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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


Phase 1/Phase 2
18 Years
N/A
Not Enrolling
Female
Breast Cancer

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Trial Information

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


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.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

To see if treatment with trastuzumab can make ER appear in ER "negative" breast cancer.Trastuzumab is an anti-Her-2 drug usually given after surgery for treatment of Her-2 "positive" breast cancer.

Outcome Time Frame:

90 days

Safety Issue:

No

Principal Investigator

Anne Schott, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Michigan Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

UMCC 2007.130

NCT ID:

NCT00726180

Start Date:

July 2008

Completion Date:

October 2010

Related Keywords:

  • Breast Cancer
  • Breast cancer
  • Women
  • w/Her2
  • positive
  • ERnegative
  • not metastasized
  • Breast Neoplasms

Name

Location
University of Michigan Comprehensive Cancer Center Ann Arbor, Michigan  48109-0752