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

NCT05536128 | Recruiting Phase 2

• 1 other identifier: H2207-207-1346
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

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

Advanced Breast Cancer

Outcome Measures

Primary Outcomes (1)

• 6-month progression-free survival (PFS) rate

  PFS rate is the number (%) of patients who are alive without any evidence of disease progression at 6 months.

  Duration of response is the time from response to progression or death from any cause whichever is earlier.

Secondary Outcomes (5)

• Progression-free survival (PFS)

  Duration of response is the time from response to progression or death from any cause whichever is earlier.

• Objective response rate (ORR)

  Duration of response is the time from response to progression or death from any cause whichever is earlier.

• Duration of response

  Duration of response is the time from response to progression or death from any cause whichever is earlier.

• Safety and toxicity according to CTCAE v5.0

  Duration of response is the time from response to progression or death from any cause whichever is earlier.

• Translational research using tumour and blood samples

  Duration of response is the time from response to progression or death from any cause whichever is earlier.

Study Arms (1)

Olaparib,Fulvestrant

EXPERIMENTAL

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.

Drug: Olaparib; Drug: Fulvestrant

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.

Also known as: (Lynparza Cap)

Olaparib,Fulvestrant

Fulvestrant DRUG

Fulvestrant 500 mg on Days 1, 15, 29, and every 4 weeks thereafter

Also known as: Faslodex®

Olaparib,Fulvestrant

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• Informed consent
• 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.
• Provision of signed and dated, written informed consent form prior to any mandatory study specific procedures, sampling, and analyses.
• Age
• Subject must be 19 years of age or older at the time of signing the informed consent form.
• Type of patient and disease characteristics
• Patients with HR+/HER2- metastatic or inoperable breast cancer
• Disease progression following treatment with endocrine therapy(ies) and CDK4/6 inhibitor
• Patients must have normal organ and bone marrow function measured within 28 days prior to administration of study treatment as defined below
• Hemoglobin ≥ 10.0 g/dL. Red blood cell/plasma transfusion is not permitted within 2 week prior to screening assessment.
• Absolute neutrophil count (ANC) ≥ 1.5 x 109/L. Granulocyte colony-stimulating factor administration is not permitted within 1 week prior to screening assessment.
• Platelet count ≥ 100 x 109/L. Platelet transfusion is not permitted within 1 week prior to screening assessment.
• Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN) if no liver metastases; or ≤ 3 × ULN in the presence of documented Gilbert's syndrome (unconjugated hyperbilirubinemia) or liver metastases at baseline.
• Aspartate aminotransferase (AST) (Serum Glutamic Oxaloacetic Transaminase (SGOT)) / Alanine aminotransferase (ALT) (Serum Glutamic Pyruvate Transaminase (SGPT)) ≤ 2.5 x institutional upper limit of normal unless liver metastases are present in which case they must be ≤ 5x ULN
• Patients must have creatinine clearance estimated of ≥51 mL/min using the Cockcroft-Gault equation or based on a 24 hour urine test :

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Hospital

Seoul, South Korea

RECRUITING

MeSH Terms

Interventions

olaparib; Fulvestrant

Intervention Hierarchy (Ancestors)

Estradiol; Estrenes; Estranes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Single arm, phase II study

Study Record Dates

• First Submitted: September 7, 2022
• First Posted: September 10, 2022
• Study Start: December 31, 2022
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: April 17, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)