Clinical trial NCT00237211: Study of High-dose Letrozole Therapy in Postmenopausal Patients With Breast Cancer
Official title: Study of High-dose Letrozole Therapy in Postmenopausal Patients With Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Postmenopausal Women With Advanced Breast Cancer
Keywords: Aromatase inhibitor
letrozole
breast cancer
Lead sponsor: Novartis
Sponsor class: INDUSTRY
Collaborators: name: Chugai Pharmaceutical
First posted: 2005-10-12
Enrollment: 31
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


Eligibility 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.

Primary outcomes:
measure: Safety during treatment
timeFrame: Until disease progression or appearance of unacceptable toxicity whichever comes first
measure: Response Rate during treatment
timeFrame: Until disease progression or appearance of unacceptable toxicity whichever comes first
Secondary outcomes:
measure: Pharmacokinetics measurement at baseline and at every 4 weeks until 28 weeks
timeFrame: Maximum 28 weeks after initiate treatment
measure: Plasma estrogens level at baseline and at every 4 weeks until 28 weeks
timeFrame: Maximum 28 weeks after initiate treatment
measure: Duration of response
timeFrame: From the first date of response confirmed and the last date of response confirmed
measure: Time to progression
timeFrame: From the first date of response confirmed and the last date of response confirmed
Other outcomes:
Locations:
city: Kashiwa
country: Japan
facility: Novartis Investigative Site
state: Chiba
city: Matsuyama
country: Japan
facility: Novartis Investigative Site
state: Ehime
city: Kooriyama
country: Japan
facility: Novartis Investigative Site
state: Fukushima
city: Maebashi
country: Japan
facility: Novartis Investigative Site
state: Gunma
city: Kurashiki
country: Japan
facility: Novartis Investigative Site
state: Okayama
city: Kitaadachi-gun
country: Japan
facility: Novartis Investigative Site
state: Saitama
city: Bunkyo-ku
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Chuo-ku
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Shinjuku-ku
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Fukushima
country: Japan
facility: Novartis Investigative Site
city: Osaka
country: Japan
facility: Novartis Investigative Site
city: Saitama
country: Japan
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: