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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05730647
Acronym
GIM 23- POSTER
Enrollment
600
Registered
2023-02-16
Start date
2019-10-24
Completion date
2032-07-31
Last updated
2023-02-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Early Breast Cancer

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).

Interventions

OTHERNone intervention (observational study)

None intervention (observational study)

Sponsors

Consorzio Oncotech
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
To record the choice, in clinical practice, of adjuvant hormone therapy.21 monthsPatients 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.

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 6, 2026