HOBOE: A Phase 3 Study of Adjuvant Triptorelin and Tamoxifen, Letrozole, or Letrozole and Zoledronic Acid in Premenopausal Patients With Breast Cancer.
This study is currently recruiting participants.
Verified January 2013 by National Cancer Institute, Naples
Sponsor:
National Cancer Institute, Naples
Collaborator:
Second University of Naples
Information provided by (Responsible Party):
National Cancer Institute, Naples
ClinicalTrials.gov Identifier:
NCT00412022
First received: December 14, 2006
Last updated: January 15, 2013
Last verified: January 2013
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Breast Cancer |
Drug: tamoxifen Drug: triptorelin Drug: letrozole Drug: zoledronic acid |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| 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. |
Resource links provided by NLM:
Genetics Home Reference related topics:
breast cancer
Drug Information available for:
Tamoxifen
Tamoxifen citrate
Letrozole
Zoledronic acid
Triptorelin pamoate
U.S. FDA Resources
Further study details as provided by National Cancer Institute, Naples:
Primary Outcome Measures:
- disease free survival in premenopausal patients [ Time Frame: observation period is 10 years from initiation of treatment ] [ Designated as safety issue: No ]
- bone mineral density [ 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 ]
- disease free survival in postmenopausal patients [ Time Frame: observation period is 10 years from initiation of treatment ] [ Designated as safety issue: No ]
- overall survival [ Time Frame: observation period is 10 years from initiation of treatment ] [ 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: | 1050 |
| Study Start Date: | March 2004 |
| Estimated Primary Completion Date: | March 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: A
Triptorelin 3.75 mg IM every 4 weeks and Tamoxifen 20 mg daily, for 5 years
|
Drug: tamoxifen
20 mg daily for 5 years
Drug: 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
|
|
Active Comparator: B
Triptorelin 3.75 mg IM every 4 weeks and Letrozole 2.5 mg daily, for 5 years
|
Drug: 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
Drug: letrozole
2.5 mg daily for 5 years
|
|
Experimental: 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.
|
Drug: 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
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 . 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:
- 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@usc-intnapoli.net |
| Contact: Massimo Di Maio, M.D. | +39 081 5903 ext 383 | massimo.dimaio@usc-intnapoli.net |
Locations
| Italy | |
| S. Giuseppe Moscati | Recruiting |
| Avellino, AV, Italy | |
| Azienda Ospedaliera Treviglio - Caravaggio | Recruiting |
| Treviglio, BG, Italy | |
| Azienda Ospedaliera G. Rummo | Recruiting |
| Benevento, BN, Italy | |
| Ospedale Senatore Antonio Perrino | Recruiting |
| Brindisi, BR, Italy | |
| Istituto Romagnolo per lo Studio e la Cura dei Tumori | Recruiting |
| Meldola, FC, Italy | |
| Presidio Ospedaliero Di Saronno Aziendo Ospedaliera di Busto Arsizio | Recruiting |
| Saronno, VA, Italy | |
| Ospedale Santa Maria Annunziata | Recruiting |
| Bagno a Ripoli, Italy | |
| Istituto Nazionale per la ricerca Sul Cancro | Recruiting |
| Genova, Italy | |
| Ospedale Riuniti | Recruiting |
| Livorno, Italy | |
| Ospedale Unico della Versilia | Recruiting |
| Lucca, Italy | |
| Ospedale Cardarelli | Recruiting |
| Napoli, Italy | |
| Università Federico II, Cattedra di Oncologia Medica | Recruiting |
| Napoli, Italy | |
| Istituto Nazionale dei Tumori, | Recruiting |
| Napoli, Italy | |
| Seconda Università di Napoli | Recruiting |
| Napoli, Italy | |
| Casa di Cura La Maddalena | Recruiting |
| Palermo, Italy | |
| Ospedale Silvestrini | Recruiting |
| Perugia, Italy | |
| Ospedale Santa Chiara | Recruiting |
| Pisa, Italy | |
| Università di Sassari | Recruiting |
| Sassari, Italy | |
| Ospedale Santa Chiara | Recruiting |
| Trento, Italy | |
| ASL Viterbo Ospedale Belcolle | Recruiting |
| Viterbo, Italy | |
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: | Ciro Gallo, M.D., Ph.D. | Second University of Naples |
| Principal Investigator: | Francesco Perrone, M.D., Ph.D. | NCI Naples, Clinical Trials Unit |
More Information
Publications:
| Responsible Party: | National Cancer Institute, Naples |
| ClinicalTrials.gov Identifier: | NCT00412022 History of Changes |
| Other Study ID Numbers: | HOBOE |
| Study First Received: | December 14, 2006 |
| Last Updated: | January 15, 2013 |
| Health Authority: | Italy: Ethics Committee |
Keywords provided by National Cancer Institute, Naples:
|
early breast cancer adjuvant therapy premenopause premenopausal menopausal status postmenopause |
bone mineral density hormone sensitive aromatase inhibitors letrozole disease-free survival |
Additional relevant MeSH terms:
|
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Adjuvants, Immunologic Tamoxifen Triptorelin Zoledronic acid Diphosphonates Letrozole Aromatase Inhibitors Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions |
Antineoplastic Agents, Hormonal Antineoplastic Agents Therapeutic Uses Selective Estrogen Receptor Modulators Estrogen Receptor Modulators Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Bone Density Conservation Agents Estrogen Antagonists Luteolytic Agents Contraceptive Agents, Female Contraceptive Agents Reproductive Control Agents Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 16, 2013