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

NCT00498901 | Terminated Phase 2

• 5 other identifiers: 6412FHCRC-6412UWCC-UW 6412UWCC- 06-4560-H/DCDR0000553612
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 2

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.

Conditions

Breast Cancer

Keywords

stage IV breast cancer; recurrent breast cancer

Outcome Measures

Primary Outcomes (1)

• Overall response rate as measured by RECIST

Secondary Outcomes (10)

• Time to treatment failure

• Time to progression

• Time to death

• Clinical benefit rate

• Qualitative and quantitative toxicity as assessed by NCI CTCAE v3.0

Interventions

goserelin DRUG

letrozole DRUG

leuprolide acetate DRUG

conventional surgery PROCEDURE

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Histologically confirmed carcinoma of the breast * Metastatic disease * Measurable disease (i.e., unidimensional by RECIST) * No rapidly progressing visceral involvement (e.g., liver or lymphangitic lung disease) * No known marrow involvement as evidenced by diffuse uptake by imaging studies or bone marrow biopsy or aspirate * No evidence of CNS metastases * Estrogen- and/or progesterone-receptor positive status confirmed in primary breast tumor or in recent biopsy of metastatic site PATIENT CHARACTERISTICS: * Female * Premenopausal\*, as defined by the following criteria: * Less than 12 months from last menstrual period or premenopausal estradiol within the past 12 months * No prior bilateral oophorectomy * 45 years old or younger with intact ovaries and not a candidate for aromatase inhibitor therapy alone due to the potential for recurrent ovarian function NOTE: \*Women are considered premenopausal after prior hysterectomy if they have intact ovaries and follicular hormone levels consistent with the institutional normal values for the premenopausal state * Women meeting premenopausal criteria prior to receiving ovarian suppression are eligible * 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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• University of Washington: lead
• National Cancer Institute (NCI): collaborator

Study Sites (2)

Seattle Cancer Care Alliance

Seattle, Washington, 98109-1023, United States

Location

University Cancer Center at University of Washington Medical Center

Seattle, Washington, 98195-6043, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Goserelin; Letrozole; Leuprolide

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Gonadotropin-Releasing Hormone; Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins; Nitriles; Organic Chemicals; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Hannah M. Linden, MD

  University of Washington

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 10, 2007
• First Posted: July 11, 2007
• Study Start: February 1, 2007
• Primary Completion: December 1, 2007
• Study Completion: November 1, 2008
• Last Updated: May 9, 2013

Record last verified: 2013-05

Locations

US (2)