Breast Cancer Clinical Trial

Genetic Analysis of Blood and Tissue Samples From Patients With Advanced Cancer, Moonshot Study

Summary

This trial studies the genetic analysis of blood and tissue samples from patients with cancer that has spread to other anatomic sites (advanced) or is no longer responding to treatment. Studying these samples in the laboratory may help doctors to learn how genes affect cancer and how they affect a person's response to treatment.

View Full Description

Full Description

PRIMARY OBJECTIVES:

I. To procure paired newly acquired tumor tissues and blood at baseline and upon progression in patients treated for advanced cancer with molecularly targeted therapies at National Cancer Institute Community Oncology Research Program (NCORP) sites.

II. To bank formalin-fixed, paraffin-embedded (FFPE) tissue, blood (for cell-free deoxyribonucleic acid [DNA] analysis), and nucleic acids from patients in the Biorepository, which is the Biopathology Center (BPC) at Nationwide Children's Hospital (NCH), that may be used to study mechanisms of sensitivity and resistance to cancer therapies.

III. To bank, when available, optional snap-frozen tissue (for future to be determined analysis) from patients in the Biorepository, which is the Biopathology Center (BPC) at Nationwide Children's Hospital (NCH), that may be used to study mechanisms of sensitivity and resistance to cancer therapies.

IV. To assess the feasibility of obtaining paired high-quality newly acquired tumor tissues and blood from patients being treated for advanced cancer in community-based healthcare settings (NCORP sites).

SECONDARY OBJECTIVES:

I. To perform molecular profiling assays on matched malignant tumor and blood (including but not limited to whole exome and messenger ribonucleic acid [RNA] sequencing) in order to provide physicians and patients with a clinical report from a Clinical Laboratory Improvement Act (CLIA)-certified laboratory from tumor obtained at baseline and upon progression that may be used to guide further treatment planning.

II. To make available biospecimens for studies to define potential resistance biomarkers using genomic and proteomic-based assessment platforms.

III. To contribute genetic analysis data from coded specimens to Genomic Data Commons, a well annotated cancer molecular and clinical data repository, for current and future research; specimens will be annotated with key clinical data including presentation, diagnosis, staging, summary treatment, and outcome, if possible.

IV. To identify potential predictive and prognostic biomarkers beyond any genomic alteration by which treatment may be assigned.

V. To identify resistance mechanisms using genomic DNA- and RNA-based assessment platforms.

OUTLINE:

Patients undergo collection of blood and tumor prior to starting treatment and upon disease progression (second collection of blood and tumor only for patients who do not continue to progress and achieve either an objective response [OR] or stable disease [SD] after 6 months of treatment). Samples are banked and analyzed via next generation sequencing.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Patient meets all eligibility criteria for treatment of the tumors with the agents listed and has agreed to provide tissue and blood samples for this study

Targeted therapy maybe as a singular/monotherapy or in combination with any Food and Drug Administration (FDA)-approved chemotherapies
Patient's primary or recurrent disease is targeted-treatment naive or will be treated with a targeted therapy listed different from any previously-received targeted therapy or combination therapy as standard of care
Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1. Patients with a PS of 2 may be enrolled only at the discretion of the treating physician and radiologist
Have an advanced malignancy being treated with one of the agents listed. Advanced cancer is cancer that is unlikely to be cured or controlled with treatment. The cancer may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body. Treatment may be given to help shrink the tumor, slow the growth of cancer cells, or relieve symptoms. Patients may be undergoing first or subsequent lines of therapy. In the case where an agent not listed is newly approved for one of the listed tumors, patients undergoing therapy with it will be able to enroll at discretion of the principal investigator (PI). This is to avoid any lag between FDA approval of a previously investigational agent and protocol modifications/updates

Have an advanced malignancy that meets one of the following criteria:

Patients must have tumor amenable to image guided or direct vision biopsy and be willing and able to undergo a tumor biopsy for molecular profiling. The biopsy must not be associated with a significant risk of severe or major complications or death. In particular, endoscopic, open or laparoscopic surgical procedures are not to be performed to provide research specimens. However, research specimens may be provided if the patient needs to undergo such procedures for clinical reasons

Severe or major complications are considered to be those

Requiring therapy, minor hospitalization (more than overnight but < 48 hours [h])
Requiring major therapy; unplanned increase in level of care, prolonged hospitalization > 48 h
Resulting in permanent adverse sequelae
Resulting in death

Patient will be undergoing a procedure due to medical necessity during which the tissue may be collected. The following tumors may be collected only under the conditions specified and not for the sole purpose of the clinical trial:

Brain biopsies: ONLY if the patient has medical necessity for craniotomy for clinical care
Mediastinal, laparoscopic, gastrointestinal, or bronchial endoscopic biopsies: ONLY to be obtained incidentally to a clinically necessary procedure

Exclusion Criteria:

Uncontrolled intercurrent illness that in the physician's assessment would pose undue risk for biopsy
Patients currently enrolled or planning to be co-enrolled (while participating on the 10231 study) on a therapeutically interventional clinical trial aimed to treat the current malignancy
If the patient is on chronic anticoagulation treatment, they must be able and willing to have this treatment discontinued for the biopsy. Discontinuation procedures will be those of the treating site

Study is for people with:

Breast Cancer

Estimated Enrollment:

150

Study ID:

NCT03707574

Recruitment Status:

Active, not recruiting

Sponsor:

National Cancer Institute (NCI)

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There are 104 Locations for this study

See Locations Near You

Holy Cross Hospital
Fort Lauderdale Florida, 33308, United States
Lewis Cancer and Research Pavilion at Saint Joseph's/Candler
Savannah Georgia, 31405, United States
Hawaii Cancer Care - Savio
'Aiea Hawaii, 96701, United States
Pali Momi Medical Center
'Aiea Hawaii, 96701, United States
Queen's Cancer Center - Pearlridge
'Aiea Hawaii, 96701, United States
The Cancer Center of Hawaii-Pali Momi
'Aiea Hawaii, 96701, United States
Hawaii Cancer Care Inc - Waterfront Plaza
Honolulu Hawaii, 96813, United States
Island Urology
Honolulu Hawaii, 96813, United States
Queen's Cancer Cenrer - POB I
Honolulu Hawaii, 96813, United States
Queen's Medical Center
Honolulu Hawaii, 96813, United States
Straub Clinic and Hospital
Honolulu Hawaii, 96813, United States
University of Hawaii Cancer Center
Honolulu Hawaii, 96813, United States
Hawaii Cancer Care Inc-Liliha
Honolulu Hawaii, 96817, United States
Kuakini Medical Center
Honolulu Hawaii, 96817, United States
Queen's Cancer Center - Kuakini
Honolulu Hawaii, 96817, United States
The Cancer Center of Hawaii-Liliha
Honolulu Hawaii, 96817, United States
Kapiolani Medical Center for Women and Children
Honolulu Hawaii, 96826, United States
Wilcox Memorial Hospital and Kauai Medical Clinic
Lihue Hawaii, 96766, United States
Illinois CancerCare-Bloomington
Bloomington Illinois, 61704, United States
Illinois CancerCare-Canton
Canton Illinois, 61520, United States
Memorial Hospital of Carbondale
Carbondale Illinois, 62902, United States
SIH Cancer Institute
Carterville Illinois, 62918, United States
Illinois CancerCare-Carthage
Carthage Illinois, 62321, United States
Centralia Oncology Clinic
Centralia Illinois, 62801, United States
Cancer Care Specialists of Illinois - Decatur
Decatur Illinois, 62526, United States
Decatur Memorial Hospital
Decatur Illinois, 62526, United States
Illinois CancerCare-Dixon
Dixon Illinois, 61021, United States
Crossroads Cancer Center
Effingham Illinois, 62401, United States
Illinois CancerCare-Eureka
Eureka Illinois, 61530, United States
Illinois CancerCare-Galesburg
Galesburg Illinois, 61401, United States
Western Illinois Cancer Treatment Center
Galesburg Illinois, 61401, United States
Illinois CancerCare-Kewanee Clinic
Kewanee Illinois, 61443, United States
Illinois CancerCare-Macomb
Macomb Illinois, 61455, United States
Cancer Care Center of O'Fallon
O'Fallon Illinois, 62269, United States
Illinois CancerCare-Ottawa Clinic
Ottawa Illinois, 61350, United States
Illinois CancerCare-Pekin
Pekin Illinois, 61554, United States
Illinois CancerCare-Peoria
Peoria Illinois, 61615, United States
Methodist Medical Center of Illinois
Peoria Illinois, 61636, United States
Illinois CancerCare-Peru
Peru Illinois, 61354, United States
Valley Radiation Oncology
Peru Illinois, 61354, United States
Illinois CancerCare-Princeton
Princeton Illinois, 61356, United States
Southern Illinois University School of Medicine
Springfield Illinois, 62702, United States
Springfield Clinic
Springfield Illinois, 62702, United States
Memorial Medical Center
Springfield Illinois, 62781, United States
Southwest Illinois Health Services LLP
Swansea Illinois, 62226, United States
Physicians' Clinic of Iowa PC
Cedar Rapids Iowa, 52402, United States
Oncology Associates at Mercy Medical Center
Cedar Rapids Iowa, 52403, United States
Iowa Methodist Medical Center
Des Moines Iowa, 50309, United States
Medical Oncology and Hematology Associates-Des Moines
Des Moines Iowa, 50309, United States
Iowa Lutheran Hospital
Des Moines Iowa, 50316, United States
Methodist West Hospital
West Des Moines Iowa, 50266, United States
East Jefferson General Hospital
Metairie Louisiana, 70006, United States
Louisiana State University Health Science Center
New Orleans Louisiana, 70112, United States
University Medical Center New Orleans
New Orleans Louisiana, 70112, United States
Mercy Medical Center
Springfield Massachusetts, 01104, United States
Saint Joseph Mercy Hospital
Ann Arbor Michigan, 48106, United States
Saint Joseph Mercy Brighton
Brighton Michigan, 48114, United States
Trinity Health IHA Medical Group Hematology Oncology - Brighton
Brighton Michigan, 48114, United States
Saint Joseph Mercy Canton
Canton Michigan, 48188, United States
Trinity Health IHA Medical Group Hematology Oncology - Canton
Canton Michigan, 48188, United States
Caro Cancer Center
Caro Michigan, 48723, United States
Saint Joseph Mercy Chelsea
Chelsea Michigan, 48118, United States
Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital
Chelsea Michigan, 48118, United States
Hematology Oncology Consultants-Clarkston
Clarkston Michigan, 48346, United States
Newland Medical Associates-Clarkston
Clarkston Michigan, 48346, United States
Ascension Saint John Hospital
Detroit Michigan, 48236, United States
Great Lakes Cancer Management Specialists-Doctors Park
East China Township Michigan, 48054, United States
Genesee Cancer and Blood Disease Treatment Center
Flint Michigan, 48503, United States
Genesee Hematology Oncology PC
Flint Michigan, 48503, United States
Genesys Hurley Cancer Institute
Flint Michigan, 48503, United States
Hurley Medical Center
Flint Michigan, 48503, United States
Academic Hematology Oncology Specialists
Grosse Pointe Woods Michigan, 48236, United States
Great Lakes Cancer Management Specialists-Van Elslander Cancer Center
Grosse Pointe Woods Michigan, 48236, United States
Michigan Breast Specialists-Grosse Pointe Woods
Grosse Pointe Woods Michigan, 48236, United States
Sparrow Hospital
Lansing Michigan, 48912, United States
Hope Cancer Clinic
Livonia Michigan, 48154, United States
Trinity Health Saint Mary Mercy Livonia Hospital
Livonia Michigan, 48154, United States
Great Lakes Cancer Management Specialists-Macomb Medical Campus
Macomb Michigan, 48044, United States
Michigan Breast Specialists-Macomb Township
Macomb Michigan, 48044, United States
Saint Mary's Oncology/Hematology Associates of Marlette
Marlette Michigan, 48453, United States
21st Century Oncology-Pontiac
Pontiac Michigan, 48341, United States
Hope Cancer Center
Pontiac Michigan, 48341, United States
Newland Medical Associates-Pontiac
Pontiac Michigan, 48341, United States
Saint Joseph Mercy Oakland
Pontiac Michigan, 48341, United States
Great Lakes Cancer Management Specialists-Rochester Hills
Rochester Hills Michigan, 48309, United States
Ascension Saint Mary's Hospital
Saginaw Michigan, 48601, United States
Oncology Hematology Associates of Saginaw Valley PC
Saginaw Michigan, 48604, United States
Bhadresh Nayak MD PC-Sterling Heights
Sterling Heights Michigan, 48312, United States
Ascension Saint Joseph Hospital
Tawas City Michigan, 48764, United States
Advanced Breast Care Center PLLC
Warren Michigan, 48088, United States
Great Lakes Cancer Management Specialists-Macomb Professional Building
Warren Michigan, 48093, United States
Macomb Hematology Oncology PC
Warren Michigan, 48093, United States
Michigan Breast Specialists-Warren
Warren Michigan, 48093, United States
Saint John Macomb-Oakland Hospital
Warren Michigan, 48093, United States
Saint Mary's Oncology/Hematology Associates of West Branch
West Branch Michigan, 48661, United States
Huron Gastroenterology PC
Ypsilanti Michigan, 48106, United States
Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus
Ypsilanti Michigan, 48197, United States
Fairview Ridges Hospital
Burnsville Minnesota, 55337, United States
Minnesota Oncology - Burnsville
Burnsville Minnesota, 55337, United States
Cambridge Medical Center
Cambridge Minnesota, 55008, United States
Mercy Hospital
Coon Rapids Minnesota, 55433, United States
Fairview Southdale Hospital
Edina Minnesota, 55435, United States
Unity Hospital
Fridley Minnesota, 55432, United States
Fairview Clinics and Surgery Center Maple Grove
Maple Grove Minnesota, 55369, United States
Minnesota Oncology Hematology PA-Maplewood
Maplewood Minnesota, 55109, United States
Saint John's Hospital - Healtheast
Maplewood Minnesota, 55109, United States
Abbott-Northwestern Hospital
Minneapolis Minnesota, 55407, United States
Hennepin County Medical Center
Minneapolis Minnesota, 55415, United States
Health Partners Inc
Minneapolis Minnesota, 55454, United States
Monticello Cancer Center
Monticello Minnesota, 55362, United States
New Ulm Medical Center
New Ulm Minnesota, 56073, United States
Fairview Northland Medical Center
Princeton Minnesota, 55371, United States
North Memorial Medical Health Center
Robbinsdale Minnesota, 55422, United States
Park Nicollet Clinic - Saint Louis Park
Saint Louis Park Minnesota, 55416, United States
Regions Hospital
Saint Paul Minnesota, 55101, United States
United Hospital
Saint Paul Minnesota, 55102, United States
Saint Francis Regional Medical Center
Shakopee Minnesota, 55379, United States
Lakeview Hospital
Stillwater Minnesota, 55082, United States
Ridgeview Medical Center
Waconia Minnesota, 55387, United States
Rice Memorial Hospital
Willmar Minnesota, 56201, United States
Minnesota Oncology Hematology PA-Woodbury
Woodbury Minnesota, 55125, United States
Fairview Lakes Medical Center
Wyoming Minnesota, 55092, United States
Parkland Health Center-Bonne Terre
Bonne Terre Missouri, 63628, United States
Saint Francis Medical Center
Cape Girardeau Missouri, 63703, United States
Southeast Cancer Center
Cape Girardeau Missouri, 63703, United States
Parkland Health Center - Farmington
Farmington Missouri, 63640, United States
Capital Region Southwest Campus
Jefferson City Missouri, 65109, United States
Missouri Baptist Medical Center
Saint Louis Missouri, 63131, United States
Sainte Genevieve County Memorial Hospital
Sainte Genevieve Missouri, 63670, United States
Missouri Baptist Sullivan Hospital
Sullivan Missouri, 63080, United States
Missouri Baptist Outpatient Center-Sunset Hills
Sunset Hills Missouri, 63127, United States
Montefiore Medical Center-Einstein Campus
Bronx New York, 10461, United States
Montefiore Medical Center-Weiler Hospital
Bronx New York, 10461, United States
Montefiore Medical Center - Moses Campus
Bronx New York, 10467, United States
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
New York New York, 10032, United States
Lehigh Valley Hospital-Cedar Crest
Allentown Pennsylvania, 18103, United States
Lehigh Valley Hospital - Muhlenberg
Bethlehem Pennsylvania, 18017, United States
Pocono Medical Center
East Stroudsburg Pennsylvania, 18301, United States
Lehigh Valley Hospital-Hazleton
Hazleton Pennsylvania, 18201, United States
Aurora Cancer Care-Grafton
Grafton Wisconsin, 53024, United States
Aurora Saint Luke's Medical Center
Milwaukee Wisconsin, 53215, United States
Cancer Center of Western Wisconsin
New Richmond Wisconsin, 54017, United States
Aurora West Allis Medical Center
West Allis Wisconsin, 53227, United States
Doctors Cancer Center
Manati , 00674, Puerto Rico

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Estimated Enrollment:

150

Study ID:

NCT03707574

Recruitment Status:

Active, not recruiting

Sponsor:


National Cancer Institute (NCI)

How clear is this clinincal trial information?

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