Clinical Trials

 

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

Intervention Type: Drug, Biological
Study Type: Interventional
Sponsors: City of Hope Medical Center, National Cancer Institute (NCI)
Participants: 105
Abstract
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.
* Consult with your doctor before enrolling in clinical trials.
Facilities
City of Hope Medical Center
Duarte, United States of America
Eligibilities
Sex: All
Minimum Age: 18
Maximum Age: 120
Healthy Volunteers: No
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

View Article From Source