Estrogen for Triple Negative Breast Cancer



Status:Terminated
Conditions:Breast Cancer, Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:January 2010
End Date:March 2015

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A Phase II Study of High Dose Estradiol in Metastatic Triple Negative Breast Cancer

The purpose of this study is to determine the effectiveness of Estradiol treatment for
advanced breast cancer that is hormone receptor negative and Her2/neu negative. The study
will also use tumor tissue from your original diagnosis or from a biopsy you may have had
for your cancer to look at hormone receptors in the lab. The tissue left over from your
previous surgery or a previous biopsy will be used for research tests to check whether a
different estrogen receptor (estrogen receptor beta) is seen in the tumor and if that makes
estrogen work better.


Inclusion Criteria:

- histologically or cytologically confirmed breast cancer which is metastatic.

- A formalin-fixed paraffin embedded tumor block (preferred) or unstained slides must
be available from either a prior biopsy of the primary tumor or a metastatic site. .

- Primary tumor or metastatic biopsy lacking estrogen and progesterone receptor and
Her2 negative

- Patients must have measurable disease.

- Eastern Cooperative Oncology Group performance status 0-1.

- Patients with bone metastasis at baseline must agree to treatment with intravenous
bisphosphonates

- Subjects may have had 0-4 lines of prior systemic chemotherapy or targeted therapy
regimens administered for treatment of their metastatic breast cancer.

- Age >18 years

- Life expectancy of greater than 3 months.

- Patients must have adequate organ and marrow function as defined below:

Exclusion Criteria:

- systemic chemotherapies, targeted therapies or radiotherapy for their cancer within 2
weeks prior to entering the study

- Patients receiving any other investigational agents for breast cancer treatment.

- Patients with known brain metastases are excluded 3.2.4 History of allergic reactions
attributed to compounds of similar chemical or biologic composition to estradiol.

- Patients with any condition of the gastrointestinal tract that is expected to result
in an inability to take oral medication

- Dysfunctional or post-menopausal vaginal bleeding.

- Uncontrolled hypercalcemia/hypocalcemia

- Prior history of or active thrombophlebitis, cerebral vascular accident, myocardial
infarction, deep venous thrombosis or pulmonary embolism.

- History of or active hepatic adenoma.

- Uncontrolled intercurrent illness

- Pregnant women are excluded from this study

- Patients with bone metastasis are excluded if they are unable to receive intravenous
bisphosphonate therapy due to the risk for developing hypercalcemia.
We found this trial at
1
site
600 Highland Ave.
Madison, Wisconsin 53792
(608) 263-6400
University of Wisconsin Carbone Cancer Center UW Carbone Cancer Center holds the unique distinction of...
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mi
from
Madison, WI
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