A Study to Assess the Efficacy of Rucaparib in Metastatic Breast Cancer Patients With a BRCAness Genomic Signature

NCT02505048 | Completed Phase 2

• 1 other identifier: UC-0105/1501
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this study is to assess the efficacy of a PARP inhibitor, rucaparib, in progressing breast cancer patients and who are carrying a BCRAness profile defined by genomic signature or BRCA 1 or 2 somatic mutation, without known BRCA 1 or 2 germline mutation.

Conditions

Metastatic Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Clinical Benefit Rate

  according to RECIST, is either complete response (CR), partial response (PR) or stable disease (SD) lasting for at least 16 weeks

  3 years

Secondary Outcomes (4)

• Number of patients with complete response, partial response or stable disease

  3 years

• Progression free survival

  3 years

• Overall Survival

  3 years

• Number of patients experiencing an adverse event.

  toxicities will be assessed during the whole treatment period (6 months expected in average) followed by a 2-year post-treatment follow-up period

Study Arms (1)

rucaparib

EXPERIMENTAL

Tablets 200 mg and 300 mg per os : 600 mg / bid every day in continuous. Patients will be treated with rucaparib Cycles are defined in 28-day periods Disease response will be assessed every 8 weeks (RECIST 1.1) Safety will be assessed continuously

Drug: rucaparib

Interventions

rucaparib DRUG

600 mg bid per os , 28 day cycle, number of cycles: until progression or unacceptable toxicity develops.

rucaparib

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women with histologically proven breast cancer.
• No Her2 over-expression.
• Progressive metastatic disease previously treated with at least one line of chemotherapy at the metastatic setting.
• Molecular analysis using the Affymetrix (CytoScan HD, SNP 6.0, or OncoScan) array available from the SAFIR02 protocol, or from other programs.
• BRCAness profile as defined by the Clovis genomic signature or BRCA1/2 somatic mutation (without known germline BRCA).
• Age ≥ 18 years
• WHO Performance Status 0/1
• Presence of measurable target lesion according to RECIST criteria v1.1
• Potentially reproductive patients must agree to use an effective contraceptive non-hormonal 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.
• 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.
• Women who are breastfeeding should discontinue nursing prior to the first dose of study drug and until 6 months after the last dose.
• Provision of signed and dated, written informed consent prior to any study specific procedures, sampling and analyses
• Patient with social insurance coverage.

You may not qualify if:

• BRCA1 or 2 germline known mutation.
• Life expectancy \<3 months.
• Less than 14 days from radiotherapy (whatever the indication). Fields should not have involved all target lesions.
• Patients previously treated with a PARP inhibitor.
• 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).
• 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
• Inability to swallow
• Major problem with intestinal absorption
• 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.
• Evidence of severe or uncontrolled systemic disease (active bleeding diatheses, or active Hepatitis B, C and HIV)
• Previous history of myelodysplastic syndrome
• History of hypersensitivity to active or inactive excipients of the rucaparib.
• Toxicities of grade ≥2 from any previous anti-cancer therapy, with the exception of alopecia.
• Altered haematopoietic or organ function, as indicated by the following criteria:
• Polynuclear neutrophils \<1.5 x 10⁹/L

Sponsors & Collaborators

• UNICANCER: lead
• Clovis Oncology, Inc.: collaborator
• Fondation ARC: collaborator

Study Sites (2)

Centre Leon Berard

Lyon, France

Location

Institut Paoli Calmettes

Marseille, France

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

rucaparib

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Fabrice André, MD PhD

  Gustave Roussy Villejuif

  PRINCIPAL INVESTIGATOR

• Anne Patsouris, MD

  Institut de Cancerologie de l'Ouest Paul Papin

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 1, 2015
• First Posted: July 22, 2015
• Study Start: March 1, 2016
• Primary Completion: February 1, 2019
• Study Completion: December 1, 2019
• Last Updated: June 8, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will share

Locations

FR (2)