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

NCT ID: NCT06254066

Last Updated: 2024-02-12

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-16
• Study Completion Date: 2028-12-31

Brief Summary

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

Conditions

Female Breast Cancer Patients; Histopathologically Confirmed Advanced HR +/HER2-invasive Breast Cancer; HRD Positive Advanced Breast Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Adebrelimab+Fluzoparib

Group Type: EXPERIMENTAL

Adebrelimab plus Fluzoparib

Intervention Type: DRUG

Adebrelimab combined with Fluzoparib in HRD-positive HR +/HER2- advanced breast cancer

Interventions

Adebrelimab plus Fluzoparib

Adebrelimab combined with Fluzoparib in HRD-positive HR +/HER2- advanced breast cancer

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Months
• Maximum Eligible Age: 75 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Jiangsu Hengrui Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: collaborator

Zhejiang Cancer Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Wenming Cao, Dr.

Role: CONTACT

caowm@zjcc.org.cn

13858064001

Other Identifiers

MA-BC-II-063

Identifier Type: -

Identifier Source: org_study_id