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

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

Status

Not yet recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07735897

Acronym

ASTRRAIV

Enrollment

1483

Registered

2026-07-30

Start date

2026-07-01

Completion date

2034-05-01

Last updated

2026-07-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Keywords

Breast cancer, Hormone receptor-positive, Premenopausal breast cancer

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.

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

FEMALE

Age

20 Years to 45 Years

Healthy volunteers

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)

Design outcomes

Primary

Measure	Time frame	Description
Long-term Disease-Free Survival Analysis of the ASTRRA Trial	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

Countries

South Korea

Contacts

CONTACTheejeong Kim, MD

heejeong_kim@amc.seoul.kr82-2-3482-7809

CONTACTTae-Kyung Yoo, MD

82-2-3482-7809

PRINCIPAL_INVESTIGATORheejeong Kim, MD

Asan Medical Center

Outcome results