Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT05730647

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

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).

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Early Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Centro di Riferimento Oncologico- IRCCS, Aviano, Italy

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • - Premenopausal patients candidate to start adjuvant hormone therapy after breast cancer surgery
  • - Age >18 years
  • - No previous hormonal treatment
  • - Written informed consent

Exclusion criteria

1- Patient's inability to provide written informed consent 2 - Stage IV disease

Treatment and study plan

None intervention (observational study)

Other

None intervention (observational study)

Primary outcomes

  1. 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:

    • tamoxifen
    • tamoxifen + LhRh
    • aromatase inhibitor + LhRh Differences between groups will be evaluated with Chi-square test and Mann-Whitney test.

Sponsors and collaborators

Lead sponsor

Consorzio Oncotech

Other

Registry information

Acronym: GIM 23- POSTER

Important dates

Study start
2019
Primary completion
2022
Study completion
2032
First posted
Feb 16, 2023
Registry last updated
Feb 16, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.