Comparing hormone therapy and chemotherapy for premenopausal women with certain breast cancers
Randomized Trial of Neoadjuvant Endocrine Therapy Versus Chemotherapy in Premenopausal Patients With Estrogen Receptor-Positive HER2 Negative Breast Cancer
This study is testing whether hormone therapy can work as well as chemotherapy for premenopausal women with certain types of breast cancer that can't be treated with surgery.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 234 (estimated) |
| Ages | 35 Years to 55 Years |
| Sex | Female |
| Sponsor | Peking University Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Beijing) |
| Trial ID | NCT02535221 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are premenopausal women aged 35 to 55 with histologically confirmed HR-positive, HER2-negative breast cancer that is not amenable to breast-conserving surgery.
Not a fit: Patients with metastatic disease or those with contraindications to the treatments being tested will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a less toxic treatment option for premenopausal women with HR-positive breast cancer.
How similar studies have performed: Previous studies have shown promising results for endocrine therapy in similar patient populations, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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 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 this trial is running
Beijing
- Beijing Cancer Hospital Breast Center — Beijing, China (Recruiting)
Study contacts
- Study coordinator: Tao Ouyang, MD
- Email: ouyanghongtao@263.net
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.