Letrozole and Goserelin or Leuprolide in Treating Premenopausal Estrogen Receptor-Positive Patients With Stage IV Breast Cancer

NCT ID: NCT00498901

Last Updated: 2013-05-09

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 1 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-02-28
• Study Completion Date: 2008-11-30

Brief Summary

RATIONALE: Aromatase inhibitors, such as letrozole, prevent the formation of estradiol, a female hormone. Giving letrozole together with goserelin, leuprolide, or surgery may be an effective treatment in women with hormone-dependent breast cancer.

PURPOSE: This phase II trial is studying how well giving letrozole together with goserelin or leuprolide works in treating premenopausal estrogen receptor-positive patients with stage IV breast cancer.

Detailed Description

OBJECTIVES:

Primary

• To measure overall response rate (ORR) in premenopausal women treated with an aromatase inhibitor (AI) and ovarian suppression (OS).

Secondary

• To measure time to treatment failure (TTF) in premenopausal women treated with an AI and OS.
• To measure time to progression (TTP) in premenopausal women treated with an AI and OS.
• To measure time to death in premenopausal women treated with an AI and OS.
• To assess the clinical benefit rate (CBR) in premenopausal women treated with an AI and OS.
• To measure the qualitative and quantitative toxicity of an AI and OS.
• To determine whether ORR, TTP, and CBR are similar to what is seen in postmenopausal women treated with an AI.
• To determine whether ORR, TTP, and CBR are similar to what is seen in premenopausal women treated with tamoxifen and OS.
• To determine if levels of estrogen (i.e., estradiol or estrone) are adequately suppressed in premenopausal women on an AI and OS.

OUTLINE: This is a pilot, open-label study.

Patients undergo surgical ovarian suppression (OS) or medical OS with luteinizing hormone-releasing hormone (LHRH) agonist (i.e., goserelin or leuprolide acetate, intramuscularly once monthly for 3 months and then every 2 months thereafter for the duration of study therapy). Beginning on day 14 after initiation of LHRH-agonist therapy or surgery, patients receive oral letrozole once daily. Treatment continues in the absence of disease progression or unacceptable toxicity.

Menopausal status is tested periodically during study by measuring serum estradiol levels. Patients not converting to a menopausal state after the first month of study therapy, receive a higher dose of LHRH and undergo repeat estradiol testing in the second month. If the patient continues to be premenopausal, they are then considered for bilateral salpingo-oophorectomy or removed from study.

After completion of study therapy, patients are followed every 3 months for 2 years, every 6 months for 2 years, and annually thereafter.

Conditions

Breast Cancer

Study Design

• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

goserelin

Intervention Type: DRUG

letrozole

Intervention Type: DRUG

leuprolide acetate

Intervention Type: DRUG

conventional surgery

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• ECOG performance status 0-2
• Life expectancy ≥ 3 months
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective nonhormonal contraception during and for 12 weeks after discontinuation of study therapy
• ANC ≥ 500 cells/mm³
• Platelet count ≥ 50,000 cells/mm³
• Hematocrit ≥ 28%
• In the absence of liver metastases:

• AST and ALT ≤ 2.5 times upper limit of normal (ULN)
• Alkaline phosphatase ≤ 2.5 times ULN
• In the presence of liver metastases:

• AST and ALT ≤ 5 times ULN
• Alkaline phosphatase ≤ 5 times ULN
• In the presence of bone metastases:

• AST and ALT ≤ 10 times ULN
• Alkaline phosphatase ≤ 10 times ULN
• Total bilirubin ≤ 2 times ULN
• No significant comorbid conditions, including any of the following:

• Clinically significant cardiac disease not well controlled with medication (e.g., congestive heart failure, symptomatic coronary artery disease, or cardiac arrhythmias)
• Myocardial infarction within the past 12 months
• Serious concurrent infection
• No lack of physical integrity of the upper gastrointestinal tract
• No inability to swallow or malabsorption syndrome
• No other carcinoma within the past 5 years except nonmelanoma skin cancer and treated in situ cervical cancer
• No mental illness
• No known hypersensitivity to luteinizing hormone-releasing hormone (LHRH), LHRH-agonist analogues, or any of the components in goserelin

PRIOR CONCURRENT THERAPY:

• No concurrent chemotherapy and/or additional hormonal therapy
• Concurrent trastuzumab (Herceptin®) for patients with HER2 overexpression allowed

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

University of Washington

OTHER

Sponsor Role: lead

Responsible Party

University Cancer Center at University of Washington Medical Center

Principal Investigators

Hannah M. Linden, MD

Role: PRINCIPAL_INVESTIGATOR

University of Washington

Locations

Seattle Cancer Care Alliance

Seattle, Washington, United States

University Cancer Center at University of Washington Medical Center

Seattle, Washington, United States

Countries

United States

Other Identifiers

FHCRC-6412

Identifier Type: -

Identifier Source: secondary_id

UWCC-UW 6412

Identifier Type: -

Identifier Source: secondary_id

UWCC- 06-4560-H/D

Identifier Type: -

Identifier Source: secondary_id

CDR0000553612

Identifier Type: REGISTRY

Identifier Source: secondary_id

6412

Identifier Type: -

Identifier Source: org_study_id