A Study to Assess the Efficacy of Rucaparib in Metastatic Breast Cancer Patients With a BRCAness Genomic Signature (RUBY)
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|ClinicalTrials.gov Identifier: NCT02505048|
Recruitment Status : Active, not recruiting
First Posted : July 22, 2015
Last Update Posted : February 26, 2019
|Condition or disease||Intervention/treatment||Phase|
|Metastatic Breast Cancer||Drug: rucaparib||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||41 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official 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|
|Actual Study Start Date :||March 2016|
|Actual Primary Completion Date :||February 2019|
|Estimated Study Completion Date :||December 2019|
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
600 mg bid per os , 28 day cycle, number of cycles: until progression or unacceptable toxicity develops.
- Clinical Benefit Rate [ Time Frame: 3 years ]according to RECIST, is either complete response (CR), partial response (PR) or stable disease (SD) lasting for at least 16 weeks
- Number of patients with complete response, partial response or stable disease [ Time Frame: 3 years ]complete response , partial response, or stable disease according to RECIST
- Progression free survival [ Time Frame: 3 years ]Progression free survival will be assessed from the time of the first dose to disease progression or death from any cause, whichever comes first.
- Overall Survival [ Time Frame: 3 years ]Overall survival will be assessed from the time of the first dose to death from any cause
- Number of patients experiencing an adverse event. [ Time Frame: toxicities will be assessed during the whole treatment period (6 months expected in average) followed by a 2-year post-treatment follow-up period ]Adverse events are graded according to the CTCAE V4.03
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02505048
|Centre Leon Berard|
|Institut Paoli Calmettes|
|Principal Investigator:||Fabrice André, MD PhD||Gustave Roussy Villejuif|
|Principal Investigator:||Anne Patsouris, MD||Institut de Cancerologie de l'Ouest Paul Papin|