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Completed

NCT Number: NCT00237211

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

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.

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Key information

Conditions

Postmenopausal Women With Advanced Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

20 year–74 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Novartis Investigative Site, Kashiwa, Chiba, Japan

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

letrozole

Drug

Other names: FEM345

Primary outcomes

  1. Safety during treatment

    Time frame: Until disease progression or appearance of unacceptable toxicity whichever comes first

  2. Response Rate during treatment

    Time frame: Until disease progression or appearance of unacceptable toxicity whichever comes first

Secondary outcomes

  1. Pharmacokinetics measurement at baseline and at every 4 weeks until 28 weeks

    Time frame: Maximum 28 weeks after initiate treatment

  2. Plasma estrogens level at baseline and at every 4 weeks until 28 weeks

    Time frame: Maximum 28 weeks after initiate treatment

  3. Duration of response

    Time frame: From the first date of response confirmed and the last date of response confirmed

  4. Time to progression

    Time frame: From the first date of response confirmed and the last date of response confirmed

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Collaborators

  • Chugai Pharmaceutical

Registry information

Important dates

Study start
2001
Primary completion
2006
Study completion
2006
First posted
Oct 12, 2005
Registry last updated
Nov 14, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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