Status:
UNKNOWN
HOBOE: A Phase 3 Study of Adjuvant Triptorelin and Tamoxifen, Letrozole, or Letrozole and Zoledronic Acid in Premenopausal Patients With Breast Cancer.
Lead Sponsor:
National Cancer Institute, Naples
Collaborating Sponsors:
University of Campania Luigi Vanvitelli
Conditions:
Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE3
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 st...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2024
Estimated Enrollment :
1294 Patients enrolled
Trial Details
Trial ID
NCT00412022
Start Date
March 1 2004
End Date
November 1 2024
Last Update
March 24 2023
Active Locations (20)
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1
S. Giuseppe Moscati
Avellino, AV, Italy
2
Azienda Ospedaliera Treviglio - Caravaggio
Treviglio, BG, Italy
3
Azienda Ospedaliera G. Rummo
Benevento, BN, Italy
4
Ospedale Senatore Antonio Perrino
Brindisi, BR, Italy