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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

April 22, 2010
July 19, 2013
May 2010
June 2013   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01111175 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
Triple Negative Breast Cancer Biomarker Study
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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

Whole blood and tumor tissue

Non-Probability Sample

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

  • Metastatic Breast Cancer
  • Triple Negative Breast Cancer
Not Provided
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
14
June 2013
June 2013   (final data collection date for primary outcome measure)

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
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01111175
09-133
No
US Oncology Research
US Oncology Research
  • Translational Drug Development
  • Life Technologies, Inc.
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
US Oncology Research
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP