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Trial record 17 of 277 for:    Estrogen usage | Breast cancer

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 : December 9, 2019
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University of Wisconsin, Madison

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.

Condition or disease Intervention/treatment Phase
Female Breast Cancer Drug: Estradiol Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 17 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study of High Dose Estradiol in Metastatic Triple Negative Breast Cancer
Study Start Date : January 2010
Actual Primary Completion Date : June 2013
Actual Study Completion Date : March 2015

Arm Intervention/treatment
Experimental: Estrogen Therapy
Estrogen therapy
Drug: Estradiol
10mg oral three times daily

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. Clinical Benefit (CB) [ Time Frame: Up to 4 years ]
    Defined as complete response, partial response, or stable disease at > 16 weeks

  2. Progression-free Survival (PFS) [ Time Frame: Up to 4 years ]
  3. Median Overall Survival (OS) [ Time Frame: Up to 4 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01083641

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United States, Wisconsin
University of Wisconsin Carbone Cancer Center
Madison, Wisconsin, United States, 53792
Sponsors and Collaborators
University of Wisconsin, Madison
National Cancer Institute (NCI)
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Principal Investigator: Kari B Wisinski, MD University of Wisconsin, Madison
Additional Information:
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Responsible Party: University of Wisconsin, Madison Identifier: NCT01083641    
Other Study ID Numbers: CO09711
H-2009-0172 ( Other Identifier: Institutional Review Board )
NCI-2011-00618 ( Registry Identifier: NCI Trial ID )
A534260 ( Other Identifier: UW Madison )
SMPH\MEDICINE\HEM-ONC ( Other Identifier: UW Madison )
P30CA014520 ( U.S. NIH Grant/Contract )
First Posted: March 10, 2010    Key Record Dates
Results First Posted: March 7, 2017
Last Update Posted: December 9, 2019
Last Verified: March 2017
Keywords provided by University of Wisconsin, Madison:
Breast Cancer
Additional relevant MeSH terms:
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Breast Neoplasms
Triple Negative Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs