Adjuvant Ovarian Suppression Plus Aromatase Inhibitor or Tamoxifen in Young Women

  • STATUS
    Recruiting
  • End date
    Dec 21, 2025
  • participants needed
    680
  • sponsor
    First Affiliated Hospital, Sun Yat-Sen University
Updated on 21 January 2021
endocrine therapy
metastasis
hormone therapy
immunohistochemistry
tamoxifen
aromatase inhibitor
invasive breast cancer
adjuvant chemotherapy
immunostimulant

Summary

The objective of this study is to compare the curative effects in patients under the age of 35 with hormone receptor positive breast cancer and high recurrent risk factors including large tumor or metastatic lymph nodes randomized to ovarian function suppression (OFS) plus aromatase inhibitors or OFS plus tamoxifen as adjuvant endocrine therapy, and explore the differences of curative effects between different subtypes to provide direct evidence for treatments of young breast cancer patients.

Details
Condition Breast Cancer, Breast Cancer Diagnosis, breast carcinoma, cancer, breast
Treatment Goserelin, tamoxifen, Aromatase Inhibitors
Clinical Study IdentifierNCT02914158
SponsorFirst Affiliated Hospital, Sun Yat-Sen University
Last Modified on21 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age less than or equal to 35 yrs?
Are you female?
Do you have Breast Cancer?
Do you have any of these conditions: breast carcinoma or cancer, breast or Breast Cancer or Breast Cancer Diagnosis?
Signed informed consent
Eastern Cooperative Oncology Group (ECOG) performance status 2
Patients pathologically diagnosed with hormone receptor positive invasive breast cancer: immunohistochemistry ER positive (1%)
Premenopausal patients with age 35 years (at least menstruate once for prior 3 months, assess menstruation situation before chemotherapy if have)
No distant metastasis
Clinical stage (TNM) meets at least one of the conditions as follow: T2cm or at least one region of regional lymph node metastasis (including micrometastases)
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
Indexes of hematology and biochemistry conform to following standards: HGB10g/dl, WBC4,000/mm3, PLT100,000/mm3, GOT, GPT, ALP2xULN, TBIL, DBIL, CCr1.5xULN

Exclusion Criteria

Pregnant or lactating women or women of childbearing potential reject contraceptive measures
History of organ transplantation (including autologous bone marrow transplantation and peripheral stem cell transplantation)
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
Prior use of neo-adjuvant chemotherapy after a definite diagnosis
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
Serious hepatopathy (e.g., cirrhosis, etc.), nephropathy, respiratory illness, digestive illness or poorly controlled diabetes
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
Concurrent treatment in another investigational trial
Sensitivity or contraindication to any of the study medications
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