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Status:

COMPLETED

Study of High-dose Letrozole Therapy in Postmenopausal Patients With Breast Cancer

Lead Sponsor:

Novartis Pharmaceuticals

Collaborating Sponsors:

Chugai Pharmaceutical

Conditions:

Postmenopausal Women With Advanced Breast Cancer

Eligibility:

FEMALE

20-74 years

Phase:

PHASE2

Brief Summary

To investigate the safety and efficacy of letrozole monotherapy at a dose of 2.5 mg/day in postmenopausal patients with breast cancer, and to determine the blood concentrations of letrozole and hormon...

Eligibility Criteria

Inclusion

  • Patients with histologically documented breast cancer.
  • Patients with hormone receptor (ER and/or PgR) status of positive or unknown
  • Patients who have been amenorrheic for the preceding 12 months or more.
  • Patients who are 20 years or older and younger than 75 years.
  • Patients with a history of postoperative adjuvant therapy or a history of endocrine therapy with tamoxifen for the treatment of progression or recurrence of the lesion. The endocrine therapy, however, should not exceed one regimen.
  • Patients with progressing lesions.
  • Patients with sufficient organ function to evaluate the safety
  • Patients whose performance status (PS) is classified in 0～2.
  • Patients who have no residual effects from previous treatments

Exclusion

  • Patients with other concurrent or previous malignant disease (excluding uterine carcinoma in-situ).
  • Patients with hypercalcemia and uncontrollable cardiac disease (including a history of serious cardiac disease)
  • Patients who have previously received aromatase inhibitor.
  • Patients who have lymphangitis-type lung metastasis or symptomatic brain metastasis.
  • Other protocol-defined inclusion / exclusion criteria may apply.

Key Trial Info

Start Date :

June 1 2001

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

October 1 2006

Estimated Enrollment :

31 Patients enrolled

Trial Details

Trial ID

NCT00237211

Start Date

June 1 2001

End Date

October 1 2006

Last Update

November 14 2018

Active Locations (12)

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Page 1 of 3 (12 locations)

1

Novartis Investigative Site

Kashiwa, Chiba, Japan, 277-8577

2

Novartis Investigative Site

Matsuyama, Ehime, Japan, 791-0280

3

Novartis Investigative Site

kooriyama, Fukushima, Japan, 963-8501

4

Novartis Investigative Site

Maebashi, Gunma, Japan, 371-8511