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Estrogen for Triple Negative Breast Cancer

Primary Purpose

Female Breast Cancer

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Estradiol
Sponsored by
University of Wisconsin, Madison
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Female Breast Cancer focused on measuring Breast Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Wisconsin Carbone Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Estrogen Therapy

Arm Description

Estrogen therapy

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Clinical Benefit (CB)
Defined as complete response, partial response, or stable disease at > 16 weeks
Progression-free Survival (PFS)
Median Overall Survival (OS)

Full Information

First Posted
March 8, 2010
Last Updated
November 19, 2019
Sponsor
University of Wisconsin, Madison
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT01083641
Brief Title
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

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Terminated
Why Stopped
did not meet efficacy goals after interim analysis
Study Start Date
January 2010 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
March 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Wisconsin, Madison
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Female Breast Cancer
Keywords
Breast Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
17 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Estrogen Therapy
Arm Type
Experimental
Arm Description
Estrogen therapy
Intervention Type
Drug
Intervention Name(s)
Estradiol
Intervention Description
10mg oral three times daily
Primary Outcome Measure Information:
Title
Determine Tumor Objective Response (OR) Rates
Description
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.
Time Frame
Up to 4 years
Secondary Outcome Measure Information:
Title
Clinical Benefit (CB)
Description
Defined as complete response, partial response, or stable disease at > 16 weeks
Time Frame
Up to 4 years
Title
Progression-free Survival (PFS)
Time Frame
Up to 4 years
Title
Median Overall Survival (OS)
Time Frame
Up to 4 years

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kari B Wisinski, MD
Organizational Affiliation
University of Wisconsin, Madison
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Wisconsin Carbone Cancer Center
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States

12. IPD Sharing Statement

Links:
URL
https://cancer.wisc.edu/
Description
University of Wisconsin Carbone Cancer Center

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Estrogen for Triple Negative Breast Cancer

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