Prospective Observational Study of Adjuvant Hormone Treatment in Estrogen-receptor Positive Premenopausal Early Breast Cancer Patients
- Conditions
- Early Breast Cancer
- Registration Number
- NCT05730647
- Lead Sponsor
- Consorzio Oncotech
- Brief 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- Female
- Target Recruitment
- 600
-
- Premenopausal patients candidate to start adjuvant hormone therapy after breast cancer surgery
-
- Age >18 years
-
- No previous hormonal treatment
-
- Written informed consent
1- Patient's inability to provide written informed consent 2 - Stage IV disease
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To record the choice, in clinical practice, of adjuvant hormone therapy. 21 months Patients will be divided in groups according to type of adjuvant hormone therapy received:
1. tamoxifen
2. tamoxifen + LhRh
3. aromatase inhibitor + LhRh Differences between groups will be evaluated with Chi-square test and Mann-Whitney test.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (40)
Centro di Riferimento Oncologico- IRCCS
🇮🇹Aviano, Italy
A.O. Consorziale Policlinico di Bari
🇮🇹Bari, Italy
IRCCS Istituto Oncologico di Bari
🇮🇹Bari, Italy
Osp. Papa Giovanni XXIII
🇮🇹Bergamo, Italy
Università degli Studi "G.d'Annunzio" Chieti-Pescara
🇮🇹Chieti, Italy
Presidio Ospedaliero "Antonio Perrino" ASL Brindisi
🇮🇹Brindisi, Italy
ASST Lariana - Ospedale S. Anna
🇮🇹Como, Italy
Azienda Ospedaliera S. Croce e Carle
🇮🇹Cuneo, Italy
I.R.C.C.S. A.O.U San Martino - IST
🇮🇹Genova, Italy
Azienda Ospedaliera Universitaria Careggi
🇮🇹Firenze, Italy
Ospedale F.Renzetti di Lanciano
🇮🇹Lanciano, Italy
Ospedale S.M. Goretti
🇮🇹Latina, Italy
Ospedale Civile di Guastalla
🇮🇹Guastalla, Italy
P.O. Vito Fazzi
🇮🇹Lecce, Italy
AUSL Toscana Nord Ovest- Osp. Versilia
🇮🇹Lido Di Camaiore, Italy
Ospedale di Macerata
🇮🇹Macerata, Italy
A.O.Papardo
🇮🇹Messina, Italy
AOU Federico II
🇮🇹Napoli, Italy
A.O. Ospedale Civile di Legnano
🇮🇹Legnano, Italy
Azienda Ospedaliera Specialistica dei Colli - Ospedale Monaldi
🇮🇹Napoli, Italy
A.O.U Policlinico di Modena
🇮🇹Modena, Italy
Istituto Nazionale dei Tumori - Fondazione G. Pascale
🇮🇹Napoli, Italy
A.O.R.N. "A. Cardarelli"
🇮🇹Napoli, Italy
Istituto Oncologico Veneto IRCCS
🇮🇹Padova, Italy
A. O. U. Pisana - Ospedale S. Chiara
🇮🇹Pisa, Italy
A.O.R. San Carlo
🇮🇹Potenza, Italy
AUSL della Romagna- P.O. di Ravenna, Lugo e Faenza
🇮🇹Ravenna, Italy
Ospedale di Prato
🇮🇹Prato, Italy
IRCCS Arcispedale S.Maria Nuova
🇮🇹Reggio Emilia, Italy
Fondazione Policlinico Gemelli
🇮🇹Roma, Italy
Istituto Nazionale Tumori Regina Elena
🇮🇹Roma, Italy
Ospedale San Camillo Forlanini
🇮🇹Roma, Italy
Policlinico Universitario Campus Biomedico
🇮🇹Roma, Italy
Istituto Clinico Humanitas Irccs
🇮🇹Rozzano, Italy
Ospedale San Vincenzo
🇮🇹Taormina, Italy
IRCCS Casa Sollievo della Sofferenza
🇮🇹San Giovanni Rotondo, Italy
Presidio Ospedaliero Martini - ASL TO1
🇮🇹Torino, Italy
Ospedale Santa Chiara
🇮🇹Trento, Italy
Ospedale San Pio da Pietrelcina
🇮🇹Vasto, Italy
Azienda Ospedaliera Universitaria SM Misericordia
🇮🇹Udine, Italy