Etude : RUBY /



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Acronyme
Nom
Traitement
Type d'étude
MÀJ
Présentation de l'étude
Acronyme : RUBY

Nom :

Traitement : Métastasique ou localement avancé

Type d'étude : Ciblage moléculaire / Innovation thérapeutique

Dernière MÀJ : 03/11/2017
Titre
Spécialité(s)
CIM10 - Localisation(s)
Informations principales
Titre : Etude de phase II évaluant l'efficacité du rucaparib chez les femmes avec un cancer du sein métastatique et un profil génomique BRCAness

Spécialité : Seins, organes génitaux de la femme
Localisation : C50 - Tumeur maligne du sein
Schéma
Phase
Stade
Ligne(s)
Informations complémentaires
Schéma : 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.

Phase : II

Stade : IV

2, 3, 4
Critères d'inclusion
Critères de non-inclusion
Critères d'inclusion et de non-inclusion
Critères d'inclusion : - 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
- 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.

Critères de non-inclusion : - 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
-> Platelets < 100 x 109/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
- 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.
NCT
Promoteur
Coordonnateur
Informations relatives au promoteur
NCT :
Promoteur :
Unicancer (IGR)
Type de sponsor : Institutionnel
94800 VILLEJUIF

Coordonnateur :
Centre investigateur
Investigateur
TEC / ARC / IDE
État
MÀJ
Informations relatives aux investigateurs
Centre investigateur :
Centre François BACLESSE - 3 avenue du Général Harris - 14000 CAEN

Investigateur :
Christelle LEVY

TEC / ARC / IDE :
Sara GROSSI
s.grossi@
baclesse.unicancer.fr

Ouverture de l'essai : OUVERT

MAJ : 05/02/2018