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
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Novartis Pharmaceuticals
With
Chugai Pharmaceutical
Age
20–79
Sex
FEMALE
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
Clareo Health | 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
