Combination Chemotherapy and Trastuzumab in Treating Women With Metastatic Breast Cancer

• Status: Completed
• Trial end date: 2019-03-15
• Target enrollment: 0
• Participant gender: Female

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. Monoclonal antibodies such as trastuzumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells.

PURPOSE: Phase II trial to study the effectiveness of combining paclitaxel, carboplatin, and trastuzumab in treating women who have metastatic breast cancer that overexpresses HER2.

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

Details

• Lead Sponsor: Alliance for Clinical Trials in Oncology
• Collaborator: National Cancer Institute (NCI)
• Treatments: Albumin-Bound Paclitaxel; Carboplatin; Paclitaxel; Trastuzumab

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed metastatic adenocarcinoma of the breast

• Strong overexpression of HER-2 by immunohistochemistry (3+)

• 0-2+ tumors allowed if demonstrate amplification by FISH

• Bidimensionally measurable disease

• Brain metastasis must not represent sole site of disease

• No untreated brain metastasis receiving radiotherapy

• Previously treated brain metastases in continued response to radiotherapy and/or surgery for at least 2 months allowed

• Hormone receptor status:

• Positive or negative

PATIENT CHARACTERISTICS:

Age:

• 18 and over

Sex:

• Female

Menopausal status:

• Not specified

Performance status:

• ECOG 0-2

Life expectancy:

• At least 3 months

Hematopoietic:

• Absolute neutrophil count at least 1,500/mm^3

• Platelet count at least 100,000/mm^3

Hepatic:

• Bilirubin no greater than 1.5 mg/dL

• AST no greater than 3 times upper limit of normal (ULN) (5 times ULN if liver metastases present)

Renal:

• Creatinine no greater than 1.5 times ULN

Cardiovascular:

• No myocardial infarction within the past 6 months

• No congestive heart failure or unstable angina

• No clinically significant pericardial effusion or arrhythmia

Other:

• No other invasive malignancy within the past 5 years except curatively treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix

• No active uncontrolled infection

• No prior allergic reaction to Cremophor EL, anesthetics, or muscle relaxants

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• No concurrent filgrastim (G-CSF)

Chemotherapy:

• Prior adjuvant chemotherapy allowed

• Prior taxane therapy allowed

• No prior cisplatin or carboplatin

• No prior chemotherapy for metastatic disease

Endocrine therapy:

• Not specified

Radiotherapy:

• See Disease Characteristics

• No prior radiotherapy to more than 25% of marrow

• At least 4 weeks since prior radiotherapy

• No concurrent radiotherapy

Surgery:

• See Disease Characteristics

• At least 4 weeks since prior surgery and recovered

Other:

• At least 7 days since prior parenteral antibiotics