Phase II Study Using Genomic & Proteomic Profiling to Influence Treatments for Patients With Metastatic Breast Cancer

NCT02008994 | Terminated Phase 2 DMC

• 1 other identifier: SH SSKT001
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

Genes are the basic "instruction book" for the cells that make up our bodies and are made out of DNA. Many research studies are done to find the best possible way to treat patients with cancer. Recently there has been a great deal of interest in developing new anticancer agents that are more targeted to a patient's individual genetic information, as well as diseases caused by defects in a person's genes. Identification of precisely which treatments to use against a specific patient's tumor is challenging. In this study, four cutting-edge technologies will be used to identify genomic (information we get from DNA and RNA) and proteomic (information we get from proteins) targets for the treatment of your tumor. These four tests will be used together to gather information about your tumor giving doctors and scientists a better understanding of the structure of your tumor and what the best treatment or combination of treatments may be for you. The therapy you receive to treat your tumor will be based on your medical history, previous treatments for your disease if applicable, current state of health, and the findings from these four tests. The therapy you ultimately receive will be selected by your doctor in consultation with a panel of experts in cancer and cancer genomics (the Treatment Selection Committee).

Conditions

Metastatic Breast Cancer

Keywords

metastatic breast cancer; breast cancer; genomics; personalized medicine; precision oncology; breast cancer treatment; metastatic breast cancer treatment; genetic testing and breast cancer treatment; breast cancer trial; metastatic breast cancer trial

Outcome Measures

Primary Outcomes (1)

• Progression free survival as a result of targeted therapy for breast cancer suggested by proteomic and genomic profiling using RPMA, targeted resequencing, IHC analysis, WGS, RNA-Seq, and Exome sequencing.

  Disease status will be assessed every 7 ± 1 weeks until progression or time of treatment discontinuation, whichever is later.

Secondary Outcomes (9)

• The frequency in which proteomic, IHC, and genomic profiling analysis of a tumor by RPMA, targeted resequencing, IHC analysis, WGS, RNA-Seq, and Exome sequencing yields a target.

  Results of profiling will be made available to investigators within 10 working days of receipt of tissue specimens.

• The frequency of changes to initial treatment recommendations after re-biopsy and analysis after 7 ± 2 days of treatment.

  After 7 ± 2 days of treatment.

• Results of LCM vs non-LCM samples on determination of driving mutations, transcripts, and alternative pathway activation.

  Within one year after enrollment.

• The percent of time in which RPMA, targeted resequencing, IHC analysis, RNA-Seq, and Exome sequencing based treatment is different than that which would have been selected by the patient's physician.

  Within one year of study closing to enrollment.

• Structural changes and copy number variants meaning after identification using low pass whole genome sequencing (WGS).

  At initial biopsy and day 7 biopsy (if performed).

Study Arms (1)

Genomic and Proteomic Profiling

EXPERIMENTAL

* Reverse Phase Protein Microarray will be used to determine how often there are specific proteins that could make your tumor susceptible or resistant to treatment. * Immunohistochemistry will look for specific markers of disease in your DNA. * RNA sequencing will be used to help doctors and scientists understand how your genes are working. * Low pass whole genome and exome sequencing will be used to help identify variants in your DNA.

Other: Genomic and Proteomic Profiling

Interventions

Genomic and Proteomic Profiling OTHER

Following review of targets by the Treatment Selection Committee, the treating physician will decide whether to continue with planned therapy or alter the course of treatment based on the genomic results.

Genomic and Proteomic Profiling

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Understand and provide written informed consent and HIPAA Authorization prior to initiation of any study-specific procedures
• Have a life expectancy of \>3 months
• Have a diagnosis of metastatic breast cancer with measurable disease (RECIST 1.1)
• Have documentation of progression if applicable (by RECIST 1.1) on the treatment regimen immediately prior to entering this study.
• Be ≥ 18 years of age
• Have an ECOG score of 0-1
• Be a good medical candidate for and willing to undergo two biopsies or surgical procedures to obtain tissue, which may or may not be part of the patient's routine care for their malignancy. The 1st biopsy is required and the 2nd biopsy is optional.
• Have documented lack of response or documented progression form last therapy.
• Have adequate organ and bone marrow function as defined below:
• Bone marrow: absolute neutrophil count (ANC) ≥ 1.5 x 109/L; hemoglobin 9 g/dL; platelets \> 100 x 109/L
• Renal: creatinine clearance ≥ 60 mL/min (calculated according to Cockcroft and Gault) or creatinine ≤ 1.5 mg/dL
• Hepatic: bilirubin ≤ 2.5 x the upper limit of normal (ULN); aspartate transaminases (AST/SGOT); alanine transaminases (ALT/SGPT) ≤ 2.5 x ULN (or ≤ 5 x ULN if due to underlying liver metastases); INR ≤ 1.5 x ULN (except in the case of anti-coagulation therapy)
• Female patients of childbearing potential must have a negative pregnancy test and agree to use at least one form of contraception during the study and for at least one month after treatment discontinuation. For the purposes of this study, child- bearing potential is defined as: all female patients that were not in post- menopause for at least one year or are surgically sterile
• Male patients must use a form of barrier contraception approved by the investigator / treating physician during the study and for at least one month after treatment discontinuation

You may not qualify if:

• Have a tumor biopsy intended for use in the current study that was performed more than 2 months prior to analysis
• Have metastatic lesions that are not accessible to biopsy
• Have had interventional cancer therapy conducted after the biopsy was collected prior to analysis
• Have symptomatic CNS metastasis. Patients with a history of CNS metastases who have been treated with whole brain irradiation must be stable without symptoms for 4 weeks after completion of treatment, with image documentation required, and must be either off steroids or on a stable dose of steroids for ≥ 2 weeks prior to enrollment
• Have any previous history of another malignancy (other than cured basal cell carcinoma of the skin or cured in-situ carcinoma of the cervix) within 5 years of study entry
• Have uncontrolled concurrent illness including, but not limited to, ongoing or active serious infection, symptomatic congestive heart failure, unstable angina pectoris, unstable cardiac arrhythmias, psychiatric illness, or situations that would limit compliance with the study requirements or the ability to willingly give written informed consent
• Have known HIV, HBV, HCV infection
• Are pregnant or breast-feeding patients or any patient with childbearing potential not using adequate contraception

Sponsors & Collaborators

• Sanford Health: lead

Study Sites (1)

Sanford Health

Sioux Falls, South Dakota, 57104, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Genome

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Genetic Structures; Genetic Phenomena

Study Officials

• David Pearce, PhD

  Sanford Research

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 30, 2013
• First Posted: December 11, 2013
• Study Start: September 1, 2013
• Primary Completion: January 1, 2014
• Study Completion: January 1, 2014
• Last Updated: March 24, 2015

Record last verified: 2015-03

Locations

US (1)