Study of High-dose Letrozole Therapy in Postmenopausal Patients With Breast Cancer

This study has been completed.
Sponsor:
Collaborator:
Chugai Pharmaceutical
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00237211
First received: October 9, 2005
Last updated: May 9, 2012
Last verified: May 2012

October 9, 2005
May 9, 2012
June 2001
October 2006   (final data collection date for primary outcome measure)
  • Safety during treatment [ Time Frame: Until disease progression or appearance of unacceptable toxicity whichever comes first ] [ Designated as safety issue: Yes ]
  • Response Rate during treatment [ Time Frame: Until disease progression or appearance of unacceptable toxicity whichever comes first ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00237211 on ClinicalTrials.gov Archive Site
  • Pharmacokinetics measurement at baseline and at every 4 weeks until 28 weeks [ Time Frame: Maximum 28 weeks after initiate treatment ] [ Designated as safety issue: No ]
  • Plasma estrogens level at baseline and at every 4 weeks until 28 weeks [ Time Frame: Maximum 28 weeks after initiate treatment ] [ Designated as safety issue: No ]
  • Duration of response [ Time Frame: From the first date of response confirmed and the last date of response confirmed ] [ Designated as safety issue: No ]
  • Time to progression [ Time Frame: From the first date of response confirmed and the last date of response confirmed ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
Study of High-dose Letrozole Therapy in Postmenopausal Patients With Breast Cancer
Study of High-dose Letrozole Therapy in Postmenopausal Patients With Breast Cancer

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.

Not Provided
Interventional
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Postmenopausal Women With Advanced Breast Cancer
Drug: Letrozole
Other Name: FEM345
Experimental: Letrozole
Intervention: Drug: Letrozole
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
31
Not Provided
October 2006   (final data collection date for primary outcome measure)

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 / exclusion criteria may apply.

Female
20 Years to 74 Years
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT00237211
CFEM345F1201
Not Provided
Novartis ( Novartis Pharmaceuticals )
Novartis Pharmaceuticals
Chugai Pharmaceutical
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Novartis
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP