Trial Title:
Prospective Observational Study of Adjuvant Hormone Treatment in Estrogen-receptor Positive Premenopausal Early Breast Cancer Patients
NCT ID:
NCT05730647
Condition:
Early Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Study type:
Observational
Overall status:
Active, not recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Other
Intervention name:
None intervention (observational study)
Description:
None intervention (observational study)
Summary:
This will be a prospective, multicenter, observational study. The primary objective is to
record the choice, in clinical practice, of adjuvant hormone therapy (tamoxifen,
tamoxifen + LhRh, aromatase inhibitors + LhRh) in premenopausal patients with
estrogen-receptor positive breast cancer.
The secondary objective is to correlate adjuvant hormone therapy choices with biological
characteristics of the tumor (T size, lymph node status, grade, receptor level, Ki67,
HER2 status) and patient characteristics (age, prior chemotherapy treatment).
Criteria for eligibility:
Study pop:
Premenopausal patients candidate to start adjuvant hormone therapy after breast cancer
surgery.
Sampling method:
Non-Probability Sample
Criteria:
Inclusion Criteria:
1.
- Premenopausal patients candidate to start adjuvant hormone therapy after breast
cancer surgery
2.
- Age >18 years
3.
- No previous hormonal treatment
4.
- Written informed consent
Exclusion Criteria:
1- Patient's inability to provide written informed consent 2 - Stage IV disease
Gender:
Female
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Centro di Riferimento Oncologico- IRCCS
Address:
City:
Aviano
Country:
Italy
Facility:
Name:
A.O. Consorziale Policlinico di Bari
Address:
City:
Bari
Country:
Italy
Facility:
Name:
IRCCS Istituto Oncologico di Bari
Address:
City:
Bari
Country:
Italy
Facility:
Name:
Osp. Papa Giovanni XXIII
Address:
City:
Bergamo
Country:
Italy
Facility:
Name:
Presidio Ospedaliero "Antonio Perrino" ASL Brindisi
Address:
City:
Brindisi
Country:
Italy
Facility:
Name:
Università degli Studi "G.d'Annunzio" Chieti-Pescara
Address:
City:
Chieti
Country:
Italy
Facility:
Name:
ASST Lariana - Ospedale S. Anna
Address:
City:
Como
Country:
Italy
Facility:
Name:
Azienda Ospedaliera S. Croce e Carle
Address:
City:
Cuneo
Country:
Italy
Facility:
Name:
Azienda Ospedaliera Universitaria Careggi
Address:
City:
Firenze
Country:
Italy
Facility:
Name:
I.R.C.C.S. A.O.U San Martino - IST
Address:
City:
Genova
Country:
Italy
Facility:
Name:
Ospedale Civile di Guastalla
Address:
City:
Guastalla
Country:
Italy
Facility:
Name:
Ospedale F.Renzetti di Lanciano
Address:
City:
Lanciano
Country:
Italy
Facility:
Name:
Ospedale S.M. Goretti
Address:
City:
Latina
Country:
Italy
Facility:
Name:
P.O. Vito Fazzi
Address:
City:
Lecce
Country:
Italy
Facility:
Name:
A.O. Ospedale Civile di Legnano
Address:
City:
Legnano
Country:
Italy
Facility:
Name:
AUSL Toscana Nord Ovest- Osp. Versilia
Address:
City:
Lido Di Camaiore
Country:
Italy
Facility:
Name:
Ospedale di Macerata
Address:
City:
Macerata
Country:
Italy
Facility:
Name:
A.O.Papardo
Address:
City:
Messina
Country:
Italy
Facility:
Name:
A.O.U Policlinico di Modena
Address:
City:
Modena
Country:
Italy
Facility:
Name:
A.O.R.N. "A. Cardarelli"
Address:
City:
Napoli
Country:
Italy
Facility:
Name:
AOU Federico II
Address:
City:
Napoli
Country:
Italy
Facility:
Name:
Azienda Ospedaliera Specialistica dei Colli - Ospedale Monaldi
Address:
City:
Napoli
Country:
Italy
Facility:
Name:
Istituto Nazionale dei Tumori - Fondazione G. Pascale
Address:
City:
Napoli
Country:
Italy
Facility:
Name:
Istituto Oncologico Veneto IRCCS
Address:
City:
Padova
Country:
Italy
Facility:
Name:
A. O. U. Pisana - Ospedale S. Chiara
Address:
City:
Pisa
Country:
Italy
Facility:
Name:
A.O.R. San Carlo
Address:
City:
Potenza
Country:
Italy
Facility:
Name:
Ospedale di Prato
Address:
City:
Prato
Country:
Italy
Facility:
Name:
AUSL della Romagna- P.O. di Ravenna, Lugo e Faenza
Address:
City:
Ravenna
Country:
Italy
Facility:
Name:
IRCCS Arcispedale S.Maria Nuova
Address:
City:
Reggio Emilia
Country:
Italy
Facility:
Name:
Fondazione Policlinico Gemelli
Address:
City:
Roma
Country:
Italy
Facility:
Name:
Istituto Nazionale Tumori Regina Elena
Address:
City:
Roma
Country:
Italy
Facility:
Name:
Ospedale San Camillo Forlanini
Address:
City:
Roma
Country:
Italy
Facility:
Name:
Policlinico Universitario Campus Biomedico
Address:
City:
Roma
Country:
Italy
Facility:
Name:
Istituto Clinico Humanitas Irccs
Address:
City:
Rozzano
Country:
Italy
Facility:
Name:
IRCCS Casa Sollievo della Sofferenza
Address:
City:
San Giovanni Rotondo
Country:
Italy
Facility:
Name:
Ospedale San Vincenzo
Address:
City:
Taormina
Country:
Italy
Facility:
Name:
Presidio Ospedaliero Martini - ASL TO1
Address:
City:
Torino
Country:
Italy
Facility:
Name:
Ospedale Santa Chiara
Address:
City:
Trento
Country:
Italy
Facility:
Name:
Azienda Ospedaliera Universitaria SM Misericordia
Address:
City:
Udine
Country:
Italy
Facility:
Name:
Ospedale San Pio da Pietrelcina
Address:
City:
Vasto
Country:
Italy
Start date:
October 24, 2019
Completion date:
July 31, 2032
Lead sponsor:
Agency:
Consorzio Oncotech
Agency class:
Other
Source:
Consorzio Oncotech
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05730647
