Actively Recruiting
Evaluating the Efficacy and Safety of Fulvestrant Plus DNA Damage Repair Inhibitors After a CDK4/6 Inhibitor
Led by Seoul National University Hospital · Updated on 2025-04-17
64
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
Evaluating the Efficacy and Safety of Fulvestrant Plus DNA Damage Repair Inhibitors After a CDK4/6 Inhibitor
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to provide signed informed consent
- Age 19 years or older at consent
- Hormone receptor-positive, HER2-negative metastatic or inoperable breast cancer
- Disease progressed after endocrine therapy and CDK4/6 inhibitor treatment
- Normal organ and bone marrow function within 28 days before treatment
- ECOG performance status of 0 or 1
- Life expectancy of at least 16 weeks
- At least one lesion measurable or assessable by CT or MRI
- Postmenopausal or non-childbearing status for women of childbearing potential
- Negative pregnancy test within 28 days before treatment for women of childbearing potential
- Male patients must use condoms during and for 3 months after treatment when having sex with women of childbearing potential
- For cohort A: known germline or somatic BRCA1 or BRCA2 mutations
- For cohort B: known somatic mutations in BRCA1, BRCA2, or other DNA damage repair genes
- Pre/peri-menopausal women must be treated with monthly LHRH agonists starting 3 weeks before treatment and continue throughout the study
You will not qualify if you...
- Any condition judged by the investigator to make participation undesirable
- Other malignancies unless disease-free for 5 or more years (exceptions apply)
- Uncontrolled or reversible cardiac conditions or congenital long QT syndrome
- Persistent toxicities greater than grade 2 from prior cancer therapy (except certain hair loss)
- Myelodysplastic syndrome or acute myeloid leukemia
- Symptomatic uncontrolled brain metastases or unstable spinal cord compression
- Serious uncontrolled medical disorders, infections, or psychiatric conditions preventing consent
- Inability to swallow oral medication or gastrointestinal disorders affecting absorption
- Immunocompromised status including HIV infection
- Active hepatitis B or C infection (with specific exceptions)
- Underweight with body weight 30 kg or less
- History of bleeding disorders or long-term anticoagulant therapy with INR above 1.6
- Prior treatment with fulvestrant, olaparib, or other investigational DNA damage response drugs
- Chemotherapy or radiotherapy within 3 weeks before study treatment (except palliative)
- Use of strong or moderate CYP3A inhibitors or inducers without required washout periods
- Major surgery within 2 weeks before treatment without recovery
- Previous allogenic bone marrow or double umbilical cord blood transplant
- Participation in another clinical trial with investigational drugs within 4 weeks or 5 half-lives
- Known hypersensitivity to fulvestrant, olaparib, or their excipients
- Involvement in planning or conduct of this study
- Likely inability to comply with study procedures
- Previous enrollment in this study
- Breastfeeding women
AI-Screening
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Trial Site Locations
Total: 1 location
1
Seoul National University Hospital
Seoul, South Korea
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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