Liposomal Doxorubicin and Docetaxel in Metastatic Breast Cancer

ARCAGY/ GINECO GROUP

Status and phase: Completed; Phase 2

Conditions: Metastatic Breast Cancer

Treatments: Drug: Docetaxel; Drug: Pegylated liposomal doxorubicin

Study type: Interventional

Funder types: Other

Identifiers

NCT00524810

CAPYTTOLE

Details and patient eligibility

About

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

Full 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.

Enrollment: 67 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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67 participants in 1 patient group

Caelyx - Taxotere

Experimental group

Treatment:

Drug: Pegylated liposomal doxorubicin

Drug: Docetaxel