Triple Negative Breast Cancer Biomarker Study

Patients with metastatic or locally recurrent triple negative breast cancer (TNBC) who are scheduled for medically indicated surgical biopsy or resection of disease will be identified. Fresh/frozen tissue will be collected and will undergo comprehensive molecular evaluation with NextGen sequencing. TGEN's clonal genomics analyses will be applied in the analysis to identify and prioritize the mutated targets. Therapeutic options, based on the genetic profile of each patient's tumor, will be discussed and an appropriate molecularly-selected agent will be recommended by the Study Investigator(s) (SI) and treating oncologist as treatment for the patient.

This is an open-label, pilot trial. Patients with metastatic or locally recurrent TNBC who are scheduled for medically indicated surgical biopsy or resection will be enrolled and therapeutic options, based on the genetic profile of each patient's tumor, will be discussed with the patient.

Time-to-progression (TTP) for these patients following the selected therapy is the primary objective and will be compared to the TTP(s) for their most recent prior therapy. A 30% increase in TTP with the molecularly-targeted agent compared with the TTP on the immediate prior therapy will be considered as evidence of clinical benefit from the selected therapy. The secondary endpoints are best response to the molecularly-selected therapy, overall survival (OS) and genetic mutation evaluation in metastatic (or locally recurrent) TNBC.

The study is designed to demonstrate that the collection and analysis of these tumor samples is feasible.

Study Overview

• Status: Completed
• Conditions: Metastatic Breast Cancer; Triple Negative Breast Cancer

• Study Type: Observational
• Enrollment (Actual): 14

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Denver, Colorado, United States, 80220
      • Rocky Mountain Cancer Centers
  • North Carolina
    • Elizabeth City, North Carolina, United States, 27909
      • Virginia Oncology Assocites
  • Oregon
    • Portland, Oregon, United States, 97227
      • Northwest Cancer Specialists, P.C.
    • Portland, Oregon, United States, 97225
      • Northwest Cancer Specialists, P.C.
    • Portland, Oregon, United States, 97213
      • Northwest Cancer Specialists, P.C.
    • Tualatin, Oregon, United States, 97062
      • Northwest Cancer Specialists, P.C.
  • Texas
    • Dallas, Texas, United States, 75246
      • Texas Oncology-Baylor Charles A. Sammons Cancer Center
    • Dallas, Texas, United States, 75231
      • Texas Oncology-Dallas Presbyterian Hospital
    • Houston, Texas, United States, 77024
      • Texas Oncology-Memorial City
    • Tyler, Texas, United States, 75702
      • Texas Oncology - Tyler
  • Virginia
    • Chesapeake, Virginia, United States, 23320
      • Virginia Oncology Associates
    • Hampton, Virginia, United States, 23666
      • Virginia Oncology Associates
    • Newport News, Virginia, United States, 23606
      • Virginia Oncology Associates
    • Norfolk, Virginia, United States, 23502
      • Virginia Oncology Associates
    • Virginia Beach, Virginia, United States, 23456
      • Virginia Oncology Associates
    • Williamsburg, Virginia, United States, 23188
      • Virginia Oncology Associates
  • Washington
    • Vancouver, Washington, United States, 98684
      • Northwest Cancer Specialists, P.C.
    • Vancouver, Washington, United States, 98686
      • Northwest Cancer Specialists, P.C.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Evaluable patients with metastatic or locally advanced TNBC who are scheduled for surgical tumor biopsy or resection

Description

Inclusion Criteria:

• Has metastatic or locally recurrent triple negative breast cancer and is scheduled for medically indicated surgical biopsy or resection of disease
• Will have measurable or evaluable (nonmeasurable) disease per RECIST v 1.1 (see Section 10) present after surgical biopsy/resection. Note: following surgical resection, if the tumor sample is found to be inadequate for comprehensive molecular analysis, the patient will be deemed ineligible and will be replaced.
• Has received at least 1 prior chemotherapeutic regimen for their metastatic or locally recurrent TNBC prior to initiating the molecularly-selected therapy. There is no limit on the prior therapy for TNBC. Note: We strongly recommend holding of on intervening therapy if possible from the time of biopsy to the completion of sequencing so as not to change the cancer under the selective pressure of treatment, so that the sequencing results are reflective of the current cancer.
• Is at least 18 years of age
• Has an expected survival of at least 6 months, as estimated by the treating oncologist
• Has planned surgical resection (indicated for the medical care of the patient) that will yield a minimum fresh/frozen tumor sample of 1 cm x 1 cm x 1 cm (~300 mg) that will be available for molecular profiling analysis.
• Is agreeable to having a blood sample (10-20 mL) drawn and analyzed to compare their normal genetic profile to that of their tumor sample
• Has signed the most recent Patient Informed Consent Form
• Has signed a Patient Authorization Form

Exclusion Criteria:

• Has breast cancer other than metastatic or locally recurrent TNBC. Note: surgical resection of the recurrent TNBC will render the patient as "no evidence of disease" (NED). NED patients are ineligible and will be replaced.
• Has a history of heart disease, other conditions that would prevent treatment with a standard chemotherapeutic agent
• Has evidence of central nervous system (CNS) involvement that is progressing or that requires radiation, resection or steroid therapy
• Has a serious uncontrolled intercurrent medical or psychiatric illness, including serious infection
• Is a pregnant or nursing woman
• Is unable to comply with requirements of study

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time-to-progression (TTP)	Time-to-progression (TTP) for these patients following the selected therapy is the primary objective and will be compared to the TTP(s) for their most recent prior therapy.	Throughout study, for up to 3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Best response	Best response to therapy selected based on genomic analysis will be determined. Response will be evaluated in this study using the international criteria published by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee v1.1.	To molecularly selected therapy, for up to 3 years
Overall survival	Survival will be measured, from the selected treatment start date to the date of death or the last date the patient was known to be alive.	Throughout the study, for up to 3 years
Genetic mutation evaluation	Genomic analysis of whole blood and resected tumor will be done	After surgical resection

Collaborators and Investigators

• Sponsor: US Oncology Research
• Collaborators: Translational Drug Development; Life Technologies, Inc.
• Investigators: Principal Investigator: Joyce A O'Shaughnessy, MD, US Oncology Research; Principal Investigator: Daniel Von Hoff, MD, Translational Drug Development; Principal Investigator: John Carpten, PhD, Translational Drug Development

Study record dates

Study Major Dates

• Study Start: May 1, 2010
• Primary Completion (Actual): June 1, 2013
• Study Completion (Actual): June 1, 2013

Study Registration Dates

• First Submitted: April 22, 2010
• First Submitted That Met QC Criteria: April 26, 2010
• First Posted (Estimate): April 27, 2010

Study Record Updates

• Last Update Posted (Estimate): July 23, 2013
• Last Update Submitted That Met QC Criteria: July 19, 2013
• Last Verified: July 1, 2013

More Information

Terms related to this study

• Keywords: Locally recurrent breast cancer
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms; Triple Negative Breast Neoplasms
• Other Study ID Numbers: 09-133