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

Active, not recruiting

• Conditions: Early Breast Cancer

• Registration Number: NCT05730647
• Lead Sponsor: Consorzio Oncotech

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2019-10-24
• Primary Completion: 2022-08-01
• Status Verified: 2023-02
• Study First Submitted: 2023-02-07
• Study First Submitted QC: 2023-02-07
• Last Update Submitted: 2023-02-07
• Study First Posted: 2023-02-16
• Last Update Posted: 2023-02-16
• Study Completion: 2032-07-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 600

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Locations

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; 🇮🇹 Chieti, Italy

ASST Lariana - Ospedale S. Anna; 🇮🇹 Como, Italy

Azienda Ospedaliera S. Croce e Carle; 🇮🇹 Cuneo, Italy

Azienda Ospedaliera Universitaria Careggi; 🇮🇹 Firenze, Italy

I.R.C.C.S. A.O.U San Martino - IST; 🇮🇹 Genova, Italy

Scroll for more (30 remaining)