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

Postmenopausal Women With Advanced Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00237211
• Other study ID #: CFEM345F1201
• Status: Completed
• Phase: Phase 2
• Start date: June 2001
• Est. completion date: October 2006

Study information

• Verified date: November 2018
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: October 2006
• Est. primary completion date: October 2006
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 74 Years

Eligibility

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.

Related Conditions & MeSH terms

• Breast Neoplasms
• Postmenopausal Women With Advanced Breast Cancer

Intervention

Drug:
• Letrozole

Locations

Country	Name	City	State
Japan	Novartis Investigative Site	Bunkyo-ku	Tokyo
Japan	Novartis Investigative Site	Chuo-ku	Tokyo
Japan	Novartis Investigative Site	Fukushima
Japan	Novartis Investigative Site	Kashiwa	Chiba
Japan	Novartis Investigative Site	Kitaadachi-gun	Saitama
Japan	Novartis Investigative Site	Kooriyama	Fukushima
Japan	Novartis Investigative Site	Kurashiki	Okayama
Japan	Novartis Investigative Site	Maebashi	Gunma
Japan	Novartis Investigative Site	Matsuyama	Ehime
Japan	Novartis Investigative Site	Osaka
Japan	Novartis Investigative Site	Saitama
Japan	Novartis Investigative Site	Shinjuku-ku	Tokyo

Sponsors (2)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals	Chugai Pharmaceutical

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety during treatment		Until disease progression or appearance of unacceptable toxicity whichever comes first
Primary	Response Rate during treatment		Until disease progression or appearance of unacceptable toxicity whichever comes first
Secondary	Pharmacokinetics measurement at baseline and at every 4 weeks until 28 weeks		Maximum 28 weeks after initiate treatment
Secondary	Plasma estrogens level at baseline and at every 4 weeks until 28 weeks		Maximum 28 weeks after initiate treatment
Secondary	Duration of response		From the first date of response confirmed and the last date of response confirmed
Secondary	Time to progression		From the first date of response confirmed and the last date of response confirmed

External Links

•   Results for CFEM345F1201 from the Novartis Clinical Trials website.