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

Ludwig Maximilian University of Munich

Status and phase

Completed

Phase 2

Conditions

Metastatic Breast Cancer

Treatments

Drug: cisplatin

Drug: capecitabine

Drug: gemcitabine

Drug: vinorelbine

Study type

Interventional

Funder types

Other

Identifiers

NCT00480597

Gemcitabin 02 MC

Details and patient eligibility

About

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

Enrollment

141 patients

Sex

Female

Ages

18 to 70 years old

Volunteers

No 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).