NCT00237211CompletedPhase 2
Study of High-dose Letrozole Therapy in Postmenopausal Patients With Breast Cancer
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Novartis Pharmaceuticals
- Enrollment
- 31
- Locations
- 1
- Primary Endpoint
- Safety during treatment
Study Overview
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 hormones.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 20 Years to 74 Years (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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～
- •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.
Arms & Interventions
Letrozole
Experimental
Intervention: Letrozole (Drug)
Outcomes
Primary Outcomes
Safety during treatment
Time Frame: Until disease progression or appearance of unacceptable toxicity whichever comes first
Response Rate during treatment
Time Frame: Until disease progression or appearance of unacceptable toxicity whichever comes first
Secondary Outcomes
- Pharmacokinetics measurement at baseline and at every 4 weeks until 28 weeks(Maximum 28 weeks after initiate treatment)
- Plasma estrogens level at baseline and at every 4 weeks until 28 weeks(Maximum 28 weeks after initiate treatment)
- Duration of response(From the first date of response confirmed and the last date of response confirmed)
- Time to progression(From the first date of response confirmed and the last date of response confirmed)
Investigators
Study Sites (1)
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