Combination Chemotherapy With or Without Trastuzumab in Treating Patients With Stage II or Stage III Breast Cancer
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Breast Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - 120 |
| Updated: | 11/2/2018 |
| Start Date: | September 14, 2005 |
| End Date: | January 2019 |
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
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.
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.
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.
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.
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
We found this trial at
1
site
Click here to add this to my saved trials
