Comparing hormone therapy and chemotherapy for premenopausal women with certain breast cancers

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to evaluate whether neoadjuvant endocrine therapy is as effective as chemotherapy for premenopausal patients with estrogen receptor-positive and HER2-negative breast cancer. Participants will receive either a combination of goserelin, tamoxifen, and aromatase inhibitors or a regimen of epirubicin, cyclophosphamide, and 5-fluorouracil. The primary outcome will be assessed through ultrasound response rates to determine the efficacy of the treatments. The study focuses on patients who are not candidates for breast-conserving surgery due to tumor size.

Why it matters

Who can join: the full rules

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 feasible or may affect the appearance of breast)
* Histologically confirmed HR+ (ER or PR positive, and \>50% cell in IHC) HER2 negative breast cancer by pathological evaluation
* No other previous treatment for primary breast cancer
* Without other tumor or unstable complication or uncontrolled infection
* No contradiction for the third generation AIs, LHRHa, chemotherapy
* Attend the study voluntarily, sign the informed consent.

Exclusion Criteria:

* Metastasis disease by pathological or radiological diagnosis
* the history of other tumor
* contradiction for the third generation AIs, LHRHa, chemotherapy
* Contradiction for adjuvant chemotherapy: serious cardiology or cerebral vessel disease, liver or kidney disfunction, blood system disease, the other situation or complication that are not suitable or cannot adaptable for chemotherapy
* Contradiction for proceeding surgery: contradiction for anesthesia, large lesion,T4, lymph node positive
* other situation not suitable for the research: psychological disease, mental disorder, social problem, geographic problem
* have been attendance in other anti-tumor treatment or other clinical trials 8) reject to attend the study

Where it's running

• Beijing Cancer Hospital Breast Center
  Beijing, China Recruiting

Study contacts

• Study coordinator: Tao Ouyang, MD
• Email: ouyanghongtao@263.net

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.