NCT00057993

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.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jul 2002

Shorter than P25 for phase_2 breast-cancer

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2002

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

April 7, 2003

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 9, 2003

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2004

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2004

Completed
Last Updated

June 11, 2012

Status Verified

June 1, 2012

Enrollment Period

2.1 years

First QC Date

April 7, 2003

Last Update Submit

June 7, 2012

Conditions

Breast Cancer

Keywords

stage IV breast cancerstage IIIA breast cancerstage IIIB breast cancerstage IIIC breast cancer

Interventions

trastuzumabBIOLOGICAL
exemestaneDRUG

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Trastuzumabexemestane

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Virginia G. Kaklamani, MD

    Robert H. Lurie Cancer Center

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 2
Masking
NONE
Purpose
TREATMENT
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 7, 2003

First Posted

April 9, 2003

Study Start

July 1, 2002

Primary Completion

August 1, 2004

Study Completion

August 1, 2004

Last Updated

June 11, 2012

Record last verified: 2012-06