Liposomal Doxorubicin and Docetaxel in Metastatic Breast Cancer

ARCAGY/ GINECO GROUP67 enrolled

Overview

Evaluation of safety and efficacy of a treatment associating Pegylated Liposomal Doxorubicin + Docetaxel 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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Metastatic Breast Cancer

Interventions

Pegylated liposomal doxorubicinDRUG

Caelyx 30 mg/m² day 1 every 3 weeks

DocetaxelDRUG

Taxotere 75 mg/m² day 2 every 3 weeks

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Hôpital HOTEL DIEU

Paris, France

Outcomes

Primary Outcomes

Non-progression rate after 6 cycles

Time frame: 6 months

Secondary Outcomes

tolerance and toxicity

Time frame: 6 months

Tumor response and duration

Time frame: 5 years

Time to Progression

Time frame: 5 years

Overall survival

Time frame: 5 years

Data from ClinicalTrials.gov

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