Randomized Phase III Trial of Herceptin® Followed by Chemotherapy Plus Herceptin® Versus the Combination of Herceptin® and Chemotherapy as Palliative Treatment in Patients With HER2- Overexpressing Advanced/Metastatic Breast Cancer.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Histologically confirmed HER2-overexpressing metastatic breast carcinoma
- Clinically or radiologically measurable or evaluable disease
- Bidimensionally or unidimensionally measurable lesions
- No ascitic, pleural, or pericardial effusions, osteoblastic bone metastases, or
carcinomatous lymphangitis of the lung as only indicator lesion
- No known clinical brain or meningeal involvement
- Hormone receptor status:
- Not specified
PATIENT CHARACTERISTICS:
Age:
- 18 to 70
Sex:
- Female
Menopausal status:
- Not specified
Performance status:
- ECOG 0-1 OR
- SAKK 0-1
Life expectancy:
- At least 12 weeks
Hematopoietic:
- Hemoglobin at least 10 g/dL
- Platelet count at least 100,000/mm^3
- Absolute neutrophil count at least 2,000/mm^3
Hepatic:
- Bilirubin normal
- SGOT and/or SGPT no greater than 2 times upper limit of normal (ULN) (3 times ULN if
proven liver metastases) OR
- No SGOT and/or SGPT greater than 1.5 times ULN if alkaline phosphatase greater than
2.5 times ULN
Renal:
- Creatinine no greater than 1.25 times ULN
Cardiovascular:
- LVEF normal
- No history of atrial ventricular arrhythmia, congestive heart failure, or angina
pectoris, even if medically controlled
- No history of second or third-degree heart blocks
- No uncontrolled hypertension
Other:
- Not pregnant or nursing
- Fertile patients must use effective contraception
- No pre-existing motor or sensory neuropathy grade 2 or greater
- No psychiatric disorder that would preclude informed consent
- No other prior malignancy except curatively treated nonmelanoma skin cancer or
carcinoma in situ of the cervix
- No definite contraindications for use of corticosteroids
- No other concurrent serious illness or medical condition
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- Prior adjuvant or neoadjuvant chemotherapy allowed
- No more than 2 prior chemotherapy regimens for metastatic disease
- No prior cumulative dose of doxorubicin greater than 240 mg/m^2
- No prior cumulative dose of epirubicin greater than 360 mg/m^2
- No prior taxanes
Endocrine therapy:
- Prior hormonal therapy as adjuvant treatment or for metastatic disease allowed
- No concurrent corticosteroids unless started more than 6 months prior to study and at
low doses (i.e., no greater than 20 mg methylprednisolone or equivalent)
Radiotherapy:
- Not specified
Surgery:
- Not specified
Other:
- No other concurrent anticancer drugs
- No other concurrent experimental drugs
- No concurrent bisphosphonates unless initiated more than 3 months prior to study
- Chronic use allowed provided bone metastases are not sole indicator lesions