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This study examined docetaxel and trastuzumab, with or without carboplatin, in women with HER2-positive breast cancer. Female patients aged 18 to 75 with stage IIIB, IIIC, or IV HER2-positive breast cancer could take part. The study was carried out in Phase 3 and has been completed.
The summary above is a plain-language rendering of the official record. The original English title is shown for reference.
Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.
DISEASE CHARACTERISTICS:
* Histologically or cytologically confirmed adenocarcinoma of the breast
* Stage IIIB, IIIC, or IV
* HER2-positive
* Measurable or evaluable disease
* Patients with osteolytic bone lesions as only site of disease must have at least 2 lytic sites confirmed by bone x-ray, MRI, or CT scan
* None of the following are eligible as only manifestation of metastatic disease:
* Blastic bone metastases
* Mixed bone metastases
* Lymphangitic carcinomatosis
* Ascites
* Pleural/pericardial effusion
* Lymphangitis cutis/pulmonis
* Inflammatory breast disease
* Abdominal masses not confirmed and followed by imaging techniques
* Cystic lesions
* No prior or known concurrent clinical manifestation of brain or leptomeningeal involvement
* Hormone receptor status:
* Not specified
PATIENT CHARACTERISTICS:
Age
* 18 to 75
Sex
* Female
Menopausal status
* Pre- or post-menopausal
Performance status
* Karnofsky 60-100%
Life expectancy
* Not specified
Hematopoietic
* Neutrophil count at least 2,000/mm3
* Platelet count at least 100,000/mm3
* Hemoglobin at least 10 g/dL
Hepatic
* Bilirubin no greater than upper limit of normal (ULN)
* AST and ALT no greater than 5 times ULN
* Alkaline phosphatase no greater than 5 times ULN (unless due to bone metastases or any nonmalignant bone disease and in absence of liver disorders)
* AST and/or ALT greater than 1.5 times ULN AND alkaline phosphatase greater than 2.5 times ULN ineligible
Renal
* Creatinine no greater than 2 mg/dL
* Creatinine clearance at least 60 mL/min
Cardiovascular
* LVEF normal by MUGA or echocardiogram
* No myocardial infarction within the past year
* No unstable angina pectoris
* No documentation of congestive heart failure
* No concurrent grade 3 or 4 cardiovascular arrhythmia
* No poorly controlled hypertension (i.e., diastolic pressure greater than 100 mmHg)
Pulmonary
* No severe dyspnea due to complications of advanced malignancy
* No respiratory insufficiency requiring supplemental oxygen
Other
* No significant neurologic or psychiatric disorders (e.g., psychotic disorders, dementia, or seizures) that would preclude study
* No pre-existing sensory or motor neuropathy grade 2 or greater
* No other serious illness or medical condition
* No active uncontrolled infection
* No active peptic ulcer disease
* No unstable diabetes mellitus
* No other prior or concurrent malignancy except for:
* Curatively treated nonmelanoma skin cancer
* Carcinoma in situ of the cervix
* Other curatively treated cancer and disease free for at least 10 years
* No known allergic reactions to study drugs
* No contraindications for the use of corticosteroids
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy
* See Chemotherapy
* No prior trastuzumab (Herceptin) for locally advanced or metastatic disease
* Prior trastuzumab-containing regimen (except with taxane) as adjuvant or neoadjuvant therapy allowed provided relapse occurred at least 6 months after therapy
Chemotherapy
* No prior chemotherapy for locally advanced or metastatic disease or local recurrence
* No prior chemotherapy with anthracycline or anthracenedione regimens with cumulative doses of more than 360 mg/m2 of doxorubicin, 720 mg/m2 of epirubicin, or 72 mg/m2 of mitoxantrone
* No prior platinum-containing regimen as adjuvant or neoadjuvant chemotherapy
* At least 4 weeks since prior anthracyclines or anthracenediones
* Prior taxanes as adjuvant or neoadjuvant chemotherapy allowed provided relapse occurred at least 6 months after therapy
* Prior taxane with trastuzumab as adjuvant or neoadjuvant chemotherapy allowed provided relapse occurred at least 12 months after therapy
* No concurrent amifostine
Endocrine therapy
* Prior hormonal therapy in the adjuvant or metastatic setting allowed provided patient has progressive disease and therapy has stopped before study entry
* Concurrent chronic corticosteroids allowed if initiated more than 6 months before study entry and at a low dose (no greater than 20 mg methylprednisolone or equivalent)
* No concurrent raloxifene, tamoxifen, or other selective estrogen receptor modulators
* No concurrent hormonal therapy
Radiotherapy
* No prior radiotherapy to study lesion unless clear progression
* At least 4 weeks since prior radiotherapy (unless radiotherapy involved only a single field to treat a single metastatic bone lesion)
* Concurrent radiotherapy for palliative treatment allowed
Surgery
* Not specified
Other
* Recovered from prior antitumor therapy
* At least 30 days since prior experimental drugs
* No other concurrent experimental drugs
* No other concurrent anticancer therapy
* No concurrent bisphosphonates if osteolytic bone metastases are only site of disease
* If receiving concurrent bisphosphonates other than for bone metastases only, must have been started at least 3 months before study entry
* No concurrent primary prophylactic antibiotics
* No concurrent cardioprotectors (e.g., dexrazoxane)