HOBOE: A Phase 3 Study of Adjuvant Triptorelin and Tamoxifen, Letrozole, or Letrozole and Zoledronic Acid in Premenopausal Patients With Breast Cancer.
- Conditions
- Breast Cancer
- Interventions
- Registration Number
- NCT00412022
- Lead Sponsor
- National Cancer Institute, Naples
- Brief 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. 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- Female
- Target Recruitment
- 1294
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description C letrozole Triptorelin 3.75 mg IM every 4 weeks and Letrozole 2.5 mg daily for 5 years + zoledronic acid 4 mg every 6 months. A tamoxifen Triptorelin 3.75 mg IM every 4 weeks and Tamoxifen 20 mg daily, for 5 years A triptorelin Triptorelin 3.75 mg IM every 4 weeks and Tamoxifen 20 mg daily, for 5 years B triptorelin Triptorelin 3.75 mg IM every 4 weeks and Letrozole 2.5 mg daily, for 5 years B letrozole Triptorelin 3.75 mg IM every 4 weeks and Letrozole 2.5 mg daily, for 5 years C triptorelin Triptorelin 3.75 mg IM every 4 weeks and Letrozole 2.5 mg daily for 5 years + zoledronic acid 4 mg every 6 months. C zoledronic acid Triptorelin 3.75 mg IM every 4 weeks and Letrozole 2.5 mg daily for 5 years + zoledronic acid 4 mg every 6 months.
- Primary Outcome Measures
Name Time Method disease free survival in premenopausal patients observation period is 10 years from initiation of treatment bone mineral density 12 months from initiation of therapy
- Secondary Outcome Measures
Name Time Method Bone mineral density measured yearly after first year of therapy overall survival observation period is 10 years from initiation of treatment toxicity of letrozole + triptorelin and letrozole + zoledronic acid + triptorelin in premenopausal patients monthly disease free survival in postmenopausal patients observation period is 10 years from initiation of treatment
Trial Locations
- Locations (19)
Istituto Nazionale per la ricerca Sul Cancro
🇮🇹Genova, Italy
Ospedale Santa Chiara
🇮🇹Trento, Italy
Ospedale Unico della Versilia
🇮🇹Lucca, Italy
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
Ospedale Santa Maria Annunziata
🇮🇹Bagno a Ripoli, 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 Riuniti
🇮🇹Livorno, 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
Università di Sassari
🇮🇹Sassari, Italy
ASL Viterbo Ospedale Belcolle
🇮🇹Viterbo, Italy