NCT00412022: HOBOE

Phase III Randomized Study of the Effects on Bone Mineral Density of Tamoxifen, Letrozole, and Letrozole + Zoledronic Acid as Adjuvant Treatment of Patients With Early Breast Cancer; VERSION 2 AMENDED Phase 3 Study of Triptorelin and Tamoxifen, Letrozole, or Letrozole + Zoledronic Acid in Adjuvant Treatment of Premenopausal Endocrine Responsive Breast Cancer Patients.

Status unknown Phase 3 Last updated 23 March 2023

What this trial tests

Phase 3 trial testing tamoxifen in Breast Cancer in 1,294 participants. Status unknown.

Timeline

1 March 2004

Primary endpoint
1 November 2024

1 November 2024

Quick facts

Lead sponsor	National Cancer Institute, Naples
Phase	Phase 3
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	1,294
Start date	1 March 2004
Primary completion	1 November 2024
Estimated completion	1 November 2024
Sites	20 locations across Italy

Drugs / interventions tested

• tamoxifen
• triptorelin (triptorelin) — full drug profile →
• letrozole — full drug profile →
• zoledronic acid (ZOLEDRONIC ACID) — full drug profile →

Conditions studied

• Breast Cancer — all drugs for Breast Cancer →

Sponsor

National Cancer Institute, Naples

Who can join

18 and older, female only, with Breast Cancer. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• disease free survival in premenopausal patients
  Time frame: observation period is 10 years from initiation of treatment
• bone mineral density
  Time frame: 12 months from initiation of therapy

Sponsor's own description

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.

Publications & conference data

7 peer-reviewed publications reference this trial (live from Europe PMC):

1. Bisphosphonates and other bone agents for breast cancer.
   O'Carrigan B, Wong MH, Willson ML, Stockler MR, et al · · 2017 · cited 113× · PMID 29082518 · DOI 10.1002/14651858.cd003474.pub4
2. Adjuvant zoledronic acid and letrozole plus ovarian function suppression in premenopausal breast cancer: HOBOE phase 3 randomised trial.
   Perrone F, De Laurentiis M, De Placido S, Orditura M, et al · · 2019 · cited 50× · PMID 31164265 · DOI 10.1016/j.ejca.2019.05.004
3. Aromatase inhibitors in premenopausal women with breast cancer: the state of the art and future prospects.
   Pistelli M, Mora AD, Ballatore Z, Berardi R. · · 2018 · cited 40× · PMID 29719441 · DOI 10.3747/co.25.3735
4. Combined effects of the bisphosphonate, zoledronic acid and the aromatase inhibitor letrozole on breast cancer cells in vitro: evidence of synergistic interaction.
   Neville-Webbe HL, Coleman RE, Holen I. · · 2010 · cited 37× · PMID 20160726 · DOI 10.1038/sj.bjc.6605579
5. Adjuvant endocrine treatment strategies for non-metastatic breast cancer: a network meta-analysis.
   Papakonstantinou A, Villacampa G, Navarro V, Oliveira M, et al · · 2025 · cited 7× · PMID 40034565 · DOI 10.1016/j.eclinm.2025.103116
6. Controversies in oncology: which adjuvant endocrine therapy is to be given to premenopausal patients with hormone receptor-positive breast cancer?
   Lambertini M, Viglietti G, de Azambuja E. · · 2018 · cited 5× · PMID 29636992 · DOI 10.1136/esmoopen-2018-000350
7. Ten-year update of HOBOE phase III trial comparing triptorelin plus either tamoxifen or letrozole or zoledronic acid + letrozole in premenopausal hormone receptor-positive early breast cancer patients.
   Gravina A, Gargiulo P, De Laurentiis M, Arenare L, et al · · 2025 · cited 4× · PMID 39754976 · DOI 10.1016/j.esmoop.2024.104085