Status:
COMPLETED
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
Lead Sponsor:
Novartis Pharmaceuticals
Collaborating Sponsors:
Chugai Pharmaceutical
Conditions:
Postmenopausal Women With Advanced Breast Cancer
Eligibility:
FEMALE
20-79 years
Phase:
PHASE2
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 inv...
Eligibility Criteria
Inclusion
- 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
- 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
- Chemotherapy for metastatic and/or locoregional recurrent disease
- Previous adjuvant endocrine therapy other than ovariectomy, anti-estrogen treatment, LH-RH analogues or radiation castration
- 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
- Patients who have not recovered from toxicity caused by previous therapy
- 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
- Previous bisphosphonate therapy started within 6 months without any other measurable or evaluable lesions
- 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/exclusion criteria may apply.
Key Trial Info
Start Date :
March 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
47 Patients enrolled
Trial Details
Trial ID
NCT00237198
Start Date
March 1 2004
Last Update
February 23 2017
Active Locations (24)
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1
Novartis Investigative Site
Nagoya, Aichi-ken, Japan, 464-8681
2
Novartis Investigative Site
Nagoya, Aichi-ken, Japan, 465-0024
3
Novartis Investigative Site
Kashiwa, Chiba, Japan, 277-8577
4
Novartis Investigative Site
Matsuyama, Ehime, Japan, 791-0280