Long Term Cohort Study of Adding Ovarian Function Suppression to Tamoxifen in Young Women (ASTRRAIV)

July 30, 2026 updated by: MedicalExcellence

Prospective Cohort Study of Adding Ovarian Function Suppression to Tamoxifen in Young Women With Hormone-sensitive Breast Cancer Who Remain Premenopausal or Resume Menstruation After Chemotherapy: ASTRRA- IV Study

This study evaluates the long-term effects of adding 2 years of ovarian function suppression (OFS) to tamoxifen therapy in young premenopausal women with hormone receptor-positive breast cancer after chemotherapy. The study will assess recurrence, breast cancer-specific survival, and overall survival beyond 10 years to determine the long-term benefits of OFS treatment.

Study Overview

Status

Not yet recruiting

Conditions

Breast Cancer

Detailed Description

To evaluate the long-term outcomes beyond 10 years of the Korean Breast Cancer Society-sponsored multicenter prospective ASTRRA trial, we aim to compare the effects of adding 2 years of ovarian function suppression (OFS) therapy to standard tamoxifen treatment in premenopausal young women with hormone receptor-positive breast cancer who preserved or recovered ovarian function after chemotherapy. Given the characteristic pattern of delayed recurrence in hormone receptor-positive breast cancer compared with other molecular subtypes, this long-term follow-up study will assess the durability and safety of the treatment strategy by evaluating disease-free survival (DFS) beyond 10 years, breast cancer-specific survival, and overall survival. In addition, through analyses of recurrence patterns according to treatment groups, we aim to determine the long-term impact of additional OFS therapy on reducing different types of recurrence.

Study Type

Observational

Enrollment (Estimated)

1483

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

Name: heejeong Kim, MD
Phone Number: 82-2-3482-7809
Email: heejeong_kim@amc.seoul.kr

Study Contact Backup

Name: Tae-Kyung Yoo, MD
Phone Number: 82-2-3482-7809

Study Locations

South Korea
- Sondpagu
  - Seoul, Sondpagu, South Korea, 05505
    - Asan Medical Center
    - Principal Investigator:
      
      Heejeong Kim, MD
    - Contact:
      
      Heejeong Kim, MD
      
      Phone Number: 821099762969
      
      Email: heejeong_kim@amc.seoul.kr
    - Contact:
      
      Minjung Kim, Master
      
      Phone Number: 821099762969
      
      Email: mj.kim@mediex.co.kr

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

Adult

Accepts Healthy Volunteers

Sampling Method

Non-Probability Sample

Study Population

Premenopausal women with hormone receptor-positive breast cancer who were enrolled and randomized in the ASTRRA trial and received adjuvant endocrine therapy after chemotherapy.

Description

Inclusion Criteria:

Premenopausal women with hormone receptor-positive breast cancer enrolled in the ASTRRA trial (NCT00912548).

Patients enrolled and randomized in the ASTRRA study between March 1, 2009, and July 17, 2018 (excluding screening failures).

Patients with available long-term follow-up information.

Exclusion Criteria:

Patients with primary breast cancer meeting any of the following criteria:

Hormone receptor-negative breast cancer Unknown hormone receptor status

Patients with a history of hysterectomy or bilateral oophorectomy

Patients with breast sarcoma or squamous cell carcinoma of the breast

Patients with a history of malignancy other than breast cancer within 5 years prior to enrollment

Patients with thrombocytopenia

Patients who had previously received CMF chemotherapy (cyclophosphamide, methotrexate, and fluorouracil)

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Long-term Disease-Free Survival Analysis of the ASTRRA Trial Time Frame: 25-year follow-up	Long-term Survival Analysis of Premenopausal Young Breast Cancer Patients with Preserved or Recovered Ovarian Function after Chemotherapy Receiving Ovarian Function Suppression Plus Tamoxifen	25-year follow-up

Collaborators and Investigators

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

Sponsor

MedicalExcellence

Collaborators

Asan Medical Center

Investigators

Principal Investigator: heejeong Kim, MD, Asan Medical Center

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 (Estimated)

July 1, 2026

Primary Completion (Estimated)

March 1, 2034

Study Completion (Estimated)

May 1, 2034

Study Registration Dates

First Submitted

July 25, 2026

First Submitted That Met QC Criteria