Status:
RECRUITING
Breast Cancer RElapsed in Patients Treated With Adjuvant CDK4/6 Inhibitors:
Lead Sponsor:
European Institute of Oncology
Conditions:
Adjuvant Therapy
CDK4/6 Inhibitor
Eligibility:
All Genders
18+ years
Brief Summary
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...
Detailed Description
The study will also evaluate clinico-pathologic characteristics, patterns of recurrence, therapeutic choices and outcomes of the subgroup of patients relapsed during or within 12 months after adjuvant...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 29 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
August 1 2030
Estimated Enrollment :
750 Patients enrolled
Trial Details
Trial ID
NCT07180693
Start Date
September 29 2025
End Date
August 1 2030
Last Update
January 6 2026
Active Locations (18)
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1
ASST Papa Giovanni XXIII
Bergamo, Italy, Italy, 24127
2
ASST Spedali Civili di Brescia
Brescia, Italy, Italy, 25123
3
P.O. Antonio Perrino - ASL Brindisi
Brindisi, Italy, Italy, 72100
4
ASST Ospedale Maggiore di Crema
Crema, Italy, Italy, 26013