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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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Breast Diseases
Neoplasms
Neoplasms by Site
Skin Diseases
Capecitabine
Cisplatin
Fluorouracil
Gemcitabine
Vinorelbine
Anti-Infective Agents
Antimetabolites
Antimetabolites, Antineoplastic
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Antiviral Agents
Enzyme Inhibitors
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Radiation-Sensitizing Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014