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

NCT ID: NCT05730647

Last Updated: 2023-02-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

600 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-10-24

Study Completion Date

2032-07-31

Brief Summary

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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).

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Detailed Description

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Conditions

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Early Breast Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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None intervention (observational study)

None intervention (observational study)

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Consorzio Oncotech

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Centro di Riferimento Oncologico- IRCCS

Aviano, , Italy

Site Status

A.O. Consorziale Policlinico di Bari

Bari, , Italy

Site Status

IRCCS Istituto Oncologico di Bari

Bari, , Italy

Site Status

Osp. Papa Giovanni XXIII

Bergamo, , Italy

Site Status

Presidio Ospedaliero "Antonio Perrino" ASL Brindisi

Brindisi, , Italy

Site Status

Università degli Studi "G.d'Annunzio" Chieti-Pescara

Chieti, , Italy

Site Status

ASST Lariana - Ospedale S. Anna

Como, , Italy

Site Status

Azienda Ospedaliera S. Croce e Carle

Cuneo, , Italy

Site Status

Azienda Ospedaliera Universitaria Careggi

Florence, , Italy

Site Status

I.R.C.C.S. A.O.U San Martino - IST

Genova, , Italy

Site Status

Ospedale Civile di Guastalla

Guastalla, , Italy

Site Status

Ospedale F.Renzetti di Lanciano

Lanciano, , Italy

Site Status

Ospedale S.M. Goretti

Latina, , Italy

Site Status

P.O. Vito Fazzi

Lecce, , Italy

Site Status

A.O. Ospedale Civile di Legnano

Legnano, , Italy

Site Status

AUSL Toscana Nord Ovest- Osp. Versilia

Lido di Camaiore, , Italy

Site Status

Ospedale di Macerata

Macerata, , Italy

Site Status

A.O.Papardo

Messina, , Italy

Site Status

A.O.U Policlinico di Modena

Modena, , Italy

Site Status

A.O.R.N. "A. Cardarelli"

Napoli, , Italy

Site Status

AOU Federico II

Napoli, , Italy

Site Status

Azienda Ospedaliera Specialistica dei Colli - Ospedale Monaldi

Napoli, , Italy

Site Status

Istituto Nazionale dei Tumori - Fondazione G. Pascale

Napoli, , Italy

Site Status

Istituto Oncologico Veneto IRCCS

Padua, , Italy

Site Status

A. O. U. Pisana - Ospedale S. Chiara

Pisa, , Italy

Site Status

A.O.R. San Carlo

Potenza, , Italy

Site Status

Ospedale di Prato

Prato, , Italy

Site Status

AUSL della Romagna- P.O. di Ravenna, Lugo e Faenza

Ravenna, , Italy

Site Status

IRCCS Arcispedale S.Maria Nuova

Reggio Emilia, , Italy

Site Status

Fondazione Policlinico Gemelli

Roma, , Italy

Site Status

Istituto Nazionale Tumori Regina Elena

Roma, , Italy

Site Status

Ospedale San Camillo Forlanini

Roma, , Italy

Site Status

Policlinico Universitario Campus Biomedico

Roma, , Italy

Site Status

Istituto Clinico Humanitas Irccs

Rozzano, , Italy

Site Status

IRCCS Casa Sollievo della Sofferenza

San Giovanni Rotondo, , Italy

Site Status

Ospedale San Vincenzo

Taormina, , Italy

Site Status

Presidio Ospedaliero Martini - ASL TO1

Torino, , Italy

Site Status

Ospedale Santa Chiara

Trento, , Italy

Site Status

Azienda Ospedaliera Universitaria SM Misericordia

Udine, , Italy

Site Status

Ospedale San Pio da Pietrelcina

Vasto, , Italy

Site Status

Countries

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Italy

Other Identifiers

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GIM23-POSTER

Identifier Type: -

Identifier Source: org_study_id

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