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

Metastatic Breast Cancer Clinical Trial

Official title:

Randomised, Multicenter Phase II Study in Patients With Metastatic Breast Cancer With Gemcitabine Plus Vinorelbine Versus Gemcitabine Plus Cisplatin Versus Gemcitabine Plus Capecitabine

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00480597
• Other study ID #: Gemcitabin 02 MC
• Status: Completed
• Phase: Phase 2
• First received: May 30, 2007
• Last updated: October 27, 2010
• Start date: October 2002

Study information

• Verified date: May 2007
• Source: Ludwig-Maximilians - University of Munich
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 141
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Neoplasms
• Metastatic Breast Cancer

Intervention

Drug:
• gemcitabine

• cisplatin

• vinorelbine

• capecitabine

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ludwig-Maximilians - University of Munich

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response rate		one year after last patient in
Secondary	Time to progression		one year after last patient in
Secondary	Overall Survival		one year after last patient in
Secondary	Toxicity