Aspirin shows promise in blocking ovarian cancer for High-Risk women
NCT ID NCT03480776
First seen Jun 27, 2026 · Last updated Sep 17, 2026 · Updated 2 times
Summary
This study tests whether taking aspirin can prevent ovarian cancer in women with BRCA1 or BRCA2 gene mutations, who are at high risk. About 117 participants will take either aspirin or a placebo daily for up to 2 years before their scheduled risk-reducing surgery. Researchers will then examine the removed tissue for pre-cancerous or early cancerous changes to see if aspirin reduces their occurrence.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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117 people
The number who actually took part.
- Started
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Jul 2018
- Expected to finish
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Jun 2027
An estimate. End dates often move.
- Lead sponsor
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A research network
The lead sponsor is a research network or cooperative group.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Female participants only
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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 Exclusion Criteria: * 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; endocrine therapy for breast cancer is allowed at any time. * 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 and/or anti-platelet agents. * 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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CHUM-Centre Hospitalier de l'Universite de Montreal
Montreal, Quebec, H2X 3E4, Canada
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CIUSSS de l'Est-de-I'lle-de-Montreal
Montreal, Quebec, H1T 2M4, Canada
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CIUSSS de l'Estrie - Centre hospitalier
Sherbrooke, Quebec, J1H 5N4, Canada
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CancerCare Manitoba
Winnipeg, Manitoba, R3E 0V9, Canada
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Clinical Research Unit at Vancouver Coastal
Vancouver, British Columbia, V5Z 1M9, Canada
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Dr. H. Bliss Murphy Cancer Centre
St. John's, Newfoundland and Labrador, A1B 3V6, Canada
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Hotel-Dieu de Quebec
Québec, Quebec, G1R 2J6, Canada
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King Edward Memorial Hospital
Subiaco, Western Australia, 6008, Australia
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Kingston Health Sciences Centre
Kingston, Ontario, K7L 2V7, Canada
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North York General Hospital
Toronto, Ontario, M2K 1E1, Canada
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Peter McCallum Cancer Institute
Melbourne, Victoria, 3002, Australia
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Prince of Wales Hospital
Randwick, New South Wales, 2031, Australia
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Royal Prince Alfred Hospital
Camperdown, New South Wales, 2050, Australia
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St John of God Subiaco
Subiaco, Western Australia, 6008, Australia
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Tom Baker Cancer Centre
Calgary, Alberta, T2N 4N2, Canada
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Westmead Hospital
Westmead, New South Wales, 2145, Australia
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Women's College Hospital
Toronto, Ontario, M5S 1B2, Canada