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

Phase 2
20 Years
74 Years
Not Enrolling
Postmenopausal Women With Advanced Breast Cancer

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Trial Information

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

Inclusion Criteria:

- 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 Criteria:

- 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.

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Safety during treatment

Outcome Time Frame:

Until disease progression or appearance of unacceptable toxicity whichever comes first

Safety Issue:


Principal Investigator

Novartis Pharmaceuticals

Investigator Role:

Study Director

Investigator Affiliation:

Novartis Pharmaceuticals


United States: Food and Drug Administration

Study ID:




Start Date:

June 2001

Completion Date:

Related Keywords:

  • Postmenopausal Women With Advanced Breast Cancer
  • Aromatase inhibitor
  • letrozole
  • breast cancer
  • Breast Neoplasms