Adebrelimab Combined With Fluzoparib in HRD-positive HR +/HER2- Advanced Breast Cancer

An Open-label, Single-arm Study of Adebrelimab Combined With Fluzoparib in HRD-positive HR +/HER2- Advanced Breast Cancer

This is an open-label, single-arm, exploratory study planned to include 40 patients with HRD-positive HR +/HER2- advanced breast cancer treated with Adebrelimab in combination with fluzoparib. To observe and evaluate the efficacy and safety of Adebrelimab combined with fluzoparib in the treatment of HRD-positive HR +/HER2-advanced breast cancer

Study Overview

• Status: Not yet recruiting
• Conditions: Female Breast Cancer Patients; Histopathologically Confirmed Advanced HR +/HER2-invasive Breast Cancer; HRD Positive Advanced Breast Cancer
• Intervention / Treatment: Drug: Adebrelimab plus Fluzoparib

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Wenming Cao, Dr.; Phone Number: 13858064001; Email: caowm@zjcc.org.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Female breast cancer patients aged ≥ 18 years and ≤ 75 years;
2. Histopathologically confirmed advanced HR +/HER2-invasive breast cancer according to the latest ASCO/CAP guidelines, meeting the following conditions: HER2 negative: IHC 0/1 + or IHC2 + but ISH negative; ER positive: IHC ≥ 1%, PR positive: IHC ≥ 1%
3. ECOG score 0 ~ 2;
4. In the treatment stage of recurrence and metastasis, ≤ 1 line of chemotherapy is allowed, at least ≥ 1 standard endocrine therapy (including CDK4/6 inhibitor therapy) is allowed, and ≤ 1 antibody-conjugated drug (ADC) is allowed;
5. HRD positive confirmed, known germline and/or systemic BRCA mutation status and HRR pathway-related gene mutation status allow preferential enrollment;
6. Appropriate level of organ function
7. Patients voluntarily participate in and sign the informed consent form, are expected to have good compliance and cooperate with the study according to the requirements of the protocol.

Exclusion Criteria:

1. Active or symptomatic brain metastases Systemic anticancer therapy (including chemotherapy, radiotherapy, immunotherapy, endocrine therapy, targeted therapy, biologic therapy, or tumor embolization) within 14 days prior to enrollment
2. Patients previously received PD-1/PD-L1 antibody, CTLA-4 antibody, or other treatments against PD-1/PD-L1 inhibitors;
3. Female patients who are pregnant and lactating, female patients who are fertile and have a positive baseline pregnancy test, or female patients of childbearing age who are unwilling to take effective contraceptive measures throughout the trial.4.Have a clear history of neurological or psychiatric disorders, including epilepsy or dementia, and the subject has a known history of psychotropic drug abuse, alcoholism

5.Human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS); positive hepatitis B surface antigen (HBsAg) test, or positive hepatitis B core antibody (HBcAb) test followed by positive HBV-DNA test (HBV-DNA test was performed only in patients with negative HBsAg test and positive HBcAb test); positive hepatitis C virus (HCV) antibody test followed by positive HCV-RNA test (HCV-RNA test was performed only in patients with positive HCV antibody test) 6.Any other condition that, in the opinion of the investigator, would make the patient inappropriate for participation in this study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Adebrelimab+Fluzoparib	Drug: Adebrelimab plus Fluzoparib; Adebrelimab combined with Fluzoparib in HRD-positive HR +/HER2- advanced breast cancer

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PFS	Progression-free survival	6-10 months

Collaborators and Investigators

• Sponsor: Zhejiang Cancer Hospital
• Collaborators: Jiangsu Hengrui Pharmaceutical Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Estimated): April 16, 2024
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): December 31, 2028

Study Registration Dates

• First Submitted: February 4, 2024
• First Submitted That Met QC Criteria: February 4, 2024
• First Posted (Actual): February 12, 2024

Study Record Updates

• Last Update Posted (Actual): February 12, 2024
• Last Update Submitted That Met QC Criteria: February 4, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Poly(ADP-ribose) Polymerase Inhibitors; Fluzoparib
• Other Study ID Numbers: MA-BC-II-063

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No