Trastuzumab, Docetaxel, and Carboplatin in Treating Women With Stage II, Stage III, or Inflammatory Breast Cancer

• Status: Terminated
• Trial end date: 2008-12-01
• Target enrollment: 0
• Participant gender: Female

Summary

RATIONALE: 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. Drugs used in chemotherapy, such as docetaxel and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving trastuzumab together with docetaxel and carboplatin may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving trastuzumab together with docetaxel and carboplatin works in treating women with stage II, stage III, or inflammatory breast cancer.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Medicine and Dentistry of New Jersey
• Collaborators: Aventis Pharmaceuticals; National Cancer Institute (NCI)
• Treatments: Carboplatin; Docetaxel; Trastuzumab

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed breast cancer, meeting 1 of the following stage criteria:

• Stage IIB (T3, N0)

• Stage IIIA (N0-N2)

• Stage IIIB (T4, N0-2)

• Stage IIIC

• Inflammatory breast cancer

• HER2/neu-positive disease by fluorescence in situ hybridization

• Biopsy-accessible tumor

• Measurable disease by physical examination or x-ray

• No stage IV disease

• Hormone receptor status:

• Not specified

PATIENT CHARACTERISTICS:

Age

• 18 and over

Sex

• Female

Menopausal status

• Not specified

Performance status

• ECOG 0-2

Life expectancy

• At least 8 weeks

Hematopoietic

• Absolute neutrophil count ≥ 1,500/mm^3

• Platelet count ≥ 100,000/mm^3

Hepatic

• Meets 1 of the following criteria:

• SGOT and SGPT ≤ 5 times upper limit of normal (ULN) AND alkaline phosphatase normal

• SGOT and SGPT ≤ 1.5 times ULN AND alkaline phosphatase ≤ 2.5 times ULN

• SGOT and SGPT normal AND alkaline phosphatase ≤ 5 times ULN

• Bilirubin normal

Renal

• Creatinine normal

• No pre-existing clinically significant renal disease that is not related to the malignancy

Cardiovascular

• Ejection fraction ≥ 50% by MUGA

• No pre-existing clinically significant cardiac disease that is not related to the malignancy

• No history of congestive heart failure

Pulmonary

• No pre-existing clinically significant pulmonary disease that is not related to the malignancy

Gastrointestinal

• No severe malnutrition

• No intractable emesis

Neurologic

• No pre-existing clinically significant neurologic disease that is not related to the malignancy

• No peripheral neuropathy ≥ grade 2

• No nerve damage from diabetes

Other

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective non-hormonal contraception during and for 4 weeks after completion of study treatment

• No known allergic reaction to study drugs

• No active infection

• No other malignancy except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix

• No other pre-existing clinically significant disease that is not related to the malignancy

• No other serious or significant medical condition that would preclude study participation

• No other contraindication to study treatment

PRIOR CONCURRENT THERAPY:

Biologic therapy

• No other concurrent immunotherapy

Chemotherapy

• No prior chemotherapy for the malignancy

• No other concurrent chemotherapy

Endocrine therapy

• No concurrent hormonal therapy for the malignancy

Radiotherapy

• No concurrent radiotherapy

Surgery

• No concurrent surgery for the malignancy

Other

• More than 2 weeks since prior and no concurrent herbal remedies or aspirin-containing products

• No other concurrent investigational or commercial agents or therapies for the malignancy