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Not yet recruitingNCT07353437Updated Jan 20, 2026

Fluzoparib as Adjuvant Treatment in Patients With Germline Homologous Recombination Repair (HRR) Mutated Primary Breast Cancer (Flamenco)

A Phase 2 interventional study of Fluzoparib and Physician choice in Breast Cancer, sponsored by Fudan University. Not yet recruiting. Open to female participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-01-20.

Sponsored by Fudan University · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
334
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
Female
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Study 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)

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Conditions studied

  • Breast Cancer

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In context

Breast Neoplasms

12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.

This study's planned enrollment of 334 is above the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.

Browse Breast Neoplasms studies →

Lead sponsor

Fudan University is the lead sponsor of 1,270 studies on the registry; 623 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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;
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Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
334 participants (estimated)

Study arms

  • Experimental
    Fluzoparib group

    Drug: Fluzoparib

  • Active comparator
    Physician choice

    Drug: Physician choice

Interventions

  • DrugFluzoparib

    Fluzoparib 100 mg bid for 1 year

  • DrugPhysician choice

    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)

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What researchers measure

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.

    Time frame: 3-year iDFS

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Study locations

No study locations are listed for this record.

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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 20, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07353437
Lead sponsor
Fudan University
Responsible party
Keda Yu (chief physician, Fudan University) — Principal investigator
First posted
Jan 20, 2026
Start date
Mar 31, 2026 (estimated)
Primary completion
Dec 31, 2031 (estimated)
Completion
Dec 31, 2032 (estimated)
Last update
Jan 20, 2026

Study contacts

Keda Yu
Contact
langguantian@126.com
021-64175590

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.

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