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| Name | Class |
|---|---|
| University of Campania Luigi Vanvitelli | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Active Comparator | Triptorelin 3.75 mg IM every 4 weeks and Tamoxifen 20 mg daily, for 5 years |
|
| B | Active Comparator | Triptorelin 3.75 mg IM every 4 weeks and Letrozole 2.5 mg daily, for 5 years |
|
| C | Experimental | Triptorelin 3.75 mg IM every 4 weeks and Letrozole 2.5 mg daily for 5 years + zoledronic acid 4 mg every 6 months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| tamoxifen | Drug | 20 mg daily for 5 years |
| |
| triptorelin |
| Measure | Description | Time Frame |
|---|---|---|
| disease free survival in premenopausal patients | observation period is 10 years from initiation of treatment | |
| bone mineral density | 12 months from initiation of therapy |
| Measure | Description | Time Frame |
|---|---|---|
| Bone mineral density measured | yearly after first year of therapy | |
| disease free survival in postmenopausal patients | observation period is 10 years from initiation of treatment | |
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Inclusion Criteria:
Please note that patients who have received neoadjuvant or adjuvant chemotherapy and/or locoregional radiation therapy may be included in the study
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Andrea De Matteis, M.D. | NCI Naples, Division of Medical Oncology C | Principal Investigator |
| Ciro Gallo, M.D., Ph.D. | University of Campania Luigi Vanvitelli | Principal Investigator |
| Francesco Perrone, M.D., Ph.D. | NCI Naples, Clinical Trials Unit | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| S. Giuseppe Moscati | Avellino | AV | Italy | |||
| Azienda Ospedaliera Treviglio - Caravaggio |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19380451 | Result | Rossi E, Morabito A, Di Rella F, Esposito G, Gravina A, Labonia V, Landi G, Nuzzo F, Pacilio C, De Maio E, Di Maio M, Piccirillo MC, De Feo G, D'Aiuto G, Botti G, Chiodini P, Gallo C, Perrone F, de Matteis A. Endocrine effects of adjuvant letrozole compared with tamoxifen in hormone-responsive postmenopausal patients with early breast cancer: the HOBOE trial. J Clin Oncol. 2009 Jul 1;27(19):3192-7. doi: 10.1200/JCO.2008.18.6213. Epub 2009 Apr 20. | |
| 18086795 |
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| Drug |
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 |
|
| letrozole | Drug | 2.5 mg daily for 5 years |
|
| zoledronic acid | Drug | 4 mg every 6 months |
|
| overall survival |
| observation period is 10 years from initiation of treatment |
| toxicity of letrozole + triptorelin and letrozole + zoledronic acid + triptorelin in premenopausal patients | monthly |
| Treviglio |
| BG |
| Italy |
| Azienda Ospedaliera G. Rummo | Benevento | BN | Italy |
| Ospedale Senatore Antonio Perrino | Brindisi | BR | Italy |
| Istituto Romagnolo per lo Studio e la Cura dei Tumori | Meldola | FC | Italy |
| Presidio Ospedaliero Di Saronno Aziendo Ospedaliera di Busto Arsizio | Saronno | VA | Italy |
| Ospedale Santa Maria Annunziata | Bagno a Ripoli | Italy |
| Istituto Nazionale per la ricerca Sul Cancro | Genova | Italy |
| Ospedale Riuniti | Livorno | Italy |
| Ospedale Unico della Versilia | Lucca | Italy |
| Istituto Nazionale dei Tumori, | Naples | Italy |
| Ospedale Cardarelli | Naples | Italy |
| Seconda Università di Napoli | Naples | Italy |
| Università Federico II, Cattedra di Oncologia Medica | Naples | Italy |
| Casa di Cura La Maddalena | Palermo | Italy |
| Ospedale Silvestrini | Perugia | Italy |
| Ospedale Santa Chiara | Pisa | Italy |
| Università di Sassari | Sassari | Italy |
| Ospedale Santa Chiara | Trento | Italy |
| ASL Viterbo Ospedale Belcolle | Viterbo | Italy |
| Result |
| Rossi E, Morabito A, De Maio E, Di Rella F, Esposito G, Gravina A, Labonia V, Landi G, Nuzzo F, Pacilio C, Piccirillo MC, D'Aiuto G, D'Aiuto M, Rinaldo M, Botti G, Gallo C, Perrone F, de Matteis A. Endocrine effects of adjuvant letrozole + triptorelin compared with tamoxifen + triptorelin in premenopausal patients with early breast cancer. J Clin Oncol. 2008 Jan 10;26(2):264-70. doi: 10.1200/JCO.2007.13.5319. Epub 2007 Dec 17. |
| 22412041 | Result | Nuzzo F, Gallo C, Lastoria S, Di Maio M, Piccirillo MC, Gravina A, Landi G, Rossi E, Pacilio C, Labonia V, Di Rella F, Bartiromo A, Buonfanti G, De Feo G, Esposito G, D'Aniello R, Maiolino P, Signoriello S, De Maio E, Tinessa V, Colantuoni G, De Laurentiis M, D'Aiuto M, Di Bonito M, Botti G, Giordano P, Daniele G, Morabito A, Normanno N, de Matteis A, Perrone F. Bone effect of adjuvant tamoxifen, letrozole or letrozole plus zoledronic acid in early-stage breast cancer: the randomized phase 3 HOBOE study. Ann Oncol. 2012 Aug;23(8):2027-2033. doi: 10.1093/annonc/mdr600. Epub 2012 Mar 12. |
| 39754976 | Derived | Gravina A, Gargiulo P, De Laurentiis M, Arenare L, De Placido S, Orditura M, Cinieri S, Riccardi F, Ribecco AS, Putzu C, Del Mastro L, Rossi E, Ciardiello F, Di Rella F, Nuzzo F, Pacilio C, Caputo R, Cianniello D, Forestieri V, Giuliano M, Arpino G, Orlando L, Mocerino C, Schettino C, Piccirillo MC, Gallo C, Perrone F. 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. ESMO Open. 2025 Jan;10(1):104085. doi: 10.1016/j.esmoop.2024.104085. Epub 2025 Jan 3. |
| 38979716 | Derived | Adams A, Jakob T, Huth A, Monsef I, Ernst M, Kopp M, Caro-Valenzuela J, Wockel A, Skoetz N. Bone-modifying agents for reducing bone loss in women with early and locally advanced breast cancer: a network meta-analysis. Cochrane Database Syst Rev. 2024 Jul 9;7(7):CD013451. doi: 10.1002/14651858.CD013451.pub2. |
| 31164265 | Derived | Perrone F, De Laurentiis M, De Placido S, Orditura M, Cinieri S, Riccardi F, Ribecco AS, Putzu C, Del Mastro L, Rossi E, Tinessa V, Mosconi AM, Nuzzo F, Di Rella F, Gravina A, Iodice G, Landi G, Pacilio C, Forestieri V, Lauria R, Fabbri A, Ibrahim T, De Maio E, Barni S, Gori S, Simeon V, Arenare L, Daniele G, Piccirillo MC, Normanno N, de Matteis A, Gallo C. Adjuvant zoledronic acid and letrozole plus ovarian function suppression in premenopausal breast cancer: HOBOE phase 3 randomised trial. Eur J Cancer. 2019 Sep;118:178-186. doi: 10.1016/j.ejca.2019.05.004. Epub 2019 Jun 1. |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D013629 | Tamoxifen |
| D017329 | Triptorelin Pamoate |
| D000077289 | Letrozole |
| D000077211 | Zoledronic Acid |
| ID | Term |
|---|---|
| D013267 | Stilbenes |
| D001597 | Benzylidene Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D007987 | Gonadotropin-Releasing Hormone |
| D010906 | Pituitary Hormone-Releasing Hormones |
| D007028 | Hypothalamic Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D009479 | Neuropeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D009842 | Oligopeptides |
| D009419 | Nerve Tissue Proteins |
| D011506 | Proteins |
| D009570 | Nitriles |
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D004164 | Diphosphonates |
| D063065 | Organophosphonates |
| D009943 | Organophosphorus Compounds |
| D007093 | Imidazoles |
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