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HOBOE: A Phase 3 Study of Adjuvant Triptorelin and Tamoxifen, Letrozole, or Letrozole and Zoledronic Acid in Premenopausal Patients With Breast Cancer.

NCT00412022 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1294

Last updated 2023-03-24

No results posted yet for this study

Summary

The HOBOE study was amended in November 2009, and, after reaching enrollment of the first 500 patients, the study began recruiting premenopausal patients only. The primary objective of the extended study is to compare disease free survival in premenopausal patients with early breast cancer. Patients receive triptorelin and are randomized in a 1:1:1 fashion to receive tamoxifen or letrozole, or letrozole + zoledronic acid.

The purpose of the HOBOE study, Version 1, was to compare the adjuvant hormonal therapy treatments of Tamoxifen, Letrozole and Letrozole + Zoledronate for their effects on bone loss in breast cancer patients. Postmenopausal and premenopausal patients were eligible, the latter also receiving monthly triptorelin. Upon reaching the enrollment of the first 500 patients in March 2010, the study began recruiting premenopausal patients only.

Conditions

Interventions

DRUG

tamoxifen

20 mg daily for 5 years

DRUG

triptorelin

Premenopausal patients will receive triptorelin 3.75 mg IM at the beginning of therapy and every 4 weeks for 5 years or up to age 55

DRUG

letrozole

2.5 mg daily for 5 years

DRUG

zoledronic acid

4 mg every 6 months

Sponsors & Collaborators

  • University of Campania Luigi Vanvitelli

    collaborator OTHER

  • National Cancer Institute, Naples

    lead OTHER

Principal Investigators

  • Andrea De Matteis, M.D. · NCI Naples, Division of Medical Oncology C

  • Ciro Gallo, M.D., Ph.D. · University of Campania Luigi Vanvitelli

  • Francesco Perrone, M.D., Ph.D. · NCI Naples, Clinical Trials Unit

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-03-31
Primary Completion
2024-11-30
Completion
2024-11-30

Countries

  • Italy

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00412022 on ClinicalTrials.gov