Triple Negative Breast Cancer Biomarker Study

NCT01111175 | Completed

• 1 other identifier: 09-133
• Study Type: observational
• Target: 14
• Locations: 1 country
• Sites: 18

Brief Summary

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.

Conditions

Metastatic Breast Cancer; Triple Negative Breast Cancer

Keywords

Locally recurrent breast cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Best response

  To molecularly selected therapy, for up to 3 years

• Overall survival

  Throughout the study, for up to 3 years

• Genetic mutation evaluation

  After surgical resection

Eligibility Criteria

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

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• US Oncology Research: lead
• Translational Drug Development: collaborator
• Life Technologies, Inc.: collaborator

Study Sites (18)

Rocky Mountain Cancer Centers

Denver, Colorado, 80220, United States

Location

Virginia Oncology Assocites

Elizabeth City, North Carolina, 27909, United States

Location

Northwest Cancer Specialists, P.C.

Portland, Oregon, 97213, United States

Location

Northwest Cancer Specialists, P.C.

Portland, Oregon, 97225, United States

Location

Northwest Cancer Specialists, P.C.

Portland, Oregon, 97227, United States

Location

Northwest Cancer Specialists, P.C.

Tualatin, Oregon, 97062, United States

Location

Texas Oncology-Dallas Presbyterian Hospital

Dallas, Texas, 75231, United States

Location

Texas Oncology-Baylor Charles A. Sammons Cancer Center

Dallas, Texas, 75246, United States

Location

Texas Oncology-Memorial City

Houston, Texas, 77024, United States

Location

Texas Oncology - Tyler

Tyler, Texas, 75702, United States

Location

Virginia Oncology Associates

Chesapeake, Virginia, 23320, United States

Location

Virginia Oncology Associates

Hampton, Virginia, 23666, United States

Location

Virginia Oncology Associates

Newport News, Virginia, 23606, United States

Location

Virginia Oncology Associates

Norfolk, Virginia, 23502, United States

Location

Virginia Oncology Associates

Virginia Beach, Virginia, 23456, United States

Location

Virginia Oncology Associates

Williamsburg, Virginia, 23188, United States

Location

Northwest Cancer Specialists, P.C.

Vancouver, Washington, 98684, United States

Location

Northwest Cancer Specialists, P.C.

Vancouver, Washington, 98686, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood and tumor tissue

MeSH Terms

Conditions

Breast Neoplasms; Triple Negative Breast Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 22, 2010
• First Posted: April 27, 2010
• Study Start: May 1, 2010
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: July 23, 2013

Record last verified: 2013-07

Locations

US (18)