Docetaxel and Carboplatin With or Without Trastuzumab Before Surgery in Treating Women With Locally Advanced Breast Cancer
This study is ongoing, but not recruiting participants.
Sponsor:
Jonsson Comprehensive Cancer Center
Collaborators:
Aventis Pharmaceuticals
Genentech
Information provided by (Responsible Party):
Jonsson Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00068341
First received: September 10, 2003
Last updated: August 2, 2012
Last verified: August 2012
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Purpose
RATIONALE: Drugs used in chemotherapy, such as docetaxel and carboplatin, use different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies, such as trastuzumab, can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. It is not yet known whether docetaxel and carboplatin are more effective with or without trastuzumab in treating breast cancer.
PURPOSE: This randomized phase II trial is studying how well giving docetaxel together with carboplatin and trastuzumab before surgery works compared to docetaxel and carboplatin alone before surgery in treating women with locally advanced breast cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Breast Cancer |
Biological: trastuzumab Drug: carboplatin Drug: docetaxel |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Neoadjuvant Treatment and Molecular Characterization of Locally Advanced Breast Cancer |
Resource links provided by NLM:
Further study details as provided by Jonsson Comprehensive Cancer Center:
Primary Outcome Measures:
- Evaluate the objective response rate of patients treated with Taxotere/carboplatin with or without Herceptin preoperatively. [ Time Frame: 5 years ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Establish profiles of biomarkers that predict chemoresponsiveness of tumors, using methods for conventional pathology studies and experimental molecular analysis. [ Time Frame: 5 years ] [ Designated as safety issue: No ]
- To establish profiles of angiogenic mediators of locally advanced breast cancer and its impact in drug response and prognosis. [ Time Frame: 5 years ] [ Designated as safety issue: No ]
- Study the role of HER-2/neu and LRP/major vault protein in chemotherapy-induced tumor response [ Time Frame: 5 years ] [ Designated as safety issue: No ]
- Determine unique gene expression patterns of responder and nonresponder tumors to the prescribed neoadjuvant chemotherapy, using DNA-microarray hybridization techniques [ Time Frame: 5 years ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 75 |
| Study Start Date: | July 2003 |
| Estimated Primary Completion Date: | May 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Arm I (neoadjuvant therapy)
see intervention description
|
Drug: carboplatin
Cycle 1-8 Day 1 or 2 AUC = 6 IV
Drug: docetaxel
Cycle 1-8 Day 1 or 2: 75 mg/m2 IV
Other Name: Taxotere
Biological: trastuzumab
Cycle 1-4 pre-op Day 1 4mg/kg IV Day 8, 15 2mg/kg IV Cycle 5-7 post-op Day 1 4mg/kg IV Day 8, 15 2mg/kg IV Cycle 8 Day 1, 8, 15 2mg/kg IV Day 22 6mg/kg IV Other Name: Herceptin
|
|
Experimental: Arm II (neoadjuvant therapy)
please see intervention description
|
Biological: trastuzumab
Cycle 5-7 post-op only Day 1 4mg/kg IV Day 8, 15 2mg/kg IV Cycle 8 Cycle 8 Day 1, 8, 15 2mg/kg IV Day 22 6mg/kg IV
Other Name: Herceptin
Drug: carboplatin
Cycle 1-8 Day 1 or 2 AUC = 6 IV
Drug: docetaxel
Cycle 1-8 Day 1 or 2: 75 mg/m2 IV
Other Name: Taxotere
|
|
Experimental: HER2/neu negative patients
please see intervention description
|
Drug: carboplatin
Cycle 1-8 Day 1 or 2 AUC = 6 IV
Drug: docetaxel
Cycle 1-8 Day 1 or 2: 75 mg/m2 IV
Other Name: Taxotere
|
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Confirmed infiltrating adenocarcinoma of the breast
- Primary breast cancer > 5cm, or skin/chest wall involvement, any N, without evidence of metastasis.
- No prior radiation to the involved breast
- ECOG performance status 0-2
- Age 18 years to 80 years
- Absolute Neutrophil count > 1500 cell/μl, platelet count > 100000 cells/μl and hemoglobin > 9 g/dl
- All liver function tests < upper limit of normal
- Serum creatinine < 2.0 mg/dl
- Normal left ventricular ejection fraction (LVEF) as determined by MUGA scan or echocardiogram
- HER-2/neu status is determined by a FISH test. [FISH (+) is HER-2/neu (+)]
- If female of childbearing potential, pregnancy test is negative
- If premenopausal and not surgically sterilized, the patient agrees to use effective birth control method for the duration of the study
- Informed consent has been obtained
Exclusion Criteria:
- Non-confirmed infiltrating adenocarcinoma breast cancer
- Evidence of metastasis
- Previous chemotherapy using the drugs proposed in this study, specifically Herceptin®, Taxotere®, and/or Carboplatin
- Prior radiation to the involved breast
- Recent breast cancer drug therapy within last 5 years of any form
- History of allergy to polysorbate or castor oil
- Ongoing active infection
- Concurrent life-limiting disease with a life expectancy of less than one year
- Past or current history of other malignancy within the past 5 years which could affect the diagnosis or assessment of breast cancer, except for curatively treated non-melanoma skin cancer and/or in situ carcinoma of the cervix
- Pregnancy, nursing, fertile women who do not use birth control device
- Inability to give informed consent
- Patients with pre-existing peripheral neuropathy > grade 2
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00068341
Locations
| United States, Arkansas | |
| Arkansas Cancer Research Center at University of Arkansas for Medical Sciences | |
| Little Rock, Arkansas, United States, 72205 | |
| United States, California | |
| Jonsson Comprehensive Cancer Center at UCLA | |
| Los Angeles, California, United States, 90095-1781 | |
| USC/Norris Comprehensive Cancer Center and Hospital | |
| Los Angeles, California, United States, 90089-9181 | |
| Wilshire Oncology Medical Group, Incorporated - Pomona | |
| Pomona, California, United States, 91767-3021 | |
Sponsors and Collaborators
Jonsson Comprehensive Cancer Center
Aventis Pharmaceuticals
Genentech
Investigators
| Principal Investigator: | Helena R. Chang, MD, PhD | Jonsson Comprehensive Cancer Center |
More Information
Additional Information:
No publications provided
| Responsible Party: | Jonsson Comprehensive Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00068341 History of Changes |
| Other Study ID Numbers: | CDR0000321924, P30CA016042, UCLA-9911084, AVENTIS-GIA-11156, GENENTECH-H2269s |
| Study First Received: | September 10, 2003 |
| Last Updated: | August 2, 2012 |
| Health Authority: | United States: Federal Government United States: Food and Drug Administration United States: Institutional Review Board |
Keywords provided by Jonsson Comprehensive Cancer Center:
|
stage IIIA breast cancer stage IIIB breast cancer stage IIIC breast cancer stage II breast cancer |
Additional relevant MeSH terms:
|
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Docetaxel |
Trastuzumab Carboplatin Antineoplastic Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 19, 2013