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 - ND

Phase 1

• Conditions: Patients with unresectable metastatic or locally recurrent breast cancer; MedDRA version: 8.1Level: PTClassification code 10055113Term: Breast cancer metastatic

• Registration Number: EUCTR2006-001139-23-IT
• Lead Sponsor: PIERRE FABRE PHARMA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2006-11-28
• Study Completion: 2011-06-30
• Last Update Posted: 21 December 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 994

Inclusion Criteria

Diagnosis and main inclusion criteria Inclusion criteria Patients must give written informed consent personally signed and dated before completing any study-related procedure which means assessment or evaluation that would not form part of the normal medical care of the patient. Women with histologically or cytologically confirmed carcinoma of the breast. Documented locally recurrent or metastatic disease not amenable to curative surgery or radiotherapy. Patients with either o HER-2 negative disease assessed by IHC 0-1 or FISH/CISH negative, on the primary tumour or on metastatic site. o HER-2 status unknown, provided that a tumour sample is available for retrospective review, if relevant. Patients must have received a prior adjuvant anthracycline based chemotherapy with or without a taxane or, if contraindicated, a non-anthracycline based chemotherapy with or without a taxane, as long as there has been more than a 12 months disease free interval from completion of the adjuvant chemotherapy. Prior hormone therapy is allowed both in the neoadjuvant and/or adjuvant setting and in the metastatic setting provided that there is documented progression of the disease and the treatment must be terminated prior to randomisation. Prior radiation therapy is allowed to 25 of the bone marrow but must be completed at least 4 weeks before randomisation Appendix 15 . Patients with measurable or non-measurable lesion using the RECIST guidelines. Estimated life expectancy 12 weeks. Karnofsky performance score 70 Appendix 3 . Age 18 and 75 years old. Adequate haematological function as defined by absolute neutrophil count ANC 1.5 x 109/L, platelet count 100x109/L and haemoglobin 10 g/dL within 7 days before first study treatment . Adequate hepatic function as defined by total bilirubin 1.5 x upper limit of normal ULN , AST and ALT 2.5 x ULN or 5 x ULN in case of liver metastases, alkaline phosphatase 5 x ULN within 7 days before first study treatment . Adequate renal function as defined by creatinine level within normal values or, in case of creatinine level ULN, calculated creatinine clearance 60 mL/min according to Cockroft-Gault formula within 7 days before first treatment administration . Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; these conditions should be assessed before randomisation ECG without clinically relevant abnormality within 7 days before first treatment administration . Women of childbearing potential must be using a medically accepted method of contraception i.e. oral contraceptives, intrauterine devices, condom to avoid pregnancy 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. Women of childbearing potential must have a negative serum or urine pregnancy test within 72 hours prior to first treatment administration.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Patients who have received previous chemotherapy for metastatic disease or progressed while on adjuvant chemotherapy or within 12 months from completion of adjuvant chemotherapy. Patients with known or with clinical evidence of brain metastasis or leptomeningeal involvement. Inflammatory breast cancer without evidence of metastatic disease. Patients who have received any other experimental or anti-cancer therapy within 30 days before randomisation except hormone therapy. Concurrent treatment with any other experimental or anti-cancer 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. Patients having as the sole tumour lesion, any of the following malignant effusion, lymphangitis, cystic lesion, bone lesion or any other lesion that is not assessed by imaging techniques or colour photography. Patients with pre-existing motor/sensory peripheral neuropathy of CTCAE version 3.0 grade 1. Prior therapy with gemcitabine and/or vinca alkaloids. History of severe hypersensitivity to vinca alkaloids and/or gemcitabine and/or taxanes or any contra indication to any of the study drugs. Pregnant or breast feeding women.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified