NCT07353437

Brief Summary

The study is a randomized, open-label, multicenter phase II clinical trial of the efficacy and safety of fluzopanib in the adjuvant treatment of early breast cancer using germline mutations in homologous recombination repair pathway genes. Study design Patients will be randomized into 2 groups in a 1:1 ratio after enrollment: Experimental group: fluzoparib, specific: fluzoparib 100 mg bid for 1 year. As well as the standard of care selected by the physician (in case of TNBC, combination therapy includes but is not limited to immunotherapy or capecitabine; in case of HR +, combination therapy includes but is not limited to endocrine therapy or CDK4/6 inhibitors). Control group: Doctors' choice of standard treatment (in case of TNBC, combination therapy includes but is not limited to immunotherapy or capecitabine; in case of HR +, combination therapy includes but is not limited to endocrine therapy or CDK4/6 inhibitors)

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
334

participants targeted

Target at P75+ for phase_2 breast-cancer

Timeline
81mo left

Started Mar 2026

Longer than P75 for phase_2 breast-cancer

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress2%
Mar 2026Dec 2032

First Submitted

Initial submission to the registry

January 8, 2026

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 20, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

March 31, 2026

Completed
5.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2031

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2032

Last Updated

January 20, 2026

Status Verified

January 1, 2026

Enrollment Period

5.8 years

First QC Date

January 8, 2026

Last Update Submit

January 19, 2026

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

  • iDFS

    DFS, Invasive Disease-Free Survival, refers to the time from randomization to the first occurrence of locoregional invasive recurrence, distant metastasis, contralateral invasive tumor, or death from any cause. The primary endpoint of this study is 3-year iDFS.

    3-year iDFS

Study Arms (2)

Fluzoparib group

EXPERIMENTAL
Drug: Fluzoparib

Physician choice

ACTIVE COMPARATOR
Drug: Physician choice

Interventions

FluzoparibDRUG

Fluzoparib 100 mg bid for 1 year

Fluzoparib group
Physician choiceDRUG

Standard treatment chosen by physician (in case of TNBC, combination therapy includes but is not limited to immunotherapy or capecitabine; in case of HR +, combination therapy includes but is not limited to endocrine therapy or CDK4/6 inhibitors)

Physician choice

Eligibility Criteria

Age18 Years - 75 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Female 18-75 years
  • ECOG 0-1
  • Histologically confirmed invasive carcinoma (regardless of pathological type)
  • No gross or microscopic residual tumor after surgical resection
  • For triple-negative early breast cancer receiving neoadjuvant therapy (at least 6 cycles of chemotherapy), postoperative pathological assessment of non-pCR is required; for ER and/or PgR-positive and HER2-negative early breast cancer receiving neoadjuvant therapy (at least 6 cycles of chemotherapy or endocrine therapy), postoperative pathological assessment of non-pCR and ypLN + is required; for triple-negative early breast cancer not receiving neoadjuvant therapy, postoperative pathological assessment of ≥ pT2 or ≥ pN1 is required; for ER and/or PgR-positive and HER2-negative early breast cancer not receiving neoadjuvant therapy, postoperative pathological assessment of ≥ 4 positive lymph nodes or 1-3 positive lymph nodes with high-risk factors (tumor diameter ≥ 5 cm, or histological grade 3, or Ki-67 ≥ 30%) is required
  • Carrying pathogenic or possibly pathogenic mutations in BARD1/BRIP1/EXO1/FANCM/NBN/PALB2/PARP1/PARP2/POLQ/RAD50/RAD51/RAD51B/RAD51C/RAD51D/RAD52/RAD54L/RE/QL5/RFC1/RPA1/TOP3A/TOP3B/BLM germline genes confirmed by second-generation sequencing or first-generation sanger sequencing

You may not qualify if:

  • Bilateral breast cancer or carcinoma in situ DCIS/LCIS;
  • Metastases at any site;
  • contralateral breast clinical or imaging suspected malignant but not confirmed, need biopsy;
  • Treated for advanced disease;
  • Patients who have received tamoxifen, raloxifene, or aromatase inhibitors (AIs) to reduce the risk of breast cancer ("chemoprevention") and/or who have previously undergone prophylactic ovariectomy within 2 years;
  • Malignant tumor (except skin basal cell carcinoma and cervical carcinoma in situ) within 5 years, including contralateral breast cancer;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Breast Neoplasms

Interventions

fluzoparib

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Central Study Contacts

Keda Yu

CONTACT

021-64175590langguantian@126.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
chief physician

Study Record Dates

First Submitted

January 8, 2026

First Posted

January 20, 2026

Study Start

March 31, 2026

Primary Completion (Estimated)

December 31, 2031

Study Completion (Estimated)

December 31, 2032

Last Updated

January 20, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share