_

• Register: EUCTR
• Last refreshed on: 4 April 2022
• Main ID: EUCTR2015-000580-14-FR
• Date of registration: 22/06/2015
• Prospective Registration: No
• Primary sponsor: UNICANCER
• Public title: _
• Scientific title: A single arm, open-label, phase II study to assess the efficacy of rucaparib in metastatic breast cancer patients with a BRCAness genomic signature. - RUBY
• Date of first enrolment: 12/05/2015
• Target sample size: 41
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2015-000580-14
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: no Open: no Single blind: no Double blind: no Parallel group: no Cross over: no Other: yes Other trial design description: Simon two-stage design If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: yes Other specify the comparator: No comparator Number of treatment arms in the trial: 1
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no

Countries of recruitment

France

Contacts

• Name: Marta JIMENEZ
• Affiliation: UNICANCER

• Name: Marta JIMENEZ
• Affiliation: UNICANCER

Key inclusion & exclusion 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:
1. BRCA1 or 2 germline known mutation.
2. Life expectancy < 3 months.
3. Less than 14 days from radiotherapy (whatever the indication). Fields should not have involved all target lesions.
4. Patients previously treated with a PARP inhibitor.
5. Spinal cord compression and/or symptomatic or progressive brain metastases (unless asymptomatic or treated and stable off steroids for at least 30 days prior to start of study drug).
6. Patients with all target lesions in a previously irradiated region, except if clear progression has been observed prior to study in at least one of them
7. Inability to swallow
8. Major problem with intestinal absorption
9. Previous or current malignancies of other histologies within the last 5 years, with the exception of in situ carcinoma of the cervix, and adequately treated basal cell or squamous cell carcinoma of the skin.
10. Evidence of severe or uncontrolled systemic disease (active bleeding diatheses, or active Hepatitis B, C and HIV)
11. Previous history of myelodysplastic syndrome
12. History of hypersensitivity to active or inactive excipients of the rucaparib.
13. Toxicities of grade =2 from any previous anti-cancer therapy, with the exception of alopecia.
14. Altered haematopoietic or organ function, as indicated by the following criteria:
• Polynuclear neutrophils < 1.5 x 10^9/L
• Platelets < 100 x 10^9/L
• Haemoglobin < 90 g/L
• ALAT/ASAT > 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.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: no

Health Condition(s) or Problem(s) studied

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

Therapeutic area: Diseases [C] - Cancer [C04]

Intervention(s)

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

Primary Outcome(s)

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.

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 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

Secondary Outcome(s)

Secondary end point(s): - Efficacy assessments
- Exploratory assessments
- Safety

Timepoint(s) of evaluation of this end point: _

Secondary ID(s)

UC-0105/1501

Source(s) of Monetary Support

Laboratoire Clovis Oncology

Ethics review

Status: Approved
Approval date: 20/04/2015
Contact:

Results

• Results available: Yes
• Date Posted: 01/03/2022
• Date Completed: 09/01/2020
• URL: https://www.clinicaltrialsregister.eu/ctr-search/trial/2015-000580-14/results