Clinical trial NCT06254066: Adebrelimab Combined With Fluzoparib in HRD-positive HR +/HER2- Advanced Breast Cancer
Official title: An Open-label, Single-arm Study of Adebrelimab Combined With Fluzoparib in HRD-positive HR +/HER2- Advanced Breast Cancer
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Female Breast Cancer Patients
Histopathologically Confirmed Advanced HR +/HER2-invasive Breast Cancer
HRD Positive Advanced Breast Cancer
Lead sponsor: Zhejiang Cancer Hospital
Sponsor class: OTHER
Collaborators: name: Jiangsu Hengrui Pharmaceutical Co., Ltd.
First posted: 2024-02-12
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


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.

Primary outcomes:
measure: PFS
timeFrame: 6-10 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: