Study of Albumin-bound Paclitaxel (Abraxane) in Combination With Carboplatin and Herceptin in Patients With Advanced Breast Cancer
NCT ID: NCT00093145
Last Updated: 2019-11-25
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
32 participants
INTERVENTIONAL
2004-06-01
2008-10-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Phase II Lapatinib Plus Nab-Paclitaxel As First And Second Line Therapy In her2+ MBC
NCT00709761
Study Of Abraxane® And Carboplatin As First-Line Treatment For Triple Negative Metastatic Breast Cancer
NCT01207102
A Phase II Trial of Abraxane™ Given Weekly as a Single Agent in First-line Treatment of Metastatic Breast Cancer
NCT00251472
Phase 2 Study of ABT-869 in Combination With Paclitaxel Versus Paclitaxel Alone to Treat Metastatic Breast Cancer
NCT00645177
A Phase I/II Study of ABI-007 (Abraxane®, Nab®-Paclitaxel)and Vinorelbine in Patients With Stage IV (Metastatic) Breast Cancer
NCT00140140
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Albumin-bound paclitaxel, Carboplatin + Herceptin
Participants 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.
Albumin-bound paclitaxel
Administered by intravenous infusion.
Carboplatin
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.
Herceptin®
Administered by IV infusion
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Albumin-bound paclitaxel
Administered by intravenous infusion.
Carboplatin
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.
Herceptin®
Administered by IV infusion
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
18 Years
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Celgene
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Andrew Seidman, MD
Role: PRINCIPAL_INVESTIGATOR
Memorial Sloan Kettering Cancer Center
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Breastlink Med Group
Long Beach, California, United States
Hematology/Oncology P.C. Carl & Dorothy Bennet Cancer Center
Stamford, Connecticut, United States
Washington Hospital Center
Washington D.C., District of Columbia, United States
Lombardi Cancer Center Georgetown University Hospital
Washington D.C., District of Columbia, United States
Florida Cancer Institute
Hudson, Florida, United States
Gulf Coast Oncology Associates
St. Petersburg, Florida, United States
Palm Beach Cancer Institute
West Palm Beach, Florida, United States
Gerogia Cancer Specialist
Atlanta, Georgia, United States
Maine Center for Cancer Medicine and Blood Disorders
Scarborough, Maine, United States
Memorial Sloan-Kettering Cancer Center
New York, New York, United States
University of Pittsburgh Medical Center Magee Womens Hospital
Pittsburgh, Pennsylvania, United States
Rhode Island Hospital
Providence, Rhode Island, United States
Southwest Regional Cancer Center
Austin, Texas, United States
Swedish Medical Center Cancer Institute Research
Seattle, Washington, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CA016
Identifier Type: -
Identifier Source: org_study_id
NCT00085605
Identifier Type: -
Identifier Source: nct_alias
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.