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

Sponsor

Ludwig-Maximilians - University of Munich (Other)

Overall Status

Completed

CT.gov ID

NCT00480597

Collaborator

(none)

141

Enrollment

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Metastatic Breast Cancer	Drug: gemcitabine Drug: cisplatin Drug: vinorelbine Drug: capecitabine	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

141 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Study Start Date :

Oct 1, 2002

Outcome Measures

Primary Outcome Measures

Response rate [one year after last patient in]

Secondary Outcome Measures

Time to progression [one year after last patient in]
Overall Survival [one year after last patient in]
Toxicity []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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).