Fluzoparib in Combination With or Without Camrelizumab for Homologous Recombinant Deficiency (HRD) HER2 Negative Advanced Breast Cancer,A Two-cohort, Open, Multicenter,Phase II Study

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

This study is planned to include 80 patients with HRD positive HER2-negative advanced breast cancer to receive fluzoparib alone or fluzoparib combined with camrelizumab to observe and evaluate the efficacy and safety of fluzoparib combined with or without camrelizumab in the treatment of HRD positive HER2-negative advanced breast cancer.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:

• Women ≥18 years old

• Histologically or cytologically confirmed locally advanced or metastatic breast cancer.

• Pathologically documented breast cancer that is HER2-negative for both primary tumor and metastases (if puncture results are available)

• ECOG PS of 0-1.

• For locally advanced or metastatic breast cancer, the tumor tissue HRD score\> 42 is needed (for HRD testing, the recipient must provide a test report from an institution with a qualified testing unit prior to enrollment; if no report is available, the relevant test sample must be provided for confirmation in the central laboratory prior to enrollment).

• Presence of at least 1 measurable lesion based on computed tomography (CT) or magnetic resonance imaging (MRI) per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1).

• If treated with PARP inhibitors or immune checkpoint inhibitors in the (neo) adjuvant phase, a relapse-free interval of more than 1 year after the end of treatment is required.

• Prior treatment with paclitaxel-based chemotherapeutic agents is allowed.

• ≤ 2 lines of prior chemotherapy in the advanced stage.

⁃ For HR+ patients, progression within two years of (neo) adjuvant endocrine therapy is required; patients who have progressed after more than two years of endocrine therapy are required to have received at least first-line endocrine therapy for metastatic disease (including CDK4/6 inhibitors, cidarabine and PI3K inhibitors, etc.).

⁃ ≤ grade 1 (CTCAE v5.0) for all toxicities occurring in relation to prior antitumor therapy. However, patients with any grade of alopecia are allowed to enter the study.

⁃ CNS metastases without symptoms may be enrolled.

∙ If there is no extracranial assessable lesion, intracranial lesions are required to be assessable and suitable for systemic therapy only

‣ If there is an extracranial evaluable lesion, patients with an intracranial lesion that has been stabilized with local therapy may be accepted for enrollment

⁃ Routine blood tests within 1 week prior to enrollment are essentially normal.

∙ White blood cell count (WBC) ≥ 2.5 × 109/L.

‣ Neutrophil count (ANC) ≥ 1.5 × 109/L.

‣ Platelet count (PLT) ≥ 75 × 109/L.

‣ Patients may receive blood transfusions or erythropoietin therapy to meet this criterion.

⁃ Basic normal liver and renal function tests within 1 week prior to enrollment.

∙ Total bilirubin (T BIL) ≤ 1.5 x the upper limit of normal (ULN).

‣ Glutathione transaminase (SGPT/ALT) ≤ 2.5 x ULN (≤ 5 x ULN in patients with liver metastases).

‣ Glutathione aminotransferase (SGOT/AST) ≤ 2.5× ULN (≤ 5× ULN in patients with liver metastases).

‣ creatinine clearance (Ccr) ≥ 60 ml/min.

⁃ Patients subjects of reproductive/childbearing potential must agree to use a highly effective form of contraception or avoid intercourse during and upon completion of the study and after the last dose of treatment medicine for at least 90 days.

⁃ A life expectancy of at least 12 weeks.

⁃ Patients must be able to participate and comply with treatment and follow-up.

Locations
Other Locations
China
Sun-yat sen university cancer center
RECRUITING
Guangzhou
Contact Information
Primary
shusen Wang
wangshs@sysucc.org.cn
+8613926168469
Backup
jingmin Zhang
zhangjm1@sysucc.org.cn
+8618826246924
Time Frame
Start Date: 2022-11-23
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 80
Treatments
Experimental: fluzoparib
Fluzoparib: 150 mg twice daily (morning and evening) for 21 consecutive days as a cycle until disease progression or intolerance.
Experimental: fluzoparib+Camrelizumab
Fluzoparib: 150 mg twice daily (morning and evening) for 21 consecutive days as a cycle until disease progression or intolerance.~Camrelizumab: 200 mg IV drip over approximately 30 minutes (no less than 20 minutes and no more than 60 minutes) on Day 1 of each 3-week treatment cycle until disease progression or intolerance.
Related Therapeutic Areas
Sponsors
Leads: wang shusen

This content was sourced from clinicaltrials.gov