Prospective Observational Study of Adjuvant Hormone Treatment in Estrogen-receptor Positive Premenopausal Early Breast Cancer Patients (GIM 23- POSTER)

February 7, 2023 updated by: Consorzio Oncotech

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).

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

600

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Premenopausal patients candidate to start adjuvant hormone therapy after breast cancer surgery.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To record the choice, in clinical practice, of adjuvant hormone therapy.
Time Frame: 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.
21 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Consorzio Oncotech

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 24, 2019

Primary Completion (Actual)

August 1, 2022

Study Completion (Anticipated)

July 31, 2032

Study Registration Dates

First Submitted

February 7, 2023

First Submitted That Met QC Criteria

February 7, 2023

First Posted (Estimate)

February 16, 2023

Study Record Updates

Last Update Posted (Estimate)

February 16, 2023

Last Update Submitted That Met QC Criteria

February 7, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GIM23-POSTER

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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