Prospective Observational Study of Adjuvant Hormone Treatment in Estrogen-receptor Positive Premenopausal Early Breast Cancer Patients
GIM 23- POSTER
1 other identifier
observational
600
1 country
40
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2019
Longer than P75 for all trials
40 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 24, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2022
CompletedFirst Submitted
Initial submission to the registry
February 7, 2023
CompletedFirst Posted
Study publicly available on registry
February 16, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
July 31, 2032
ExpectedFebruary 16, 2023
February 1, 2023
2.8 years
February 7, 2023
February 7, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
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: 1. tamoxifen 2. tamoxifen + LhRh 3. aromatase inhibitor + LhRh Differences between groups will be evaluated with Chi-square test and Mann-Whitney test.
21 months
Interventions
None intervention (observational study)
Eligibility Criteria
Premenopausal patients candidate to start adjuvant hormone therapy after breast cancer surgery.
You may qualify if:
- \- Premenopausal patients candidate to start adjuvant hormone therapy after breast cancer surgery
- \- Age \>18 years
- \- No previous hormonal treatment
- \- Written informed consent
You may not qualify if:
- Patient's inability to provide written informed consent 2 - Stage IV disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (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
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
Florence, 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
Padua, 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, Italy
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 7, 2023
First Posted
February 16, 2023
Study Start
October 24, 2019
Primary Completion
August 1, 2022
Study Completion (Estimated)
July 31, 2032
Last Updated
February 16, 2023
Record last verified: 2023-02