Authorised Therapeutic confirmatory (Phase III) Breast Cancer

Olaparib as adjuvant treatment in patients with germline BRCA mutated high risk HER2negative primary breast cancer.

EU CTIS ID: 2024-511096-15-00

What this study is testing

Efficacy of adjuvant treatment with olaparib on Invasive Disease Free Survival (IDFS).

  • Therapeutic confirmatory (Phase III)

A plain-language read of the study's public EU CTIS listing. The study team confirms the details.

Who can take part

You may be able to join if

  • 18 years old and older
  • Histologically confirmed non-metastatic primary invasive adenocarcinoma of the breast that is one of the following phenotypes: a) TNBC ER and PgR negative AND HER2 negative (not eligible for anti-HER2 therapy) b) ER and/or PgR positive, HER2 negative ER and/or PgR positive AND HER2 negative (not eligible for anti-HER2 therapy)
  • Documented germline mutation in BRCA1 or BRCA2 that is predicted to be deleterious or suspected deleterious (known or predicted to be detrimental/lead to loss of function).
  • Completed adequate breast and axilla surgery.
  • Completed at least 6 cycles of neoadjuvant or adjuvant chemotherapy containing anthracyclines, taxanes or the combination of both. Prior platinum as potentially curative treatment for prior cancer (e.g. ovarian) or as adjuvant or neoadjuvant treatment for breast cancer is allowed.
  • ECOG 0-1.R50

You likely can't join if

  • Any previous treatment with a PARP inhibitor, including olaparib and/or known hypersensitivity to any of the excipients of study treatment.
  • Patients with second primary malignancy. EXCEPTIONS are: a) adequately treated non-melanoma skin cancer, curatively treated in situ cancer of the cervix, Ductal Carcinoma in situ (DCIS) of the breast, stage 1 grade 1 endometrial carcinoma b) other solid tumours and lymphomas (without bone marrow involvement) diagnosed ≥ 5years prior to randomisation and treated with no evidence of disease recurrence and for whom no more than one line of chemotherapy was applied.
  • Concomitant use of known strong CYP3A inhibitors (e.g., itraconazole, telithromycin, clarithromycin, protease inhibitors boosted with ritonavir or cobicistat, indinavir, saquinavir, nelfinavir, boceprevir, telaprevir) or moderate CYP3A inhibitors (e.g., ciprofloxacin, erythromycin, diltiazem, fluconazole, verapamil). The required washout period prior to starting study treatment is 2 weeks. Concomitant use of known strong (e.g., phenobarbital, enzalutamide, phenytoin, rifampicin, rifabutin, rifapentine, carbamazepine, nevirapine and St John’s Wort) or moderate CYP3A inducers (e.g., bosentan, efavirenz, modafinil). The required washout period prior to starting study treatment is 5 weeks for enzalutamide orphenobarbital and 3 weeks for other agents.
  • Whole blood transfusions in the last 120 days prior to entry to the study which may interfere with gBRCA testing
  • Evidence of metastatic breast cancer

The study team makes the final eligibility decision.

Where it's taking place

  • Switzerland
  • United States
  • Australia
  • Taiwan
  • Israel
  • United Kingdom
  • Canada
  • Argentina
  • Japan
  • Korea, Republic of
  • China

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include Switzerland; United States; Australia; Taiwan; Israel; United Kingdom and 5 more location(s). Enter your location above to see the nearest site and check your eligibility.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.