Study of High-Dose Letrozole Therapy in Postmenopausal Patients With Breast Cancer - Full Text View

Sponsors and Collaborators:	Novartis Chugai Pharmaceutical
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00237211

Purpose

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.

Condition	Intervention	Phase
Postmenopausal Women With Advanced Breast Cancer	Drug: Letrozole	Phase II

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

Drug Information available for: Letrozole

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	Study of High-Dose Letrozole Therapy in Postmenopausal Patients With Breast Cancer

Further study details as provided by Novartis:

Primary Outcome Measures:

Safety during treatment
Response Rate during treatment

Secondary Outcome Measures:

Pharmacokinetics measurement at baseline and at every 4 weeks until 28 weeks
Plasma estrogens level at baseline and at every 4 weeks until 28 weeks
Duration of response
Time to progression

Estimated Enrollment:	30
Study Start Date:	June 2001

Eligibility

Ages Eligible for Study:	20 Years to 74 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00237211

Sponsors and Collaborators

Novartis

Chugai Pharmaceutical

Investigators

Study Chair:

Novartis

More Information

Study ID Numbers:	CFEM345F1201
Study First Received:	October 9, 2005
Last Updated:	July 5, 2007
ClinicalTrials.gov Identifier:	NCT00237211
Health Authority:	Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by Novartis:

Aromatase inhibitor
letrozole
breast cancer

Study placed in the following topic categories:

Skin Diseases
Breast Neoplasms
Letrozole
Breast Diseases

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents

Therapeutic Uses
Enzyme Inhibitors
Aromatase Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009