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Breast CancerPhase 3NCT05891093

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

A Phase 3 study testing Fluzoparib, Anastrozole and Letrozole in people with Breast Cancer, run by Fudan University at 15 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 70 years, women only
Conditions the study is for
Breast Cancer
What is being tested?
Fluzoparib, Anastrozole and Letrozole
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
766 participants
Where
15 sitesChina
Study dates
1 Jun 2023to 31 May 2031
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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;
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  • 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.

Who cannot join

  • 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;
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  • 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.

Trial locations and contacts

15 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Zhimin Shao, MD, PhD contact

+86-021-64175590 ext. 8808

zhimingshao@yahoo.com

15 sites in 1 country

China15 sites, 15 recruiting

  • Beijing Cancer Hospital

    Beijing, Beijing Municipality, 100142

    HuiPing Li, MD, +86-010-88121122

    Recruiting

  • West China Hospital of Sichuan University

    Chengdu, Sichuan, 610041

    Ting Luo, MD, +86-028-85422114

    Recruiting

  • Chongqing Cancer Hospital

    Chongqing, Chongqing Municipality, 400030

    Xiaohua Zeng, MD, +86-023-65311341

    Recruiting

  • Fujian Medical University Union Hospital

    Fuzhou, Fujian, 350001

    ChuanGui Song, MD, +86-591-83357896

    Recruiting

  • Sun Yat-sen University Cancer Center

    Guangdong, Guangzhou, 510062

    ShuSen Wang, MD, +86-020-87343292

    Recruiting

  • Guangdong Academy of Medical Sciences Guangdong Provincial People's Hospital

    Guangzhou, Guangdong, 519041

    Kun Wang, MD, +86-020-83827812

    Recruiting

  • Affiliated Hospital of Nantong University

    Nantong, Jiangsu, 226006

    ZhiXian He, MD, +86-513-85052504

    SuJie Ni, MD

    Recruiting

  • Ningbo Medical Center Lihuili Hospital

    Ningbo, Zhejiang

    WeiZhu Wu, MD, +86-574-87018701

    Recruiting

  • Fudan University Shanghai Cancer Center

    Shanghai, Shanghai Municipality, 200032

    Zhi-Ming Shao, MD;PhD, +862164175590

    Recruiting

  • Shanghai Sixth People's Hospital Affiliated to Shanghai Jiaotong University

    Shanghai, Shanghai Municipality, 200233

    Zan Shen, MD, +86-021-64369181

    Recruiting

  • Shanghai First Maternity and Infant Hospital

    Shanghai, Shanghai Municipality, 201204

    ZhiGang Zhuang, MD, +86-021-20261000

    Recruiting

  • The First Hospital of China Medical University

    Shenyang, Liaoning, 110002

    YueE Teng, MD, +86-024-83283333

    YingYing Xu, MD

    Recruiting

  • Liaoning Cancer Hospital & Institute

    Shenyang, Liaoning, 110801

    Tao Shen, MD, +86-024-81916684

    Qiang Zhang, MD

    Recruiting

  • The First Affiliated Hospital of Xi'an Jiaotong University

    Xi’an, Shanxi, 710061

    Jin Yang, MD, +86-029-85323217

    Recruiting

  • Northern Jiangsu People's Hospital

    Yangzhou, Jiangsu, 225009

    DeYuan Fu, MD, +86-0514-87373114

    Recruiting

Other trials in China

About this study

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)

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.

Read the 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.

Conditions
Breast Cancer
Being tested
Fluzoparib, Anastrozole, Letrozole, Exemestane, Tamoxifen
Keywords
fluzoparib, adjuvant treatment, SNF3-subtype
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • FluzoparibDrug

    Fluzoparib 50mg bid orally for 1 year.

  • AnastrozoleDrug

    1mg, qd orally

  • LetrozoleDrug

    2.5mg, qd orally

  • ExemestaneDrug

    25mg, qd orally

  • TamoxifenDrug

    10mg, bid orally

  • ToremifeneDrug

    60mg, qd orally

  • AbemaciclibDrug

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

  • LHRH agonistDrug

    Leuprorelin acetate, goserelin acetate

Study groups in NCT05891093
Study groupRoleWhat they receive
Fluzoparib+Endocrine TherapyExperimentalFluzoparib 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).
Receives: Drug: Fluzoparib; Drug: Anastrozole; Drug: Letrozole; Drug: Exemestane; Drug: Tamoxifen; Drug: Toremifene; Drug: Abemaciclib; Drug: LHRH agonist
Endocrine TherapyActive comparatorPhysician'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).
Receives: Drug: Anastrozole; Drug: Letrozole; Drug: Exemestane; Drug: Tamoxifen; Drug: Toremifene; Drug: Abemaciclib; Drug: LHRH agonist

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 5 years

Secondary outcomes (4)

  1. 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

    Measured: 5 years

  2. overall survival (OS)

    the time from treatment to death, regardless of disease recurrence

    Measured: 5 years

  3. Adverse Effects

    an undesired harmful effect resulting from a medication or other intervention

    Measured: 5 years

  4. Number of participants with Patient Reported Outcome (PRO)

    a health outcome directly reported by the patient who experienced it.

    Measured: 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Jun 2023
  2. Study start1 Jun 2023
  3. Primary completion31 May 2028 (estimated)
  4. Study completion31 May 2031 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
766 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05891093
Sponsor's protocol ID
SCHBCC-N056
Status last verified
Feb 2024
First submitted
24 May 2023
Last updated
8 Feb 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Fluzoparib, Anastrozole and Letrozole in people with Breast Cancer, run by Fudan University at 15 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 8 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Zhimin Shao, MD, PhD (+86-021-64175590 ext. 8808, zhimingshao@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

invasive disease free survival (iDFS) (time frame: 5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05891093.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2024.

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