Combining fluzoparib with hormone therapy for early breast cancer

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)

This study is testing if adding a new drug called fluzoparib to hormone therapy can help women with a specific type of early breast cancer do better after surgery.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 766 (estimated)
• Ages: 18 Years to 70 Years
• Sex: Female
• Sponsor: Fudan University (Academic / other)
• Drugs / interventions: chemotherapy
• Locations: 15 sites (Beijing, Beijing Municipality and 14 other locations)
• Trial ID: NCT05891093 on ClinicalTrials.gov

What this trial studies

This phase III clinical study evaluates the efficacy and safety of fluzoparib when combined with adjuvant endocrine therapy compared to endocrine therapy alone in women with HR+/HER2- SNF3-subtype early breast cancer. A total of 766 patients who have undergone surgery and have been classified as SNF3 subtype will be enrolled. The study involves molecular typing of primary tumors and random assignment to treatment groups. The goal is to determine if the addition of fluzoparib improves outcomes for these patients.

Who should consider this trial

Good fit: Ideal candidates are women aged 18-70 with HR+/HER2- SNF3-subtype early breast cancer who have undergone surgery.

Not a fit: Patients with other breast cancer subtypes or those who have not undergone surgery may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a more effective option for women with early breast cancer, potentially improving survival rates.

How similar studies have performed: Other studies have shown promise in combining targeted therapies with endocrine treatments, suggesting potential for success in this approach.

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.

Where this trial is running

Beijing, Beijing Municipality and 14 other locations

• Beijing Cancer Hospital — Beijing, Beijing Municipality, China (Recruiting)
• Chongqing Cancer Hospital — Chongqing, Chongqing Municipality, China (Recruiting)
• Fujian Medical University Union Hospital — Fuzhou, Fujian, China (Recruiting)
• Guangdong Academy of Medical Sciences Guangdong Provincial People's Hospital — Guangzhou, Guangdong, China (Recruiting)
• Sun Yat-sen University Cancer Center — Guangdong, Guangzhou, China (Recruiting)
• Affiliated Hospital of Nantong University — Nantong, Jiangsu, China (Recruiting)
• Northern Jiangsu People's Hospital — Yangzhou, Jiangsu, China (Recruiting)
• The First Hospital of China Medical University — Shenyang, Liaoning, China (Recruiting)
• Liaoning Cancer Hospital & Institute — Shenyang, Liaoning, China (Recruiting)
• Fudan University Shanghai Cancer Center — Shanghai, Shanghai Municipality, China (Recruiting)
• Shanghai Sixth People's Hospital Affiliated to Shanghai Jiaotong University — Shanghai, Shanghai Municipality, China (Recruiting)
• Shanghai First Maternity and Infant Hospital — Shanghai, Shanghai Municipality, China (Recruiting)
• The First Affiliated Hospital of Xi'an Jiaotong University — Xi’an, Shanxi, China (Recruiting)
• West China Hospital of Sichuan University — Chengdu, Sichuan, China (Recruiting)
• Ningbo Medical Center Lihuili Hospital — Ningbo, Zhejiang, China (Recruiting)

Study contacts

• Study coordinator: Zhimin Shao, MD, PhD

Conditions Breast Cancer; fluzoparib; adjuvant treatment; SNF3-subtype