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

NCT ID: NCT01313039

Last Updated: 2017-02-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 4 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-02-28
• Study Completion Date: 2014-04-30

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.

Conditions

Breast Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

AZD6244

Group Type: EXPERIMENTAL

AZ6244

Intervention Type: DRUG

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

Interventions

AZ6244

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

Intervention Type: DRUG

Other Intervention Names

AZD6244

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of Miami

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Judith Hurley, MD

Role: STUDY_CHAIR

University of Miami Sylvester Comprehensive Cancer Center

Locations

University of Miami Sylvester Comprehensive Cancer Center

Miami, Florida, United States

Countries

United States

Other Identifiers

20100252

Identifier Type: -

Identifier Source: org_study_id