Cancer Landscape - Early Adjuvant Retrospective Registry - Breast Cancer (CLEAR-B)

NCT05870813 UNKNOWN

This is a non-interventional retrospective cohort study of premenopausal patients with HR+/HER2- breast cancer who are treated in the adjuvant setting with either Tamoxifen, Tamoxifen + Ovarial Function Suppression or Aromatase inhibitor + Ovarial Function Suppression.

Details

Lead sponsor	Institut fuer Frauengesundheit
Status	UNKNOWN
Enrolment	3000
Start date	2023-03-10
Completion	2023-12

Conditions

• Breast Cancer
• HER2-negative Breast Cancer
• Hormone Receptor Positive Breast Carcinoma

Primary outcomes

• iDFS — First start of adjuvant endocrine therapy until date of the above mentioned events up to 5 years
  The primary study aim is to show that aromatase inhibitor (AI) based treatments (AI arm) are not inferior to treatments based on tamoxifen (tamoxifen arm) in terms of invasive diseasefree survival (iDFS). iDFS will be assessed as time to event. Events for iDFS include: Invasive Ipsilateral Breast Tumor Recurrence (IBTR), Local/Regional Invasive Recurrence, Distant Recurrence, Death from BC, Death from Non-BC Cause, Death From unknown cause, Invasive Contralateral BC, Second Primary Invasive Cancer (non-breast)
• Comparison of iDFS — First start of adjuvant endocrine therapy until date of the above mentioned events up to 5 years
  In case non-inferiority is confirmed, the superiority of Cohort AI+OFS over Cohort TAM will be tested with regard to iDFS. iDFS will be assessed as time to event. Events for iDFS include: Invasive Ipsilateral Breast Tumor Recurrence (IBTR), Local/Regional Invasive Recurrence, Distant Recurrence, Death from BC, Death from Non-BC Cause, Death From unknown cause, Invasive Contralateral BC, Second Primary Invasive Cancer (non-breast)

Countries

Germany