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Trial Title:
Adebrelimab Combined With Fluzoparib in HRD-positive HR +/HER2- Advanced Breast Cancer
NCT ID:
NCT06254066
Condition:
Female Breast Cancer Patients
Histopathologically Confirmed Advanced HR +/HER2-invasive Breast Cancer
HRD Positive Advanced Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Fluzoparib
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Adebrelimab plus Fluzoparib
Description:
Adebrelimab combined with Fluzoparib in HRD-positive HR +/HER2- advanced breast cancer
Arm group label:
Adebrelimab+Fluzoparib
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
Criteria for 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.
Gender:
Female
Minimum age:
18 Months
Maximum age:
75 Years
Healthy volunteers:
No
Start date:
April 16, 2024
Completion date:
December 31, 2028
Lead sponsor:
Agency:
Zhejiang Cancer Hospital
Agency class:
Other
Collaborator:
Agency:
Jiangsu Hengrui Pharmaceutical Co., Ltd.
Agency class:
Industry
Source:
Zhejiang Cancer Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06254066
