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

Postmenopausal Women With Advanced Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00237198
• Other study ID #: CFEM345F1203
• Status: Completed
• Phase: Phase 2
• First received: October 9, 2005
• Last updated: February 21, 2017
• Start date: March 2004

Study information

• Verified date: February 2017
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 investigate changes in blood drug concentrations and blood hormone kinetics.

• To investigate gene polymorphisms of CYP2A6, an enzyme involved in the metabolism of letrozole

Recruitment information / eligibility

• Status: Completed
• Enrollment: 47
• Est. primary completion date: July 2006
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 79 Years

Eligibility

Inclusion Criteria:

• 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 Criteria:

• 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

1. Chemotherapy for metastatic and/or locoregional recurrent disease

2. Previous adjuvant endocrine therapy other than ovariectomy, anti-estrogen treatment, LH-RH analogues or radiation castration

3. 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

4. Patients who have not recovered from toxicity caused by previous therapy

5. 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

6. Previous bisphosphonate therapy started within 6 months without any other measurable or evaluable lesions

7. 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.

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	Cyuo-ku	Tokyo
Japan	Novartis Investigative Site	Fukuoka
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	Koto	Tokyo
Japan	Novartis Investigative Site	Kurashiki	Okayama
Japan	Novartis Investigative Site	Kure	Hiroshima
Japan	Novartis Investigative Site	Maebashi	Gunma
Japan	Novartis Investigative Site	Matsuyama	Ehime
Japan	Novartis Investigative Site	Nagoya	Aichi
Japan	Novartis Investigative Site	Nagoya	Aichi
Japan	Novartis Investigative Site	Niigata
Japan	Novartis Investigative Site	Osaka
Japan	Novartis Investigative Site	Sapporo	Hokkaido
Japan	Novartis Investigative Site	Sapporo	Hokkaido
Japan	Novartis Investigative Site	Sapporo	Hokkaido
Japan	Novartis Investigative Site	Shinjuku-ku	Tokyo
Japan	Novartis Investigative Site	Shizuoka
Japan	Novartis Investigative Site	Sunto-gun	Shizuoka
Japan	Novartis Investigative Site	Yokohama	Kanagawa

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	Clinical Benefit Rate during treatment		Until disease progression or appearance of unacceptable toxicity whichever comes first
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
Secondary	Time to treatment failure		from the date of study initiation and the date of disease progression confirmed or discontinuation other than disease progression
Secondary	Plasma drug concentration from baseline, every 4 weeks until 28 weeks, at 40 weeks and at 52 weeks		Baseline, 52 weeks
Secondary	Plasma estrogens level		baseline, 52 weeks

External Links

•   Results for CFEM345F1203 from the Novartis Clinical Trails website.