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Triple Negative Breast Cancer Biomarker Study

18 Years
Open (Enrolling)
Metastatic Breast Cancer, Triple Negative Breast Cancer

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Trial Information

Triple Negative Breast Cancer Biomarker Study

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

- 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

Type of Study:


Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

Time-to-progression (TTP)

Outcome Description:

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.

Outcome Time Frame:

Throughout study, for up to 3 years

Safety Issue:


Principal Investigator

Joyce A O'Shaughnessy, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

US Oncology Research


United States: Institutional Review Board

Study ID:




Start Date:

May 2010

Completion Date:

Related Keywords:

  • Metastatic Breast Cancer
  • Triple Negative Breast Cancer
  • Locally recurrent breast cancer
  • Breast Neoplasms



Virginia Oncology AssociatesNewport News, Virginia  23606
Rocky Mountain Cancer CentersThornton, Colorado  80260
Northwest Cancer Specialists, P.C.Vancouver, Washington  
Northwest Cancer Specialists, P.C.Portland, Oregon  97227
Texas Oncology - TylerTyler, Texas  75702
Texas Oncology-Dallas Presbyterian HospitalDallas, Texas  75231
Texas Oncology-Memorial CityHouston, Texas  77024
Virginia Oncology AssocitesElizabeth City, North Carolina  27909
Texas Oncology-Baylor Charles A. Sammons Cancer CenterDallas, Texas  75246