Endocrine Therapy vs Chemotherapy for Breast Cancer

Neoadjuvant Endocrine Therapy Versus Chemotherapy in Premenopausal Patients With ER+ & HER2- Breast Cancer

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.
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At a Glance
Age
35 – 55
Sex
Female
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
234 (estimated)
Sponsor
Peking University · Other
Who this trial is looking for

This trial is looking for premenopausal women with certain types of breast cancer. Participation involves receiving either endocrine therapy or chemotherapy and regular check-ups to see how the treatment is working.

Are You a Good Fit for This Trial?

You may be able to join if

  • I am a woman aged 35 to 55 years old and premenopausal.
  • I have been diagnosed with primary invasive breast cancer.
  • My breast cancer is HR+ (hormone receptor positive) and HER2 negative.
  • I have T2N0M0 stage breast cancer that makes surgery difficult.
  • I have not received any other treatment for my breast cancer.
  • I do not have any other tumors or uncontrolled infections.
  • I am willing to participate and will sign the informed consent.

You may not be able to join if

  • I have metastatic breast cancer.
  • I have a history of another type of tumor.
  • I have serious heart or brain vessel problems.
  • I have liver or kidney dysfunction.
  • I have blood system diseases.
  • I have a psychological condition or mental disorder.
  • I am involved in another clinical trial.
  • I do not wish to participate in the study.

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 study proposes to prove that the efficacy of adjuvant endocrine therapy for the premenopausal HR positive breast cancer patients is non-inferiority to adjuvant chemotherapy assessed by ultrasound response rate.

Trial Locations
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Eligibility Criteria
Inclusion Criteria: * 35 years old \<age≤55 years old, in premenopausal status(with the judgement by researchers when the patients are recruited) Histologically confirmed primary invasive breast cancer * Stage: T2N0M0(cT\>2cm, SLNB negative), hard to proceed the breast conserving surgery(not feasib…
Contacts

Tao Ouyang, MD

ouyanghongtao@263.net

CONTACT