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Completed

NCT Number: NCT01313039

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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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Early Phase 1

Primary location

University of Miami Sylvester Comprehensive Cancer Center

Miami, Florida, 33136, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

AZ6244

Drug

AZD6244 75 mg (3 x 25mg capsules) orally twice per day on Days 1 - 15

Other names: AZD6244

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of Miami

Other

Registry information

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Mar 11, 2011
Registry last updated
Feb 7, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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