HRD Tests for Ovarian cancER (HERO)

Centre Francois Baclesse

Status and phase: Enrolling; Phase 2

Conditions: Ovarian Cancer

Treatments: Genetic: tests to determine HRD status

Study type: Interventional

Funder types: Other

Identifiers

NCT06152731

2023-A01585-40

Details and patient eligibility

About

The study concerns patients with Invasive epithelial ovarian cancer, primary Fallopian tube carcinoma, ovarian-type peritoneal carcinoma, and with an indication of a first-line platinum-based chemotherapy.

To determine HRD status, 2 separate tests will be performed in the study:

1. Giscar assay : developed by the sponsor
2. myChoice assay

If one or two tests identifies a HRD status :

a PARP inhibitor treatment may be initiated according to current recommendations

Enrollment: 88 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patient aged 18-year or more

• Histologically documented high grade serous epithelial ovarian cancer, fallopian tube or peritoneum cancer

• Newly diagnosed advanced (International Federation of Gynecology and Obstetrics [FIGO] stage III or IV) ovarian carcinoma, candidate to a first line platinum-based chemotherapy

• Tumor tissue must be available for HRD analyses (FFPE tissue block) and

  • Collected if possible during the initial surgery or the initial biopsy (before chemotherapy)
  • With sufficient tumour surface area (> 25 mm²), with a final cellularity of at least 20%

• Patient affiliated to an appropriate social security system

• Patient signed consent form before any trial related activities

Exclusion criteria

• Recurrent high grade serous epithelial ovarian cancer, fallopian tube or peritoneum cancer
• Non epithelial or borderline ovarian cancer
• Other tumor, for which the treatment may interfere with the ovarian cancer treatment and/or that may have a major impact on prognosis
• Exclusive palliative setting
• Patient deprived of liberty or placed under the authority of a tutor

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

88 participants in 1 patient group

HRD tests

Other group

Description:

To determine HRD status on the tumor, 2 different tests will be used concomitantly

Treatment:

Genetic: tests to determine HRD status