Actively Recruiting
Efficacy and Safety of Fluzoparib Combined With Adjuvant Endocrine Therapy for HR+/HER2- SNF3-subtype Early Breast Cancer (BCTOP-L-A01)
Led by Fudan University · Updated on 2024-02-08
766
Participants Needed
15
Research Sites
417 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a prospective, randomized, open-label phase III clinical study on the efficacy and safety of fluzoparib combined with adjuvant endocrine therapy versus adjuvant endocrine therapy for HR+/HER2- SNF3-subtype early breast cancer.
CONDITIONS
Official Title
Efficacy and Safety of Fluzoparib Combined With Adjuvant Endocrine Therapy for HR+/HER2- SNF3-subtype Early Breast Cancer (BCTOP-L-A01)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Women aged 18 to 70 years old
- ECOG performance status of 0 or 1
- Hormone receptor positive (ER+) and HER2 negative breast cancer confirmed by histopathology
- SNF3 subtype confirmed by digital pathology of H&E sections
- Postoperative pathological stage T2-4N0-3M0
- Previous neoadjuvant and/or adjuvant chemotherapy
- Randomization within 16 months after surgery
- Endocrine therapy started within 12 weeks after last non-endocrine anti-tumor treatment
- Adequate bone marrow, liver, and kidney function
- At least 14 days recovery from radiotherapy acute phase before randomization
- At least 21 days recovery from chemotherapy acute adverse reactions (grade ≤1 except hair loss or grade 2 neuropathy) before randomization
- Able to take medication orally
- Use medically approved contraception if of childbearing potential during study treatment
- Voluntary participation with signed informed consent, good compliance, and agreement to follow-up
You will not qualify if you...
- Bilateral breast cancer
- Previous additional malignancies except treated basal cell carcinoma or cervical carcinoma in situ
- Metastatic (stage 4) breast cancer
- Pregnant, breastfeeding, or unable to use effective contraceptives if of childbearing age
- Participation in other clinical trials concurrently
- Severe organ dysfunction or cardiac issues including LVEF <50%, recent cardiovascular events, uncontrolled hypertension, poorly controlled diabetes
- Known allergy to fluzoparib or its components
- Severe or uncontrolled infections
- History of psychotropic substance abuse or mental disorders preventing study participation
- Judged unsuitable for the study by researchers
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 15 locations
1
Beijing Cancer Hospital
Beijing, Beijing Municipality, China, 100142
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2
Chongqing Cancer Hospital
Chongqing, Chongqing Municipality, China, 400030
Actively Recruiting
3
Fujian Medical University Union Hospital
Fuzhou, Fujian, China, 350001
Actively Recruiting
4
Guangdong Academy of Medical Sciences Guangdong Provincial People's Hospital
Guangzhou, Guangdong, China, 519041
Actively Recruiting
5
Sun Yat-sen University Cancer Center
Guangdong, Guangzhou, China, 510062
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6
Affiliated Hospital of Nantong University
Nantong, Jiangsu, China, 226006
Actively Recruiting
7
Northern Jiangsu People's Hospital
Yangzhou, Jiangsu, China, 225009
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8
The First Hospital of China Medical University
Shenyang, Liaoning, China, 110002
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9
Liaoning Cancer Hospital & Institute
Shenyang, Liaoning, China, 110801
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10
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China, 200032
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11
Shanghai Sixth People's Hospital Affiliated to Shanghai Jiaotong University
Shanghai, Shanghai Municipality, China, 200233
Actively Recruiting
12
Shanghai First Maternity and Infant Hospital
Shanghai, Shanghai Municipality, China, 201204
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13
The First Affiliated Hospital of Xi'an Jiaotong University
Xi’an, Shanxi, China, 710061
Actively Recruiting
14
West China Hospital of Sichuan University
Chengdu, Sichuan, China, 610041
Actively Recruiting
15
Ningbo Medical Center Lihuili Hospital
Ningbo, Zhejiang, China
Actively Recruiting
Research Team
Z
Zhimin Shao, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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