Long Term Cohort Study of Adding Ovarian Function Suppression to Tamoxifen in Young Women
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Breast Cancer. Basic parameters: 20 years — 45 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- South Korea
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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
Overview
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.
Primary outcome measures
- Long-term Disease-Free Survival Analysis of the ASTRRA Trial [Time frame: 25-year follow-up]
Eligibility criteria
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
South Korea · 1 center
- Asan Medical Center — Seoul
Identifiers
NCT: NCT07735897 · ASTRRA IV Study