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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

May 30, 2007
October 27, 2010
October 2002
Not Provided
Response rate [ Time Frame: one year after last patient in ]
Same as current
Complete list of historical versions of study NCT00480597 on ClinicalTrials.gov Archive Site
  • Time to progression [ Time Frame: one year after last patient in ]
  • Overall Survival [ Time Frame: one year after last patient in ]
  • Toxicity
Same as current
Not Provided
Not Provided
 
Gemcitabine/Vinorelbine Versus Gemcitabine/Cisplatin Versus Gemcitabine/Capecitabine in Metastatic Breast Cancer
Randomised, Multicenter Phase II Study in Patients With Metastatic Breast Cancer With Gemcitabine Plus Vinorelbine Versus Gemcitabine Plus Cisplatin Versus Gemcitabine Plus Capecitabine

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

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Metastatic Breast Cancer
  • Drug: gemcitabine
  • Drug: cisplatin
  • Drug: vinorelbine
  • Drug: capecitabine
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
141
Not Provided
Not Provided

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).
Female
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00480597
Gemcitabin 02 MC
Yes
Not Provided
Ludwig-Maximilians - University of Munich
Not Provided
Principal Investigator: Volker Heinemann, PhD, MD University of Munich - Klinikum Grosshadern
Ludwig-Maximilians - University of Munich
May 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP