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


Phase 2
18 Years
70 Years
Not Enrolling
Female
Metastatic Breast Cancer

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Trial Information

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


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).

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Response rate

Outcome Time Frame:

one year after last patient in

Principal Investigator

Volker Heinemann, PhD, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Munich - Klinikum Grosshadern

Authority:

Germany: Federal Institute for Drugs and Medical Devices

Study ID:

Gemcitabin 02 MC

NCT ID:

NCT00480597

Start Date:

October 2002

Completion Date:

Related Keywords:

  • Metastatic Breast Cancer
  • gemcitabine
  • vinorelbine
  • cisplatin
  • capecitabine
  • pretreated metastatic breast cancer
  • Breast Neoplasms

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