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

Phase 2

Completed

• Conditions: Postmenopausal Women With Advanced Breast Cancer
• Interventions: Drug: Letrozole

• Registration Number: NCT00237198
• Lead Sponsor: Novartis Pharmaceuticals

Brief 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

Detailed Description

Not available

Study Timeline

• Study Start: 2004-03
• Study First Submitted: 2005-10-09
• Study First Submitted QC: 2005-10-09
• Study First Posted: 2005-10-12
• Primary Completion: 2006-07
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-21
• Last Update Posted: 2017-02-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 47

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Letrozole	Letrozole	-

Primary Outcome Measures

Name	Time	Method
Response Rate during treatment	Until disease progression or appearance of unacceptable toxicity whichever comes first
Safety during treatment	Until disease progression or appearance of unacceptable toxicity whichever comes first

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Novartis Investigative Site; 🇯🇵 Shizuoka, Japan