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Trial record 1 of 119 for:    Estrogen for Triple Negative Breast Cancer
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Estrogen for Triple Negative Breast Cancer

This study has been terminated.
(did not meet efficacy goals after interim analysis)
Sponsor:
Information provided by (Responsible Party):
University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT01083641
First received: March 8, 2010
Last updated: March 6, 2017
Last verified: March 2017
  Purpose
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 Intervention Phase
Female Breast Cancer
Drug: Estradiol
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: A Phase II Study of High Dose Estradiol in Metastatic Triple Negative Breast Cancer

Resource links provided by NLM:


Further study details as provided by University of Wisconsin, Madison:

Primary Outcome Measures:
  • 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:
  • 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 ]

Enrollment: 17
Study Start Date: January 2010
Study Completion Date: March 2015
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Estrogen Therapy
Estrogen therapy
Drug: Estradiol
10mg oral three times daily

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01083641

Locations
United States, Wisconsin
University of Wisconsin Carbone Cancer Center
Madison, Wisconsin, United States, 53792
Sponsors and Collaborators
University of Wisconsin, Madison
Investigators
Principal Investigator: Kari B Wisinski, MD University of Wisconsin, Madison
  More Information

Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT01083641     History of Changes
Other Study ID Numbers: CO09711
Study First Received: March 8, 2010
Results First Received: January 13, 2017
Last Updated: March 6, 2017

Keywords provided by University of Wisconsin, Madison:
Breast Cancer

Additional relevant MeSH terms:
Breast Neoplasms
Triple Negative Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Estrogens
Skin Diseases
Estradiol
Polyestradiol phosphate
Estradiol 3-benzoate
Estradiol 17 beta-cypionate
Estradiol valerate
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Contraceptive Agents
Reproductive Control Agents
Contraceptive Agents, Female

ClinicalTrials.gov processed this record on April 24, 2017