, Texas, 78705, United States
Swedish Medical Center Cancer Institute Research
Seattle, Washington, 98104, United States
Related Publications (1)
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.
PMID: 20705560RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Associate Director, Clinical Trials Disclosure
- Organization
- Celgene Corporation
Study Officials
- PRINCIPAL INVESTIGATOR
Andrew Seidman, MD
Memorial Sloan Kettering Cancer Center
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 4, 2004
First Posted
October 5, 2004
Study Start
June 1, 2004
Primary Completion
October 1, 2008
Study Completion
October 1, 2008
Last Updated
November 25, 2019
Results First Posted
July 17, 2013
Record last verified: 2019-11