Efficacy and Safety of Fluzoparib Combined With Adjuvant Endocrine Therapy for HR+/HER2- SNF3-subtype Early Breast Cancer (BCTOP-L-A01)
NCT ID: NCT05891093
Last Updated: 2024-02-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
766 participants
INTERVENTIONAL
2023-06-01
2031-05-31
Brief Summary
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Detailed Description
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A total of 766 patients with luminal-type early breast cancer who received surgery at the Fudan University Shanghai Cancer Cancer and were classified as SNF3 (proliferative) by SNF algorithm fusion clustering will be collected for this study. Before enrollment, the primary tumors of the patients were subjected to molecular typing based on H\&E slices combined with digital pathology, and subsequent enrollment could be considered if patient pathology was confirmed as SNF3 subtype.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Fluzoparib+Endocrine Therapy
Fluzoparib 50mg bid orally for 1 year, combined with physician's choice of endocrine therapy as clinically indicated (eg, aromatase inhibitor, tamoxifen, toremifene endocrine therapy for 5 to 10 years; CDK4/6 inhibitor therapy for 2 years; ovarian function suppression with LHRH agonist).
Fluzoparib
Fluzoparib 50mg bid orally for 1 year.
Anastrozole
1mg, qd orally
Letrozole
2.5mg, qd orally
Exemestane
25mg, qd orally
Tamoxifen
10mg, bid orally
Toremifene
60mg, qd orally
Abemaciclib
150mg/100mg/50mg, bid orally for 2 years
LHRH agonist
Leuprorelin acetate, goserelin acetate
Endocrine Therapy
Physician's choice of endocrine therapy as clinically indicated (eg, aromatase inhibitor, tamoxifen, toremifene endocrine therapy for 5 to 10 years; CDK4/6 inhibitor therapy for 2 years; ovarian function suppression with LHRH agonist).
Anastrozole
1mg, qd orally
Letrozole
2.5mg, qd orally
Exemestane
25mg, qd orally
Tamoxifen
10mg, bid orally
Toremifene
60mg, qd orally
Abemaciclib
150mg/100mg/50mg, bid orally for 2 years
LHRH agonist
Leuprorelin acetate, goserelin acetate
Interventions
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Fluzoparib
Fluzoparib 50mg bid orally for 1 year.
Anastrozole
1mg, qd orally
Letrozole
2.5mg, qd orally
Exemestane
25mg, qd orally
Tamoxifen
10mg, bid orally
Toremifene
60mg, qd orally
Abemaciclib
150mg/100mg/50mg, bid orally for 2 years
LHRH agonist
Leuprorelin acetate, goserelin acetate
Eligibility Criteria
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Inclusion Criteria
2. ECOG score 0 or 1;
3. ER+/HER2- confirmed by histopathology after early breast cancer surgery（ER positive is defined as immunohistochemistry(IHC) detection of ER ≥ 1% HER2-negative is defined as a negative in situ hybridization test or an IHC status of 0, 1+ or 2+. If IHC is 2+, a negative in situ hybridization (Fluorescence in situ hybridization (FISH), Chromogenic in situ hybridization (CISH) , or Silver in situ hybridization (SISH)) test is required by local laboratory testing.); definition of SNF3 subtype: SNF3 subtype confirmed by digital pathology of H\&E sections;
4. Postoperative pathological stage T2-4N0-3M0;
5. Patients who have previously received neoadjuvant chemotherapy and/or adjuvant chemotherapy;
6. Time of randomization from surgery does not exceed 16 months;
7. Time of endocrine therapy from last non-endocrine anti-tumor treatment does not exceed 12 weeks;
8. Has adequate organ function meeting the following criteria: (1) adequate bone marrow function: hemoglobin ≥ 90 g/L (no blood transfusion within 14 days); absolute neutrophil count ≥ 1.5 x 10\^9 /L; platelet count ≥ 100 \* 10\^9 /L; (2)adequate liver and kidney function: Alanine Aminotransferase (ALT) ≤ 3×upper limit of normal (ULN), Aspartate Aminotransferase (AST) ≤ 3×ULN, Total Bilirubin (TBIL)≤ 1.5×ULN, serum creatinine ≤ 1×ULN，and with endogenous creatinine clearance rate of \>50 ml/min (Cockcroft-Gault formula);
9. Patients receiving radiotherapy must recover from the acute phase reaction of radiotherapy, with a washout period of at least 14 days from the end of radiotherapy to randomization;
10. Patients who received chemotherapy in the early stage must recover from acute adverse reactions to chemotherapy (\[CTCAE\] grade ≤ 1) before randomization, except for hair loss or grade 2 peripheral neuropathy. There is a washout period of at least 21 days from the last chemotherapy administration to randomization (assuming the patient has not received radiotherapy);
11. Patients can take medication orally on their own;
12. Female subjects with fertility are required to use a medically approved contraceptive method during the study treatment
13. Participants voluntarily joined the study, has signed informed consent before any trial related activities are conducted, has good compliance and has agreed to follow-up.
Exclusion Criteria
2. Has previous history of additional malignancy, with the exception of adequately treated basal cell carcinoma and cervical carcinoma in situ.
3. Has metastatic (Stage 4) breast cancer;
4. Is pregnant, is breast feeding women, or women of childbearing age who cannot practice effective contraceptives;
5. Patients participating in other clinical trials at the same time;
6. Has severe organ dysfunction (cardiopulmonary liver and kidney) insufficiency, left ventricular ejection fraction (LVEF) \< 50% (cardiac ultrasound); severe cardio cerebral vascular disease within the 6 months previous of randomization (such as unstable angina, chronic heart failure, uncontrolled hypertension with blood pressure\>150/90mmgh, myocardial infarction, or cerebral blood vessel); diabetic patients with poor blood glucose control; patients with severe hypertension;
7. Has known allergy to fluzoparib and excipients.
8. Has severe or uncontrolled infection;
9. Has a history of psychotropic substance abuse and were unable to abandon drug habits, or those with history of mental disorders;
10. The researchers judged patients to be unsuitable for the study.
18 Years
70 Years
FEMALE
No
Sponsors
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Fudan University
OTHER
Responsible Party
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Zhimin Shao
Chief Physician
Locations
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Beijing Cancer Hospital
Beijing, Beijing Municipality, China
Chongqing Cancer Hospital
Chongqing, Chongqing Municipality, China
Fujian Medical University Union Hospital
Fuzhou, Fujian, China
Guangdong Academy of Medical Sciences Guangdong Provincial People's Hospital
Guangzhou, Guangdong, China
Sun Yat-sen University Cancer Center
Guangdong, Guangzhou, China
Affiliated Hospital of Nantong University
Nantong, Jiangsu, China
Northern Jiangsu People's Hospital
Yangzhou, Jiangsu, China
The First Hospital of China Medical University
Shenyang, Liaoning, China
Liaoning Cancer Hospital & Institute
Shenyang, Liaoning, China
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
Shanghai Sixth People's Hospital Affiliated to Shanghai Jiaotong University
Shanghai, Shanghai Municipality, China
Shanghai First Maternity and Infant Hospital
Shanghai, Shanghai Municipality, China
The First Affiliated Hospital of Xi'an Jiaotong University
Xi’an, Shanxi, China
West China Hospital of Sichuan University
Chengdu, Sichuan, China
Ningbo Medical Center Lihuili Hospital
Ningbo, Zhejiang, China
Countries
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Central Contacts
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Facility Contacts
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HuiPing Li, MD
Role: primary
Xiaohua Zeng, MD
Role: primary
ChuanGui Song, MD
Role: primary
Kun Wang, MD
Role: primary
ShuSen Wang, MD
Role: primary
ZhiXian He, MD
Role: primary
SuJie Ni, MD
Role: backup
DeYuan Fu, MD
Role: primary
YueE Teng, MD
Role: primary
YingYing Xu, MD
Role: backup
Tao Shen, MD
Role: primary
Qiang Zhang, MD
Role: backup
Zhi-Ming Shao, MD;PhD
Role: primary
Zan Shen, MD
Role: primary
ZhiGang Zhuang, MD
Role: primary
Jin Yang, MD
Role: primary
Ting Luo, MD
Role: primary
WeiZhu Wu, MD
Role: primary
Other Identifiers
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SCHBCC-N056
Identifier Type: -
Identifier Source: org_study_id
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