Use of Trastuzumab to Induce Increased ER Expression in ER-negative/Low, Her-2/Neu Positive Breast Cancer

Study Overview
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Brief Summary
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The majority pf breast cancers present as ER-positive, many of which are able to be targeted with multiple hormonal therapies. Altering ER-negative tumors to increase ER expression has the potential to benefit patients by making hormonal therapies a therapeutic option and possibly improving their overall prognosis.

Official Title
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Evaluation of the Use of Trastuzumab to Induce Increased ER Expression in ER-Negative/Low, Her-2/Neu Positive Breast Cancer

Conditions
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Breast Cancer

Intervention / Treatment
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* Drug: trastuzumab (Herceptin®)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women who have Her-2 positive and ER- negative or ER-low breast cancer that has not metastasized, or spread to other parts of the body, are eligible for the study. Participants must have had either a core biopsy or incisional biopsy of their breast cancer, but not yet had definitive breast surgery, including lumpectomy or mastectomy. Participants may not have had a BRCA mutation found on genetic testing. Participants should have not yet received treatment for their breast cancer, including: chemotherapy, hormonal therapy, trastuzumab.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment arm<br> | Drug: trastuzumab (Herceptin®)<br>* About 1 week (4 - 7 days) before scheduled breast surgery, consisting of lumpectomy or mastectomy, subjects will receive a dose of trastuzumab (Herceptin®). Trastuzumab will be given through an IV or port for approximately 90 minutes. During this time, subjects will be closely monitored by a chemotherapy nurse to make sure that subjects do not have a reaction to the medication. It is possible that the infusion of the medication will need to be slowed down, in which case, the time for the infusion will be longer than 90 minutes. The one dose of the trastuzumab drug will be provided by the study (not billed to insurance), but the charges to administer the drug will be billed to subjects or subjects health insurance.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Standard Immunohistochemistry and Allred Scores Were to be Used to Measure the Estrogen Receptor (ER) Response Rate in Patients With ER-negative/Low, and Human Epidermal Growth Factor Receptor 2 (HER2)/Neu-positive Breast Cancer. |  | 90 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Breast cancer, Women, w/Her2, positive, ERnegative, not metastasized