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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01313039
Recruitment Status : Completed
First Posted : March 11, 2011
Results First Posted : July 2, 2014
Last Update Posted : February 7, 2017
Information provided by (Responsible Party):
University of Miami

March 9, 2011
March 11, 2011
May 1, 2014
July 2, 2014
February 7, 2017
February 2011
April 2014   (Final data collection date for primary outcome measure)
Increase of ER Protein Expression in ER-Negative/Low Breast Cancer [ Time Frame: 2 years ]
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.
Same as current
Complete list of historical versions of study NCT01313039 on Archive Site
  • Changes in ER-regulated Gene Expression in E-negative/Low Breast Cancer [ Time Frame: 2 Years ]
    To assess for changes in ER-regulated gene expression in ER-negative/low breast tumors following AZD6244 therapy through assessment of protein expression by immunhistochemistry in paraffin embedded tissues.
  • Rate of ER Promoter Methylation in ER-negative/Low Breast Cancer [ Time Frame: 2 years ]
    To determine the rate of ER promoter methylation in ER-negative/low breast cancer tumors that do not attain an ER response following AZD6244 therapy.
  • In Vitro Tamoxifen Response in Tumors [ Time Frame: 2 years ]
    To assess for in vitro tamoxifen response in tumors following therapy with AZD6244.
Same as current
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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
Evaluation of the Use of AZD6244 to Induce Increased ER Expression and Anti-Estrogen Response in ER-Negative/Low Breast Cancer
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.
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Early Phase 1
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Breast Cancer
Drug: AZ6244
AZD6244 75 mg (3 x 25mg capsules) orally twice per day on Days 1 - 15
Other Name: AZD6244
Experimental: AZD6244
Intervention: Drug: AZ6244
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
April 2014
April 2014   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: Female
18 Years and older   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
United States
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University of Miami
University of Miami
Not Provided
Study Chair: Judith Hurley, MD University of Miami Sylvester Comprehensive Cancer Center
University of Miami
December 2016

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