Adjuvant Ovarian Suppression Plus Aromatase Inhibitor or Tamoxifen in Young Women (ASPAIT)

January 12, 2023 updated by: Ying Lin, First Affiliated Hospital, Sun Yat-Sen University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

680

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
      • Beijing, China
        • Active, not recruiting
        • Cancer Hospital Chinese Academy of Medical Sciences
      • Beijing, China
        • Active, not recruiting
        • Peking University First Hospital
      • Dongguan, China
        • Recruiting
        • Dongguan people's hospital
        • Contact:
          • Ailing Zhang
      • Guangzhou, China
        • Recruiting
        • Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
        • Contact:
          • Yao H Rui
      • Guangzhou, China
        • Recruiting
        • Sun Yat-sen University Cancer Center
        • Contact:
          • Yuan Z Yu
      • Guangzhou, China
        • Recruiting
        • Guangdong Hospital of Traditional Chinese Medicine
        • Contact:
          • Qianjun Chen
      • Guangzhou, China
        • Active, not recruiting
        • Guangdong People's Hospital
      • Guangzhou, China
        • Recruiting
        • Guangdong Provincial Women and Children's Hospital
        • Contact:
          • Zhang A Qin
      • Guangzhou, China
        • Recruiting
        • Guangzhou First Municipal People's Hospital
        • Contact:
          • Li Zhao
      • Guangzhou, China
        • Recruiting
        • Guangzhou Women and Childrens Medical Center
        • Contact:
          • Hongming Ma
      • Guangzhou, China
        • Recruiting
        • the Second Affiliated Hospital of Guangzhou Medical University
        • Contact:
          • Lehong Zhang
      • Guilin, China
        • Recruiting
        • Guilin TCMhospital of China
        • Contact:
          • Rui Zhuo
      • Hangzhou, China
        • Active, not recruiting
        • Zhejiang Provincial People's Hospital
      • Harbin, China
        • Recruiting
        • Harbin Medical University Cancer Hospital
      • Kunming, China
        • Active, not recruiting
        • Yunnan cancer hospital
      • Maoming, China
        • Recruiting
        • Maoming People's Hospital
        • Contact:
          • Weixiong Yang
      • Nanning, China
        • Recruiting
        • The First Affiliated Hospital of Guangxi Medical University
        • Contact:
          • Jingcai Zhong
      • Qingdao, China
        • Active, not recruiting
        • The Affiliated Hospital of Qingdao University
      • Wenzhou, China
        • Active, not recruiting
        • The First Affiliated Hospital of Wenzhou Medical University
      • Zhanjiang, China
        • Recruiting
        • Affiliated hospital of Guangdong Medicine College
        • Contact:
          • Zhang Y Qi
      • Zhanjiang, China
        • Recruiting
        • Lian Jiang People' s Hospital
        • Contact:
          • Huang Heng
      • Zhengzhou, China
        • Active, not recruiting
        • Henan Cancer Hospital
      • Zhongshan, China
        • Recruiting
        • Zhongshan People's Hospital
        • Contact:
          • Feihai Ling
      • Zhuhai, China
        • Recruiting
        • The Fifth Affiliated Hospital Sun Yat-Sen University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 35 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ovarian Suppression and aromatase inhibitors

Ovarian Suppression：Goserelin 3.6 mg or Leuprolide 3.75 mg administered intravenously every 28 days, for 5 years.

AI: no restriction of specific drugs, oral by standard dose of post-menopause breast cancer, for 5 years.
Drug: Leuprolide
Other Names:
  • leuprolide acetate
Drug: Goserelin
Drug: Aromatase Inhibitors
Active Comparator: Ovarian Suppression and tamoxifen

Ovarian Suppression：Goserelin 3.6 mg or Leuprolide 3.75 mg administered intravenously every 28 days, for 5 years.

Tamoxifen: 20mg oral for every day, for 5 years.
Drug: Tamoxifen
Drug: Leuprolide
Other Names:
  • leuprolide acetate
Drug: Goserelin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disease-Free Survival (DFS)
Time Frame: 5 years
DFS is defined as the time between randomization and the date of the first occurrence of events as follow: local, regional recurrence or distant metastasis of invasive breast cancer, contralateral invasive breast cancer, or death due to any diseases. Patients who have not had disease progression or death at the end of follow-up (5 years) will be censored at the date last known to be alive and distant metastasis free. Subgroup analysis DFS of Luminal A and Luminal B breast cancer.
5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival (OS)
Time Frame: 5 years
The time from randomization to death due to any cause. Patients still alive at the end of follow-up (5 years) will be censored at the last known alive date.
5 years
Invasive Breast Cancer Recurrence-Free Interval（BCFI)
Time Frame: 5 years
The time between randomization and the first occurrence of local, regional recurrence or distant metastasis of invasive breast cancer, or contralateral invasive breast cancer. Patients who have not had invasive breast cancer recurrence at the end of follow-up (5 years) will be censored at the date last known to be distant metastasis free.
5 years
Adverse Effects Rate
Time Frame: 5 years
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

First Affiliated Hospital, Sun Yat-Sen University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 30, 2016

Primary Completion (Anticipated)

December 30, 2023

Study Completion (Anticipated)

December 1, 2025

Study Registration Dates

First Submitted

September 18, 2016

First Submitted That Met QC Criteria

September 23, 2016

First Posted (Estimate)

September 26, 2016

Study Record Updates

Last Update Posted (Estimate)

January 16, 2023

Last Update Submitted That Met QC Criteria

January 12, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20160818GD

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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