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

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ClinicalTrials.gov Identifier: NCT00057993
Recruitment Status : Withdrawn (Unable to accrue subjects to the study after 2 years - closed per request by Data Monitoring Committee.)
First Posted : April 9, 2003
Last Update Posted : June 11, 2012
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Northwestern University

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.

Condition or disease Intervention/treatment Phase
Breast Cancer Biological: trastuzumab Drug: exemestane Phase 2

Detailed Description:


  • 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study Of Herceptin And Exemestane For Treatment Of Postmenopausal Women With Metastatic Hormone-Responsive, HER2/NEU Positive Breast Cancer
Study Start Date : July 2002
Primary Completion Date : August 2004
Study Completion Date : August 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No


  • 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



  • 18 and over


  • 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


  • Not specified


  • Bilirubin less than 1.5 times upper limit of normal


  • Creatinine less than 2 mg/dL


  • Ejection fraction greater than 50%


  • Not pregnant or nursing


Biologic therapy

  • No prior trastuzumab (Herceptin)


  • Prior chemotherapy allowed

Endocrine therapy

  • No prior exemestane
  • No other prior hormonal agent (except tamoxifen)


  • Not specified


  • Not specified

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00057993

Sponsors and Collaborators
Northwestern University
National Cancer Institute (NCI)
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Principal Investigator: Virginia G. Kaklamani, MD Robert H. Lurie Cancer Center
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Responsible Party: Northwestern University
ClinicalTrials.gov Identifier: NCT00057993    
Other Study ID Numbers: NU 01B4
First Posted: April 9, 2003    Key Record Dates
Last Update Posted: June 11, 2012
Last Verified: June 2012
Keywords provided by Northwestern University:
stage IV breast cancer
stage IIIA breast cancer
stage IIIB breast cancer
stage IIIC breast cancer
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Antineoplastic Agents, Immunological
Antineoplastic Agents
Aromatase Inhibitors
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs