Clinical trial · Observational
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Long-term Disease-Free Survival Analysis of the ASTRRA Trial
- timeFrame
- 25-year follow-up
- description
- Long-term Survival Analysis of Premenopausal Young Breast Cancer Patients with Preserved or Recovered Ovarian Function after Chemotherapy Receiving Ovarian Function Suppression Plus Tamoxifen
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 20 Years
- Maximum age
- 45 Years
Show eligibility criteria text
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)
References
Publications (0)
Data not yet available