Trial record 1 of 113 for:    Estrogen for Triple Negative Breast Cancer
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Estrogen for Triple Negative Breast Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01083641
Recruitment Status : Terminated (did not meet efficacy goals after interim analysis)
First Posted : March 10, 2010
Results First Posted : March 7, 2017
Last Update Posted : April 4, 2017
Information provided by (Responsible Party):
University of Wisconsin, Madison

March 8, 2010
March 10, 2010
January 13, 2017
March 7, 2017
April 4, 2017
January 2010
June 2013   (Final data collection date for primary outcome measure)
Determine Tumor Objective Response (OR) Rates [ Time Frame: Up to 4 years ]
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.
Determine tumor objective response rates [ Time Frame: based on estimated enrollment timeframe of 2 years ]
Complete list of historical versions of study NCT01083641 on Archive Site
  • Clinical Benefit (CB) [ Time Frame: Up to 4 years ]
    Defined as complete response, partial response, or stable disease at > 16 weeks
  • Progression-free Survival (PFS) [ Time Frame: Up to 4 years ]
  • Median Overall Survival (OS) [ Time Frame: Up to 4 years ]
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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.
Not Provided
Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Female Breast Cancer
Drug: Estradiol
10mg oral three times daily
Experimental: Estrogen Therapy
Estrogen therapy
Intervention: Drug: Estradiol
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
March 2015
June 2013   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: Female
18 Years and older   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
United States
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University of Wisconsin, Madison
University of Wisconsin, Madison
Not Provided
Principal Investigator: Kari B Wisinski, MD University of Wisconsin, Madison
University of Wisconsin, Madison
March 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP