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Efficacy and Safety of Fluzoparib Combined With Adjuvant Endocrine Therapy for HR+/HER2- SNF3-subtype Early Breast Cancer (BCTOP-L-A01) Phase 3 766 Randomized Open-Label

Recruiting
Clinical Trial NCT05891093 is designed to study Treatment for Breast Cancer. It is a Phase 3 interventional study that is recruiting, having started on 1 June 2023, with plans to enroll 766 participants. Led by Fudan University, it is expected to complete by 31 May 2031. The latest data from ClinicalTrials.gov was last updated on 8 February 2024.
Brief 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 alg...

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Official Title

A Prospective, Randomized, Open-label Phase III Clinical Study of the Efficacy and Safety of Fluzoparib Combined With Adjuvant Endocrine Therapy Versus Adjuvant Endocrine Therapy for HR+/HER2- SNF3-subtype Early Breast Cancer (BCTOP-L-A01)

Conditions
Breast Cancer
Other Study IDs
  • SCHBCC-N056
NCT ID Number
NCT05891093
Start Date (Actual)
2023-06-01
Last Update Posted
2024-02-08
Completion Date (Estimated)
2031-05-31
Enrollment (Estimated)
766
Study Type
Interventional
PHASE
Phase 3
Status
Recruiting
Keywords
fluzoparib
adjuvant treatment
SNF3-subtype
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Parallel
Masking
None (Open Label)
Arms / Interventions
Participant Group/ArmIntervention/Treatment
ExperimentalFluzoparib+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
Active ComparatorEndocrine 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
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
invasive disease free survival (iDFS)
defined as occurrence of any of the following: ipsilateral invasive breast cancer recurrence, regional invasive breast cancer recurrence, distant recurrence, death attributable to any cause, contralateral invasive breast cancer, or second non-breast invasive cancer.In-situ events are not included.
5 years
Secondary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
distant relapse free survival (DRFS)
the time from operation to the first distant recurrence, and the cases of death without distant recurrence was censored at the time of the death
5 years
overall survival (OS)
the time from treatment to death, regardless of disease recurrence
5 years
Adverse Effects
an undesired harmful effect resulting from a medication or other intervention
5 years
Number of participants with Patient Reported Outcome (PRO)
a health outcome directly reported by the patient who experienced it.
5 years
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
Female
  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.

  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.
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Study Responsible Party
Zhimin Shao, Principal Investigator, Chief Physician, Fudan University
Study Central Contact
Contact: Zhimin Shao, MD, PhD, +86-021-64175590, [email protected]
15 Study Locations in 1 Countries

Beijing Municipality

Beijing Cancer Hospital, Beijing, Beijing Municipality, 100142, China
HuiPing Li, MD, Contact, +86-010-88121122
Recruiting

Chongqing Municipality

Chongqing Cancer Hospital, Chongqing, Chongqing Municipality, 400030, China
Xiaohua Zeng, MD, Contact, +86-023-65311341
Recruiting

Fujian

Fujian Medical University Union Hospital, Fuzhou, Fujian, 350001, China
ChuanGui Song, MD, Contact, +86-591-83357896
Recruiting

Guangdong

Guangdong Academy of Medical Sciences Guangdong Provincial People's Hospital, Guangzhou, Guangdong, 519041, China
Kun Wang, MD, Contact, +86-020-83827812
Recruiting

Guangzhou

Sun Yat-sen University Cancer Center, Guangdong, Guangzhou, 510062, China
ShuSen Wang, MD, Contact, +86-020-87343292
Recruiting

Jiangsu

Affiliated Hospital of Nantong University, Nantong, Jiangsu, 226006, China
ZhiXian He, MD, Contact, +86-513-85052504
SuJie Ni, MD, Contact
Recruiting
Northern Jiangsu People's Hospital, Yangzhou, Jiangsu, 225009, China
DeYuan Fu, MD, Contact, +86-0514-87373114
Recruiting

Liaoning

The First Hospital of China Medical University, Shenyang, Liaoning, 110002, China
YueE Teng, MD, Contact, +86-024-83283333
YingYing Xu, MD, Contact
Recruiting
Liaoning Cancer Hospital & Institute, Shenyang, Liaoning, 110801, China
Tao Shen, MD, Contact, +86-024-81916684
Qiang Zhang, MD, Contact
Recruiting

Shanghai Municipality

Fudan University Shanghai Cancer Center, Shanghai, Shanghai Municipality, 200032, China
Zhi-Ming Shao, MD;PhD, Contact, +862164175590
Recruiting
Shanghai Sixth People's Hospital Affiliated to Shanghai Jiaotong University, Shanghai, Shanghai Municipality, 200233, China
Zan Shen, MD, Contact, +86-021-64369181
Recruiting
Shanghai First Maternity and Infant Hospital, Shanghai, Shanghai Municipality, 201204, China
ZhiGang Zhuang, MD, Contact, +86-021-20261000
Recruiting

Shanxi

The First Affiliated Hospital of Xi'an Jiaotong University, Xi’an, Shanxi, 710061, China
Jin Yang, MD, Contact, +86-029-85323217
Recruiting

Sichuan

West China Hospital of Sichuan University, Chengdu, Sichuan, 610041, China
Ting Luo, MD, Contact, +86-028-85422114
Recruiting

Zhejiang

Ningbo Medical Center Lihuili Hospital, Ningbo, Zhejiang, China
WeiZhu Wu, MD, Contact, +86-574-87018701
Recruiting