Herceptin Followed by Chemotherapy in Treating Women With Metastatic Breast Cancer That Overexpresses HER2

• Status: Active, not recruiting
• Trial end date: 2024-07-01
• Target enrollment: 0
• Participant gender: Female

Summary

RATIONALE: To compare efficacy, toxicity and quality of life of the sequential administration of Her alone followed, at PD, by the combination with Chemotherapy (Arm A) vs. the upfront combination of Her and Chemotherapy (Arm B) in patients with advanced/metastatic breast cancer.

PURPOSE: Trial SAKK 22/99 addresses clinically relevant and currently unresolved questions regarding the optimal use of Herceptin in the treatment of patients with advanced/metastatic breast cancer.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Swiss Group for Clinical Cancer Research
• Treatments: Trastuzumab

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