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.

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Key information

Conditions

Metastatic Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases Triple Negative Breast Cancer Triple Negative Breast Neoplasms

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Rocky Mountain Cancer Centers, Denver, Colorado, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

Time-to-progression (TTP)

Time frame: Throughout study, for up to 3 years

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 outcomes

Best response

Time frame: To molecularly selected therapy, for up to 3 years

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

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

Genomic analysis of whole blood and resected tumor will be done

Sponsors and collaborators

Lead sponsor

US Oncology Research

Industry

Collaborators

Life Technologies, Inc.
Translational Drug Development

Registry information

Important dates

Study start: 2010
Primary completion: 2013
Study completion: 2013
First posted: Apr 27, 2010
Registry last updated: Jul 23, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed