Postmenopausal Women With Advanced Breast Cancer
Conditions
Keywords
Aromatase inhibitor, letrozole, breast cancer
Brief summary
* Safety and efficacy of letrozole 2.5 mg/day monotherapy as second-line endocrine therapy in postmenopausal patients with advanced breast cancer who received previous anti-estrogen treatment * To investigate changes in blood drug concentrations and blood hormone kinetics. * To investigate gene polymorphisms of CYP2A6, an enzyme involved in the metabolism of letrozole
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 79 Years
Healthy volunteers
No
Inclusion criteria
* Patients with histologically or cytologically documented breast cancer * Patients with progressive breast cancer (advanced breast cancer, locoregional recurrence not operative, or metastatic breast cancer) * Patients with hormone receptor (ER and/or PgR) positive or both unknown. * Postmenopausal patients between ages 20 and 79 years, inclusive * Patients with a history of adjuvant therapy or advanced breast cancer treated with anti-estrogens * Patients with documented measurable or evaluable lesions. * Patients with sufficient organ function to evaluate the safety * Patients whose performance status (PS) is 0～2
Exclusion criteria
* Patients with diffuse lymphangitis carcinomatosa of the lung or CNS involvement, liver metastasis occupying more than one third of the liver, or inflammatory breast cancer * Patients with other concurrent or previous malignant disease (excluding contralateral breast cancer, in situ carcinoma of cervix uteri, and adequately treated basal or squamous cell carcinoma of the skin) * Patients in whom one of the following is the sole manifestation of disease: hilar enlargement, pleural effusion and ascites * Patients with only blastic bone metastases or a mixed blastic and lytic bone metastases at the same site and no other measurable or evaluable lesions * Patients with serious current disease such as uncontrolled cardiac diseases and/or uncontrolled diabetes mellitus by any medications (including a historical serious cardiac disease) * Patients with adrenal insufficiency (treated or untreated) or Cushing's syndrome * Patients with any of the following previous treatments 1. Chemotherapy for metastatic and/or locoregional recurrent disease 2. Previous adjuvant endocrine therapy other than ovariectomy, anti-estrogen treatment, LH-RH analogues or radiation castration 3. Previous first-line endocrine therapy (e.g., aromatase inhibitors and gastagens) for the treatment of metastatic and/or locoregional recurrent breast cancer other than anti-estrogen or LH-RH analogues treatment 4. Patients who have not recovered from toxicity caused by previous therapy 5. For patients on investigational drugs, adequate wash-out periods of at least 7 days in the case of topical investigational drugs and at least 30 days in the case of systemic 6. Previous bisphosphonate therapy started within 6 months without any other measurable or evaluable lesions 7. Patients who have not stopped treatment with other anti-estrogen or anti-cancer drugs (other than bisphosphonates) before starting the trial medication 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 |
|---|---|
| Clinical Benefit Rate during treatment | Until disease progression or appearance of unacceptable toxicity whichever comes first |
| Duration of response | from the first date of response confirmed and the last date of response confirmed |
| Plasma drug concentration from baseline, every 4 weeks until 28 weeks, at 40 weeks and at 52 weeks | Baseline, 52 weeks |
| Time to treatment failure | from the date of study initiation and the date of disease progression confirmed or discontinuation other than disease progression |
| Time to progression | from the first date of response confirmed and the last date of response confirmed |
| Plasma estrogens level | baseline, 52 weeks |
Countries
Japan
Outcome results
None listed