Metastatic Breast CancerPhase 2RUBYNCT02505048
A Study to Assess the Efficacy of Rucaparib in Metastatic Breast Cancer Patients With a BRCAness Genomic Signature
A Phase 2 study testing rucaparib in people with Metastatic Breast Cancer, run by UNICANCER at 2 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 years, women only
- Conditions the study is for
- Metastatic Breast Cancer
- What is being tested?
- rucaparib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 2 sitesFrance
- Study dates
- Mar 2016to Dec 2019
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 14Show fewer
- WHO Performance Status 0/1
- Presence of measurable target lesion according to RECIST criteria v1.1
- 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.
- 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.
Who cannot join
- 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
Show all 24Show fewer
- 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
- Platelets <100 x 10⁹/L
- Haemoglobin <90 g/L
- ALAT/ASAT >2.5 x upper limit of normal (ULN) in the absence of or >5 x ULN in the presence of liver metastases
- Bilirubin >1.5 x ULN
- Creatinine clearance ≤30 mL/min (measured or calculated by Cockcroft and Gault formula
- Women who are pregnant.
- 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
- 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.
- Individuals deprived of liberty or placed under the authority of a tutor.
Trial locations and contacts
2 sites in 1 country.
About this study
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
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.
Read the detailed description
This is a single arm, open-label, multicentric, phase II trial, with a Simon two-stage design, assessing the efficacy of a PARP inhibitor, rucaparib, in 41 progressing breast cancer patients with at least one line of chemotherapy at the metastatic setting., and who are carrying a BRCAness profile defined by Clovis genomic signature or a BRCA1 or 2 somatic mutation, without known BRCA1 or 2 germline mutation.
- Conditions
- Metastatic Breast Cancer
- Being tested
- rucaparib
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rucaparibDrug
600 mg bid per os , 28 day cycle, number of cycles: until progression or unacceptable toxicity develops.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: rucaparib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Benefit Rate
according to RECIST, is either complete response (CR), partial response (PR) or stable disease (SD) lasting for at least 16 weeks
Measured: 3 years
Secondary outcomes (4)
Number of patients with complete response, partial response or stable disease
complete response , partial response, or stable disease according to RECIST
Measured: 3 years
Progression free survival
Progression free survival will be assessed from the time of the first dose to disease progression or death from any cause, whichever comes first.
Measured: 3 years
Overall Survival
Overall survival will be assessed from the time of the first dose to death from any cause
Measured: 3 years
Number of patients experiencing an adverse event.
Adverse events are graded according to the CTCAE V4.03
Measured: toxicities will be assessed during the whole treatment period (6 months expected in average) followed by a 2-year post-treatment follow-up period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2015 (estimated)
- Study startMar 2016
- Primary completionFeb 2019
- Study completionDec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Breast CancerStudies of the same condition, open and under way.
- More trials run by UNICANCERThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- UNICANCER
- Sponsor type
- University, hospital or other
- Collaborators
- Clovis Oncology, Inc., Fondation ARC
- Responsible party
- Sponsor
- Investigators
- Fabrice André, MD PhD, Principal investigator, Gustave Roussy VillejuifAnne Patsouris, MD, Principal investigator, Institut de Cancerologie de l'Ouest Paul Papin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02505048
- Sponsor's protocol ID
- UC-0105/1501
- Acronym
- RUBY
- Status last verified
- Jun 2021
- First submitted
- 1 Jul 2015
- Last updated
- 8 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: In the medical clinical patient file
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02505048
- Acronym / sponsor ID
- RUBY / UC-0105/1501
- Conditions
- Metastatic Breast Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- UNICANCERUniversity, hospital or other
- Collaborators
- Clovis Oncology, Inc., Fondation ARC
- Study start
- Mar 2016 (actual)
- Primary completion
- Feb 2019 (actual)
- Study completion
- Dec 2019 (actual)
- First posted
- 22 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a single arm, open-label, multicentric, phase II trial, with a Simon two-stage design, assessing the efficacy of a PARP inhibitor, rucaparib, in 41 progressing breast cancer patients with at least one line of chemotherapy at the metastatic setting., and who are carrying a BRCAness profile defined by Clovis genomic signature or a BRCA1 or 2 somatic mutation, without known BRCA1 or 2 germline mutation.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| rucaparib | Experimental | Drug: rucaparibTablets 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 |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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).
Key exclusion criteria (24 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| rucaparib600 mg bid per os , 28 day cycle, number of cycles: until progression or unacceptable toxicity develops. | Drug | rucaparib |
Primary outcome
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
4 secondary outcomes
Number of patients with complete response, partial response or stable disease
Time frame: 3 years
Progression free survival
Time frame: 3 years
Overall Survival
Time frame: 3 years
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2021.
- Individual participant dataSharing planned: Yes. In the medical clinical patient file
Related trials for Metastatic Breast Cancer
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruiting
Augmented-Reality ICG Fluorescence Second-Look for Residual Nodal Disease After Axillary Dissection in Breast Cancer
Breast Cancer, Breast Neoplasms
RecruitingPhase 2
BrAin Metastasis in tripLe Negateive Breast Cancer: IvoneScimab and Trop2 ADC
Triple-Negative Breast Cancer (TNBC), Brain Metastases
RecruitingPhase 1/2
A Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Patients With Metastatic or Locally Advanced Breast Cancer
Metastatic Breast Cancer
RecruitingObservational study
Collection of CSF Samples From Participants With Metastatic Triple Negative Breast Cancer (TNBC) and HER2+ Breast Cancer With no Prior History Nor Active Radiographically Detectable Brain Metastases
Breast Cancer, Breast Carcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fabrice André, MD PhD principal investigator
Gustave Roussy Villejuif
Anne Patsouris, MD principal investigator
Institut de Cancerologie de l'Ouest Paul Papin
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing rucaparib in people with Metastatic Breast Cancer, run by UNICANCER at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Benefit Rate (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2021.