Fluzoparib in Combination With or Without Camrelizumab for Homologous Recombinant Deficiency (HRD) HER2 Negative Advanced Breast Cancer

NCT05656131 | Suspended Phase 2 DMC

• 1 other identifier: MA-BC-II-042
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Advanced HER2 Negative Breast Carcinoma HRD+Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate

  Objective response is defined as a complete response (CR) or partial response (PR) according to RECIST v.1.1.recorded from randomization until disease progression or death due to any cause

  Up to 3 years

Secondary Outcomes (4)

• Progress-free survival

  Up to 3 years

• Overall Survival

  Up to 3 years

• QoL questionnaire （quality of life）

  Up to 3 years

• Adverse effect (AE)

  Up to 3 years

Study Arms (2)

fluzoparib

EXPERIMENTAL

Fluzoparib: 150 mg twice daily (morning and evening) for 21 consecutive days as a cycle until disease progression or intolerance.

Drug: Fluzoparib

fluzoparib+Camrelizumab

EXPERIMENTAL

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.

Drug: Fluzoparib+Camrelizumab

Interventions

Fluzoparib DRUG

Arms A will be treated with fluzoparib alone

fluzoparib

Fluzoparib+Camrelizumab DRUG

Arms B will be treated with fluzoparib in combination with camrelizumab

fluzoparib+Camrelizumab

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Has multiple primary malignancies and requires standardized treatment or major surgery within 2 years of the first dose of study treatment.
• Treated with PARP inhibitors in advanced stages.
• BRCA1/2 germline mutation.
• Symptomatic or unstable brain metastases.
• Any severe or poorly controlled systemic disease such as poorly controlled hypertension, active bleeding susceptibility or active infection, as judged by the investigator. Chronic disease needs to be excluded.
• Refractory nausea, vomiting or chronic gastrointestinal disease, inability to swallow study drug or previous extensive bowel resection that may interfere with adequate absorption of PARP inhibitors.
• Clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses including, but not limited to, any underlying pulmonary disorder (ie, interstitial lung disease, pulmonary emboli within three months of the study enrollment, severe asthma, severe chronic obstructive pulmonary disease \[COPD\], restrictive lung disease, pleural effusion etc), and any autoimmune, connective tissue or inflammatory disorders with pulmonary involvement (ie, rheumatoid arthritis, Sjögren's, sarcoidosis etc), or prior pneumonectomy.
• Otherwise considered inappropriate for the study by the Investigator.

Sponsors & Collaborators

• wang shusen: lead

Study Sites (1)

Sun-yat sen university cancer center

Guangzhou, Guangdong, China

Location

MeSH Terms

Interventions

fluzoparib

Study Officials

• shusen Wang

  Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief Physician

Study Record Dates

• First Submitted: December 11, 2022
• First Posted: December 19, 2022
• Study Start: November 23, 2022
• Primary Completion: March 30, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: March 17, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)