HERO: Characterization of High-Grade Ovarian Cancer Patients in Terms of Homologous Recombination Phenotype
Study Details
Study Description
Brief Summary
This is a prospective observational multi-country, multi-center study of a large real-world cohort of first line (1L) FIGO stage III-IV high-grade ovarian cancer patients, exposed to standard of care treatment stratified according to BRCA1/2 and HRD status.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Detailed Description
The overall objective of the study is to demonstrate the distribution of advanced ovarian cancer by HRD and BRCA1/2 mutational status and further characterize sub-cohorts of long- and short-term responders. Additionally, to collect representative clinical samples for further translational analyses.
The overall objective is separated by two distinct observational periods defined as
Observational Period 1 (OP1) and Observational Period 2 (OP2):
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OP1: From date of diagnosis to date of first response assessment following 1L chemotherapy, progression or death, whichever occurs first
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OP2: From date of first response assessment following 1L chemotherapy to maximum 36 months following 1L chemotherapy, death or withdrawal of consent, whichever occurs first.
Objective for Observational Period 1 (OP1) The objective for OP1 is to demonstrate the distribution of advanced ovarian cancer patients whose cancer is HRD, defined by either a BRCA1/2 mutation and/or genomic instability.
Objective for Observational Period 2 (OP2) The objective for OP2 is to further characterize sub-cohorts of short-term responders (progressing < 6 months following maintenance treatment) and long-term responders (progressing ≥ 32 months following maintenance treatment) in real-world cohorts of advanced ovarian cancer patients defined by HRD status determined by Myriad myChoice® CDx.
In total 300 patients will be enrolled in Denmark, Sweden, Norway, and Finland. Competitive enrollment will be applied. Eligible patients must have newly diagnosed, histologically confirmed advanced stage (FIGO stage III-IV) HGSOC or HGEOC, or ovarian cancer of any histology with a known BRCA1/2 mutation, who are intended for platinum-based chemotherapy.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Ovarian cancer patients Newly diagnosed patients with ovarian cancer, fallopian tube cancer or primary peritoneal cancer |
Other: Standard of care
Patients receive standard of care treatment according to local and national guidelines
|
Outcome Measures
Primary Outcome Measures
- Endpoint OP1 [36 months]
Frequency of surgical resection
Secondary Outcome Measures
- Endpoints OP1 - 1.1 [36 months]
- First line anti-cancer treatment including outcome
- Endpoints OP1 - 1.2 [36 months]
- +/- Residual disease following Primary Cytoreductive Surgery (P-CRS)
- Endpoints OP1 - 1.3 [36 months]
- Overall Response Rate (ORR)
- Endpoints OP1 - 1.4 [36 months]
- BRCA1/2 and HRD status
- Endpoint OP2 - 2.1 [36 months]
- Number of patients receiving maintenance treatment or not
- Endpoint OP2 - 2.2 [36 months]
- Progression-Free-Survival (PFS) at 6, 12, 24 and 32 months
Eligibility Criteria
Criteria
Patients are eligible to be included in the study only if all the following inclusion criteria are met:
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Patients with newly diagnosed histologically confirmed advanced (FIGO stage III-IV) ovarian cancer:
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High-grade serous ovarian cancer (HGSOC), or
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High-grade endometroid ovarian cancer (HGEOC), or
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Any other histology with a known BRCA1/2 mutation
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Women aged ≥ 18 years of age at the time of diagnosis
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Patients intended for platinum-based doublet chemotherapy treatment
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Patients capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol
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Patients consent to provide archival tumor tissue sample
Patients are ineligible to be included in the study if any of the exclusion criteria are met:
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Non-epithelial ovarian cancer, borderline tumors, low-grade epithelial tumors, or mucinous histology
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Patients with early stage disease (FIGO stage I-II)
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All other malignancies unless curatively treated with no evidence of disease for ≥ 5 years except adequately treated non-melanoma skin cancer, curatively treated in situ cancer of the cervix, ductal carcinoma in situ, stage 1, grade 1 endometrial carcinoma
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Nordic Society of Gynaecological Oncology - Clinical Trials Unit
Investigators
- Study Chair: Mansoor R Mirza, MD, NSGO-CTU
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- NSGO-CTU-HERO