Estrogen for Triple Negative Breast Cancer

NCT01083641 | Terminated Phase 2 Results DMC

• 6 other identifiers: CO09711H-2009-0172NCI-2011-00618A534260SMPH\MEDICINE\HEM-ONCP30CA014520
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

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.

Conditions

Female Breast Cancer

Keywords

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Clinical Benefit (CB)

  Up to 4 years

• Progression-free Survival (PFS)

  Up to 4 years

• Median Overall Survival (OS)

  Up to 4 years

Study Arms (1)

Estrogen Therapy

EXPERIMENTAL

Estrogen therapy

Drug: Estradiol

Interventions

Estradiol DRUG

10mg oral three times daily

Estrogen Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Wisconsin, Madison: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

University of Wisconsin Carbone Cancer Center

Madison, Wisconsin, 53792, United States

Location

Related Links

• University of Wisconsin Carbone Cancer Center

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Estradiol

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Estrenes; Estranes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Results Point of Contact

• Title: Dr. Kari Wisinski
• Organization: University of Wisconsin Carbone Cancer Center

kbwisinski@medicine.wisc.edu

608-262-2876

Study Officials

• Kari B Wisinski, MD

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 8, 2010
• First Posted: March 10, 2010
• Study Start: January 1, 2010
• Primary Completion: June 1, 2013
• Study Completion: March 1, 2015
• Last Updated: December 9, 2019
• Results First Posted: March 7, 2017

Record last verified: 2017-03

Locations

US (1)