Fluzoparib as Adjuvant Treatment in Patients With Germline Homologous Recombination Repair (HRR) Mutated Primary Breast Cancer (Flamenco)
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)
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Phase 2
Contacts and Locations
Study Contact
- Name: Keda Yu
- Phone Number: 021-64175590
- Email: langguantian@126.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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:
- 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;
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Fluzoparib group
|
Fluzoparib 100 mg bid for 1 year
|
|
Active Comparator: Physician 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)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
iDFS
Time Frame: 3-year 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
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Flamenco
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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