Clinical trial NCT01111175: Triple Negative Breast Cancer Biomarker Study
Official title: Triple Negative Breast Cancer Biomarker Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Metastatic Breast Cancer
Triple Negative Breast Cancer
Keywords: Locally recurrent breast cancer
Lead sponsor: US Oncology Research
Sponsor class: INDUSTRY
Collaborators: name: Translational Drug Development
name: Life Technologies, Inc.
First posted: 2010-04-27
Enrollment: 14
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Evaluable patients with metastatic or locally advanced TNBC who are scheduled for surgical tumor biopsy or resection

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.


Eligibility 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

Primary outcomes:
measure: Time-to-progression (TTP)
timeFrame: Throughout study, for up to 3 years
Secondary outcomes:
measure: Best response
timeFrame: To molecularly selected therapy, for up to 3 years
measure: Overall survival
timeFrame: Throughout the study, for up to 3 years
measure: Genetic mutation evaluation
timeFrame: After surgical resection
Other outcomes:
Locations:
city: Denver
country: United States
facility: Rocky Mountain Cancer Centers
state: Colorado
city: Elizabeth City
country: United States
facility: Virginia Oncology Assocites
state: North Carolina
city: Portland
country: United States
facility: Northwest Cancer Specialists, P.C.
state: Oregon
city: Portland
country: United States
facility: Northwest Cancer Specialists, P.C.
state: Oregon
city: Portland
country: United States
facility: Northwest Cancer Specialists, P.C.
state: Oregon
city: Tualatin
country: United States
facility: Northwest Cancer Specialists, P.C.
state: Oregon
city: Dallas
country: United States
facility: Texas Oncology-Dallas Presbyterian Hospital
state: Texas
city: Dallas
country: United States
facility: Texas Oncology-Baylor Charles A. Sammons Cancer Center
state: Texas
city: Houston
country: United States
facility: Texas Oncology-Memorial City
state: Texas
city: Tyler
country: United States
facility: Texas Oncology - Tyler
state: Texas
city: Chesapeake
country: United States
facility: Virginia Oncology Associates
state: Virginia
city: Hampton
country: United States
facility: Virginia Oncology Associates
state: Virginia
city: Newport News
country: United States
facility: Virginia Oncology Associates
state: Virginia
city: Norfolk
country: United States
facility: Virginia Oncology Associates
state: Virginia
city: Virginia Beach
country: United States
facility: Virginia Oncology Associates
state: Virginia
city: Williamsburg
country: United States
facility: Virginia Oncology Associates
state: Virginia
city: Vancouver
country: United States
facility: Northwest Cancer Specialists, P.C.
state: Washington
city: Vancouver
country: United States
facility: Northwest Cancer Specialists, P.C.
state: Washington
Study officials:
affiliation: US Oncology Research
name: Joyce A O'Shaughnessy, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Translational Drug Development
name: Daniel Von Hoff, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Translational Drug Development
name: John Carpten, PhD
role: PRINCIPAL_INVESTIGATOR
References: