Clinical trial · Interventional
Neoadjuvant Endocrine Therapy Versus Chemotherapy in Premenopausal Patients With ER+ & HER2- Breast Cancer
Randomized Trial of Neoadjuvant Endocrine Therapy Versus Chemotherapy in Premenopausal Patients With Estrogen Receptor-Positive HER2 Negative Breast Cancer
NCT02535221CI-TRIAL-00055264recruitingPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Epirubicin+CTX+5-Fu | Drug | — | UNRESOLVED |
| Goserelin+TAM+AI | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Endocrine therapy;
- description
- Interventions：Goserelin+TAM+AI：Goserelin 3.6mg subcutaneous injection per 4 weeks, for 16-20weeks. TAM 10mg oral twice a day for the first four weeks(to wait the Goserelin start to work in body) than change to AI 1mg oral once a day with Goserelin for the next 12-16 weeks.
- interventionNames
- Drug: Goserelin+TAM+AI
- type
- ACTIVE_COMPARATOR
- label
- Chemotherapy
- description
- Interventions：Epirubicin+CTX+5-Fu：Epirubicin(80-100 mg/m2 Q21 days) + CTX(600 mg/m2 Q 21days) + 5-Fu (600 mg/m2 Q21 days or 200 mg/m2 •day from Day1 to day 21) for four to six cycles.
- interventionNames
- Drug: Epirubicin+CTX+5-Fu
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 35 Years
- Maximum age
- 55 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDGu C, He Y, Zhang N, Liu Y, Li J, Wang T, Fan T, Fan Z, Ouyang T. A Non-Inferior Randomized Trial of Neoadjuvant Endocrine Therapy Compared to Neoadjuvant Chemotherapy in Premenopausal Patients With Hormone-Responsive and HER2-Negative Lymph Node-Negative Breast Cancer. Cancer Control. 2025 Jan-Dec;32:10732748251339958. doi: 10.1177/10732748251339958. Epub 2025 May 7. PMID 40331570