Estrogen for Triple Negative Breast Cancer

Study Overview
=================
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.

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

Conditions
-----------------
Female Breast Cancer

Intervention / Treatment
-----------------
* Drug: Estradiol


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Estrogen Therapy<br>Estrogen therapy | Drug: Estradiol<br>* 10mg oral three times daily<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Benefit (CB) | Defined as complete response, partial response, or stable disease at > 16 weeks | Up to 4 years | 
| Progression-free Survival (PFS) |  | Up to 4 years | 
| Median Overall Survival (OS) |  | Up to 4 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Breast Cancer