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OpenTrials
Completed

NCT Number: NCT00480597

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

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

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Key information

Conditions

Metastatic Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Gemcitabine

Drug

Cisplatin

Drug

Vinorelbine

Drug

Capecitabine

Drug

Primary outcomes

  1. Response rate

    Time frame: one year after last patient in

Secondary outcomes

  1. Time to progression

    Time frame: one year after last patient in

  2. Overall Survival

    Time frame: one year after last patient in

  3. Toxicity

Sponsors and collaborators

Lead sponsor

Ludwig-Maximilians - University of Munich

Other

Registry information

Official study title

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

Important dates

Study start
2002
First posted
May 31, 2007
Registry last updated
Oct 28, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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