Estrogen for Triple Negative Breast Cancer

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.

Study Overview

• Status: Terminated
• Conditions: Female Breast Cancer
• Intervention / Treatment: Drug: Estradiol

• Study Type: Interventional
• Enrollment (Actual): 17
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Wisconsin
    • Madison, Wisconsin, United States, 53792
      • University of Wisconsin Carbone Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Estrogen Therapy; Estrogen therapy	Drug: Estradiol; 10mg oral three times daily

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

Collaborators and Investigators

• Sponsor: University of Wisconsin, Madison
• Collaborators: National Cancer Institute (NCI)

Publications and helpful links

Helpful Links

• University of Wisconsin Carbone Cancer Center

Study record dates

Study Major Dates

• Study Start: January 1, 2010
• Primary Completion (Actual): June 1, 2013
• Study Completion (Actual): March 1, 2015

Study Registration Dates

• First Submitted: March 8, 2010
• First Submitted That Met QC Criteria: March 8, 2010
• First Posted (Estimate): March 10, 2010

Study Record Updates

• Last Update Posted (Actual): December 9, 2019
• Last Update Submitted That Met QC Criteria: November 19, 2019
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Keywords: Breast Cancer
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms; Triple Negative Breast Neoplasms; Physiological Effects of Drugs; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Estrogens; Estradiol
• Other Study ID Numbers: CO09711; P30CA014520 (U.S. NIH Grant/Contract); A534260 (Other Identifier: UW Madison); SMPH\MEDICINE\HEM-ONC (Other Identifier: UW Madison); H-2009-0172 (Other Identifier: Institutional Review Board); NCI-2011-00618 (Registry Identifier: NCI Trial ID)