Gemcitabine/Vinorelbine Versus Gemcitabine/Cisplatin Versus Gemcitabine/Capecitabine in Metastatic Breast Cancer

Phase 2

Completed

• Conditions: Metastatic Breast Cancer

• Registration Number: NCT00480597
• Lead Sponsor: Ludwig-Maximilians - University of Munich

Brief 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, 47 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 Gemcitabine 1000 mg/m2 d1, 8; Vinorelbine 25 mg/m2 d1, 8 q 3 weeks

Arm B Gemcitabine 1000 mg/m2 d1, 8; Cisplain 30 mg/m2 d1, 8 q 3 weeks

Arm C Gemcitabine 1000 mg/m2 d1, 8; Capecitabine 1650 mg/m2 oral d1-14 q 3 weeks

Detailed Description

Not available

Study Timeline

• Study Start: 2002-10
• Status Verified: 2007-05
• Study First Submitted: 2007-05-30
• Study First Submitted QC: 2007-05-30
• Study First Posted: 2007-05-31
• Last Update Submitted: 2010-10-27
• Last Update Posted: 2010-10-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 141

Inclusion Criteria

• Histologically confirmed metastatic breast cancer
• All patients were required to give written informed consent
• Only one prior chemotherapy for metastatic breast cancer was allowed. This clinical trial was designed to test the efficacy of a second-line chemotherapy.
• Antracycline-pretreatment during aduvant or palliative first line therapy
• Bidimensionally measurable lesion outside a previous radiation field.
• Age >= 18 years
• Karnofsky Performance status >= 70%
• Adequate heamatological, renal, cardiac and hepatic function
• No radiation of the measurable lesion during the study was allowed.

Exclusion Criteria

• Only bone metastases
• Active infection
• Previous treatment with one of the study drugs
• Application of other cytotoxic chemotherapy
• Insufficent renal function (creatinine clearance < 60ml/min)
• Known DPD deficiency
• clinically unstable brain metastasis
• pregancy or lactation
• other primary malignancies (other than carcinoma-in-situ of the cervix or adequately treated basal cell cancer of the skin).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Response rate	one year after last patient in

Secondary Outcome Measures

Name	Time	Method
Overall Survival	one year after last patient in
Toxicity
Time to progression	one year after last patient in