Fluzoparib with Hormone Therapy for Early Breast Cancer

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

Recruiting Phase 3 Interventional Study
Breast Cancer
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
Ready to participate?

Review the details below, then apply to join this clinical trial.

At a Glance
Age
18 – 70
Sex
Female
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
766 (estimated)
Sponsor
Fudan University · Other
Who this trial is looking for

This trial is looking for women with early breast cancer who have had surgery. Participants will receive a drug called fluzoparib along with hormone therapy, and they will be monitored for safety and effectiveness.

Are You a Good Fit for This Trial?

You may be able to join if

  • I am a woman aged 18-70 years old.
  • I have been diagnosed with HR+/HER2- early breast cancer.
  • I have had surgery for my breast cancer.
  • I have received chemotherapy before.
  • I can take medication by mouth.
  • I am willing to use effective contraception during the study.
  • I have good organ function.
  • I am available for follow-up.

You may not be able to join if

  • I have bilateral breast cancer.
  • I have had another type of cancer before, except for treated skin cancer.
  • I have metastatic breast cancer.
  • I am pregnant or breastfeeding.
  • I have a severe heart or kidney problem.
  • I have an allergy to fluzoparib.
  • I currently have a serious infection.
  • I have a history of substance abuse or mental disorders.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

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About This Trial

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.

Trial Locations
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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 st…
Contacts

Zhimin Shao, MD, PhD

+86-021-64175590

zhimingshao@yahoo.com

CONTACT