HOBOE: A Phase 3 Study of Adjuvant Triptorelin and Tamoxifen, Letrozole, or Letrozole and Zoledronic Acid in Premenopausal Patients With Breast Cancer.
NCT ID: NCT00412022
Last Updated: 2023-03-24
Study Results
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Basic Information
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UNKNOWN
PHASE3
1294 participants
INTERVENTIONAL
2004-03-31
2024-11-30
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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A
Triptorelin 3.75 mg IM every 4 weeks and Tamoxifen 20 mg daily, for 5 years
tamoxifen
20 mg daily for 5 years
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
B
Triptorelin 3.75 mg IM every 4 weeks and Letrozole 2.5 mg daily, for 5 years
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
letrozole
2.5 mg daily for 5 years
C
Triptorelin 3.75 mg IM every 4 weeks and Letrozole 2.5 mg daily for 5 years + zoledronic acid 4 mg every 6 months.
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
letrozole
2.5 mg daily for 5 years
zoledronic acid
4 mg every 6 months
Interventions
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tamoxifen
20 mg daily for 5 years
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
letrozole
2.5 mg daily for 5 years
zoledronic acid
4 mg every 6 months
Eligibility Criteria
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Inclusion Criteria
* Surgical resection of breast cancer (breast conserving surgery or mastectomy)
* No evidence of disease
* Indication for adjuvant hormonal therapy (ER and/or PgR positive with IHC exam in at least 1% of primary tumor cells, according to St. Gallen criteria)
* Patient age at least 18 years
* Written informed consent . Premenopausal status defined as LMP within 12 months of randomization (FSH, LH will not be considered as determinants of menopausal status due the chemotherapy induced reversible ovarian suppression)
Please note that patients who have received neoadjuvant or adjuvant chemotherapy and/or locoregional radiation therapy may be included in the study
Exclusion Criteria
* Previous or concomitant malignancy (with the exception of adequately treated nonmalignant skin cancer and carcinoma in situ of the uterine cervix
* Metastatic breast cancer
* Creatinine \> 1.25 times the value of upper normal limit
* Pregnant or lactating females
* Clinical or radiologic evidence of bone fractures
* Treatment with systemic cortisone therapy within 12 months prior to randomization
* Treatment with drugs that could alter bone metabolism (calcitonin, mithramycin, gallium nitrate) within 2 weeks prior to randomization
* Previous treatment with tamoxifen or aromatase inhibitors
* AST and/or ALT \> 3 times the value of upper normal limit with clinical and laboratory findings that indicate a grade of hepatic insufficiency that could potentially increase the risk of assuming letrozole
* Any concomitant conditions that would, in the Investigator's opinion, contraindicate the use of any of the drugs used in this study
* Inability to provide informed consent
* Inability to comply with followup
* Patient undergoing invasive dental work at time of baseline evaluation or foreseen during the course of adjuvant therapy
18 Years
FEMALE
No
Sponsors
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University of Campania Luigi Vanvitelli
OTHER
National Cancer Institute, Naples
OTHER
Responsible Party
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Principal Investigators
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Andrea De Matteis, M.D.
Role: PRINCIPAL_INVESTIGATOR
NCI Naples, Division of Medical Oncology C
Ciro Gallo, M.D., Ph.D.
Role: PRINCIPAL_INVESTIGATOR
University of Campania Luigi Vanvitelli
Francesco Perrone, M.D., Ph.D.
Role: PRINCIPAL_INVESTIGATOR
NCI Naples, Clinical Trials Unit
Locations
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S. Giuseppe Moscati
Avellino, AV, Italy
Azienda Ospedaliera Treviglio - Caravaggio
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,
Napoli, , Italy
Ospedale Cardarelli
Napoli, , Italy
Seconda Università di Napoli
Napoli, , Italy
Università Federico II, Cattedra di Oncologia Medica
Napoli, , 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
Countries
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References
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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.
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.
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.
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.
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.
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.
Other Identifiers
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HOBOE
Identifier Type: -
Identifier Source: org_study_id
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