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

This study has been completed.
Sponsor:
Collaborator:
Chugai Pharmaceutical
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00237198
First received: October 9, 2005
Last updated: August 15, 2012
Last verified: August 2012
  Purpose
  • 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

Condition Intervention Phase
Postmenopausal Women With Advanced Breast Cancer
Drug: Letrozole
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Safety during treatment [ Time Frame: Until disease progression or appearance of unacceptable toxicity whichever comes first ] [ Designated as safety issue: Yes ]
  • Response Rate during treatment [ Time Frame: Until disease progression or appearance of unacceptable toxicity whichever comes first ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Clinical Benefit Rate during treatment [ Time Frame: Until disease progression or appearance of unacceptable toxicity whichever comes first ] [ Designated as safety issue: No ]
  • Duration of response [ Time Frame: from the first date of response confirmed and the last date of response confirmed ] [ Designated as safety issue: No ]
  • Time to progression [ Time Frame: from the first date of response confirmed and the last date of response confirmed ] [ Designated as safety issue: No ]
  • Time to treatment failure [ Time Frame: from the date of study initiation and the date of disease progression confirmed or discontinuation other than disease progression ] [ Designated as safety issue: No ]
  • Plasma drug concentration from baseline, every 4 weeks until 28 weeks, at 40 weeks and at 52 weeks [ Time Frame: Baseline, 52 weeks ] [ Designated as safety issue: No ]
  • Plasma estrogens level [ Time Frame: baseline, 52 weeks ] [ Designated as safety issue: No ]

Enrollment: 47
Study Start Date: March 2004
Primary Completion Date: July 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Letrozole Drug: Letrozole
Other Name: FEM345

  Eligibility

Ages Eligible for Study:   20 Years to 79 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00237198

Locations
Japan
Novartis Investigative Site
Nagoya, Aichi, Japan, 464-8681
Novartis Investigative Site
Nagoya, Aichi, Japan, 465-0024
Novartis Investigative Site
Kashiwa, Chiba, Japan, 277-8577
Novartis Investigative Site
Matsuyama, Ehime, Japan, 791-0280
Novartis Investigative Site
Kooriyama, Fukushima, Japan, 963-8501
Novartis Investigative Site
Maebashi, Gunma, Japan, 371-8511
Novartis Investigative Site
Kure, Hiroshima, Japan, 737-0023
Novartis Investigative Site
Sapporo, Hokkaido, Japan, 003-0804
Novartis Investigative Site
Sapporo, Hokkaido, Japan, 063-0812
Novartis Investigative Site
Sapporo, Hokkaido, Japan, 060-0001
Novartis Investigative Site
Yokohama, Kanagawa, Japan, 241-0815
Novartis Investigative Site
Kurashiki, Okayama, Japan, 701-0192
Novartis Investigative Site
Kitaadachi-gun, Saitama, Japan, 338-8553
Novartis Investigative Site
Sunto-gun, Shizuoka, Japan, 411-8777
Novartis Investigative Site
Bunkyo-ku, Tokyo, Japan, 113-8677
Novartis Investigative Site
Chuo-ku, Tokyo, Japan, 104-0045
Novartis Investigative Site
Cyuo-ku, Tokyo, Japan, 104-8560
Novartis Investigative Site
Koto, Tokyo, Japan, 135-8550
Novartis Investigative Site
Shinjuku-ku, Tokyo, Japan, 160-8582
Novartis Investigative Site
Fukuoka, Japan, 811-1395
Novartis Investigative Site
Fukushima, Japan, 960-1295
Novartis Investigative Site
Niigata, Japan, 951-8566
Novartis Investigative Site
Osaka, Japan, 537-8511
Novartis Investigative Site
Shizuoka, Japan, 420-0881
Sponsors and Collaborators
Novartis Pharmaceuticals
Chugai Pharmaceutical
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT00237198     History of Changes
Other Study ID Numbers: CFEM345F1203
Study First Received: October 9, 2005
Last Updated: August 15, 2012
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by Novartis:
Aromatase inhibitor
letrozole
breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Breast Diseases
Neoplasms
Neoplasms by Site
Skin Diseases
Estrogen Antagonists
Estrogen Receptor Modulators
Estrogens
Letrozole
Antineoplastic Agents
Aromatase Inhibitors
Enzyme Inhibitors
Hormone Antagonists
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014