Breast Cancer RElapsed in Patients Treated With Adjuvant CDK4/6 Inhibitors:

NCT07180693 | Recruiting

• 1 other identifier: UID 4879
• Study Type: observational
• Target: 750
• Locations: 1 country
• Sites: 18

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 risk of recurrence treated with ribociclib or abemaciclib in combination with ET in the adjuvant setting.

Conditions

Adjuvant Therapy; CDK4/6 Inhibitor

Outcome Measures

Primary Outcomes (1)

• Invasive-disease free survival (IDFS)

  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.

  3 years

Secondary Outcomes (3)

• Distant relapse-free survival (DRFS)

  5 years

• progression-free survival (PFS)

  5 years

• Overall survival (OS)

  5 years

Study Arms (1)

Group 1

Patients undergoing treatment with CDK4/6 inhibitors

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients diagnosed with HR+/HER2- breast cancer who have received medical treatment in the neoadjuvant or adjuvant setting (chemotherapy, radiotherapy and hormonotherapy) and who have received or are scheduled to initiate adjuvant treatment with CDK4/6 inhibitors (abemaciclib or ribociclib) in combination with ET in the adjuvant setting.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• European Institute of Oncology: lead

Study Sites (18)

ASST Papa Giovanni XXIII

Bergamo, Italy, 24127, Italy

NOT YET RECRUITING

ASST Spedali Civili di Brescia

Brescia, Italy, 25123, Italy

RECRUITING

P.O. Antonio Perrino - ASL Brindisi

Brindisi, Italy, 72100, Italy

NOT YET RECRUITING

ASST Ospedale Maggiore di Crema

Crema, Italy, 26013, Italy

RECRUITING

ASST Lecco - PO Alessandro Manzoni

Lecco, Italy, 23900, Italy

NOT YET RECRUITING

Asst Ovest Milanese

Legnano, Italy, 20025, Italy

NOT YET RECRUITING

IRCCS Ospedale San Raffaele

Milan, Italy, 20132, Italy

RECRUITING

Fondazione IRCCS Istituto Nazionale dei Tumori di Milano

Milan, Italy, 20133, Italy

NOT YET RECRUITING

European Institute of Oncology

Milan, Italy, 20141, Italy

RECRUITING

PO Luigi Sacco - ASST Fatebenefratelli Sacco

Milan, Italy, 20157, Italy

NOT YET RECRUITING

Azienda Ospedaliero-Universitaria di Modena

Modena, Italy, 41125, Italy

NOT YET RECRUITING

Fondazione IRCCS San Gerardo dei Tintori

Monza, Italy, 20900, Italy

NOT YET RECRUITING

Istituto Nazionale Tumori IRCCS Fondazione G. Pascale

Naples, Italy, 80131, Italy

RECRUITING

ICS Maugeri IRCCS

Pavia, Italy, 27100, Italy

RECRUITING

Policlinico San Matteo

Pavia, Italy, 27100, Italy

NOT YET RECRUITING

Azienda USL IRCCS di Reggio Emilia

Reggio Emilia, Italy, 42122, Italy

RECRUITING

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Roma, Italy, 00168, Italy

NOT YET RECRUITING

Ospedale Isola Tiberina - Gemelli Isola

Roma, Italy, 00186, Italy

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples

Study Officials

• Nadia Bianco, MD

  European Institute of Oncology

  STUDY CHAIR

Central Study Contacts

Nadia Bianco, MD

CONTACT

+39 02 94371977; nadia.bianco@ieo.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2025
• First Posted: September 18, 2025
• Study Start: September 29, 2025
• Primary Completion (Estimated): August 1, 2028
• Study Completion (Estimated): August 1, 2030
• Last Updated: April 1, 2026

Record last verified: 2026-01

Locations

IT (18)