Adjuvant Therapy, CDK4/6 Inhibitor
Conditions
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.
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.
Interventions
None listed
Sponsors
European Institute of Oncology
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Invasive-disease free survival (IDFS) | 3 years | 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
| Measure | Time frame | Description |
|---|---|---|
| Distant relapse-free survival (DRFS) | 5 years | DRFS will be defined as the time from surgery to distant recurrence or death from any cause, whichever occurs first. |
| progression-free survival (PFS) | 5 years | PFS will be defined as the time from the disease recurrence to the date of documented disease progression or death from any cause, whichever occurs first. |
| Overall survival (OS) | 5 years | OS will be defined as the time from surgery to death from any cause. |
Countries
Italy
Contacts
CONTACTNadia Bianco, MD
STUDY_CHAIRNadia Bianco, MD
European Institute of Oncology
Outcome results
None listed