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OpenTrials
Completed

NCT Number: NCT00524810

Liposomal Doxorubicin and Docetaxel in Metastatic Breast Cancer

Evaluation of safety and efficacy of a treatment associating Pegylated Liposomal Doxorubicin + Docetaxel in patients with metastatic breast cancer

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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 and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Hôpital HOTEL DIEU

Paris, 75004, France

About this study

Evaluation of safety and efficacy of a treatment associating Pegylated Liposomal Doxorubicin + Docetaxel in patients with metastatic breast cancer. Patients will receive pyridoxin to prevent cutaneo-mucinous toxicities.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • first metastatic chemo line
  • presence of measurable or bone lesion
  • at least one lesion outside the radiated areas
  • can have previously received hormonotherapy, chemotherapy in adjuvant phase, radiotherapy if older than 4 weeks

Exclusion criteria

  • only local tumoral progression
  • symptomatic cerebral metastasis
  • neuropathy > NCI-CTC 2
  • previous cancer within 10 years _ previous cancer within 10 years

Treatment and study plan

Pegylated liposomal doxorubicin

Drug

Caelyx 30 mg/m² day 1 every 3 weeks

Other names: Caelyx

docetaxel

Drug

Taxotere 75 mg/m² day 2 every 3 weeks

Other names: Taxotere

Primary outcomes

  1. Non-progression rate after 6 cycles

    Time frame: 6 months

Secondary outcomes

  1. tolerance and toxicity

    Time frame: 6 months

  2. Tumor response and duration

    Time frame: 5 years

  3. Time to Progression

    Time frame: 5 years

  4. Overall survival

    Time frame: 5 years

Sponsors and collaborators

Lead sponsor

ARCAGY/ GINECO GROUP

Other

Registry information

Official study title

A Multi-center Phase II Study Evaluating the Efficacy and Tolerance of the Association of Liposomal Doxorubicin and Docetaxel in First Line Chemotherapy in Patients With Metastatic Breast Cancer

Important dates

Study start
2004
Primary completion
2009
Study completion
2009
First posted
Sep 5, 2007
Registry last updated
Jun 30, 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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