Combination Chemotherapy With or Without Trastuzumab in Treating Patients With Stage II or Stage III Breast Cancer
This study is ongoing, but not recruiting participants.
Sponsor:
City of Hope Medical Center
Collaborator:
Information provided by (Responsible Party):
City of Hope Medical Center
ClinicalTrials.gov Identifier:
NCT00295893
First received: February 23, 2006
Last updated: September 12, 2012
Last verified: September 2012
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Purpose
RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Monoclonal antibodies, such as trastuzumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Giving combination chemotherapy with or without trastuzumab before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. It is not yet known whether combination chemotherapy is more effective with or without trastuzumab in treating breast cancer.
PURPOSE: This randomized phase II trial is comparing two different regimens of combination chemotherapy given together with or without trastuzumab to see how well they work in treating patients with stage II or stage III breast cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Breast Cancer |
Biological: trastuzumab Drug: carboplatin Drug: cyclophosphamide Drug: docetaxel Drug: doxorubicin hydrochloride Drug: paclitaxel |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Randomized Phase II Study of Docetaxel, Adriamycin, and Cytoxan (TAC) Versus Adriamycin/Cytoxan, Followed by Abraxane/Carboplatin (ACAC) +/- Trastuzumab as Neoadjuvant Therapy for Patients With Stage II-III Breast Cancer |
Resource links provided by NLM:
Genetics Home Reference related topics:
breast cancer
Drug Information available for:
Cyclophosphamide
Doxorubicin
Doxorubicin hydrochloride
Paclitaxel
Carboplatin
Docetaxel
Trastuzumab
U.S. FDA Resources
Further study details as provided by City of Hope Medical Center:
Primary Outcome Measures:
- Complete response rate [ Time Frame: At the time of surgery within 4 weeks of the end of chemotherapy ] [ Designated as safety issue: No ]
- Feasibility [ Time Frame: At the time of surgery within 4 weeks of the end of chemotherapy ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Quality of life and neuropathy assessment of prognostic and predictive markers as measured by FACT exploratory methods at 1 year [ Time Frame: 1 year post treatment ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 105 |
| Study Start Date: | September 2005 |
| Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Arm I
Patients receive doxorubicin hydrochloride IV, cyclophosphamide IV, and docetaxel IV on day 1. Treatment repeats every 21 days for 6 courses.
|
Drug: carboplatin
Given IV
Drug: cyclophosphamide
Given IV
Drug: docetaxel
Given IV
Drug: doxorubicin hydrochloride
Given IV
Drug: paclitaxel
Given IV
|
|
Experimental: Arm II
Patients receive doxorubicin hydrochloride IV and cyclophosphamide IV on day 1; treatment repeats every 2 weeks for 4 courses. Patients then receive carboplatin IV on day 1 and paclitaxel IV on days 1, 8, and 15; treatment with carboplatin and paclitaxel repeats every 4 weeks for 3 courses.
|
Drug: carboplatin
Given IV
Drug: cyclophosphamide
Given IV
Drug: doxorubicin hydrochloride
Given IV
Drug: paclitaxel
Given IV
|
|
Experimental: Arm III
Patients receive chemotherapy as in arm II. They also receive trastuzumab (Herceptin®) IV weekly, beginning with the first doses of paclitaxel and carboplatin.
|
Biological: trastuzumab
Given IV
Drug: carboplatin
Given IV
Drug: cyclophosphamide
Given IV
Drug: doxorubicin hydrochloride
Given IV
Drug: paclitaxel
Given IV
|
Detailed Description:
OBJECTIVES:
Primary
- Compare 2 neoadjuvant chemotherapy regimens (docetaxel, doxorubicin hydrochloride, and cyclophosphamide [TAC] vs doxorubicin and cyclophosphamide followed by paclitaxel and carboplatin [ACAC]), in terms of toxicities and effectiveness as defined by the pathological complete remission rate, in patients with non HER2/neu overexpressing stage II or III breast cancer.
- Evaluate the probability of achieving a pathological complete remission when adding trastuzumab (Herceptin®) to ACAC in the subset of patients with HER2/neu overexpressing stage II or III breast cancer.
Secondary
- Identify prognostic and predictive markers of outcome, recurrence, and targets of therapy.
OUTLINE: This is a randomized study. Patients with non HER2/neu overexpressing tumors are randomized to 1 of 2 treatment arms. Patients with HER2/neu overexpressing tumors are assigned to arm III.
- Arm I: Patients receive doxorubicin hydrochloride IV, cyclophosphamide IV, and docetaxel IV on day 1. Treatment repeats every 21 days for 6 courses.
- Arm II: Patients receive doxorubicin hydrochloride IV and cyclophosphamide IV on day 1; treatment repeats every 2 weeks for 4 courses. Patients then receive carboplatin IV on day 1 and paclitaxel IV on days 1, 8, and 15; treatment with carboplatin and paclitaxel repeats every 4 weeks for 3 courses.
- Arm III: Patients receive chemotherapy as in arm II. They also receive trastuzumab (Herceptin®) IV weekly, beginning with the first doses of paclitaxel and carboplatin.
Within 4 weeks after completion of chemotherapy with or without trastuzumab (Herceptin®), all patients undergo surgery.
PROJECTED ACCRUAL: A total of 105 patients will be accrued for this study.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
DISEASE CHARACTERISTICS:
Histologically proven infiltrating ductal or lobular breast carcinoma
- Stage II or III disease
- Inflammatory breast cancer allowed
- Hormone-receptor status not specified
PATIENT CHARACTERISTICS:
- ECOG performance status < 2
- Male or female
- Menopausal status not specified (for female patients)
- Absolute neutrophil count ≥ 1,500/mm^3
- Platelet count ≥ 100,000/mm^3
- Bilirubin normal (except for patient's with Gilbert's disease)
- Creatinine ≤ 1.2 mg/dL
- Creatinine clearance ≥ 70 mL/min
- Ejection fraction ≥ 50% on MUGA
- No neuropathy ≥ grade 1
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective nonhormonal contraception
No prior malignant disease within the past 5 years, excluding:
- Squamous cell or basal cell skin carcinoma
- Stage I or in situ cervical carcinoma
- No noninvasive (in situ) breast carcinoma within the past 5 years
PRIOR CONCURRENT THERAPY:
- At least 5 years since prior antiestrogen treatment for any indication other than breast cancer prevention (tamoxifen, raloxifene, or an aromatase inhibitor)
- No prior radiotherapy to the chest wall
Contacts and Locations More Information
Additional Information:
No publications provided
| Responsible Party: | City of Hope Medical Center |
| ClinicalTrials.gov Identifier: | NCT00295893 History of Changes |
| Other Study ID Numbers: | 05015, P30CA033572, CDR0000455631 |
| Study First Received: | February 23, 2006 |
| Last Updated: | September 12, 2012 |
| Health Authority: | United States: Food and Drug Administration United States: Institutional Review Board |
Keywords provided by City of Hope Medical Center:
|
inflammatory breast cancer stage II breast cancer stage IIIA breast cancer stage IIIB breast cancer stage IIIC breast cancer male breast cancer Paget disease of the breast with invasive ductal carcinoma invasive ductal breast carcinoma with predominant intraductal component |
invasive ductal breast carcinoma medullary ductal breast carcinoma with lymphocytic infiltrate comedo ductal breast carcinoma invasive lobular breast carcinoma with predominant in situ component invasive lobular breast carcinoma mucinous ductal breast carcinoma papillary ductal breast carcinoma tubular ductal breast carcinoma |
Additional relevant MeSH terms:
|
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Cyclophosphamide Docetaxel Trastuzumab Doxorubicin Carboplatin Paclitaxel Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs |
Pharmacologic Actions Antirheumatic Agents Therapeutic Uses Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Myeloablative Agonists Antibiotics, Antineoplastic Tubulin Modulators Antimitotic Agents Mitosis Modulators Antineoplastic Agents, Phytogenic |
ClinicalTrials.gov processed this record on May 22, 2013