Genomic and Proteomic Profiling Targets Influenced Treatment in Metastatic Breast Cancer

NCT02470819 | Withdrawn DMC

• 1 other identifier: AMEM-2014-DOD001
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective is to examine the impact on progression-free survival of targeted therapy for breast cancer suggested by proteomic and genomic profiling.

Conditions

Metastatic Breast Cancer; Breast Tumor; Advanced Gynecologic Cancer

Outcome Measures

Primary Outcomes (1)

• Progression-free survival

  Progression-free survival will be defined as the interval between the first dose of therapy and the occurrence of disease progression (fatal or non-fatal). Disease status will be assessed every 7 +/- 1 week until progression or time of treatment discontinuation, whichever is later. If progression is not observed at the end of therapy, patients will be assessed every 3 months until progression or further anti-cancer therapy.

  4 months

Secondary Outcomes (1)

• Tumor assessment

  4 months

Study Arms (1)

Targeted Therapy

EXPERIMENTAL

Those who will receive targeted therapy based on their genetic profiling

Genetic: Genetic profiling

Interventions

Genetic profiling GENETIC

genetic profiling

Targeted Therapy

Eligibility Criteria

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

You may qualify if:

• Life expectancy of \>3 months
• Diagnosis of metastatic breast cancer or an advanced gynecological malignancy with measurable disease
• Age greater than or equal to 18 years
• ECOG performance status of 0-1
• Able to undergo two biopsies to obtain tissue with first biopsy required and second biopsy optional
• Have failed or unable to tolerate previous treatment regimen
• Adequate organ and bone marrow function as defined by ANC ≥ 1.5 x 109/L; Hgb 9 g/dL; platelets greater than 100 x 109/L; creatinine ≤ 1.5 mg/dL; bilirubin ≤ 2.5 x ULN; AST and ALT ≤ 2.5 x ULN (or ≤ 5 x ULN if due to underlying liver metastases); INR ≤ 1.5 x ULN (except in the case of anticoagulation therapy)

You may not qualify if:

• Metastatic lesions that are not accessible to biopsy
• Symptomatic CNS metastasis
• Previous history of another malignancy within 5 years of study entry
• Uncontrolled concurrent illness
• Known HIV, HBB, and/or HCV infection
• Pregnant or breast feeding or childbearing potential and not using adequate birth control

Sponsors & Collaborators

• Avera McKennan Hospital & University Health Center: lead

Study Sites (1)

Avera Cancer Institute

Sioux Falls, South Dakota, 57105, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

DNA Fingerprinting

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Biometric Identification; Biometry; Statistics as Topic; Epidemiologic Methods; Investigative Techniques; Genetic Techniques; Security Measures; Organization and Administration; Health Services Administration

Study Officials

• Brian Leyland-Jones, MD

  Avera McKennan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 9, 2015
• First Posted: June 12, 2015
• Study Start: March 1, 2014
• Primary Completion: October 30, 2018
• Study Completion: October 30, 2018
• Last Updated: November 7, 2018

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)