Trial Title:
Efficacy and Safety of Fluzoparib Combined With Adjuvant Endocrine Therapy for HR+/HER2- SNF3-subtype Early Breast Cancer (BCTOP-L-A01)
NCT ID:
NCT05891093
Condition:
Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Tamoxifen
Toremifene
Letrozole
Anastrozole
Exemestane
Fluzoparib
Conditions: Keywords:
fluzoparib
adjuvant treatment
SNF3-subtype
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Fluzoparib
Description:
Fluzoparib 50mg bid orally for 1 year.
Arm group label:
Fluzoparib+Endocrine Therapy
Intervention type:
Drug
Intervention name:
Anastrozole
Description:
1mg, qd orally
Arm group label:
Endocrine Therapy
Arm group label:
Fluzoparib+Endocrine Therapy
Intervention type:
Drug
Intervention name:
Letrozole
Description:
2.5mg, qd orally
Arm group label:
Endocrine Therapy
Arm group label:
Fluzoparib+Endocrine Therapy
Intervention type:
Drug
Intervention name:
Exemestane
Description:
25mg, qd orally
Arm group label:
Endocrine Therapy
Arm group label:
Fluzoparib+Endocrine Therapy
Intervention type:
Drug
Intervention name:
Tamoxifen
Description:
10mg, bid orally
Arm group label:
Endocrine Therapy
Arm group label:
Fluzoparib+Endocrine Therapy
Intervention type:
Drug
Intervention name:
Toremifene
Description:
60mg, qd orally
Arm group label:
Endocrine Therapy
Arm group label:
Fluzoparib+Endocrine Therapy
Intervention type:
Drug
Intervention name:
Abemaciclib
Description:
150mg/100mg/50mg, bid orally for 2 years
Arm group label:
Endocrine Therapy
Arm group label:
Fluzoparib+Endocrine Therapy
Intervention type:
Drug
Intervention name:
LHRH agonist
Description:
Leuprorelin acetate, goserelin acetate
Arm group label:
Endocrine Therapy
Arm group label:
Fluzoparib+Endocrine Therapy
Summary:
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.
Detailed description:
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.
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Women aged 18-70 years old;
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:
1. Has bilateral breast cancer;
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.
Gender:
Female
Minimum age:
18 Years
Maximum age:
70 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Beijing Cancer Hospital
Address:
City:
Beijing
Zip:
100142
Country:
China
Status:
Recruiting
Contact:
Last name:
HuiPing Li, MD
Phone:
+86-010-88121122
Facility:
Name:
Chongqing Cancer Hospital
Address:
City:
Chongqing
Zip:
400030
Country:
China
Status:
Recruiting
Contact:
Last name:
Xiaohua Zeng, MD
Phone:
+86-023-65311341
Facility:
Name:
Fujian Medical University Union Hospital
Address:
City:
Fuzhou
Zip:
350001
Country:
China
Status:
Recruiting
Contact:
Last name:
ChuanGui Song, MD
Phone:
+86-591-83357896
Facility:
Name:
Guangdong Academy of Medical Sciences Guangdong Provincial People's Hospital
Address:
City:
Guangzhou
Zip:
519041
Country:
China
Status:
Recruiting
Contact:
Last name:
Kun Wang, MD
Phone:
+86-020-83827812
Facility:
Name:
Sun Yat-sen University Cancer Center
Address:
City:
Guangdong
Zip:
510062
Country:
China
Status:
Recruiting
Contact:
Last name:
ShuSen Wang, MD
Phone:
+86-020-87343292
Facility:
Name:
Affiliated Hospital of Nantong University
Address:
City:
Nantong
Zip:
226006
Country:
China
Status:
Recruiting
Contact:
Last name:
ZhiXian He, MD
Phone:
+86-513-85052504
Contact backup:
Last name:
SuJie Ni, MD
Facility:
Name:
Northern Jiangsu People's Hospital
Address:
City:
Yangzhou
Zip:
225009
Country:
China
Status:
Recruiting
Contact:
Last name:
DeYuan Fu, MD
Phone:
+86-0514-87373114
Facility:
Name:
The First Hospital of China Medical University
Address:
City:
Shenyang
Zip:
110002
Country:
China
Status:
Recruiting
Contact:
Last name:
YueE Teng, MD
Phone:
+86-024-83283333
Contact backup:
Last name:
YingYing Xu, MD
Facility:
Name:
Liaoning Cancer Hospital & Institute
Address:
City:
Shenyang
Zip:
110801
Country:
China
Status:
Recruiting
Contact:
Last name:
Tao Shen, MD
Phone:
+86-024-81916684
Contact backup:
Last name:
Qiang Zhang, MD
Facility:
Name:
Fudan University Shanghai Cancer Center
Address:
City:
Shanghai
Zip:
200032
Country:
China
Status:
Recruiting
Contact:
Last name:
Zhi-Ming Shao, MD;PhD
Phone:
+862164175590
Facility:
Name:
Shanghai Sixth People's Hospital Affiliated to Shanghai Jiaotong University
Address:
City:
Shanghai
Zip:
200233
Country:
China
Status:
Recruiting
Contact:
Last name:
Zan Shen, MD
Phone:
+86-021-64369181
Facility:
Name:
Shanghai First Maternity and Infant Hospital
Address:
City:
Shanghai
Zip:
201204
Country:
China
Status:
Recruiting
Contact:
Last name:
ZhiGang Zhuang, MD
Phone:
+86-021-20261000
Facility:
Name:
The First Affiliated Hospital of Xi'an Jiaotong University
Address:
City:
Xi'an
Zip:
710061
Country:
China
Status:
Recruiting
Contact:
Last name:
Jin Yang, MD
Phone:
+86-029-85323217
Facility:
Name:
West China Hospital of Sichuan University
Address:
City:
Chengdu
Zip:
610041
Country:
China
Status:
Recruiting
Contact:
Last name:
Ting Luo, MD
Phone:
+86-028-85422114
Facility:
Name:
Ningbo Medical Center Lihuili Hospital
Address:
City:
Ningbo
Country:
China
Status:
Recruiting
Contact:
Last name:
WeiZhu Wu, MD
Phone:
+86-574-87018701
Start date:
June 1, 2023
Completion date:
May 31, 2031
Lead sponsor:
Agency:
Fudan University
Agency class:
Other
Source:
Fudan University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05891093
