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OpenTrials
Completed

NCT Number: NCT00270491

Capecitabine Associated With Weekly Paclitaxel in Metastatic Breast Cancer.

Tolerance and efficacy of administration of capecitabine 5 out of 7 days associated with weekly paclitaxel compared to the recommended treatment plan of weekly paclitaxel - capecitabine, in patients with metastatic breast cancer.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Hôpital HOTEL DIEU

Paris, 75004, France

About this study

The purpose of this study is to know if we can optimize in term of tolerance even of efficacy the plan of administration of weekly paclitaxel associated with capecitabine.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Femal patient aged > 18 years
  • Histologically proven breast adenocarcinoma
  • HER2 negative receptors
  • previously received first or second line chemotherapy for metastatic disease
  • previously treated with anthracycline and/or docetaxel in adjuvant and/or as first or second line therapy
  • presence of one or several evaluable metastatic lesion(s)
  • presence of at least one target lesion not previously irradiated
  • previously treated with hormonotherapy in adjuvant or in metastatic line (treatment will be ceased upon patient registration in the study)
  • ECOG Performance status < 2
  • adequate biological values
  • patient who has clearly given her consent by signing on informed consent form prior to participation

Exclusion criteria

  • patient previously treated with paclitaxel or capecitabine for metastatic breast cancer
  • patient with only local metastatic disease (with the exception of axillary lymph nodes)
  • active symptomatic brain metastasis
  • patient with an history of significant cardiovascular impairment (congestive heart failure> NYHA grade II, unstable angina or myocardial infraction within the past six months or serious cardiac arrhythmia)
  • peripheric neuropathy grade ≥ 2
  • history of another malignancy within past 5 years that could confound diagnosis or staging of breast cancer (with the exception of in situ cacinoma of the cervix or adequately treated basel cell carcinoma of the skin)
  • patient with any medical or psychiatric condition that, in the opinion of the Principal Investigator, would preclude her from participating in this study
  • patient with a known allergy to one or several of the study compounds
  • patients who may not be regularly available due to geographical, social or family reasons
  • history of renal, hepatic or metabolic pathology that could preclude with metabolism or elimination of the study product
  • deficiencies of the upper intestinal tract, malabsorption syndrome
  • patient who is pregnant, breast-feeding or using inadequate contraception

Treatment and study plan

paclitaxel

Drug

Capecitabine

Drug

Primary outcomes

  1. tolerance of the patients in the both groups.

Secondary outcomes

  1. - Response rates and duration of response.

  2. - Haematological and non-haematological toxicities.

  3. - Progression free survival.

  4. - Overall survival.

Sponsors and collaborators

Lead sponsor

ARCAGY/ GINECO GROUP

Other

Registry information

Official study title

A Multicenter Randomized Phase II Study Evaluating Tolerance and Efficacy of Capecitabine 5/7 Days With Weekly Paclitaxel Versus the Recommended Treatment Plan of Weekly Paclitaxel-capecitabine, in Patients With Metastatic Breast Cancer.

Important dates

Study start
2005
Primary completion
2009
Study completion
2010
First posted
Dec 28, 2005
Registry last updated
Feb 25, 2011

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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