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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.


Phase 3
18 Years
N/A
Open (Enrolling)
Female
Breast Cancer

Thank you

Trial Information

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.


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

disease free survival in premenopausal patients

Outcome Time Frame:

observation period is 10 years from initiation of treatment

Safety Issue:

No

Principal Investigator

Andrea De Matteis, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

NCI Naples, Division of Medical Oncology C

Authority:

Italy: Ethics Committee

Study ID:

HOBOE

NCT ID:

NCT00412022

Start Date:

March 2004

Completion Date:

Related Keywords:

  • Breast Cancer
  • early breast cancer
  • adjuvant therapy
  • premenopause
  • premenopausal
  • menopausal status
  • postmenopause
  • bone mineral density
  • hormone sensitive
  • aromatase inhibitors
  • letrozole
  • disease-free survival
  • Breast Neoplasms

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