NCT03205761

Analysis of Olaparib Response in Patients With BRCA1 and/or 2 Promoter Methylation Diagnosed of Advanced Breast Cancer

A Phase II Clinical Trial to Analyse Olaparib Response in Patients With BRCA1 and/or 2 Promoter Methylation Diagnosed of Advanced Breast Cancer (COMETA-Breast Study)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 11 (actual)
• Sponsor: Spanish Breast Cancer Research Group · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a multicenter single-arm phase II clinical trial to evaluate the efficacy and safety of olaparib in patients diagnosed of advanced triple negative breast cancer (TNBC) with methylation of BRCA1 and/or BRCA2 promoters assessed in DNA from metastatic lesions and absence of BRCA1 and 2 germline mutations.

Detailed description

Patients must have received at least one previous regimen in the advance disease setting and must have at least one measurable lesion that can be accurately assessed according to RECIST v.1.1. Potential eligible patients will be screened to assess somatic (s) BRCA promoter methylation at an reference central laboratory. Germinal (g) BRCA mutational status will be analyzed also centrally at 'Myriad Genetics GmBh' laboratory unless the BRCA mutational status is already known based on a Myriad previous report. Patients with a positive methylation status on at least one of the two genes and lacking of known deleterious or suspected deleterious mutations in both genes could be enrolled in the study and receive olaparib. Blood and tumor samples collected from all screened patients could be used for the biomarker analysis, including the assessment of germline methylation status and gene expression levels of BRCA1/2. An early efficacy review will be performed after 12 evaluable patients are enrolled; if at least 4 of them show tumour response, additional patients will be included to complete a total of 34 patients.

Conditions

• Advanced Breast Cancer

Interventions

Type	Name	Description
DRUG	Olaparib	Olaparib tablet formulation at 600 mg total daily dose (given in two oral administrations of 300 mg every 12 hours approximately). Patients will continue to receive their treatment until objective disease progression, symptomatic deterioration, unacceptable toxicity, death or withdrawal of consent, whichever occurs first.

Timeline

• Start date: 2017-10-23
• Primary completion: 2022-12-15
• Completion: 2022-12-15
• First posted: 2017-07-02
• Last updated: 2024-10-18
• Results posted: 2024-05-01

Locations

16 sites across 1 country: Spain