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Long-term outcomes and predictive factors for survival in premenopausal breast cancer treated with tamoxifen

Premenopausal patients randomized to adjuvant tamoxifen versus not: long-term survival in relation to genomic and tumor related factors

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN12474687
Enrollment
500
Registered
2019-12-06
Start date
2018-05-01
Completion date
Unknown
Last updated
2026-02-16

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

Conditions

Premenopausal patients with invasive breast cancer Cancer Malignant neoplasm of breast

Interventions

The SBII:2 BioLong study is based on a prospective multicenter randomized clinical trial with > 30 years of follow-up of adjuvant tamoxifen We will collect formalin-fixed archival tissue for gross ev

Sponsors

Lund University
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: Patients radically operated for invasive breast cancer stage II in the SBII:2 trial

Exclusion criteria

Exclusion criteria: 1. Postmenopausal status 2. Metastatic disease

Design outcomes

Primary

MeasureTime frame
BCFi (Breast cancer free interval) over the ~30-year period, measured using patient notes

Secondary

MeasureTime frame
1. D-RFi (Distant Recurrence Free interval) over the ~30-year period, measured using patient notes 2. Breast cancer mortality over the ~30-year period, measured using patient notes 3. Overall mortality over the ~30-year period, measured using patient notes

Countries

Sweden

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 24, 2026