Liposomal Doxorubicin and Docetaxel in Metastatic Breast Cancer

Metastatic Breast Cancer Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00524810
• Other study ID #: CAPYTTOLE
• Status: Completed
• Phase: Phase 2
• First received: September 3, 2007
• Last updated: June 29, 2011
• Start date: February 2004
• Est. completion date: June 2009

Study information

• Verified date: June 2011
• Source: ARCAGY/ GINECO GROUP
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 67
• Est. completion date: June 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Breast Neoplasms
• Metastatic Breast Cancer

Intervention

Drug:
• Pegylated liposomal doxorubicin
Caelyx 30 mg/m² day 1 every 3 weeks
• Docetaxel
Taxotere 75 mg/m² day 2 every 3 weeks

Locations

Country	Name	City	State
France	Hôpital HOTEL DIEU	Paris

Sponsors (1)

Lead Sponsor	Collaborator
ARCAGY/ GINECO GROUP

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Non-progression rate after 6 cycles		6 months	No
Secondary	tolerance and toxicity		6 months	Yes
Secondary	Tumor response and duration		5 years	No
Secondary	Time to Progression		5 years	No
Secondary	Overall survival		5 years	No