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Clinical Trials in Italy / NCT05730647
Active, not recruiting Observational

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

NCT05730647 · tracked via the Priya Life Science Italy tracker
Sponsor
Consorzio Oncotech
Phase
Observational
Started
2019-10-24
Last updated
2023-02-16

Condition(s) studied

Early Breast Cancer

Investigational drug(s) / intervention(s)

None intervention (observational study)

None intervention (observational study): None intervention (observational study)

Study 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

Sex
FEMALE
Min age
18 Years
Max age
—
Healthy volunteers
No
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 outcome measure(s)

  • To record the choice, in clinical practice, of adjuvant hormone therapy. — 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.

Trial sites (40)

FacilityCityRegionStatus
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
A.O.Papardo Messina Italy
A.O.U Policlinico di Modena Modena Italy
A.O.R.N. "A. Cardarelli" Naples Italy
AOU Federico II Naples Italy
Azienda Ospedaliera Specialistica dei Colli - Ospedale Monaldi Naples Italy
Istituto Nazionale dei Tumori - Fondazione G. Pascale Naples 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
Ospedale di Macerata Province of Macerata 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

More Consorzio Oncotech trials in Italy

Measure of Outcomes in Patients With Advanced Ovarian Cancer According to Homologous Recombination Status and Matched Therapies in a Real-world Scenario Recruiting
Axitinib Intensification Plus Nivolumab or Nivolumab Alone After Nivolumab Plus Ipilimumab in mRCC Patients Recruiting
"Observational, Retrospective and Prospective, Non-interventional, Multicentre on the Use of Genomic Testing in the Management of Early Stage HR+/HER2- Breast Cancer" Starting soon

Other trials for the same condition

Chemotherapy-Free pCR-Guided Strategy With Trastuzumab-pertuzumab and T-DM1 in HER2-positive Early Breast Cancer Active, not recruiting
A Study Evaluating the Efficacy and Safety of Adjuvant Giredestrant Compared With Physician's Choice of Adjuvant Endocrine Monotherapy in Participants With Estrogen Receptor-Positive, HER2-Negative Early Breast Cancer (lidERA Breast Cancer) Active, not recruiting
Optimising Adjuvant Chemotherapy Prescription in Young Patients With Hormone-dependent Breast Cancer Using Genomic Tests Recruiting
Pregnancy Outcome and Safety of Interrupting Therapy for Women With Endocrine Responsive Breast Cancer Active, not recruiting
A Trial to Evaluate Efficacy and Safety of Ribociclib With Endocrine Therapy as Adjuvant Treatment in Patients With HR+/HER2- Early Breast Cancer Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05730647 on ClinicalTrials.gov ↗ ← All trials in Italy