Postmenopausal Women With Advanced Breast Cancer
Conditions
Keywords
Aromatase inhibitor, letrozole, breast cancer
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.
Interventions
DRUGLetrozole
Sponsors
Chugai Pharmaceutical
Novartis Pharmaceuticals
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 74 Years
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 0～2. * 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 /
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety during treatment | Until disease progression or appearance of unacceptable toxicity whichever comes first |
| Response Rate during treatment | Until disease progression or appearance of unacceptable toxicity whichever comes first |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
Japan
Outcome results
None listed