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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

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

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: AZ6244 Early Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of the Use of AZD6244 to Induce Increased ER Expression and Anti-Estrogen Response in ER-Negative/Low Breast Cancer
Study Start Date : February 2011
Actual Primary Completion Date : April 2014
Actual Study Completion Date : April 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
Drug Information available for: Estrogens

Arm Intervention/treatment
Experimental: AZD6244 Drug: AZ6244
AZD6244 75 mg (3 x 25mg capsules) orally twice per day on Days 1 - 15
Other Name: AZD6244

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. In Vitro Tamoxifen Response in Tumors [ Time Frame: 2 years ]
    To assess for in vitro tamoxifen response in tumors following therapy with AZD6244.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01313039

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United States, Florida
University of Miami Sylvester Comprehensive Cancer Center
Miami, Florida, United States, 33136
Sponsors and Collaborators
University of Miami
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Study Chair: Judith Hurley, MD University of Miami Sylvester Comprehensive Cancer Center

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Responsible Party: University of Miami Identifier: NCT01313039    
Other Study ID Numbers: 20100252
First Posted: March 11, 2011    Key Record Dates
Results First Posted: July 2, 2014
Last Update Posted: February 7, 2017
Last Verified: December 2016
Keywords provided by University of Miami:
Breast Cancer
Allred Score
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Estrogen Receptor Modulators
Estrogen Antagonists
Estrogen Receptor Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Hormone Antagonists