Clinical trial NCT01083641: Estrogen for Triple Negative Breast Cancer
Official title: A Phase II Study of High Dose Estradiol in Metastatic Triple Negative Breast Cancer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Female Breast Cancer
Keywords: Breast Cancer
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2010-03-10
Enrollment: 17
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: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Determine Tumor Objective Response (OR) Rates
timeFrame: Up to 4 years
Secondary outcomes:
measure: Clinical Benefit (CB)
timeFrame: Up to 4 years
measure: Progression-free Survival (PFS)
timeFrame: Up to 4 years
measure: Median Overall Survival (OS)
timeFrame: Up to 4 years
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin Carbone Cancer Center
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Kari B Wisinski, MD
role: PRINCIPAL_INVESTIGATOR
References: