Gemcitabine/Vinorelbine Versus Gemcitabine/Cisplatin Versus Gemcitabine/Capecitabine in Metastatic Breast Cancer
Information source: Ludwig-Maximilians - University of Munich
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Metastatic Breast Cancer
Intervention: gemcitabine (Drug); cisplatin (Drug); vinorelbine (Drug); capecitabine (Drug)
Phase: Phase 2
Status: Active, not recruiting
Sponsored by: Ludwig-Maximilians - University of Munich
Official(s) and/or principal investigator(s):
Volker Heinemann, PhD, MD, Principal Investigator, Affiliation: University of Munich - Klinikum Grosshadern
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
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.
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
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 design: Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Response rate
Time to progression
Minimum age: 18 Years.
Maximum age: 70 Years.
- 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.
- 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).
Locations and Contacts
Starting date: October 2002
Last updated: May 30, 2007