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

This study has been withdrawn prior to enrollment.
(Unable to accrue subjects to the study after 2 years - closed per request by Data Monitoring Committee.)
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Northwestern University
ClinicalTrials.gov Identifier:
NCT00057993
First received: April 7, 2003
Last updated: June 7, 2012
Last verified: June 2012
History of Changes
  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
 Biological: trastuzumab
Drug: exemestane
 Phase 2

Study Type: Interventional
Study Design: Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Northwestern University:

Enrollment: 0
Study Start Date: July 2002
Estimated Study Completion Date: August 2004
Estimated 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

Sponsors and Collaborators
Northwestern University
National Cancer Institute (NCI)
Investigators
Principal Investigator: Virginia G. Kaklamani, MD Robert H. Lurie Cancer Center
  More Information

No publications provided

Responsible Party: Northwestern University
ClinicalTrials.gov Identifier: NCT00057993     History of Changes
Other Study ID Numbers: NU 01B4, NU-01B4, PHARMACIA-NU-01B4
Study First Received: April 7, 2003
Last Updated: June 7, 2012
Health Authority: United States: Federal Government

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:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Exemestane
Trastuzumab
 Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Aromatase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 16, 2013