NCT00726180

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

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

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 1 (actual)
• Sponsor: University of Michigan Rogel Cancer Center · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2008-07-01
• Primary completion: 2010-06-01
• Completion: 2010-10-01
• First posted: 2008-07-31
• Last updated: 2013-10-15
• Results posted: 2013-10-15

Locations

1 site across 1 country: United States