Triple Negative Breast Cancer Biomarker Study - Full Text View

Sponsor:	US Oncology Research
Collaborators:	TGen Drug Development Services Life Technologies, Inc.
Information provided by:	US Oncology Research
ClinicalTrials.gov Identifier:	NCT01111175

Purpose

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.

Condition
Metastatic Breast Cancer Triple Negative Breast Cancer

Study Type:	Observational
Study Design:	Observational Model: Cohort Time Perspective: Prospective
Official Title:	Triple Negative Breast Cancer Biomarker Study

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

U.S. FDA Resources

Further study details as provided by US Oncology Research:

Primary Outcome Measures:

Time-to-progression (TTP) [ Time Frame: Throughout study, for up to 3 years ] [ Designated as safety issue: No ]
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.

Secondary Outcome Measures:

Best response [ Time Frame: To molecularly selected therapy, for up to 3 years ] [ Designated as safety issue: No ]
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.
Overall survival [ Time Frame: Throughout the study, for up to 3 years ] [ Designated as safety issue: Yes ]
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.
Genetic mutation evaluation [ Time Frame: After surgical resection ] [ Designated as safety issue: No ]
Genomic analysis of whole blood and resected tumor will be done

Biospecimen Retention: Samples With DNA

Whole blood and tumor tissue

Estimated Enrollment:	14
Study Start Date:	May 2010

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

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

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01111175

Locations

United States, Colorado
Rocky Mountain Cancer Centers
Denver, Colorado, United States, 80220
United States, North Carolina
Virginia Oncology Assocites
Elizabeth City, North Carolina, United States, 27909
United States, Oregon
Northwest Cancer Specialists, P.C.
Portland, Oregon, United States, 97225
Northwest Cancer Specialists, P.C.
Portland, Oregon, United States, 97227
Northwest Cancer Specialists, P.C.
Portland, Oregon, United States, 97213
Northwest Cancer Specialists, P.C.
Tualatin, Oregon, United States, 97062
United States, Texas
Texas Oncology-Dallas Presbyterian Hospital
Dallas, Texas, United States, 75231
Texas Oncology-Baylor Charles A. Sammons Cancer Center
Dallas, Texas, United States, 75246
Texas Oncology-Memorial City
Houston, Texas, United States, 77024
Texas Oncology - Tyler
Tyler, Texas, United States, 75702
United States, Virginia
Virginia Oncology Associates
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
United States, Washington
Northwest Cancer Specialists, P.C.
Vancouver, Washington, United States, 98686
Northwest Cancer Specialists, P.C.
Vancouver, Washington, United States, 98684

Sponsors and Collaborators

US Oncology Research

TGen Drug Development Services

Life Technologies, Inc.

Investigators

Principal Investigator:	Joyce A O'Shaughnessy, MD	US Oncology Research
Principal Investigator:	Daniel Von Hoff, MD	TGen Drug Development Services
Principal Investigator:	John Carpten, PhD	TGen Drug Development Services

More Information

No publications provided

Responsible Party:	Dr. Joyce O'Shaughnessy / Principle Investigator, US Oncology Research
ClinicalTrials.gov Identifier:	NCT01111175 History of Changes
Other Study ID Numbers:	09-133
Study First Received:	April 22, 2010
Last Updated:	May 18, 2011
Health Authority:	United States: Institutional Review Board

Keywords provided by US Oncology Research:

Locally recurrent breast cancer

Additional relevant MeSH terms:

Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on February 09, 2012