Phase III study of vinflunine plus gemcitabine versus paclitaxel plus gemcitabine in patients with unresectable, locally recurrent or metastatic breast cancer after prior anthracycline-based adjuvant chemotherapy

PIERRE FABRE MEDICAMENT0 sites994 target enrollmentJuly 13, 2006

DrugsGEMZAR TAXOL

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Not specified
Sponsor: PIERRE FABRE MEDICAMENT
Enrollment: 994
Status: Active, not recruiting
Last Updated: 14 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

July 13, 2006

End Date

TBD

Last Updated

14 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

Female

Investigators

Sponsor

PIERRE FABRE MEDICAMENT

Eligibility Criteria

Inclusion Criteria

•\- Patient must given written informed consent (personnaly dated and signed)
•\- Age between 18 and 75 years old
•\- Woman with histologically or cytologically confirmed carcinoma of the breast
•\- Woman of chilbearing potential must be using a medically accepted method of contraception to avoid pregancy during the 2 months preceding the start of study treatment, throughout the study period and for up to 3 months after the last dose of study treatment. Woman of childbearing potential must have a negative serum or urine pregnancy test within 72 hours prior to first treatment administration
•\-Documented locally recurrent or metastatic disease not amenable to curative surgery or radiotherapy.
•\- Patient with eiter HER\-2 negative disease assessed by IHC 0\-1\+ or FISH/CISH negative, on the primary tumour or on metastatic site, or HER\-2 status unknown, provided that a tumour sample is available for retrospective review, if relevant.
•\- Patient must have received a prior neo\-adjuvant and/or adjuvant anthracycline based chemotherapy ( or if contraindicated, a non\-anthracycline based chemotherapy) with or without a taxane. The disease free interval from completion of the prior chemotherapy must be more than 12 months.
•\- Prior hormone therapy is allowed either in the neoadjuvant and/or adjuvant setting and in the metastatic setting provided that there is a documented progression of the disease ant the treatment must be terminated prior to randomisation.
•\- Prior radiation therapy allowed to inferior25% of the bone marrow and must be completed at least 4 weeks before randomisation.
•\- Patient with measurable or non\-measurable lesion usong the RECIST guidelines.

Exclusion Criteria

•\- Patient having received previous chemotherapy for metastatic disease or having progressed while on adjuvant chemotherapy or within 12 months from completion of adjuvant chemotherapy.
•\- Patient with known or with clinical evidence of brain metastatic or leptomeningeal involment.
•\- Inflammatory breast cancer without evidence of metastatic disease.
•\- Patient having received any other experimental or anti\-cancer therapy within 30 days before randomisation, except hormone therapy
•\- History of second primary malignancy, except: bilateral breast carcinoma, in situ carcinoma of the cervix, adequately treated non melanomatous carcinoma of the skin, or other malignancy treated at least 5 years previously with no evidence of recurrence.
•\- Patient having as the sole tumour lesion, any of the following: malignant effusion, lymphangitis, cystic lesion, bone lesion and any other lesion that is not assessed by imaging techniques or colour photography.
•\- Patient with pre\-existing motor or sensory peripheral neuropathy of CTCAE version 3\.0 grade \>1\.
•\- History of severe hypersensitivity to vinca alkaloids and/or gemcitabine and/or taxanes or any contraindication to any of the study drugs.
•\- Pregnant or breast feeding woman.
•\- Patient who had a serious, concurrent uncontrolled medical disorder especially uncontrolled hypercalcaemia, congestive heart failure, uncontrolled high\-risk hypertension, arrhythmia, angina pectoris or previous history of myocardial infarction within 6 months prior to randomisation.