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

Conditions:Breast Cancer, Cancer
Therapuetic Areas:Oncology
Age Range:18 - Any
Start Date:February 2011

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If AZD6244 is able to increase ER expression in ER-negative/low cancers then it may be
possible to effectively use hormonal therapy in these patients resulting in improved
outcomes. The investigators propose a single-arm Simon two-step study to examine whether
treatment with AZD6244 will result in increased ER expression in ER-negative/low primary
breast tumors.

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.
We found this trial at
1475 NW 12th Ave
Miami, Florida 33136
(305) 243-1000
University of Miami, Sylvester Comprehensive Cancer Center Sylvester Comprehensive Cancer Center integrates all cancer-related activities...
Miami, FL
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