Clinical trial NCT05730647: Prospective Observational Study of Adjuvant Hormone Treatment in Estrogen-receptor Positive Premenopausal Early Breast Cancer Patients
Official title: Prospective Observational Study of Adjuvant Hormone Treatment in Estrogen-receptor Positive Premenopausal Early Breast Cancer Patients
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Early Breast Cancer
Lead sponsor: Consorzio Oncotech
Sponsor class: OTHER
First posted: 2023-02-16
Enrollment: 600
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Premenopausal patients candidate to start adjuvant hormone therapy after breast cancer surgery.

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).


Eligibility 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

Primary outcomes:
measure: To record the choice, in clinical practice, of adjuvant hormone therapy.
timeFrame: 21 months
Secondary outcomes:
Other outcomes:
Locations:
city: Aviano
country: Italy
facility: Centro di Riferimento Oncologico- IRCCS
city: Bari
country: Italy
facility: A.O. Consorziale Policlinico di Bari
city: Bari
country: Italy
facility: IRCCS Istituto Oncologico di Bari
city: Bergamo
country: Italy
facility: Osp. Papa Giovanni XXIII
city: Brindisi
country: Italy
facility: Presidio Ospedaliero "Antonio Perrino" ASL Brindisi
city: Chieti
country: Italy
facility: Università degli Studi "G.d'Annunzio" Chieti-Pescara
city: Como
country: Italy
facility: ASST Lariana - Ospedale S. Anna
city: Cuneo
country: Italy
facility: Azienda Ospedaliera S. Croce e Carle
city: Firenze
country: Italy
facility: Azienda Ospedaliera Universitaria Careggi
city: Genova
country: Italy
facility: I.R.C.C.S. A.O.U San Martino - IST
city: Guastalla
country: Italy
facility: Ospedale Civile di Guastalla
city: Lanciano
country: Italy
facility: Ospedale F.Renzetti di Lanciano
city: Latina
country: Italy
facility: Ospedale S.M. Goretti
city: Lecce
country: Italy
facility: P.O. Vito Fazzi
city: Legnano
country: Italy
facility: A.O. Ospedale Civile di Legnano
city: Lido Di Camaiore
country: Italy
facility: AUSL Toscana Nord Ovest- Osp. Versilia
city: Macerata
country: Italy
facility: Ospedale di Macerata
city: Messina
country: Italy
facility: A.O.Papardo
city: Modena
country: Italy
facility: A.O.U Policlinico di Modena
city: Napoli
country: Italy
facility: A.O.R.N. "A. Cardarelli"
city: Napoli
country: Italy
facility: AOU Federico II
city: Napoli
country: Italy
facility: Azienda Ospedaliera Specialistica dei Colli - Ospedale Monaldi
city: Napoli
country: Italy
facility: Istituto Nazionale dei Tumori - Fondazione G. Pascale
city: Padova
country: Italy
facility: Istituto Oncologico Veneto IRCCS
city: Pisa
country: Italy
facility: A. O. U. Pisana - Ospedale S. Chiara
city: Potenza
country: Italy
facility: A.O.R. San Carlo
city: Prato
country: Italy
facility: Ospedale di Prato
city: Ravenna
country: Italy
facility: AUSL della Romagna- P.O. di Ravenna, Lugo e Faenza
city: Reggio Emilia
country: Italy
facility: IRCCS Arcispedale S.Maria Nuova
city: Roma
country: Italy
facility: Fondazione Policlinico Gemelli
city: Roma
country: Italy
facility: Istituto Nazionale Tumori Regina Elena
city: Roma
country: Italy
facility: Ospedale San Camillo Forlanini
city: Roma
country: Italy
facility: Policlinico Universitario Campus Biomedico
city: Rozzano
country: Italy
facility: Istituto Clinico Humanitas Irccs
city: San Giovanni Rotondo
country: Italy
facility: IRCCS Casa Sollievo della Sofferenza
city: Taormina
country: Italy
facility: Ospedale San Vincenzo
city: Torino
country: Italy
facility: Presidio Ospedaliero Martini - ASL TO1
city: Trento
country: Italy
facility: Ospedale Santa Chiara
city: Udine
country: Italy
facility: Azienda Ospedaliera Universitaria SM Misericordia
city: Vasto
country: Italy
facility: Ospedale San Pio da Pietrelcina
Study officials:
References: