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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00726180
• Other study ID #: UMCC 2007.130
• Status: Terminated
• Phase: Phase 1/Phase 2
• First received: July 28, 2008
• Last updated: August 9, 2013
• Start date: July 2008
• Est. completion date: October 2010

Study information

• Verified date: August 2013
• Source: University of Michigan Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: October 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• trastuzumab (Herceptin®)
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.

Locations

Country	Name	City	State
United States	University of Michigan Comprehensive Cancer Center	Ann Arbor	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
University of Michigan Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No