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

University of Michigan Rogel Cancer Center

Status and phase: Terminated; Phase 2; Phase 1

Conditions: Breast Cancer

Treatments: Drug: trastuzumab (Herceptin®)

Study type: Interventional

Funder types: Other

Identifiers

NCT00726180

UMCC 2007.130

Details and patient eligibility

About

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.

Enrollment: 1 patient

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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1 participants in 1 patient group

Treatment arm

Experimental group

Treatment:

Drug: trastuzumab (Herceptin®)