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

ConditionsAdjuvant TherapyCDK4/6 Inhibitor
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorEuropean Institute of Oncology

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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;

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

750 Participants
are grouped into 1 trial group
Group A: Group 1

Trial outcomes

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.

Time frame
3 years

Secondary outcomes

1

Distant relapse-free survival (DRFS)

DRFS will be defined as the time from surgery to distant recurrence or death from any cause, whichever occurs first.

Time frame
5 years
2

progression-free survival (PFS)

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.

Time frame
5 years
3

Overall survival (OS)

OS will be defined as the time from surgery to death from any cause.

Time frame
5 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

European Institute of Oncology

Lead sponsor

Source ClinicalTrials.gov
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