NCT lookup
Pull any trial record directly from ClinicalTrials.gov.
Adjuvant Treatment in Premenopausal Breast Cancer
Adjuvant Treatment in Premenopausal Breast Cancer
RecruitingN/A
Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Conditions: Breast Cancer Early Stage Breast Cancer (Stage 1-3)
Countries: Italy
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 overview
Sex: FEMALE
Age: — to 60 Years
Healthy volunteers: No
Study type: OBSERVATIONAL
Eligibility criteria
Inclusion Criteria: 1. Female, premenopausal and ≥18 years age patients. 2. Agree to participate in study and signing informed consent or declaration in lieu of informed consent form, if applicable 3. Histological diagnosis of early breast cancer hormone positive (ER and/or PgR), HER2-negative. 4. Pathological nodal stage of pN0 or pN1 (1-3 nodes) and pathological tumor stage of pT1 to pT3. 5. Surgery for primary breast cancer and axillary staging by sentinel node biopsy or axillary lymph node dissection (ALND). 6. Availability of 21-multigene assay Oncotype DX recurrence score results performed according to physician choice from 1st January 2013 to 31st December 2022 7. Availability of clinical and pathological information. 8. Availability of information about adjuvant treatment received. 9. Availability of patient' outcome information (relapse, site of relapse, survival). Exclusion Criteria: 1. Evidence of distant metastases 2. Inflammatory breast cancer 3. Neoadjuvant treatment 4. No surgery for primary breast cancer and axillary staging 5. Patients not tested with 21-multigene assay Oncotype DX
Locations (2)
- Roma, Antonella Palazzo, Italy
- Salerno, Italy