Clinical trial · Observational
Breast Cancer RElapsed in Patients Treated With Adjuvant CDK4/6 Inhibitors:
Breast Cancer RElapsed in Patients Treated With Adjuvant CDK4/6 Inhibitors: Evaluation in the Real-world Setting
NCT07180693CI-TRIAL-00112927BREAKERrecruitingClinicalTrials.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 multicenter observational study with both retrospective and prospective phase, designed to evaluate the clinico-pathologic characteristics and outcomes of patients with HR+/HER2- EBC at high risk of recurrence treated with ribociclib or abemaciclib in combination with ET in the adjuvant setting.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adjuvant Therapy | — | UNRESOLVED | — |
| CDK4/6 Inhibitor | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (1)
- label
- Group 1
- description
- Patients undergoing treatment with CDK4/6 inhibitors
Primary outcomes (1)
- measure
- Invasive-disease free survival (IDFS)
- timeFrame
- 3 years
- description
- Invasive disease-free survival (IDFS) will be defined as the time from surgery to invasive loco-regional recurrence, metastasis, other primary non-breast carcinomas, or death from any cause, whichever occurs first.
Secondary outcomes (3)
- measure
- Distant relapse-free survival (DRFS)
- timeFrame
- 5 years
- description
- DRFS will be defined as the time from surgery to distant recurrence or death from any cause, whichever occurs first.
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Female (regardless of menopausal status) or male ≥18 years of age; * The patient has confirmed HR+, HER2-, early-stage resected invasive breast cancer candidate to adjuvant CDK4/6 inhibitors (abemaciclib or ribociclib); * ER and PgR positivity is defined as evidence of immunohistochemical staining ≥ 1% according to ASCO/CAP recommendations; HER2 negativity is defined as expression of the membrane protein in immunohistochemistry 0 or 1+ or with a 2+ in situ hybridization (ISH) test negative as per ASCO/CAP recommendations; * Patients who are initiating or have initiated adjuvant treatment with a CDK4/6 inhibitor (abemaciclib or ribociclib) in combination with endocrine therapy (ET). Treatment must have started on or after January 1, 2021. * Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2; * Consent to data treatment according to the local regulation. Exclusion Criteria: * Current participation in any other HR+/HER2- EBC study with any investigational products; * Patients who have already received adjuvant treatment with a CDK4/6 inhibitor as part of a clinical trial; * Patients unable to comply with the requirements of the study or who, in the judge of the study physician, should not be included in the study; * Patients with a history of previous BC, with the exception of Ductal carcinoma in situ (DCIS) treated by locoregional therapy alone ≥5 years ago; * Patients with a history of any other cancer (except non-melanoma skin cancer or carcinoma in situ of the cervix), unless in complete remission with no therapy for a minimum of 5 years from the index date, will be excluded, as well.
References
Publications (0)
Data not yet available
No reference posted for this study.