Clinical trial · Observational
CLEAR-B: Cancer Landscape - Early Adjuvant Retrospective Registry - Breast Cancer
Cancer Landscape - Early Adjuvant Retrospective Registry - Breast Cancer (CLEAR-B)
NCT05870813CI-TRIAL-00066609CLEAR-BunknownClinicalTrials.gov clinicaltrialsProvenance
- 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 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.
Conditions
Conditions (3)
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 |
| HER2-negative Breast Cancer | Breast Neoplasm | PROBABILISTIC | 0.70 |
| Hormone Receptor Positive Breast Carcinoma | Hormone Receptor-Positive Breast Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (2)
- label
- AI+OFS
- description
- adjuvant treatment with aromatase inhibitor + OFS (ovarian function suppression)
- label
- TAM
- description
- Patients started the adjuvant treatment with Tamoxifen ± OFS
Primary outcomes (2)
- measure
- iDFS
- timeFrame
- First start of adjuvant endocrine therapy until date of the above mentioned events up to 5 years
- description
- 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)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 60 Years
Show eligibility criteria text
Inclusion Criteria: * Female patients with a first primary diagnosis of hormone receptor-positive, HER2- negative unilateral early breast cancer for whom an endocrine treatment is indicated * Patients must be at least 18 years of age but not older than 60 * Premenopausal defined as all statements must be true * No oophorectomy before the diagnosis of breast cancer * Women with uterus: Regular, physiological menses at the timepoint of therapy decision for anti-endocrine treatment in the absence of contraceptives and hormonal treatment * Women without uterus and remaining ovaries: premenopausal hormone levels must be documented at the time of therapy decision for anti-endocrine treatment * Patients with an intermediate or high-risk early-stage breast cancer defined as: At least one of the following must be fulfilled * (Neo)adjuvant chemotherapy * pT≥2cm at the timepoint of definitive surgery * at least one positive lymph node at the time of definite surgery (pN+) * Patient must be previously registered in and must have been documented as part of the certification process for a certified breast cancer center according to the Deutsche Krebsgesellschaft/Deutsche Gesellschaft für Senologie * Breast Cancer must have been diagnosed between Jan 2016 and Jun 2019 Exclusion Criteria: * Patients with a low recurrence risk (see inclusion criteria for definition) * Locally advanced breast cancer or distant metastases at diagnosis * Male biological sex * Patients not treated in a certified breast cancer center * Treatment with CDK4/6Previous diagnosis of invasive breast cancer or in situ breast cancer * Concurrent invasive malignancy * Bilateral breast cancer at the timepoint of diagnosis * Previous diagnosis of invasive breast cancer or in situ breast cancer is not allowed
References
Publications (0)
Data not yet available
No reference posted for this study.