Adjuvant Ovarian Suppression Plus Aromatase Inhibitor or Tamoxifen in Young Women

Last updated: January 12, 2023
Sponsor: First Affiliated Hospital, Sun Yat-Sen University
Overall Status: Active - Recruiting

Phase

3

Condition

Cancer

Breast Cancer

Treatment

N/A

Clinical Study ID

NCT02914158
20160818GD
  • Ages < 35
  • Female

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Signed informed consent;
  2. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2;
  3. Patients pathologically diagnosed with hormone receptor positive invasive breastcancer: immunohistochemistry ER positive (≥1%);
  4. Premenopausal patients with age ≤35 years (at least menstruate once for prior 3months, 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 leastone region of regional lymph node metastasis (including micrometastases);
  7. Patients must have undergone a surgery and (neo)adjuvant chemotherapy, targetedtherapy, radiotherapy (if necessary) according to Chinese Anti-Cancer Associationguidelines and specifications version 2015 for diagnosis and treatment of breastcancer;
  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

Exclusion Criteria:

  1. Pregnant or lactating women or women of childbearing potential reject contraceptivemeasures;
  2. History of organ transplantation (including autologous bone marrow transplantation andperipheral stem cell transplantation);
  3. Concurrent malignancies or history of non-breast malignancies within the 5 years priorto study entry, except for curatively treated basal cell and squamous cell carcinomasof the skin, carcinoma in situ of the cervix; peripheral nervous system disorderscaused 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 wouldaffect patients right to consent and compliance, or make patients in criticalcondition;
  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 congestiveheart failure, coronary atherosclerotic heart disease with obvious symptoms,arrhythmia difficult to control by drugs, or history of myocardial infarction withinthe 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.

Study Design

Total Participants: 680
Study Start date:
March 30, 2016
Estimated Completion Date:
December 31, 2025

Connect with a study center

  • First People's Hospital of FoShan City

    FoShan, Guangdong 528000
    China

    Site Not Available

  • Cancer Hospital Chinese Academy of Medical Sciences

    Beijing,
    China

    Site Not Available

  • Peking University First Hospital

    Beijing,
    China

    Site Not Available

  • Dongguan People's Hospital

    Dongguan,
    China

    Active - Recruiting

  • GuangDong Hospital Of Traditional Chinese Medicine

    Guangzhou,
    China

    Active - Recruiting

  • Guangdong People's Hospital

    Guangzhou,
    China

    Site Not Available

  • Guangdong Provincial Women and Children's Hospital

    Guangzhou,
    China

    Active - Recruiting

  • Guangzhou First Municipal People's Hospital

    Guangzhou,
    China

    Active - Recruiting

  • Guangzhou Women and Childrens Medical Center

    Guangzhou,
    China

    Active - Recruiting

  • Sun Yat-sen Memorial Hospital, Sun Yat-sen University

    Guangzhou,
    China

    Active - Recruiting

  • Sun Yat-sen University Cancer Center

    Guangzhou,
    China

    Active - Recruiting

  • The Second Affiliated Hospital of Guangzhou Medical University

    Guangzhou,
    China

    Active - Recruiting

  • Guilin TCMhospital of China

    Guilin,
    China

    Active - Recruiting

  • Zhejiang Provincial People's Hospital

    Hangzhou,
    China

    Site Not Available

  • Harbin Medical University Cancer Hospital

    Harbin,
    China

    Active - Recruiting

  • Yunnan Cancer Hospital

    Kunming,
    China

    Site Not Available

  • Maoming People's Hospital

    Maoming,
    China

    Active - Recruiting

  • The first Affiliated Hospital of Guangxi Medical University

    Nanning,
    China

    Active - Recruiting

  • The Affiliated Hospital of Qingdao University

    Qingdao,
    China

    Site Not Available

  • The First Affiliated Hospital of Wenzhou Medical University

    Wenzhou,
    China

    Site Not Available

  • Affiliated hospital of Guangdong Medicine College

    Zhanjiang,
    China

    Active - Recruiting

  • Lian Jiang People' s Hospital

    Zhanjiang,
    China

    Active - Recruiting

  • Henan Cancer Hospital

    Zhengzhou,
    China

    Site Not Available

  • Zhongshan People's Hospital

    Zhongshan,
    China

    Active - Recruiting

  • The Fifth Affiliated Hospital Sun Yat-Sen University

    Zhuhai,
    China

    Active - Recruiting

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