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

NCT ID: NCT00726180

Last Updated: 2013-10-15

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 1 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-07-31
• Study Completion Date: 2010-10-31

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment arm

Group Type: EXPERIMENTAL

trastuzumab (Herceptin®)

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of Michigan Rogel Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Ann Schott, MD

Associate Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Anne Schott, MD

Role: PRINCIPAL_INVESTIGATOR

University of Michigan Rogel Cancer Center

Locations

University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, United States

Countries

United States

Other Identifiers

UMCC 2007.130

Identifier Type: -

Identifier Source: org_study_id