Breast CancerPhase 3HOBOENCT00412022
HOBOE: A Phase 3 Study of Adjuvant Triptorelin and Tamoxifen, Letrozole, or Letrozole and Zoledronic Acid in Premenopausal Patients With Breast Cancer.
A Phase 3 study testing tamoxifen, triptorelin and letrozole in people with Breast Cancer, run by National Cancer Institute, Naples at 20 sites in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- tamoxifen, triptorelin and letrozole
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,294 participants
- Where
- 20 sitesItaly
- Study dates
- Mar 2004to Nov 2024
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histological diagnosis of breast cancer
- 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
Who cannot join
- Performance status (ECOG)>2.
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
20 sites in 1 country.
20 sites in 1 country
Italy20 sites
S. Giuseppe Moscati
Avellino, AV
Ospedale Santa Maria Annunziata
Bagno a Ripoli
Azienda Ospedaliera G. Rummo
Benevento, BN
Ospedale Senatore Antonio Perrino
Brindisi, BR
Istituto Nazionale per la ricerca Sul Cancro
Genova
Ospedale Riuniti
Livorno
Ospedale Unico della Versilia
Lucca
Istituto Romagnolo per lo Studio e la Cura dei Tumori
Meldola, FC
Istituto Nazionale dei Tumori,
Naples
Ospedale Cardarelli
Naples
Seconda Università di Napoli
Naples
Università Federico II, Cattedra di Oncologia Medica
Naples
Casa di Cura La Maddalena
Palermo
Ospedale Silvestrini
Perugia
Ospedale Santa Chiara
Pisa
Presidio Ospedaliero Di Saronno Aziendo Ospedaliera di Busto Arsizio
Saronno, VA
Università di Sassari
Sassari
Ospedale Santa Chiara
Trento
Azienda Ospedaliera Treviglio - Caravaggio
Treviglio, BG
ASL Viterbo Ospedale Belcolle
Viterbo
About this study
Official title: 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.
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
- Breast Cancer
- Being tested
- tamoxifen, triptorelin, letrozole, zoledronic acid
- Keywords
- early breast cancer, adjuvant therapy, premenopause, premenopausal, menopausal status, postmenopause, bone mineral density, hormone sensitive, aromatase inhibitors, letrozole, disease-free survival
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tamoxifenDrug
20 mg daily for 5 years
triptorelinDrug
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
letrozoleDrug
2.5 mg daily for 5 years
zoledronic acidDrug
4 mg every 6 months
| Study group | Role | What they receive |
|---|---|---|
| A | Active comparator | Triptorelin 3.75 mg IM every 4 weeks and Tamoxifen 20 mg daily, for 5 years Receives: Drug: tamoxifen; Drug: triptorelin |
| B | Active comparator | Triptorelin 3.75 mg IM every 4 weeks and Letrozole 2.5 mg daily, for 5 years Receives: Drug: triptorelin; Drug: letrozole |
| 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. Receives: Drug: triptorelin; Drug: letrozole; Drug: zoledronic acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
disease free survival in premenopausal patients
Measured: observation period is 10 years from initiation of treatment
bone mineral density
Measured: 12 months from initiation of therapy
Secondary outcomes (4)
Bone mineral density measured
Measured: yearly after first year of therapy
disease free survival in postmenopausal patients
Measured: observation period is 10 years from initiation of treatment
overall survival
Measured: observation period is 10 years from initiation of treatment
toxicity of letrozole + triptorelin and letrozole + zoledronic acid + triptorelin in premenopausal patients
Measured: monthly
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2006 (estimated)
- Study startMar 2004
- Primary completionNov 2024 (estimated)
- Study completionNov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,294 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute, Naples
- Sponsor type
- University, hospital or other
- Collaborators
- University of Campania Luigi Vanvitelli
- Responsible party
- Sponsor
- Investigators
- Andrea De Matteis, M.D., Principal investigator, NCI Naples, Division of Medical Oncology CCiro Gallo, M.D., Ph.D., Principal investigator, University of Campania Luigi VanvitelliFrancesco Perrone, M.D., Ph.D., Principal investigator, NCI Naples, Clinical Trials Unit
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00412022
- Sponsor's protocol ID
- HOBOE
- Acronym
- HOBOE
- Status last verified
- Mar 2023
- First submitted
- 14 Dec 2006
- Last updated
- 24 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 19380451Rossi 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.
PubMed 18086795Nuzzo 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.
PubMed 22412041Gravina 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.
PubMed 39754976Adams 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.
PubMed 38979716Perrone 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.
PubMed 31164265
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT00412022
- Acronym / sponsor ID
- HOBOE / HOBOE
- Conditions
- Breast Cancer
- Keywords
- early breast cancer, adjuvant therapy, premenopause, premenopausal, menopausal status, postmenopause, bone mineral density, hormone sensitive
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,294 participants (actual)
- Lead sponsor
- National Cancer Institute, NaplesUniversity, hospital or other
- Collaborators
- University of Campania Luigi Vanvitelli
- Study start
- Mar 2004
- Primary completion
- Nov 2024 (estimated)
- Study completion
- Nov 2024 (estimated)
- First posted
- 15 Dec 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| A | Active comparator | Drug: tamoxifen, Drug: triptorelinTriptorelin 3.75 mg IM every 4 weeks and Tamoxifen 20 mg daily, for 5 years |
| B | Active comparator | Drug: triptorelin, Drug: letrozoleTriptorelin 3.75 mg IM every 4 weeks and Letrozole 2.5 mg daily, for 5 years |
| C | Experimental | Drug: triptorelin, Drug: letrozole, Drug: zoledronic acidTriptorelin 3.75 mg IM every 4 weeks and Letrozole 2.5 mg daily for 5 years + zoledronic acid 4 mg every 6 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Histological diagnosis of breast cancer
- 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
Key exclusion criteria (14 listed)
- Performance status (ECOG)>2.
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| tamoxifen20 mg daily for 5 years | Drug | A |
| triptorelinPremenopausal 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 | A, B, C |
| letrozole2.5 mg daily for 5 years | Drug | B, C |
| zoledronic acid4 mg every 6 months | Drug | C |
Primary outcome
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
4 secondary outcomes
Bone mineral density measured
Time frame: yearly after first year of therapy
disease free survival in postmenopausal patients
Time frame: observation period is 10 years from initiation of treatment
overall survival
Time frame: observation period is 10 years from initiation of treatment
toxicity of letrozole + triptorelin and letrozole + zoledronic acid + triptorelin in premenopausal patients
Time frame: monthly
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2023.
- Results publication: PubMed 19380451Rossi 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.
- Results publication: PubMed 18086795Rossi 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.
- Results publication: PubMed 22412041Nuzzo 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.
- Derived from this study: PubMed 39754976Gravina 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.
- Derived from this study: PubMed 38979716Adams 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.
- Derived from this study: PubMed 31164265Perrone 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrea De Matteis, M.D. principal investigator
NCI Naples, Division of Medical Oncology C
Ciro Gallo, M.D., Ph.D. principal investigator
University of Campania Luigi Vanvitelli
Francesco Perrone, M.D., Ph.D. principal investigator
NCI Naples, Clinical Trials Unit
20 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing tamoxifen, triptorelin and letrozole in people with Breast Cancer, run by National Cancer Institute, Naples at 20 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
disease free survival in premenopausal patients (time frame: observation period is 10 years from initiation of treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00412022, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2023.