Evaluating the Efficacy and Safety of Fulvestrant Plus DNA Damage Repair Inhibitors After a CDK4/6 Inhibitor

Sponsor
Seoul National University Hospital
Study ID
NCT05536128
Phase
PHASE2
Status
Recruiting
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Conditions

  • Advanced Breast Cancer

Eligibility Criteria

Sex
ALL
Age
19 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Olaparib — DRUG
    Olaparib tablet 300 mg taken orally twice daily Olaparib 500 mg on Days 1, 15, 29, and every 4 weeks thereafter The treatment will continue till disease progression or unacceptable toxicity or withdrawal of consent or another discontinuation criterion is met.
  • Fulvestrant — DRUG
    Fulvestrant 500 mg on Days 1, 15, 29, and every 4 weeks thereafter

Study Details

Protocol Title: A Phase II open label, umbrella study evaluating the efficacy and safety of Fulvestrant plus DNA damage repair inhibitors in hormone receptor-positive advanced breast cancer after a CDK4/6 inhibitor

Key Dates

Start date
Dec 31, 2022
Status verified
Dec 2024
Primary completion
Dec 31, 2025
Completion
Dec 31, 2025

Study Design

Enrollment
64 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Olaparib,Fulvestrant
    Olaparib tablets should be taken at the same time each day, approximately 12 hours apart with one glass of water. The tablets should be swallowed whole and not chewed, crushed, dissolved or divided. Olaparib tablets can be taken with or without food. Fulvestrant should be administered on days 1, 15, 29, and then once monthly at 500 mg per dose.

Primary Outcome Measure

6-month progression-free survival (PFS) rate [ Time Frame: Duration of response is the time from response to progression or death from any cause whichever is earlier. ]

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