Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
Trastuzumab and Exemestane in Treating Postmenopausal Women With Metastatic or Locally Advanced Breast Cancer
This study has been completed.
Sponsors and Collaborators: Robert H. Lurie Cancer Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00057993
  Purpose

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.


Condition Intervention Phase
Breast Cancer
Drug: exemestane
Drug: trastuzumab
Phase II

Genetics Home Reference related topics: breast cancer
MedlinePlus related topics: Breast Cancer Cancer
Drug Information available for: Trastuzumab Exemestane
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Open Label
Official Title: Phase II Study Of Herceptin And Exemestane For Treatment Of Postmenopausal Women With Metastatic Hormone-Responsive, HER2/NEU Positive Breast Cancer

Further study details as provided by National Cancer Institute (NCI):

Study Start Date: July 2002
Primary Completion Date: August 2004 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00057993

Locations
United States, Georgia
Winship Cancer Institute of Emory University
Atlanta, Georgia, United States, 30322
United States, Illinois
Hematology-Oncology Associates of Illinois
Chicago, Illinois, United States, 60611-2998
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
Chicago, Illinois, United States, 60611-3013
Silver Cross Hospital
Joliet, Illinois, United States, 60432
United States, Wisconsin
Marshfield Clinic
Marshfield, Wisconsin, United States, 54449
Sponsors and Collaborators
Robert H. Lurie Cancer Center
Investigators
Principal Investigator: Virginia G. Kaklamani, MD Robert H. Lurie Cancer Center
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Study ID Numbers: CDR0000285670, NU-01B4, PHARMACIA-NU-01B4
Study First Received: April 7, 2003
Last Updated: July 23, 2008
ClinicalTrials.gov Identifier: NCT00057993  
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage IV breast cancer
stage IIIA breast cancer
stage IIIB breast cancer
stage IIIC breast cancer

Study placed in the following topic categories:
Skin Diseases
Trastuzumab
Breast Neoplasms
Exemestane
Breast Diseases

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Therapeutic Uses
Enzyme Inhibitors
Aromatase Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009