Metastatic Breast Cancer
Conditions
Brief summary
Evaluation of safety and efficacy of a treatment associating Pegylated Liposomal Doxorubicin + Docetaxel in patients with metastatic breast cancer
Detailed 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.
Interventions
DRUGPegylated liposomal doxorubicin
Caelyx 30 mg/m² day 1 every 3 weeks
DRUGDocetaxel
Taxotere 75 mg/m² day 2 every 3 weeks
Sponsors
ARCAGY/ GINECO GROUP
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Non-progression rate after 6 cycles | 6 months |
Secondary
| Measure | Time frame |
|---|---|
| tolerance and toxicity | 6 months |
| Tumor response and duration | 5 years |
| Time to Progression | 5 years |
| Overall survival | 5 years |
Countries
France
Outcome results
None listed