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

N/AActive Not RecruitingNCT05730647

Consorzio Oncotech600 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

600

Conditions

Early Breast Cancer

Interventions

None intervention (observational study)OTHER

None intervention (observational study)

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (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

Outcomes

Primary Outcomes

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.

Time frame: 21 months