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

NCT07735897 | Not Yet Recruiting

• 1 other identifier: ASTRRA IV Study
• Study Type: observational
• Target: 1,483
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Breast Cancer

Keywords

Breast cancer, Hormone receptor-positive, Premenopausal breast cancer

Outcome Measures

Primary Outcomes (1)

• Long-term Disease-Free Survival Analysis of the ASTRRA Trial

  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

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• MedicalExcellence: lead
• Asan Medical Center: collaborator

Study Sites (1)

Asan Medical Center

Seoul, Sondpagu, 05505, South Korea

Location

Biospecimen

Retention: SAMPLES WITH DNA

Buccal swab, Blood samples, Breast cancer tissue samples

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• heejeong Kim, MD

  Asan Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

heejeong Kim, MD

CONTACT

82-2-3482-7809; heejeong_kim@amc.seoul.kr

Tae-Kyung Yoo, MD

CONTACT

82-2-3482-7809

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Target Duration: 25 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 25, 2026
• First Posted: July 30, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): March 1, 2034
• Study Completion (Estimated): May 1, 2034
• Last Updated: July 31, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)