Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II Treatment Completed 18 and over NCI, Pharmaceutical / Industry NU-01B4 PHARMACIA-NU-01B4, NCT00057993

Objectives

1. 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.
2. Determine the toxicity of this regimen in these patients.

Entry 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

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

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

Expected Enrollment

A total of 18-60 patients will be accrued for this study.

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.

Trial Contact Information

Trial Lead Organizations

Robert H. Lurie Comprehensive Cancer Center at Northwestern University

Virginia Kaklamani, MD, Principal investigator		Ph: 312-695-0320

Registry Information
Official Title		Phase II Study Of Herceptin And Exemestane For Treatment Of Postmenopausal Women With Metastatic Hormone-Responsive, HER2/NEU Positive Breast Cancer
Trial Start Date		2002-07-10
Trial Completion Date		2004-08-10
Registered in ClinicalTrials.gov		NCT00057993
Date Submitted to PDQ		2003-02-10
Information Last Verified		2004-04-13
NCI Grant/Contract Number		P30-CA60553

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