Clinical trial NCT01313039: Evaluation of the Use of AZD6244 to Induce Increased ER Expression and Anti-Estrogen Response in ER-Negative/Low Breast Cancer
Official title: Evaluation of the Use of AZD6244 to Induce Increased ER Expression and Anti-Estrogen Response in ER-Negative/Low Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Breast Cancer
Keywords: Breast Cancer
ER-negative
Allred Score
Lead sponsor: University of Miami
Sponsor class: OTHER
First posted: 2011-03-11
Enrollment: 4
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Increase of ER Protein Expression in ER-Negative/Low Breast Cancer
timeFrame: 2 years
Secondary outcomes:
measure: Changes in ER-regulated Gene Expression in E-negative/Low Breast Cancer
timeFrame: 2 Years
measure: Rate of ER Promoter Methylation in ER-negative/Low Breast Cancer
timeFrame: 2 years
measure: In Vitro Tamoxifen Response in Tumors
timeFrame: 2 years
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami Sylvester Comprehensive Cancer Center
state: Florida
Study officials:
affiliation: University of Miami Sylvester Comprehensive Cancer Center
name: Judith Hurley, MD
role: STUDY_CHAIR
References: