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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


Phase 2
18 Years
N/A
Not Enrolling
Female
Metastatic Breast Cancer

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Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Non-progression rate after 6 cycles

Outcome Time Frame:

6 months

Safety Issue:

No

Principal Investigator

Laure CHAUVENET, MD, PHD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Hôpital HOTEL DIEU - Paris

Authority:

France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:

CAPYTTOLE

NCT ID:

NCT00524810

Start Date:

February 2004

Completion Date:

June 2009

Related Keywords:

  • Metastatic Breast Cancer
  • Breast Neoplasms

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