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NCT05730647 Clinical Trial

Prospective Observational Study of Adjuvant Hormone Treatment in Estrogen-receptor Positive Premenopausal Early Breast Cancer Patients

Early Breast Cancer Clinical Trial

— GIM 23- POSTER  

Official title:
Prospective Observational Study of Adjuvant Hormone Treatment in Estrogen-receptor Positive Premenopausal Early Breast Cancer Patients

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT05730647
Other study ID # GIM23-POSTER
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date October 24, 2019
Est. completion date July 31, 2032

Study information
Verified date February 2023
Source Consorzio Oncotech
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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).

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 600
Est. completion date July 31, 2032
Est. primary completion date August 1, 2022
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• None intervention (observational study)
None intervention (observational study)

Locations
Country Name City State
Italy 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 Presidio Ospedaliero "Antonio Perrino" ASL Brindisi Brindisi
Italy Università degli Studi "G.d'Annunzio" Chieti-Pescara Chieti
Italy ASST Lariana - Ospedale S. Anna Como
Italy Azienda Ospedaliera S. Croce e Carle Cuneo
Italy Azienda Ospedaliera Universitaria Careggi Firenze
Italy I.R.C.C.S. A.O.U San Martino - IST Genova
Italy Ospedale Civile di Guastalla Guastalla
Italy Ospedale F.Renzetti di Lanciano Lanciano
Italy Ospedale S.M. Goretti Latina
Italy P.O. Vito Fazzi Lecce
Italy A.O. Ospedale Civile di Legnano Legnano
Italy AUSL Toscana Nord Ovest- Osp. Versilia Lido Di Camaiore
Italy Ospedale di Macerata Macerata
Italy A.O.Papardo Messina
Italy A.O.U Policlinico di Modena Modena
Italy A.O.R.N. "A. Cardarelli" Napoli
Italy AOU Federico II Napoli
Italy Azienda Ospedaliera Specialistica dei Colli - Ospedale Monaldi Napoli
Italy Istituto Nazionale dei Tumori - Fondazione G. Pascale Napoli
Italy Istituto Oncologico Veneto IRCCS Padova
Italy A. O. U. Pisana - Ospedale S. Chiara Pisa
Italy A.O.R. San Carlo Potenza
Italy Ospedale di Prato Prato
Italy AUSL della Romagna- P.O. di Ravenna, Lugo e Faenza Ravenna
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 IRCCS Casa Sollievo della Sofferenza San Giovanni Rotondo
Italy Ospedale San Vincenzo Taormina
Italy Presidio Ospedaliero Martini - ASL TO1 Torino
Italy Ospedale Santa Chiara Trento
Italy Azienda Ospedaliera Universitaria SM Misericordia Udine
Italy Ospedale San Pio da Pietrelcina Vasto

Sponsors (1)
Lead Sponsor Collaborator
Consorzio Oncotech

Country where clinical trial is conducted

Italy, 

Outcome
Type Measure Description Time frame Safety issue
Primary To record the choice, in clinical practice, of adjuvant hormone therapy. Patients will be divided in groups according to type of adjuvant hormone therapy received:
tamoxifen
tamoxifen + LhRh
aromatase inhibitor + LhRh Differences between groups will be evaluated with Chi-square test and Mann-Whitney test.		 21 months
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