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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)

Status: Recruiting
Location: See all (15) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:

• Women aged 18-70 years old;

• ECOG score 0 or 1;

• 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;

• Postoperative pathological stage T2-4N0-3M0;

• Patients who have previously received neoadjuvant chemotherapy and/or adjuvant chemotherapy;

• Time of randomization from surgery does not exceed 16 months;

• Time of endocrine therapy from last non-endocrine anti-tumor treatment does not exceed 12 weeks;

• 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);

• 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;

⁃ 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);

⁃ Patients can take medication orally on their own;

⁃ Female subjects with fertility are required to use a medically approved contraceptive method during the study treatment

⁃ 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.

Locations
Other Locations
China
Beijing Cancer Hospital
RECRUITING
Beijing
West China Hospital of Sichuan University
RECRUITING
Chengdu
Chongqing Cancer Hospital
RECRUITING
Chongqing
Fujian Medical University Union Hospital
RECRUITING
Fuzhou
Sun Yat-sen University Cancer Center
RECRUITING
Guangdong
Guangdong Academy of Medical Sciences Guangdong Provincial People's Hospital
RECRUITING
Guangzhou
Affiliated Hospital of Nantong University
RECRUITING
Nantong
Ningbo Medical Center Lihuili Hospital
RECRUITING
Ningbo
Fudan University Shanghai Cancer Center
RECRUITING
Shanghai
Shanghai First Maternity and Infant Hospital
RECRUITING
Shanghai
Shanghai Sixth People's Hospital Affiliated to Shanghai Jiaotong University
RECRUITING
Shanghai
Liaoning Cancer Hospital & Institute
RECRUITING
Shenyang
The First Hospital of China Medical University
RECRUITING
Shenyang
The First Affiliated Hospital of Xi'an Jiaotong University
RECRUITING
Xi’an
Northern Jiangsu People's Hospital
RECRUITING
Yangzhou
Contact Information
Primary
Zhimin Shao, MD, PhD
zhimingshao@yahoo.com
+86-021-64175590
Time Frame
Start Date: 2023-06-01
Estimated Completion Date: 2031-05-31
Participants
Target number of participants: 766
Treatments
Experimental: 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).
Active_comparator: 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).
Related Therapeutic Areas
Sponsors
Leads: Fudan University

This content was sourced from clinicaltrials.gov

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