HOBOE: A Study of Hormonal Adjuvant Treatment Effect on Bone Mineral Density in Early Breast Cancer Patients - Full Text View

Sponsors and Collaborators:	National Cancer Institute, Naples Second University of Naples
Information provided by:	National Cancer Institute, Naples
ClinicalTrials.gov Identifier:	NCT00412022

Purpose

The purpose of the HOBOE study (HOrmonal adjuvant treatment BOne Effects)is 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 are eligible, the latter also receiving monthly triptorelin.

Condition	Intervention	Phase
Breast Cancer	Drug: tamoxifen Drug: triptorelin Drug: letrozole Drug: zoledronic acid	Phase III

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer Minerals

Drug Information available for: Zoledronic acid Tamoxifen Tamoxifen citrate Letrozole Triptorelin Triptorelin pamoate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy 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

Further study details as provided by National Cancer Institute, Naples:

Primary Outcome Measures:

Bone mineral density measured [ Time Frame: 12 months from initiation of therapy ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Bone mineral density measured [ Time Frame: yearly after first year of therapy ] [ Designated as safety issue: No ]
Bone resorption measured with urinary biomarkers [ Time Frame: yearly ] [ Designated as safety issue: No ]
disease free survival [ Time Frame: end of study ] [ Designated as safety issue: No ]
overall survival [ Time Frame: end of study ] [ Designated as safety issue: No ]
toxicity of letrozole + triptorelin and letrozole + zoledronic acid + triptorelin in premenopausal patients [ Time Frame: monthly ] [ Designated as safety issue: No ]

Estimated Enrollment:	500
Study Start Date:	March 2004
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Active Comparator Tamoxifen 20 mg daily for 5 years (may switch to an approved aromatase inhibitor after 2-3 years) premenopausal patients will also receive triptorelin 3.75mg every 4 weeks	Drug: tamoxifen 20 mg daily for 5 years (may switch after 2-3 years to an approved aromatase inhibitor) Drug: triptorelin 3.75 mg every 4 weeks for premenopausal patients
B: Active Comparator Letrozole 2.5 mg daily for 5 years Triptorelin 3.75 mg every 4 weeks for premenopausal patients	Drug: triptorelin 3.75 mg every 4 weeks for premenopausal patients Drug: letrozole 2.5 mg daily for 5 years
C: Experimental Letrozole 2.5 mg daily for 5 years + zoledronic acid 4 mg every 6 months. Premenopausal patients will receive triptorelin 3.75 mg every 4 weeks.	Drug: triptorelin 3.75 mg every 4 weeks for premenopausal patients Drug: letrozole 2.5 mg daily for 5 years Drug: zoledronic acid 4 mg every 6 months

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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

Please note that patients who have received neoadjuvant or adjuvant chemotherapy and/or locoregional radiation therapy may be included in the study

Exclusion Criteria:

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
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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00412022

Contacts

Contact: Francesco Perrone, M.D., Ph.D	+39 081 5903 ext 571	francesco.perrone@uosc.fondazionepascale.it
Contact: Alessandro Morabito, M.D.	+39 081 5903 ext 383	alessandro.morabito@uosc.fondazionepascale.it

Locations

Italy
Istituto Nazionale dei Tumori, Divisione di Oncologia Medica C	Recruiting
Napoli, Italy, 80131
Principal Investigator: Andrea De Matteis, M.D.
Italy, BN
Azienda Ospedaliera G. Rummo	Recruiting
Benevento, BN, Italy
Principal Investigator: Bruno Daniele, M.D.
Italy, PA
Policlinico Giaccone	Recruiting
Palermo, PA, Italy, 90127
Principal Investigator: Nicola Gebbia, M.D.

Sponsors and Collaborators

National Cancer Institute, Naples

Second University of Naples

Investigators

Principal Investigator:	Andrea De Matteis, M.D.	NCI Naples, Division of Medical Oncology C
Principal Investigator:	Giuseppe D'Aiuto, M.D.	NCI Naples, Division of Surgical Oncology A
Principal Investigator:	Francesco Perrone, M.D., Ph.D.	NCI Naples, Clinical Trials Unit

More Information

Responsible Party:	National Cancer Institute Naples ( Francesco Perrone, Director, Clinical Trials Unit )
Study ID Numbers:	HOBOE
Study First Received:	December 14, 2006
Last Updated:	November 7, 2008
ClinicalTrials.gov Identifier:	NCT00412022
Health Authority:	Italy: Ethics Committee

Keywords provided by National Cancer Institute, Naples:

early breast cancer
adjuvant therapy
premenopausal
postmenopausal

bone mineral density
hormone sensitive
aromatase inhibitors

Study placed in the following topic categories:

Zoledronic acid
Skin Diseases
Triptorelin
Breast Neoplasms

Letrozole
Tamoxifen
Breast Diseases

Additional relevant MeSH terms:

Estrogen Antagonists
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Hormonal
Contraceptive Agents
Antineoplastic Agents
Hormone Antagonists
Physiological Effects of Drugs
Contraceptive Agents, Female
Hormones, Hormone Substitutes, and Hormone Antagonists
Enzyme Inhibitors

Bone Density Conservation Agents
Reproductive Control Agents
Luteolytic Agents
Selective Estrogen Receptor Modulators
Pharmacologic Actions
Estrogen Receptor Modulators
Neoplasms
Neoplasms by Site
Therapeutic Uses
Aromatase Inhibitors

ClinicalTrials.gov processed this record on January 14, 2009