Study of Safety and Efficacy of Letrozole Monotherapy as Second-line Endocrine Therapy in Postmenopausal Patients With Advanced Breast Cancer Who Received Previous Anti-estrogen Treatment

Novartis

Status and phase

Completed

Phase 2

Conditions

Postmenopausal Women With Advanced Breast Cancer

Treatments

Drug: Letrozole

Study type

Interventional

Funder types

Industry

Identifiers

NCT00237198

CFEM345F1203

Details and patient eligibility

About

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

Enrollment

47 patients

Sex

Female

Ages

20 to 79 years old

Volunteers

No Healthy Volunteers

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