Breast Cancer RElapsed in Patients Treated With Adjuvant CDK4/6 Inhibitors:
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Adjuvant Therapy, CDK4/6 Inhibitor. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Breast Cancer RElapsed in Patients Treated With Adjuvant CDK4/6 Inhibitors: Evaluation in the Real-world Setting
Overview
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.
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 therapy with CDK4/6 inhibitors in combination with ET.
Primary outcome measures
- Invasive-disease free survival (IDFS) [Time frame: 3 years]
Secondary outcome measures (3)
- Distant relapse-free survival (DRFS) [Time frame: 5 years]
- progression-free survival (PFS) [Time frame: 5 years]
- Overall survival (OS) [Time frame: 5 years]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Italy · 18 centers
- ASST Papa Giovanni XXIII — Bergamo
- ASST Spedali Civili di Brescia — Brescia
- P.O. Antonio Perrino - ASL Brindisi — Brindisi
- ASST Ospedale Maggiore di Crema — Crema
- ASST Lecco - PO Alessandro Manzoni — Lecco
- Asst Ovest Milanese — Legnano
- IRCCS Ospedale San Raffaele — Milan
- Fondazione IRCCS Istituto Nazionale dei Tumori di Milano — Milan
- … and 10 more centers
Identifiers
NCT: NCT07180693 · UID 4879