Adjuvant Treatment in Premenopausal Breast Cancer
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
AgeUp to 60
SponsorFondazione Policlinico Universitario Agostino Gemelli IRCCS
About this trial
Multicentric retroprospective observational study to collect outcome in premenopausal breast cancer patients who undergone the 21-multigene assay Oncotype DX from 1st January 2013 to 31st December 2022 and adjuvant treatment.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Female, premenopausal and ≥18 years age patients.
Agree to participate in study and signing informed consent or declaration in lieu of informed consent form, if applicable
Histological diagnosis of early breast cancer hormone positive (ER and/or PgR), HER2-negative.
Pathological nodal stage of pN0 or pN1 (1-3 nodes) and pathological tumor stage of pT1 to pT3.
Disqualifiers
Evidence of distant metastases
Inflammatory breast cancer
Neoadjuvant treatment
No surgery for primary breast cancer and axillary staging
Trial population
Patients with premenopausal early breast cancer HR+ HER2 negative diagnosis with any Recurrence Score (RS) and pathological nodal status pN0/pN1 and who underwent the 21-multigene assay Oncotype DX from 1st January 2013 to 31st December 2022 and adjuvant treatment.
Trial design
Design model
Cohort
Time perspective
Other
Treatments tested in this trial
Not listed
Trial groups
800 Participants
are grouped into 2 trial groupsGroup A: node negative (pN0)
Group B: node positive (pN1)
Trial outcomes
Primary outcomes
1
Invasive Disease-Free Survival (iDFS) at 5 years
The primary endpoint of the study will be the invasive Disease-Free Survival (iDFS) at 5 years among pN0 and pN1 premenopausal breast cancer patients in subgroups formed according to their genomic risk according to 21- multigene assay Oncotype DX.
Time frame
up to 30 monthsSecondary outcomes
1
To describe the effect of the different adjuvant treatments according to clinical and genomic risk
Descriptive statistics, statistical measure of association, and logistic binomial regression modeling of the association measures between the iDFS at 5 years and explicative variables including adjuvant treatment received (chemo/endocrine therapy; endocrine therapy with or without OSF), pathological tumor status, and genomic risk score according to 21-multigene assay Oncotype DX.
Time frame
up to 30 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Lead sponsor
Clinical Research Technology S.r.l.
Collaborator
Source ClinicalTrials.gov