Estrogen for Triple Negative Breast Cancer

Female Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01083641
• Other study ID #: CO09711
• Secondary ID: H-2009-0172NCI-2
• Status: Terminated
• Phase: Phase 2
• Start date: January 2010
• Est. completion date: March 2015

Study information

• Verified date: March 2017
• Source: University of Wisconsin, Madison
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 17
• Est. completion date: March 2015
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Neoplasms
• Female Breast Cancer
• Triple Negative Breast Neoplasms

Intervention

Drug:
• Estradiol
10mg oral three times daily

Locations

Country	Name	City	State
United States	University of Wisconsin Carbone Cancer Center	Madison	Wisconsin

Sponsors (2)

Lead Sponsor	Collaborator
University of Wisconsin, Madison	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determine Tumor Objective Response (OR) Rates	OR=complete response (CR) + partial response (PR) as defined by RECIST version 1.1, where CR=disappearance of all target lesions, and PR=At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.	Up to 4 years
Secondary	Clinical Benefit (CB)	Defined as complete response, partial response, or stable disease at > 16 weeks	Up to 4 years
Secondary	Progression-free Survival (PFS)		Up to 4 years
Secondary	Median Overall Survival (OS)		Up to 4 years

External Links

•   University of Wisconsin Carbone Cancer Center