Vinorelbine/Gemcitabine Versus Vinorelbine/Cisplatin in Metastatic Breast Cancer

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: Female

Summary

Development of an active second-line treatment option for metastatic breast cancer patients previously pre-treated with anthracyclines and taxanes in neoadjuvant, adjuvant or palliative settings.For each randomisation arm, 100 patients will be included. The trial was performed as a 2-stage phase II study according to the optimal design by Simon with overall response rate as the primary objective.

Study Design:

Arm A Vinorelbine 25 mg/m2 d1, 8;Gemcitabine 1000 mg/m2 d1, 8 q 3 weeks Arm B Vinorelbine 25 mg/m2 d1, 8;Cisplatin 25 mg/m2 d1, 2,3 q 3 weeks

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

Details

• Lead Sponsor: Shandong Cancer Hospital and Institute
• Treatments: Cisplatin; Gemcitabine; Vinblastine; Vinorelbine

Criteria

Inclusion Criteria:

• Histologically confirmed metastatic breast cancer

• All patients were required to give written informed consent

• To have received a previous treatment with anthracyclines and taxanes

• Previous radiotherapy is allowed, whenever the radiated area is not the only disease location

• At least 4 weeks since the last previous antineoplastic treatment

• Patients must have recovered from all previous toxicities

• Karnofsky Performance status >= 70%

• Adequate hematological, renal, cardiac and hepatic function

• Life expectancy of at least 12 weeks

• Patients able to comply and to receive an adequate follow-up

Exclusion Criteria:

• Only bone metastases

• Active infection

• Previous treatment with one of the study drugs

• Application of other cytotoxic chemotherapy

• Insufficient renal function (creatinine clearance < 60ml/min)

• Clinically unstable brain metastasis

• Pregnancy or lactation

• Other primary malignancies (other than carcinoma-in-situ of the cervix or adequately treated basal cell cancer of the skin)

• Abnormal liver function (bilirubin > 2.0-fold upper normal limit (UNL); Alanine aminotransferase and aspartate aminotransferase >2.5-fold UNL). In patients with hepatic metastasis, a value of Alanine aminotransferase and aspartate aminotransferase of up to 5-fold UNL is permitted

• Males

• Second malignancy (except for cervix carcinoma in situ or skin carcinoma - no melanoma- with an adequate treatment). Previous malignancies are allowed if disease-free survival is superior to 5 years, except for renal carcinoma or melanoma