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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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Miami
ClinicalTrials.gov Identifier:
NCT01313039
First received: March 9, 2011
Last updated: December 14, 2016
Last verified: December 2016
  Purpose
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 Intervention Phase
Breast Cancer Drug: AZ6244 Early Phase 1

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by University of Miami:

Primary Outcome Measures:
  • 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:
  • 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.


Enrollment: 4
Study Start Date: February 2011
Study Completion Date: April 2014
Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: AZD6244 Drug: AZ6244
AZD6244 75 mg (3 x 25mg capsules) orally twice per day on Days 1 - 15
Other Name: AZD6244

  Eligibility

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

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01313039

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

Responsible Party: University of Miami
ClinicalTrials.gov Identifier: NCT01313039     History of Changes
Other Study ID Numbers: 20100252
Study First Received: March 9, 2011
Results First Received: May 1, 2014
Last Updated: December 14, 2016

Keywords provided by University of Miami:
Breast Cancer
ER-negative
Allred Score

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Estrogens
Estrogen Receptor Modulators
Estrogen Antagonists
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Hormone Antagonists

ClinicalTrials.gov processed this record on September 21, 2017