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OpenTrials
Completed

NCT Number: NCT03887130

Study of Oral Vinorelbine Plus Capecitabine Versus Taxane-gemcitabine Combinations as 1st Line Chemotherapy in Metastatic Breast Cancer

The aim of this international open-label randomized phase II trial is to evaluate the efficacy and safety of an all-oral combination and two all-intravenous combinations as first-line therapy for HER2-negative mBC patients.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

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 adenocarcinoma of the breast;
  • Documented metastatic disease previously untreated by chemotherapy;
  • HER2 negative (assessed by 0-1+ IHC or 2+ IHC with FISH-) on the primary tumor or on metastatic site;
  • Karnofsky Performance Status 70%.

Exclusion criteria

  • Local relapse alone after conservative treatment or contra-lateral tumor;
  • Patients with symptoms suggesting CNS involvement or leptomeningeal metastases;
  • Concomitant hormonal therapy for metastatic breast cancer;
  • Prior chemotherapy in the metastatic setting;
  • Patients previously treated with a vinca-alkaloid, capecitabine, gemcitabine or taxanes;
  • Prior severe and unexpected reaction to fluoropyrimidine therapy (with or without documented DPD deficiency) or known hypersensitivity to 5-fluorouracil.

Treatment and study plan

ORAL VINORELBINE

Drug

Oral vinorelbine 60 mg/m² on day 1 & day 8, for cycle 1, and then 80 mg/m² on day 1 & day 8, every 3 weeks for subsequent cycles

Capecitabine

Drug

Capecitabine 1000 mg/m² twice a day (2000 mg/m² daily) from day 1 to day 14

Gemcitabine 1250 mg/m²

Drug

Gemcitabine 1250 mg/m² on day 1 & day 8

Gemcitabine 1000 mg/m²

Drug

Gemcitabine: 1000 mg/m² on day 1 & 8

paclitaxel

Drug

Paclitaxel 175 mg/m² on day 1

docetaxel

Drug

Docetaxel 75 mg/m² on day 1

Primary outcomes

  1. Disease Control Rate (DCR)

    Time frame: From Baseline to disease progression or death, up to 6 years

    Disease control rate (DCR) defined as the sum of complete response, partial response and stable disease for at least 3 months according to RECIST criteria version 1.1.

    Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI:

    Complete Response (CR)= Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions.

    Stable disease: no partial response or progression of the disease

Sponsors and collaborators

Lead sponsor

Pierre Fabre Medicament

Industry

Registry information

Official study title

Randomised Phase II Study of the Combination of Oral Vinorelbine With Capecitabine Versus Gemcitabine in Combination With Paclitaxel Versus Gemcitabine in Combination With Docetaxel as First Line Chemotherapy in Patients With Metastatic Breast Cancer

Important dates

Study start
2007
Primary completion
2013
Study completion
2013
First posted
Mar 22, 2019
Registry last updated
Apr 30, 2024

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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