||A Randomized Phase II Double-Blind Placebo-Controlled Trial of Acetylsalicylic Acid (ASA) in Prevention of Ovarian Cancer in Women With BRCA 1/2 Mutations
| Protocole ID
| ClinicalTrials.gov ID
| Type(s) de cancer
| Type étude
CIUSSS DE L'EST-DE-L'ILE-DE-MONTREAL
PAV. MAISONNEUVE/PAV. MARCEL-LAMOUREUX
5415 boul. de l'Assomption, Montréal, QC, H1T2M4
| Investigateur(trice) principal(e)
Dre Suzanne Fortin
Leïla Idrissi Kaïtouni
|| Actif en recrutement
| Critètes d'éligibilité
- Previously documented germline BRCA1/2 pathogenic mutation or likely pathogenic variant based on the ACMG 2015 guidelines
- Risk-reducing surgery (bilateral salpingo-oophorectomy or bilateral salpingectomy inclusive of fimbria) scheduled for within 6 months to 2 years after the date of randomization as standard of care, for women who have completed their families
- ECOG performance status 0 or 1
- Age ≥ 18 years old
- Subject is able (i.e. sufficiently literate) and willing to complete the Credibility/Expectancy questionnaire in English or French.
- Subject consent must be appropriately obtained in accordance with applicable local and regulatory requirements. Each subject must sign a consent form prior to enrollment in the trial to document their willingness to participate
- Subjects must be accessible for treatment and follow up. Subjects randomized on this trial must be treated and followed at the participating centre.
- In accordance with CCTG policy, protocol treatment is to begin within 2 working days after subject randomization
- Women of childbearing potential must have agreed to use a highly effective contraceptive method for the duration of the study treatment and for 30 days post last dose of study medication
| Critètes d'exclusion
Subjects with history of other malignancies, except:
- adequately treated non-melanoma skin cancer;
- curatively treated in-situ cancer of the cervix;
- previously diagnosed (at any point) breast cancer, treated with curative intent; prior chemotherapy is allowed and the last dose must be ≥ 12 months prior to randomization;
- other solid tumours curatively treated with no evidence of disease for > 5 years.
- Subjects who have been treated with any PARP-inhibitors (e.g. olaparib) at any time.
- Subjects with active bleeding or bleeding diathesis.
- Subjects with active peptic ulcer.
- Subjects with renal, hepatic or congestive heart failure.
- Subjects with concurrent use of anti-coagulants.
- Subjects with prior bilateral salpingectomy.
- Subjects with history of chronic daily use of ASA or NSAIDs.
- Subjects with intolerance of ASA including subjects with a history of asthma induced by salicylates or substances with a similar action, notably non-steroidal-anti-inflammatory drugs.
- Ongoing or planned pregnancy.
- Subjects who are breastfeeding.