Trastuzumab and Exemestane in Treating Postmenopausal Women With Metastatic or Locally Advanced Breast Cancer - Full Text View

Sponsor:	Northwestern University
Collaborator:	National Cancer Institute (NCI)
Information provided by:	Northwestern University
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	Biological: trastuzumab Drug: exemestane	Phase II

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:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

Drug Information available for: Exemestane Trastuzumab

U.S. FDA Resources

Further study details as provided by Northwestern University:

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:	Virginia Kaklamani, MD, 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:	August 24, 2011
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 February 12, 2012