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Evaluation of the Use of AZD6244 to Induce Increased ER Expression and Anti-Estrogen Response in ER-Negative/Low Breast Cancer

18 Years
Open (Enrolling)
Breast Cancer

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Trial Information

Evaluation of the Use of AZD6244 to Induce Increased ER Expression and Anti-Estrogen Response in ER-Negative/Low Breast Cancer

Inclusion Criteria:

- Female breast cancer patient > 18 years.

- Patients must have biopsy-proven clinical Stage Ic-III invasive breast carcinoma with
≤ 10% ER expression by immunohistochemistry (IHC) analysis.

- Patients must have a pre-treatment baseline core biopsy or incisional biopsy
available for additional testing (ER, protein/gene expression analysis).

- Patients must have sufficient tumor remaining following diagnostic biopsy that
requires an additional definitive surgical procedure per the standard of care.
Planned procedure may include lumpectomy or mastectomy as clinically indicated.

- Patients must have an ECOG Performance Status of 0 - 1.

- Patients must have the ability to understand and willingness to sign an English or a
Spanish language written informed consent document.

Exclusion Criteria:

- Male breast cancer patient.

- Patients who are pregnant or breast-feeding are excluded from the study due to
potential harm to the fetus or nursing infant from the study therapy. Patients of
reproductive potential must consent to use of contraception or abstinence to be
eligible for the study.

- Patients may not have received prior chemotherapy or hormonal therapy for treatment
of the current breast cancer.

- Patients should not have known or strongly suspected BRCA mutation by history
(genetic testing not required).

- Patients will have pre-study testing, including history and physical exam, complete
blood count, and measurement of renal and hepatic function. Patients will be
ineligible for the study if significant abnormalities are detected, in accordance
with good medical practice.

Type of Study:


Study Design:

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Increase of ER protein expression in ER-Negative/Low breast Cancer

Outcome Description:

To evaluate in a clinical neoadjuvant model whether MEK inhibitor AZD6244 can increase ER protein expression in ER-negative/low breast cancer, as measured by the "ER response rate" by both standard immunohistochemistry and Allred Score.

Outcome Time Frame:

2 years

Safety Issue:


Principal Investigator

Judith Hurley, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Miami Sylvester Comprehensive Cancer Center


United States: Food and Drug Administration

Study ID:




Start Date:

February 2011

Completion Date:

Related Keywords:

  • Breast Cancer
  • Breast Cancer
  • ER-negative
  • Allred Score
  • Breast Neoplasms



University of Miami Sylvester Comprehensive Cancer Center Miami, Florida  33136