Triple Negative Breast Cancer Biomarker Study

This study has been completed.
Sponsor:
Collaborators:
Translational Drug Development
Life Technologies, Inc.
Information provided by (Responsible Party):
US Oncology Research
ClinicalTrials.gov Identifier:
NCT01111175
First received: April 22, 2010
Last updated: July 19, 2013
Last verified: July 2013
  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:


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


Enrollment: 14
Study Start Date: May 2010
Study Completion Date: June 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
  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
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
  More Information

No publications provided

Responsible Party: US Oncology Research
ClinicalTrials.gov Identifier: NCT01111175     History of Changes
Other Study ID Numbers: 09-133
Study First Received: April 22, 2010
Last Updated: July 19, 2013
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 April 14, 2014