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

NCT05891093 | Recruiting Phase 3

• 1 other identifier: SCHBCC-N056
• Study Type: interventional
• Target: 766
• Locations: 1 country
• Sites: 15

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.

Conditions

Breast Cancer

Keywords

fluzoparib; adjuvant treatment; SNF3-subtype

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• distant relapse free survival (DRFS)

  5 years

• overall survival (OS)

  5 years

• Adverse Effects

  5 years

• Number of participants with Patient Reported Outcome (PRO)

  5 years

Study Arms (2)

Fluzoparib+Endocrine Therapy

EXPERIMENTAL

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).

Drug: Fluzoparib; Drug: Anastrozole; Drug: Letrozole; Drug: Exemestane; Drug: Tamoxifen; Drug: Toremifene; Drug: Abemaciclib; Drug: LHRH agonist

Endocrine Therapy

ACTIVE COMPARATOR

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).

Drug: Anastrozole; Drug: Letrozole; Drug: Exemestane; Drug: Tamoxifen; Drug: Toremifene; Drug: Abemaciclib; Drug: LHRH agonist

Interventions

Fluzoparib DRUG

Fluzoparib 50mg bid orally for 1 year.

Fluzoparib+Endocrine Therapy

Anastrozole DRUG

1mg, qd orally

Endocrine Therapy; Fluzoparib+Endocrine Therapy

Letrozole DRUG

2.5mg, qd orally

Endocrine Therapy; Fluzoparib+Endocrine Therapy

Exemestane DRUG

25mg, qd orally

Endocrine Therapy; Fluzoparib+Endocrine Therapy

Tamoxifen DRUG

10mg, bid orally

Endocrine Therapy; Fluzoparib+Endocrine Therapy

Toremifene DRUG

60mg, qd orally

Endocrine Therapy; Fluzoparib+Endocrine Therapy

Abemaciclib DRUG

150mg/100mg/50mg, bid orally for 2 years

Endocrine Therapy; Fluzoparib+Endocrine Therapy

LHRH agonist DRUG

Leuprorelin acetate, goserelin acetate

Endocrine Therapy; Fluzoparib+Endocrine Therapy

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Has bilateral breast cancer;
• Has previous history of additional malignancy, with the exception of adequately treated basal cell carcinoma and cervical carcinoma in situ.
• Has metastatic (Stage 4) breast cancer;
• Is pregnant, is breast feeding women, or women of childbearing age who cannot practice effective contraceptives;
• Patients participating in other clinical trials at the same time;
• 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;
• Has known allergy to fluzoparib and excipients.
• Has severe or uncontrolled infection;
• Has a history of psychotropic substance abuse and were unable to abandon drug habits, or those with history of mental disorders;
• The researchers judged patients to be unsuitable for the study.

Sponsors & Collaborators

• Fudan University: lead

Study Sites (15)

Beijing Cancer Hospital

Beijing, Beijing Municipality, 100142, China

RECRUITING

Chongqing Cancer Hospital

Chongqing, Chongqing Municipality, 400030, China

RECRUITING

Fujian Medical University Union Hospital

Fuzhou, Fujian, 350001, China

RECRUITING

Guangdong Academy of Medical Sciences Guangdong Provincial People's Hospital

Guangzhou, Guangdong, 519041, China

RECRUITING

Sun Yat-sen University Cancer Center

Guangdong, Guangzhou, 510062, China

RECRUITING

Affiliated Hospital of Nantong University

Nantong, Jiangsu, 226006, China

RECRUITING

Northern Jiangsu People's Hospital

Yangzhou, Jiangsu, 225009, China

RECRUITING

The First Hospital of China Medical University

Shenyang, Liaoning, 110002, China

RECRUITING

Liaoning Cancer Hospital & Institute

Shenyang, Liaoning, 110801, China

RECRUITING

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

Shanghai Sixth People's Hospital Affiliated to Shanghai Jiaotong University

Shanghai, Shanghai Municipality, 200233, China

RECRUITING

Shanghai First Maternity and Infant Hospital

Shanghai, Shanghai Municipality, 201204, China

RECRUITING

The First Affiliated Hospital of Xi'an Jiaotong University

Xi’an, Shanxi, 710061, China

RECRUITING

West China Hospital of Sichuan University

Chengdu, Sichuan, 610041, China

RECRUITING

Ningbo Medical Center Lihuili Hospital

Ningbo, Zhejiang, China

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Interventions

fluzoparib; Anastrozole; Letrozole; exemestane; Tamoxifen; Toremifene; abemaciclib; Gonadotropin-Releasing Hormone

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Nitriles; Organic Chemicals; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Stilbenes; Benzylidene Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins

Central Study Contacts

Zhimin Shao, MD, PhD

CONTACT

+86-021-64175590; zhimingshao@yahoo.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician

Study Record Dates

• First Submitted: May 24, 2023
• First Posted: June 6, 2023
• Study Start: June 1, 2023
• Primary Completion (Estimated): May 31, 2028
• Study Completion (Estimated): May 31, 2031
• Last Updated: February 8, 2024

Record last verified: 2024-02

Locations

CN (15)