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Ovarian suppression with hormone therapy for young women with breast cancer

Adjuvant Ovarian Suppression Plus Aromatase Inhibitor or Tamoxifen for Hormone Receptor-Positive Breast Cancer in Women Younger Than 35: A Multicenter Randomized Clinical Trial

Phase 3 Interventional First Affiliated Hospital, Sun Yat-Sen University · NCT02914158

This study is testing if combining ovarian suppression with either aromatase inhibitors or tamoxifen helps young women under 35 with hormone receptor positive breast cancer reduce their risk of recurrence after surgery and chemotherapy.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment680 (estimated)
AgesN/A to 35 Years
SexFemale
SponsorFirst Affiliated Hospital, Sun Yat-Sen University Academic / other
Drugs / interventionschemotherapy
Locations25 sites (Beijing and 24 other locations)
Trial IDNCT02914158 on ClinicalTrials.gov

What this trial studies

This study aims to compare the effectiveness of ovarian function suppression combined with either aromatase inhibitors or tamoxifen in young women under 35 years old who have hormone receptor positive breast cancer with high recurrence risks. Participants will be randomized to receive one of the two treatment regimens as adjuvant endocrine therapy following surgery and chemotherapy. The study seeks to provide evidence on the differences in treatment outcomes based on breast cancer subtypes in this specific patient population.

Who should consider this trial

Good fit: Ideal candidates are premenopausal women aged 35 or younger with hormone receptor positive invasive breast cancer and high recurrence risk factors.

Not a fit: Patients with distant metastasis or those who do not meet the specific inclusion criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to more effective treatment options for young women with hormone receptor positive breast cancer.

How similar studies have performed: Other studies have shown promise in using ovarian suppression combined with hormone therapies for breast cancer, indicating a potential for success in this approach.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

1. Signed informed consent;
2. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2;
3. Patients pathologically diagnosed with hormone receptor positive invasive breast cancer: immunohistochemistry ER positive (≥1%);
4. Premenopausal patients with age ≤35 years (at least menstruate once for prior 3 months, assess menstruation situation before chemotherapy if have);
5. No distant metastasis;
6. Clinical stage (TNM) meets at least one of the conditions as follow: T≥2cm or at least one region of regional lymph node metastasis (including micrometastases);
7. Patients must have undergone a surgery and (neo)adjuvant chemotherapy, targeted therapy, radiotherapy (if necessary) according to Chinese Anti-Cancer Association guidelines and specifications version 2015 for diagnosis and treatment of breast cancer;
8. Indexes of hematology and biochemistry conform to following standards: HGB≥10g/dl, WBC≥4,000/mm3, PLT≥100,000/mm3, GOT, GPT, ALP≤2xULN, TBIL, DBIL, CCr≤1.5xULN.

Exclusion Criteria:

1. Pregnant or lactating women or women of childbearing potential reject contraceptive measures;
2. History of organ transplantation (including autologous bone marrow transplantation and peripheral stem cell transplantation);
3. Concurrent malignancies or history of non-breast malignancies within the 5 years prior to study entry, except for curatively treated basal cell and squamous cell carcinomas of the skin, carcinoma in situ of the cervix; peripheral nervous system disorders caused by diseases or history of obvious mental and central nervous system disorders;
4. Prior use of neo-adjuvant chemotherapy after a definite diagnosis;
5. Nervous system disorders caused by diseases or obvious mental disorder, which would affect patients right to consent and compliance, or make patients in critical condition;
6. Serious hepatopathy (e.g., cirrhosis, etc.), nephropathy, respiratory illness, digestive illness or poorly controlled diabetes;
7. Cardiac illness with obvious abnormal EKG or clinical symptoms, namely congestive heart failure, coronary atherosclerotic heart disease with obvious symptoms, arrhythmia difficult to control by drugs, or history of myocardial infarction within the 12 months prior to study entry or class III/IV of cardiac function;
8. Concurrent treatment in another investigational trial;
9. Sensitivity or contraindication to any of the study medications.

Where this trial is running

Beijing and 24 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Breast Cancerbreast cancerovarian function suppressionaromatase inhibitors（AIs）tamoxifen（TAM）
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.