Evaluation of the Use of AZD6244 to Induce Increased ER Expression and Anti-Estrogen Response in ER-Negative/Low Breast Cancer
This study is currently recruiting participants.
Verified April 2013 by University of Miami Sylvester Comprehensive Cancer Center
Sponsor:
University of Miami Sylvester Comprehensive Cancer Center
Information provided by (Responsible Party):
University of Miami Sylvester Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT01313039
First received: March 9, 2011
Last updated: April 18, 2013
Last verified: April 2013
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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 |
|---|---|
|
Breast Cancer |
Drug: AZ6244 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: 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 Sylvester Comprehensive Cancer Center:
Primary Outcome Measures:
- Increase of ER protein expression in ER-Negative/Low breast Cancer [ Time Frame: 2 years ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]To assess for in vitro tamoxifen response in tumors following therapy with AZD6244.
| Estimated Enrollment: | 30 |
| Study Start Date: | February 2011 |
| Estimated Primary Completion Date: | February 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Single Arm |
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 |
| Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01313039
Locations
| United States, Florida | |
| University of Miami Sylvester Comprehensive Cancer Center | Recruiting |
| Miami, Florida, United States, 33136 | |
| Contact: University of Miami Sylvester Comprehensive Cancer Center 866-574-5124 Sylvester@emergingmed.com | |
| Principal Investigator: Judith Hurley, MD | |
| Principal Investigator: Dorraya El-Ashry, PhD | |
| Sub-Investigator: Jennifer Clarke, PhD | |
Sponsors and Collaborators
University of Miami Sylvester Comprehensive Cancer Center
Investigators
| Study Chair: | Judith Hurley, MD | University of Miami Sylvester Comprehensive Cancer Center |
More Information
No publications provided
| Responsible Party: | University of Miami Sylvester Comprehensive Cancer Center |
| ClinicalTrials.gov Identifier: | NCT01313039 History of Changes |
| Other Study ID Numbers: | EPROST-20100252 |
| Study First Received: | March 9, 2011 |
| Last Updated: | April 18, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by University of Miami Sylvester Comprehensive Cancer Center:
|
Breast Cancer ER-negative Allred Score |
Additional relevant MeSH terms:
|
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Estrogen Antagonists Estrogen Receptor Modulators |
Estrogens Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Pharmacologic Actions Hormones |
ClinicalTrials.gov processed this record on June 18, 2013