Health Condition 1: null- Breast Cancer Health Condition 2: C509- Malignant neoplasm of breast of unspecified site
Conditions
Interventions
Intervention1: SAR439281: Fixed-dose combination of Capecitabine and Cyclophosphamide
The three treatments in this study will be the following:
Cohort 1-Standard Regimen. Full-dose Pill (600/40): 1 B
Sponsors
SanofiSynthelabo India Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: Female >= 18 and 2. Patients with histologically or cytologically confirmed Metastatic Breast Cancer (HER2 negative, ER/PR positive or negative), who are candidates to receive capecitabine and cyclophosphamide as per investigatorâ??s judgment, and meet either one of the following characteristics: a. Recurrence of the disease following at least 2 lines of chemotherapy failure for metastatic triple negative breast cancer b. In ER/PR positive breast cancer, recurrence of the disease following at least 1 line of chemotherapy failure and 2 lines of hormonal therapy failure 3. Patients who have been previously treated with capecitabine can be recruited in the study provided : a) As per the Investigatorâ??s opinion, patients will benefit from this chemotherapy AND b) For prior single administration of capecitabine: at least 6 months has elapsed between last capecitabine treatment and initiation of study treatment. c) For prior capecitabine-based combination regimen: at least 12 months has elapsed between last capecitabine-based treatment and initiation of study treatment. 4. At least one uni-dimensionally measurable lesion according to RECIST criteria version 1.1 5. An Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1 or 2 6. Life expectancy of >3 months, 7. Patients who are willing to undergo (oral) chemotherapy for the treatment of their disease and who are expected to comply with the treatment and study procedures, as per the Investigatorâ??s judgment 8. For women of child bearing potential, documented negative pregnancy test and agreement to use acceptable birth control measures during the duration of the study therapy 9. Signed Informed consent obtained prior to any study related procedures
Exclusion criteria
Exclusion criteria: 1. Patients who are HER 2 positive 2. Patients with 3 or more lines of chemotherapy failure for metastatic triple negative breast cancer 3. In ER/PR positive breast cancer, recurrence of the disease following 2 or more lines of chemotherapy failure and/or 3 or more lines of hormonal therapy failure 4. Patients presenting with de novo stage IV metastatic breast cancer, not previously treated for their disease 5. Patients who have already received any metronomic chemotherapy regimen 6. Known hypersensitivity to capecitabine or to any of its components 7. Known hypersensitivity to 5-fluorouracil 8. Known hypersensitivity to cyclophosphamide or any of its components 9. History of bladder carcinoma 10. Systemic anticancer therapy (chemotherapy, hormone therapy or radiotherapy) within 4 weeks of randomization for the study 11. History of unexplained hematuria 12. History of dihydropyrimidine dehydrogenase (DPD) deficiency 13. Severe renal impairment (creatinine clearance below 30 mL/min [Cockroft and Gault]) 14. Concomitant warfarin treatment 15. History of significant cardiac disease (e.g. unstable angina, congestive heart failure, myocardial infarction, ventricular arrhythmias) within the previous 6 months 16. Conditions/situations such as: a. Patient is the Investigator or any Sub-Investigator, research assistant, pharmacist, Study co-ordinator, other staff, or relative thereof, directly involved in the conduct of the protocol b. Uncooperative Patient or any condition that could make the Patient potentially non-compliant to the study procedures 17. Pregnant or breast-feeding women 18. Women of childbearing potential not protected by effective contraceptive method of birth control and/or who are unwilling or unable to be tested for pregnancy. 19. Patients with a possibility of active tuberculosis as suggested by: a. Any signs or symptoms suggestive of active tuberculosis upon medical history or clinical examination b. Chest radiograph within 3 months prior to the screening visit consistent with tuberculosis infection c. Patients with close contact with a person with active tuberculosis 20. Known history of Human Immunodeficiency Virus (HIV) 21. Any other significant medical conditions which in the judgment of the Investigator would preclude completion of the study 22. Participation in a clinical research study evaluating another investigational drug or therapy within 30 days prior to the Screening Visit 23. Presence of any of the following laboratory abnormalities at the Screening Visit: a. Hemoglobin 8.5g/L b. WBC 3000/μL; c. platelet count 100 000/μL; d. Absolute neutrophil count (ANC) 1500/μL; e. AST or ALT 1.5 x ULN (or 5 x ULN in patients with liver metastasis) f. Total Bilirubin 1.5 X ULN (or 2 x ULN in patients with liver metastasis) 24. Patients with a body surface area (BSA) 1.0 m² or1.8 m² Total expected number of patients 36-54 patients
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients with adverse events [ Time Frame: 12 weeks ] [ Designated as safety issue: Y] Assessment of PK parameter: [ Time Frame: Daily 12 weeks ] [ Designated as safety issue: N] Timepoint: 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease Control Rate (DCR) [ Time Frame: 12 weeks ] [ Designated as safety issue: N] Objective Response Rate (ORR) [ Time Frame: 12 weeks ] [ Designated as safety issue: N] Time to Progression (TTP) [ Time Frame: 12 weeks ] [ Designated as safety issue: N] Proportion of patients compliant with treatment [ Time Frame: 12 weeks ] [ Designated as safety issue: N]Timepoint: 12 weeks | — |
Countries
India
Contacts
Public ContactMs Salini James
Sanofi-Synthelabo (India) Private Limited
Outcome results
None listed