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

This study has been completed.
Sponsor:
Information provided by:
Ludwig-Maximilians - University of Munich
ClinicalTrials.gov Identifier:
NCT00480597
First received: May 30, 2007
Last updated: October 27, 2010
Last verified: May 2007
History of Changes
  Purpose

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 Intervention Phase
Metastatic Breast Cancer
 Drug: gemcitabine
Drug: cisplatin
Drug: vinorelbine
Drug: capecitabine
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Ludwig-Maximilians - University of Munich:

Primary Outcome Measures:
  • Response rate [ Time Frame: one year after last patient in ]

Secondary Outcome Measures:
  • Time to progression [ Time Frame: one year after last patient in ]
  • Overall Survival [ Time Frame: one year after last patient in ]
  • Toxicity

Enrollment: 141
Study Start Date: October 2002
  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00480597

Sponsors and Collaborators
Ludwig-Maximilians - University of Munich
Investigators
Principal Investigator: Volker Heinemann, PhD, MD University of Munich - Klinikum Grosshadern
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00480597     History of Changes
Other Study ID Numbers: Gemcitabin 02 MC
Study First Received: May 30, 2007
Last Updated: October 27, 2010
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Ludwig-Maximilians - University of Munich:
gemcitabine
vinorelbine
cisplatin
capecitabine
pretreated metastatic breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Gemcitabine
Vinorelbine
Capecitabine
Cisplatin
Vinblastine
Fluorouracil
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
 Radiation-Sensitizing Agents
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Antineoplastic Agents, Phytogenic
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators

ClinicalTrials.gov processed this record on May 23, 2013