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Breast CancerNCT01615068

An Observational Study in Patients With HER2 Positive Metastatic Breast Cancer (SystHERs Registry)

An observational study of Breast Cancer, run by Genentech, Inc. at 142 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This multi-center, prospective observational study will evaluate the treatment patterns, and the safety in patients with HER2-positive (HER2+) metastatic breast cancer (MBC). Eligible patients will have an initial metastatic breast cancer diagnosis that has not been previously treated with systemic therapy; patients… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Breast Cancer
How many people
1,007 participants
Where
142 sitesUnited States
Study dates
5 Jun 2012to 16 Nov 2017
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients with HER2 positive (HER2+) metastatic breast cancer

Who may be able to join

  • Adult patients, >/=18 years of age
  • Initial diagnosis of HER2+ MBC, as diagnosed by the treating physician, no more than 6 months prior to study enrollment
  • Availability of cancer-specific historical data points in the patient's medical records

Who cannot join

  • Any inability to provide informed consent

Trial locations and contacts

142 sites in 1 country.

142 sites in 1 country

United States142 sites

  • Hendrick Cancer Center

    Abilene, Texas, 79601-2301

  • Alton Memorial Hospital; Outpatient Clinic and Infusion Center

    Alton, Illinois, 62002

  • McFarland Clinic

    Ames, Iowa, 50010

  • Hope A Women's Cancer Center

    Asheville, North Carolina, 28806

  • Peachtree Hematology & Oncology Consultants, Pc

    Atlanta, Georgia, 30318

  • Mary Bird Perkins Cancer Ctr

    Baton Rouge, Louisiana, 70809

  • Medical Oncology LLC

    Baton Rouge, Louisiana, 70809

  • Texas Oncology

    Bedford, Texas, 76022

  • Summit Medical Group

    Berkeley Heights, New Jersey, 07922

  • Billings Clinic Research Center

    Billings, Montana, 59101

  • St. Vincent'S Hospital; Birmingham Hematology Oncology Associates, Llc

    Birmingham, Alabama, 35205

  • Lynn Cancer Institute - West

    Boca Raton, Florida, 33428

  • St. Joseph Regional Cancer Ct

    Bryan, Texas, 77802

  • East Valley Hem/Onc Med Group; Metropolitan Hem Onc.

    Burbank, California, 91505

  • South Bay Oncology Hematology Partners

    Campbell, California, 95008

  • Charleston Hematology Oncology

    Charleston, South Carolina, 29414

  • Medical Univ of South Carolina

    Charleston, South Carolina, 29425

  • Chattanooga Oncology and Hematology Associates, PC

    Chattanooga, Tennessee, 37404

  • Rush University Medical Center

    Chicago, Illinois, 60612

  • Metro Health Medical Center

    Cleveland, Ohio, 44109

  • South Carolina Oncology Associates - SCRI

    Columbia, South Carolina, 29210

  • Mid Ohio Onc Hematology Inc

    Columbus, Ohio, 43219

  • The Mary Imogene Bassett Hospi

    Cooperstown, New York, 13326

  • Western Maryland Health Sys

    Cumberland, Maryland, 21502

  • Texas Oncology-Baylor Sammons Cancer Center

    Dallas, Texas, 75246

  • University of Miami; Dept Sylvester Cancer Center

    Deerfield Beach, Florida, 33442

  • Kaiser Permanente Of Colorado

    Denver, Colorado, 80218

  • Rocky Mountain Cancer Center - Denver

    Denver, Colorado, 80220

  • Onc & Hematology Specialists

    Denville, New Jersey, 07834

  • Hematology & Oncology Assoc; North Eastern Pennsylvania

    Dunmore, Pennsylvania, 18512

  • North Shore Hem Onc Associates

    East Setauket, New York, 11733

  • Southdale Cancer Clinic U of M Medical Center, Fairview- Edina

    Edina, Minnesota, 55435

  • Texas Oncology- El Paso Cancer Treatment Center Gateway

    El Paso, Texas, 79915

  • California Cancer Associates for Research & Excellence, Inc.

    Encinitas, California, 92008

  • Oncology Hematology Assoc

    Evansville, Indiana, 47714

  • Florida Cancer Specialists - Fort Myers (New Hampshire Ct)

    Fort Myers, Florida, 33901-8101

  • Texas Oncology, P.A. - Fort Worth

    Fort Worth, Texas, 76104

  • ROBERT A. MOSS, M.D., F.A.C.P., Inc

    Fountain Valley, California, 92708-7510

  • California Oncology of the Central Valley

    Fresno, California, 93710

  • Cancer Care Associates

    Fresno, California, 93720

  • St. Jude Heritage Healthcare; Virgiia K.Crosson Can Ctr

    Fullerton, California, 92835

  • Gaston Hematology/Oncology

    Gastonia, North Carolina, 28054

  • Cancer & Hematology Centers of Western Michigan

    Grand Rapids, Michigan, 49503

  • Cone Health Cancer Center

    Greensboro, North Carolina, 27403

  • Hackensack University Medical Center

    Hackensack, New Jersey, 07601

  • Memorial Cancer Institute

    Hollywood, Florida, 33021

  • Genesis Cancer Center

    Hot Springs, Arkansas, 71913

  • Texas Oncology - Houston (Gessner)

    Houston, Texas, 77024

  • University of Iowa

    Iowa City, Iowa, 52242

  • Jackson Oncology Associates, PLLC

    Jackson, Mississippi, 39202

  • Baptist - MD Anderson Cancer Center

    Jacksonville, Florida, 32207

  • Florida Oncology Associates

    Jacksonville, Florida, 32256

  • Queens Hospital Center

    Jamaica, New York, 11432

  • Jefferson City Medical Group

    Jefferson City, Missouri, 65109

  • NEA Baptist Clinic

    Jonesboro, Arkansas, 72401

  • West Michigan Cancer Center

    Kalamazoo, Michigan, 49007

  • Research Medical Center; Pharmacy

    Kansas City, Missouri, 64132

  • Kingsport Hematology Oncology Associates

    Kingsport, Tennessee, 37660

  • Center for Biomedical Research LLC

    Knoxville, Tennessee, 37909

  • Lafayette General Medical Center

    Lafayette, Louisiana, 70503-2616

  • Lakeland Regional Cancer Center

    Lakeland, Florida, 33804-1057

  • Lancaster Cancer Center, Ltd.

    Lancaster, Pennsylvania, 17605

  • Comprehensive Cancer Centers of Nevada

    Las Vegas, Nevada, 89128

  • Dartmouth Hitchcock Medical Center; Gastroenterology Section

    Lebanon, New Hampshire, 03756

  • Southeast Nebraska Cancer Center;; Southeast Nebraska Hematology and Oncology

    Lincoln, Nebraska, 68510

  • Hematology Oncology Services of Arkansas

    Little Rock, Arkansas, 72205

  • Mile High Oncology

    Littleton, Colorado, 80122

  • University of Southern California

    Los Angeles, California, 90033

  • UCLA School of Medicine

    Los Angeles, California, 90095

  • James Graham Brown Cancer Center, University of Louisville

    Louisville, Kentucky, 40202

  • Baptist Hospital East

    Louisville, Kentucky, 40207

  • Southeastern Regional Medical Center

    Lumberton, North Carolina, 28358

  • Lynchburg Hem Onc Clinic Inc

    Lynchburg, Virginia, 24501

  • University of Wisconsin

    Madison, Wisconsin, 53792

  • Northwest Georgia Oncology Centers PC - Marietta

    Marietta, Georgia, 30060

  • Mercy Medical Ctr-North Iowa ; Mercy Cancer Center

    Mason City, Iowa, 50401

  • Texas Oncology, P.A. - McAllen; South Texas Cancer Center-McAllen

    McAllen, Texas, 78503

  • Connecticut Oncology Group

    Middletown, Connecticut, 06457

  • Signal Point Clinical; Research Center, LLC

    Middletown, Ohio, 45042

  • Columbia Saint Mary's; Medical Oncology

    Milwaukee, Wisconsin, 53211

  • Minnesota Oncology Hematology, Pa

    Minneapolis, Minnesota, 55407

  • Montana Cancer Specialists

    Missoula, Montana, 59802

  • University of South Alabama; Mitchell Cancer Institute

    Mobile, Alabama, 36604

  • West Virginia University Hospitals Inc

    Morgantown, West Virginia, 26056

  • Hematology Oncology Associates; Carol G. Simon Ctr

    Morristown, New Jersey, 07960

  • Boston Baskin Cancer Foundation

    Nashville, Tennessee, 37203

  • Sarah Cannon Research Inst.

    Nashville, Tennessee, 37203

  • Yale Cancer Center

    New Haven, Connecticut, 06520

  • Beth Israel Comprehensive Cancer Center Pharmacy

    New York, New York, 10011

  • Herbert Irving Comprehensive Cancer Center; Herbert Irving Pavillion

    New York, New York, 10032

  • Peninsula Cancer Institute

    Newport News, Virginia, 23601

  • Mid-Illinois Hematology

    Normal, Illinois, 61761

  • Northern Utah Associates

    Ogden, Utah, 84403

  • Mercy Clinic Oklahoma Communties, Inc

    Oklahoma City, Oklahoma, 73120

  • Cancer Alliance of Nebraska

    Omaha, Nebraska, 68106

  • Md Anderson Cancer Center Orlando

    Orlando, Florida, 32806

  • Comprehensive Cancer Care

    Palm Springs, California, 92262

  • Luckow Pavillion, Valley Hosp; Office of Clinical Trials

    Paramus, New Jersey, 07652

  • Texas Oncology - Paris

    Paris, Texas, 75460

  • Oncology Specialists, S.C.

    Park Ridge, Illinois, 60068

  • Temple University Hospital

    Philadelphia, Pennsylvania, 19140

  • First Health of the Carolinas

    Pinehurst, North Carolina, 28374

  • Allegheny General Hospital; Transplantation Services

    Pittsburgh, Pennsylvania, 15212

  • Univ of Pittsburgh Sch of Med; Magee-Womens Hospital

    Pittsburgh, Pennsylvania, 15213

  • Berkshire Hematology, Oncology Pc

    Pittsfield, Massachusetts, 01201

  • Florida Cancer Research Institute

    Plantation, Florida, 33324

  • Mercy Oncology / Hematology Center; Oncology

    Portland, Maine, 04102

  • Providence Cancer Center

    Portland, Oregon, 97231

  • Portsmouth Regional Hospital; Hem/Onc Clinic

    Portsmouth, New Hampshire, 03801

  • Kootenai Cancer Center

    Post Falls, Idaho, 83854

  • Virginia Cancer Institute

    Richmond, Virginia, 23226

  • Associates in Oncology/Hematology P.C.

    Rockville, Maryland, 20850

  • Highlands Oncology Group

    Rogers, Arkansas, 72758

  • Park Nicollet Clinic Cancer Center

    Saint Louis Park, Minnesota, 55416

  • Huntsman Cancer Institute; Oncology

    Salt Lake City, Utah, 84112

  • Univ of Calif, San Francisco; Breast Cancer Center

    San Francisco, California, 94115

  • Coastal Integrative Cancer Care

    San Luis Obispo, California, 93401

  • Central Coast Medical Oncology

    Santa Maria, California, 93454

  • Sutter Pacific Medical Foundation

    Santa Rosa, California, 95403

  • Summit Cancer Care PC

    Savannah, Georgia, 31405

  • Guthrie Clinic

    Sayre, Pennsylvania, 18840

  • Virginia Mason Medical Center

    Seattle, Washington, 98101

  • Arizona Oncology Associates, PC - NAHOA

    Sedona, Arizona, 86336

  • Capitol Hematology & Oncology

    Silver Spring, Maryland, 20902

  • Orchard Healthcare Research Inc.

    Skokie, Illinois, 60076

  • Christian Hospital; Outpatient Cancer and Infusion Center

    St Louis, Missouri, 63136

  • St. John'S Mercy Medical Center; David C. Pratt Cancer Center

    St Louis, Missouri, 63141

  • Florida Cancer Specialists (St. Petersburg - St. Anthony's Professional Building)

    St. Petersburg, Florida, 33705

  • Hematology Oncology P.C.

    Stamford, Connecticut, 06902

  • Flower Memorial Hospital

    Sylvania, Ohio, 43560

  • Space Coast Medical Associates

    Titusville, Florida, 32795

  • St. Joseph Medical Center

    Towson, Maryland, 21204

  • Arizona Oncology

    Tucson, Arizona, 85704

  • Cancer Care Assoc-15th St

    Tulsa, Oklahoma, 74104

  • Tyler Hematololgy Oncology, PA

    Tyler, Texas, 75701

  • Carle Cancer Center

    Urbana, Illinois, 61801

  • Texas Oncology, PA

    Waco, Texas, 76712

  • MedStar Washington Hosp Center

    Washington D.C., District of Columbia, 20010

  • Texas Oncology, P.A.; Duke Slayton Cancer Center

    Webster, Texas, 77598-4420

  • Carroll County Cancer Center

    Westminster, Maryland, 21157

  • Cancer Center of Kansas

    Wichita, Kansas, 67214-3728

  • Shenandoah Oncology Associates

    Winchester, Virginia, 22601

Other trials in United States

About this study

Official title: An Observational Cohort Study of Treatment Patterns and Outcomes in Patients With HER2 Positive (HER2+) Metastatic Breast Cancer (SystHERs Registry (Systemic Therapies for HER2+ Metastatic Breast Cancer Study)).

This multi-center, prospective observational study will evaluate the treatment patterns, and the safety in patients with HER2-positive (HER2+) metastatic breast cancer (MBC). Eligible patients will have an initial metastatic breast cancer diagnosis that has not been previously treated with systemic therapy; patients may be enrolled up to 6 months after the diagnosis. Data will be collected for up to 8 years.

Conditions
Breast Cancer
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT01615068
Study groupRoleWhat they receive
CohortNot described

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Distribution of patients receiving unique treatment regimen/sequence of treatment regimens

    Measured: Up to 8 years

Secondary outcomes (7)

  1. Progression-free survival (PFS)

    Measured: Up to 8 years

  2. Overall survival (OS)

    Measured: Up to 8 years

  3. Post-progression survival (PPS)

    Measured: Up to 8 years

  4. Time-to-treatment failure (TTF)

    Measured: Up to 8 years

  5. Response rate (RR)

    Measured: Up to 8 years

  6. Safety: Incidence of adverse events

    Measured: Up to 8 years

  7. Patient-reported outcome assessment (PRO)

    Measured: Up to 8 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Jun 2012 (estimated)
  2. Study start5 Jun 2012
  3. Primary completion16 Nov 2017
  4. Study completion16 Nov 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
1,007 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01615068
Sponsor's protocol ID
ML28257
Status last verified
Jul 2018
First submitted
6 Jun 2012
Last updated
16 Jul 2018
Results posted
No

Publications

  • Tripathy D, Brufsky A, Cobleigh M, Jahanzeb M, Kaufman PA, Mason G, O'Shaughnessy J, Rugo HS, Swain SM, Yardley DA, Chu L, Li H, Antao V, Hurvitz SA. De Novo Versus Recurrent HER2-Positive Metastatic Breast Cancer: Patient Characteristics, Treatment, and Survival from the SystHERs Registry. Oncologist. 2020 Feb;25(2):e214-e222. doi: 10.1634/theoncologist.2019-0446. Epub 2019 Oct 14.

    PubMed 32043771

  • Cobleigh M, Yardley DA, Brufsky AM, Rugo HS, Swain SM, Kaufman PA, Tripathy D, Hurvitz SA, O'Shaughnessy J, Mason G, Antao V, Li H, Chu L, Jahanzeb M. Baseline Characteristics, Treatment Patterns, and Outcomes in Patients with HER2-Positive Metastatic Breast Cancer by Hormone Receptor Status from SystHERs. Clin Cancer Res. 2020 Mar 1;26(5):1105-1113. doi: 10.1158/1078-0432.CCR-19-2350. Epub 2019 Nov 26.

    PubMed 31772121

  • Hurvitz SA, O'Shaughnessy J, Mason G, Yardley DA, Jahanzeb M, Brufsky A, Rugo HS, Swain SM, Kaufman PA, Tripathy D, Chu L, Li H, Antao V, Cobleigh M. Central Nervous System Metastasis in Patients with HER2-Positive Metastatic Breast Cancer: Patient Characteristics, Treatment, and Survival from SystHERs. Clin Cancer Res. 2019 Apr 15;25(8):2433-2441. doi: 10.1158/1078-0432.CCR-18-2366. Epub 2018 Dec 28.

    PubMed 30593513

  • Tripathy D, Rugo HS, Kaufman PA, Swain S, O'Shaughnessy J, Jahanzeb M, Mason G, Beattie M, Yoo B, Lai C, Masaquel A, Hurvitz S. The SystHERs registry: an observational cohort study of treatment patterns and outcomes in patients with human epidermal growth factor receptor 2-positive metastatic breast cancer. BMC Cancer. 2014 May 2;14:307. doi: 10.1186/1471-2407-14-307.

    PubMed 24885258

Questions about this trial

What is this clinical trial studying?

An observational study of Breast Cancer, run by Genentech, Inc. at 142 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 142 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Distribution of patients receiving unique treatment regimen/sequence of treatment regimens (time frame: Up to 8 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01615068, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2018.

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