HOBOE: A Phase 3 Study of Adjuvant Triptorelin and Tamoxifen, Letrozole, or Letrozole and Zoledronic Acid in Premenopausal Patients With Breast Cancer.

Last updated: March 23, 2023
Sponsor: National Cancer Institute, Naples
Overall Status: Active - Not Recruiting

Phase

3

Condition

Breast Cancer

Cancer

Treatment

N/A

Clinical Study ID

NCT00412022
HOBOE
  • Ages > 18
  • Female

Study 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.

Eligibility Criteria

Inclusion

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 atleast 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 ofrandomization (FSH, LH will not be considered as determinants of menopausal status duethe chemotherapy induced reversible ovarian suppression) Please note that patients who have received neoadjuvant or adjuvant chemotherapy and/orlocoregional radiation therapy may be included in the study

Exclusion

Exclusion Criteria:

  • Performance status (ECOG)>2.
  • Previous or concomitant malignancy (with the exception of adequately treatednonmalignant 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 laboratoryfindings that indicate a grade of hepatic insufficiency that could potentiallyincrease the risk of assuming letrozole
  • Any concomitant conditions that would, in the Investigator's opinion, contraindicatethe 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 foreseenduring the course of adjuvant therapy

Study Design

Total Participants: 1294
Study Start date:
March 01, 2004
Estimated Completion Date:
November 30, 2024

Connect with a study center

  • S. Giuseppe Moscati

    Avellino, AV
    Italy

    Site Not Available

  • Azienda Ospedaliera Treviglio - Caravaggio

    Treviglio, BG
    Italy

    Site Not Available

  • Azienda Ospedaliera G. Rummo

    Benevento, BN
    Italy

    Site Not Available

  • Ospedale Senatore Antonio Perrino

    Brindisi, BR
    Italy

    Site Not Available

  • Istituto Romagnolo per lo Studio e la Cura dei Tumori

    Meldola, FC
    Italy

    Site Not Available

  • Presidio Ospedaliero Di Saronno Aziendo Ospedaliera di Busto Arsizio

    Saronno, VA
    Italy

    Site Not Available

  • Ospedale Santa Maria Annunziata

    Bagno a Ripoli,
    Italy

    Site Not Available

  • Istituto Nazionale per la ricerca Sul Cancro

    Genova,
    Italy

    Site Not Available

  • Ospedale Riuniti

    Livorno,
    Italy

    Site Not Available

  • Ospedale Unico della Versilia

    Lucca,
    Italy

    Site Not Available

  • Istituto Nazionale dei Tumori,

    Napoli,
    Italy

    Site Not Available

  • Ospedale Cardarelli

    Napoli,
    Italy

    Site Not Available

  • Seconda Università di Napoli

    Napoli,
    Italy

    Site Not Available

  • Università Federico II, Cattedra di Oncologia Medica

    Napoli,
    Italy

    Site Not Available

  • Casa di Cura La Maddalena

    Palermo,
    Italy

    Site Not Available

  • Ospedale Silvestrini

    Perugia,
    Italy

    Site Not Available

  • Ospedale Santa Chiara

    Pisa,
    Italy

    Site Not Available

  • Università di Sassari

    Sassari,
    Italy

    Site Not Available

  • Ospedale Santa Chiara

    Trento,
    Italy

    Site Not Available

  • ASL Viterbo Ospedale Belcolle

    Viterbo,
    Italy

    Site Not Available

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