Text Size

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

This study has been terminated.
(Due to low enrollment)
Sponsor:
Information provided by (Responsible Party):
Ann Schott, MD, University of Michigan Cancer Center
ClinicalTrials.gov Identifier:
NCT00726180
First received: July 28, 2008
Last updated: June 15, 2012
Last verified: June 2012
History of Changes

July 28, 2008
June 15, 2012
July 2008
June 2010   (final data collection date for primary 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. [ Time Frame: 90 days ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00726180 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
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

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.
Not Provided
Interventional
Phase 1
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Breast Cancer
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.
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
1
October 2010
June 2010   (final data collection date for primary outcome measure)

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.
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00726180
UMCC 2007.130
Yes
Ann Schott, MD, University of Michigan Cancer Center
University of Michigan Cancer Center
Not Provided
Principal Investigator: Anne Schott, MD University of Michigan Cancer Center
University of Michigan Cancer Center
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP