Patients with progressing metastatic breast cancer pretreated with at least one line of chemotherapy at the metastatic setting. MedDRA version: 18.0 Level: LLT Classification code 10027475 Term: Metastatic breast cancer System Organ Class: 100000004864
Conditions
Interventions
Product Name: Rucaparib
Pharmaceutical Form: Tablet
INN or Proposed INN: RUCAPARIB
CAS Number: 283173-50-2
Concentration unit: mg milligram(s)
Concentration type: range
Concentration number: 120-300
Sponsors
UNICANCER
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Women with histologically proven breast cancer. 2. No Her2 over-expression. 3. Progressive metastatic disease previously treated with at least one line of chemotherapy at the metastatic setting. 4. Molecular analysis using the Affymetrix (CytoScan HD, SNP 6.0, or OncoScan) array available from the SAFIR02 protocol, or from other programs. 5. BRCAness profile as defined by the Clovis genomic signature or BRCA1/2 somatic mutation (without known germline BRCA). 6. Age = 18 years 7. WHO Performance Status 0/1 8. Presence of measurable target lesion according to RECIST criteria v1.1 9. Patients will have had at least a 21-day wash-out period from last chemotherapy or targeted therapy administration prior to inclusion and should have recover (grade =1) from all residual toxicities, excluding alopecia. 10. Potentially reproductive patients must agree to use an effective contraceptive method or practice adequate methods of birth control or practice complete abstinence while on treatment, and for at least 6 months after the last dose of study drug. 11. Women of childbearing potential must have a negative serum pregnancy test done within 14 days of enrollment and/or urine pregnancy test 72 hours prior to the administration of the study drug. 12. Women who are breastfeeding should discontinue nursing prior to the first dose of study drug and until 6 months after the last dose. 13. Provision of signed and dated, written informed consent prior to any study specific procedures, sampling and analyses 14. Patient with social insurance coverage. 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 21 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 20
Exclusion criteria
Exclusion criteria: 1. BRCA1 or 2 germline known mutation. 2. Life expectancy 2.5x ULN in the absence of or > 5x ULN in the presence of liver metastases • Bilirubin > 1.5xULN • Creatinine clearance =30 mL/min (measured or calculated by Cockroft and Gault formula 15. Women who are pregnant. 16. Patients using drugs that are known potent inhibitors or potent inducers of CYP1A2 or CYP3A4 are not eligible if those treatments cannot be substituted before inclusion 17. Any condition which in the Investigator’s opinion makes it undesirable for the subject to participate in the trial or which would jeopardize compliance with the protocol. 18. Individuals deprived of liberty or placed under the authority of a tutor.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the clinical benefit rate with rucaparib in previously treated patients with metastatic breast cancer with BRCAness profile (defined by Clovis genomic signature), and if it is significant, to assess the overall response rate.;Secondary Objective: • To evaluate progression free survival • To evaluate overall survival • To evaluate safety • To evaluate the predictive value of the BRCAness signature • To evaluate the prognosis value of the Clovis BRCAness genomic signature ;Primary end point(s): Tumor response assessments. According to a prespecified hierarchical sequential testing, if the statistical significance of the Clinical benefit rate is achieved, significance of the ORR will be investigated.;Timepoint(s) of evaluation of this end point: Tumor response assessments will be made by the investigators and performed at baseline and every 8 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Efficacy assessments - Exploratory assessments - Safety ;Timepoint(s) of evaluation of this end point: _ | — |
Countries
France
Contacts
Public ContactMarta JIMENEZ
UNICANCER
Outcome results
None listed