Breast Cancer RElapsed in Patients Treated With Adjuvant CDK4/6 Inhibitors:
Recruiting
Observational Study
Adjuvant TherapyCDK4/6 Inhibitor
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
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At a Glance
Age
18 and older
Sex
Any
Study type
Observational
Participants needed
750 (estimated)
Sponsor
European Institute of Oncology · Other
Who this trial is looking for
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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.
Trial Locations
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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 immunoh…
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.
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