Breast cancer relapse after adjuvant CDK4/6 inhibitor therapy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a multicenter observational project with retrospective and prospective phases collecting clinicopathologic data and outcomes for adults with resected HR+/HER2- early breast cancer treated with adjuvant ribociclib or abemaciclib plus endocrine therapy. The cohort includes patients who started adjuvant CDK4/6 inhibitors on or after January 1, 2021 and have ECOG performance status 0–2. Data collected will include tumor characteristics, patterns and timing of recurrence, subsequent therapies, and clinical outcomes, with special focus on relapses during or within 12 months of completing adjuvant treatment. Participating sites are in Bergamo, Brescia, and Brindisi, Italy, and data will be analyzed to describe real-world patterns and outcomes.

Why it matters

Who can join: the full rules

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.

Where it's running

• ASST Spedali Civili di Brescia
  Brescia, Italy, Italy Recruiting
• ASST Ospedale Maggiore di Crema
  Crema, Italy, Italy Recruiting
• IRCCS Ospedale San Raffaele
  Milan, Italy, Italy Recruiting
• European Institute of Oncology
  Milan, Italy, Italy Recruiting
• PO Luigi Sacco - ASST Fatebenefratelli Sacco
  Milan, Italy, Italy Recruiting
• Fondazione IRCCS San Gerardo dei Tintori
  Monza, Italy, Italy Recruiting

Study contacts

• Study coordinator: Nadia Bianco, MD
• Email: nadia.bianco@ieo.it
• Phone: +39 02 94371977

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.