NCT06807749Recruiting
Adjuvant Treatment in Premenopausal Breast Cancer
PrEmenopausal bReaSt cancEr adjuVant thERapy Benefit According to OncotypE DX Test
Source: ClinicalTrials.gov · Last updated 3 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 800 (estimated)
- First submitted
- 10 Jan 2025
- Start date
- 24 Dec 2025
- Primary completion date
- Sept 2027
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Diseases
- Childhood cancers
- NCT number
- NCT06807749
What you commit to
- Study type: Observational
- Planned participants: 800
- From 24 Dec 2025 to the primary completion date, Sept 2027
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Inflammatory breast cancer
- No surgery for primary breast cancer and axillary staging
Other
- Evidence of distant metastases
- Neoadjuvant treatment
- Patients not tested with 21-multigene assay Oncotype DX
Who the study is looking for
- 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.
- Surgery for primary breast cancer and axillary staging by sentinel node biopsy or axillary lymph node dissection (ALND).
- Availability of 21-multigene assay Oncotype DX recurrence score results performed according to physician choice from 1st January 2013 to 31st December 2022
- Availability of clinical and pathological information.
- Availability of information about adjuvant treatment received.
- Availability of patient' outcome information (relapse, site of relapse, survival).
Age in the registry: - to 60 years · Sex: Female · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Fondazione Policlinico Gemelli Coordinator of this site? Confirm its status | Roma | Italy | Recruiting |
| Clinical Research Technology Coordinator of this site? Confirm its status | Salerno | Italy | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.