Trial record 1 of 51 for:
Estrogen for Triple Negative Breast Cancer
Estrogen for Triple Negative Breast Cancer
This study is currently recruiting participants.
Verified January 2013 by University of Wisconsin, Madison
Sponsor:
University of Wisconsin, Madison
Information provided by (Responsible Party):
University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT01083641
First received: March 8, 2010
Last updated: January 16, 2013
Last verified: January 2013
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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: | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase II Study of High Dose Estradiol in Metastatic Triple Negative Breast Cancer |
Resource links provided by NLM:
Genetics Home Reference related topics:
breast cancer
Drug Information available for:
Estradiol
Estradiol cypionate
Estradiol valerate
Estradiol acetate
Estradiol hemihydrate
U.S. FDA Resources
Further study details as provided by University of Wisconsin, Madison:
Primary Outcome Measures:
- Determine tumor objective response rates [ Time Frame: based on estimated enrollment timeframe of 2 years ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 39 |
| Study Start Date: | January 2010 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | December 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 |
| Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01083641
Contacts
| Contact: Clinical Trials Office Cancer Connect | (800) 622-8922 |
Locations
| United States, Wisconsin | |
| University of Wisconsin Carbone Cancer Center | Recruiting |
| Madison, Wisconsin, United States, 53792 | |
| Principal Investigator: Kari B Wisinski, MD | |
Sponsors and Collaborators
University of Wisconsin, Madison
Investigators
| Principal Investigator: | Kari B Wisinski, MD | University of Wisconsin, Madison |
More Information
No publications provided
| Responsible Party: | University of Wisconsin, Madison |
| ClinicalTrials.gov Identifier: | NCT01083641 History of Changes |
| Other Study ID Numbers: | CO09711 |
| Study First Received: | March 8, 2010 |
| Last Updated: | January 16, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of Wisconsin, Madison:
|
Breast Cancer |
Additional relevant MeSH terms:
|
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Estrogens Carcinoma Skin Diseases Estradiol Polyestradiol phosphate |
Estradiol valerate Estradiol 3-benzoate Estradiol 17 beta-cypionate Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Pharmacologic Actions Contraceptive Agents Reproductive Control Agents Therapeutic Uses Contraceptive Agents, Female |
ClinicalTrials.gov processed this record on May 22, 2013