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

NCT01313039 | Completed Early Phase 1 Results DMC

• 1 other identifier: 20100252
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

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

Keywords

Breast Cancer; ER-negative; Allred Score

Outcome Measures

Primary Outcomes (1)

• Increase of ER Protein Expression in ER-Negative/Low Breast Cancer

  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.

  2 years

Secondary Outcomes (3)

• Changes in ER-regulated Gene Expression in E-negative/Low Breast Cancer

  2 Years

• Rate of ER Promoter Methylation in ER-negative/Low Breast Cancer

  2 years

• In Vitro Tamoxifen Response in Tumors

  2 years

Study Arms (1)

AZD6244

EXPERIMENTAL

Drug: AZ6244

Interventions

AZ6244 DRUG

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

Also known as: AZD6244

AZD6244

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Miami: lead

Study Sites (1)

University of Miami Sylvester Comprehensive Cancer Center

Miami, Florida, 33136, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

AZD 6244

Condition Hierarchy (Ancestors)

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

Limitations and Caveats

Only 4 patients were enrolled and of these 4 only 1 patient had evaluable study data.

Results Point of Contact

• Title: Judith Hurley MD
• Organization: University of Miami Sylvester Comprehensive Cancer Center

JHurley@med.miami.edu

305-243-6462

Study Officials

• Judith Hurley, MD

  University of Miami Sylvester Comprehensive Cancer Center

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 9, 2011
• First Posted: March 11, 2011
• Study Start: February 1, 2011
• Primary Completion: April 1, 2014
• Study Completion: April 1, 2014
• Last Updated: February 7, 2017
• Results First Posted: July 2, 2014

Record last verified: 2016-12

Locations

US (1)