Triple Negative Breast Cancer Biomarker Study

Metastatic Breast Cancer Clinical Trial

Official title:

Triple Negative Breast Cancer Biomarker Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01111175
• Other study ID #: 09-133
• Status: Completed
• Phase: N/A
• First received: April 22, 2010
• Last updated: July 19, 2013
• Start date: May 2010
• Est. completion date: June 2013

Study information

• Verified date: July 2013
• Source: US Oncology Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Breast Neoplasms
• Metastatic Breast Cancer
• Triple Negative Breast Cancer
• Triple Negative Breast Neoplasms

Locations

Country	Name	City	State
United States	Virginia Oncology Associates	Chesapeake	Virginia
United States	Texas Oncology-Baylor Charles A. Sammons Cancer Center	Dallas	Texas
United States	Texas Oncology-Dallas Presbyterian Hospital	Dallas	Texas
United States	Rocky Mountain Cancer Centers	Denver	Colorado
United States	Virginia Oncology Assocites	Elizabeth City	North Carolina
United States	Virginia Oncology Associates	Hampton	Virginia
United States	Texas Oncology-Memorial City	Houston	Texas
United States	Virginia Oncology Associates	Newport News	Virginia
United States	Virginia Oncology Associates	Norfolk	Virginia
United States	Northwest Cancer Specialists, P.C.	Portland	Oregon
United States	Northwest Cancer Specialists, P.C.	Portland	Oregon
United States	Northwest Cancer Specialists, P.C.	Portland	Oregon
United States	Northwest Cancer Specialists, P.C.	Tualatin	Oregon
United States	Texas Oncology - Tyler	Tyler	Texas
United States	Northwest Cancer Specialists, P.C.	Vancouver	Washington
United States	Northwest Cancer Specialists, P.C.	Vancouver	Washington
United States	Virginia Oncology Associates	Virginia Beach	Virginia
United States	Virginia Oncology Associates	Williamsburg	Virginia

Sponsors (3)

Lead Sponsor	Collaborator
US Oncology Research	Life Technologies, Inc., Translational Drug Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Best response	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.	To molecularly selected therapy, for up to 3 years	No
Secondary	Overall survival	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.	Throughout the study, for up to 3 years	Yes
Secondary	Genetic mutation evaluation	Genomic analysis of whole blood and resected tumor will be done	After surgical resection	No