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Trastuzumab and Exemestane in Treating Postmenopausal Women With Metastatic or Locally Advanced Breast Cancer

Primary Purpose

Breast Cancer

Status
Withdrawn
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
trastuzumab
exemestane
Sponsored by
Northwestern University
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring stage IV breast cancer, stage IIIA breast cancer, stage IIIB breast cancer, stage IIIC breast cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

DISEASE CHARACTERISTICS: Histologically confirmed breast cancer Stage IV or locally advanced disease Staged by bone scan or CT scan of chest and/or abdomen within the past 6 weeks HER2/neu positive by fluorescent in situ hybridization (if 2+ by immunohistochemistry) or 3+ by immunohistochemistry Measurable disease defined by 1 of the following criteria: At least 1 dimension at least 1 cm by CT scan or other imaging scan At least 1 diameter at least 1 cm by plain x-ray (excluding bone lesions) Palpable lesion with both diameters at least 1 cm with caliper OR Evaluable disease defined by 1 of the following criteria: Positive bone scan Palpable masses with diameter less than 1 cm, masses with margins not clearly defined on CT scan or x-ray, or with both diameters less than 1 cm Bone scan and CA 27.29 if bone scan only evaluable disease Hormone receptor status: Estrogen receptor and/or progesterone receptor positive PATIENT CHARACTERISTICS: Age 18 and over Sex Female Menopausal status Postmenopausal by 1 of the following criteria: 60 years of age and over 45 years of age and over with amenorrhea more than 12 months and an intact uterus Follicle-stimulating hormone levels within postmenopausal range Undergone bilateral oophorectomy Performance status ECOG 0-2 Life expectancy Not specified Hematopoietic Not specified Hepatic Bilirubin less than 1.5 times upper limit of normal Renal Creatinine less than 2 mg/dL Cardiovascular Ejection fraction greater than 50% Other Not pregnant or nursing PRIOR CONCURRENT THERAPY: Biologic therapy No prior trastuzumab (Herceptin) Chemotherapy Prior chemotherapy allowed Endocrine therapy No prior exemestane No other prior hormonal agent (except tamoxifen) Radiotherapy Not specified Surgery Not specified

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    April 7, 2003
    Last Updated
    June 7, 2012
    Sponsor
    Northwestern University
    Collaborators
    National Cancer Institute (NCI)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00057993
    Brief Title
    Trastuzumab and Exemestane in Treating Postmenopausal Women With Metastatic or Locally Advanced Breast Cancer
    Official Title
    Phase II Study Of Herceptin And Exemestane For Treatment Of Postmenopausal Women With Metastatic Hormone-Responsive, HER2/NEU Positive Breast Cancer
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2012
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Unable to accrue subjects to the study after 2 years - closed per request by Data Monitoring Committee.
    Study Start Date
    July 2002 (undefined)
    Primary Completion Date
    August 2004 (undefined)
    Study Completion Date
    August 2004 (undefined)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Northwestern University
    Collaborators
    National Cancer Institute (NCI)

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    RATIONALE: The monoclonal antibody trastuzumab can locate breast cancer cells that have HER2 on their surface and either kill them or deliver tumor-killing substances to them without harming normal cells. Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using exemestane may fight breast cancer by reducing the production of estrogen. Combining trastuzumab with exemestane may be an effective treatment for breast cancer with high amounts of HER2. PURPOSE: Phase II trial to study the effectiveness of combining trastuzumab with exemestane in treating postmenopausal women who have metastatic or locally advanced HER2-positive breast cancer.
    Detailed Description
    OBJECTIVES: Determine the efficacy of exemestane and trastuzumab (Herceptin), in terms of response rate and time to progression, in postmenopausal women with metastatic or locally advanced hormone-responsive, HER2/neu positive breast cancer. Determine the toxicity of this regimen in these patients. OUTLINE: This is a multicenter study. Patients receive trastuzumab (Herceptin) IV over 30-90 minutes on day 1 and oral exemestane once daily. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months. PROJECTED ACCRUAL: A total of 18-60 patients will be accrued for this study.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Breast Cancer
    Keywords
    stage IV breast cancer, stage IIIA breast cancer, stage IIIB breast cancer, stage IIIC breast cancer

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Masking
    None (Open Label)
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Intervention Type
    Biological
    Intervention Name(s)
    trastuzumab
    Intervention Type
    Drug
    Intervention Name(s)
    exemestane

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    DISEASE CHARACTERISTICS: Histologically confirmed breast cancer Stage IV or locally advanced disease Staged by bone scan or CT scan of chest and/or abdomen within the past 6 weeks HER2/neu positive by fluorescent in situ hybridization (if 2+ by immunohistochemistry) or 3+ by immunohistochemistry Measurable disease defined by 1 of the following criteria: At least 1 dimension at least 1 cm by CT scan or other imaging scan At least 1 diameter at least 1 cm by plain x-ray (excluding bone lesions) Palpable lesion with both diameters at least 1 cm with caliper OR Evaluable disease defined by 1 of the following criteria: Positive bone scan Palpable masses with diameter less than 1 cm, masses with margins not clearly defined on CT scan or x-ray, or with both diameters less than 1 cm Bone scan and CA 27.29 if bone scan only evaluable disease Hormone receptor status: Estrogen receptor and/or progesterone receptor positive PATIENT CHARACTERISTICS: Age 18 and over Sex Female Menopausal status Postmenopausal by 1 of the following criteria: 60 years of age and over 45 years of age and over with amenorrhea more than 12 months and an intact uterus Follicle-stimulating hormone levels within postmenopausal range Undergone bilateral oophorectomy Performance status ECOG 0-2 Life expectancy Not specified Hematopoietic Not specified Hepatic Bilirubin less than 1.5 times upper limit of normal Renal Creatinine less than 2 mg/dL Cardiovascular Ejection fraction greater than 50% Other Not pregnant or nursing PRIOR CONCURRENT THERAPY: Biologic therapy No prior trastuzumab (Herceptin) Chemotherapy Prior chemotherapy allowed Endocrine therapy No prior exemestane No other prior hormonal agent (except tamoxifen) Radiotherapy Not specified Surgery Not specified
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Virginia G. Kaklamani, MD
    Organizational Affiliation
    Robert H. Lurie Cancer Center
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Trastuzumab and Exemestane in Treating Postmenopausal Women With Metastatic or Locally Advanced Breast Cancer

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