Breast Cancer Clinical Trial
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)).
| NCT number | NCT01615068 |
| Other study ID # | ML28257 |
| Secondary ID | |
| Status | Completed |
| Phase | |
| First received | |
| Last updated | |
| Start date | June 5, 2012 |
| Est. completion date | November 16, 2017 |
| Verified date | July 2018 |
| Source | Genentech, Inc. |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Completed |
| Enrollment | 1007 |
| Est. completion date | November 16, 2017 |
| Est. primary completion date | November 16, 2017 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - 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 Exclusion Criteria: - Any inability to provide informed consent |
| Country | Name | City | State |
|---|---|---|---|
| United States | Hendrick Cancer Center | Abilene | Texas |
| United States | Alton Memorial Hospital; Outpatient Clinic and Infusion Center | Alton | Illinois |
| United States | McFarland Clinic | Ames | Iowa |
| United States | Hope A Women's Cancer Center | Asheville | North Carolina |
| United States | Peachtree Hematology & Oncology Consultants, Pc | Atlanta | Georgia |
| United States | Mary Bird Perkins Cancer Ctr | Baton Rouge | Louisiana |
| United States | Medical Oncology LLC | Baton Rouge | Louisiana |
| United States | Texas Oncology | Bedford | Texas |
| United States | Summit Medical Group | Berkeley Heights | New Jersey |
| United States | Billings Clinic Research Center | Billings | Montana |
| United States | St. Vincent'S Hospital; Birmingham Hematology Oncology Associates, Llc | Birmingham | Alabama |
| United States | Lynn Cancer Institute - West | Boca Raton | Florida |
| United States | St. Joseph Regional Cancer Ct | Bryan | Texas |
| United States | East Valley Hem/Onc Med Group; Metropolitan Hem Onc. | Burbank | California |
| United States | South Bay Oncology Hematology Partners | Campbell | California |
| United States | Charleston Hematology Oncology | Charleston | South Carolina |
| United States | Medical Univ of South Carolina | Charleston | South Carolina |
| United States | Chattanooga Oncology and Hematology Associates, PC | Chattanooga | Tennessee |
| United States | Rush University Medical Center | Chicago | Illinois |
| United States | Metro Health Medical Center | Cleveland | Ohio |
| United States | South Carolina Oncology Associates - SCRI | Columbia | South Carolina |
| United States | Mid Ohio Onc Hematology Inc | Columbus | Ohio |
| United States | The Mary Imogene Bassett Hospi | Cooperstown | New York |
| United States | Western Maryland Health Sys | Cumberland | Maryland |
| United States | Texas Oncology-Baylor Sammons Cancer Center | Dallas | Texas |
| United States | University of Miami; Dept Sylvester Cancer Center | Deerfield Beach | Florida |
| United States | Kaiser Permanente Of Colorado | Denver | Colorado |
| United States | Rocky Mountain Cancer Center - Denver | Denver | Colorado |
| United States | Onc & Hematology Specialists | Denville | New Jersey |
| United States | Hematology & Oncology Assoc; North Eastern Pennsylvania | Dunmore | Pennsylvania |
| United States | North Shore Hem Onc Associates | East Setauket | New York |
| United States | Southdale Cancer Clinic U of M Medical Center, Fairview- Edina | Edina | Minnesota |
| United States | Texas Oncology- El Paso Cancer Treatment Center Gateway | El Paso | Texas |
| United States | California Cancer Associates for Research & Excellence, Inc. | Encinitas | California |
| United States | Oncology Hematology Assoc | Evansville | Indiana |
| United States | Florida Cancer Specialists - Fort Myers (New Hampshire Ct) | Fort Myers | Florida |
| United States | Texas Oncology, P.A. - Fort Worth | Fort Worth | Texas |
| United States | ROBERT A. MOSS, M.D., F.A.C.P., Inc | Fountain Valley | California |
| United States | California Oncology of the Central Valley | Fresno | California |
| United States | Cancer Care Associates | Fresno | California |
| United States | St. Jude Heritage Healthcare; Virgiia K.Crosson Can Ctr | Fullerton | California |
| United States | Gaston Hematology/Oncology | Gastonia | North Carolina |
| United States | Cancer & Hematology Centers of Western Michigan | Grand Rapids | Michigan |
| United States | Cone Health Cancer Center | Greensboro | North Carolina |
| United States | Hackensack University Medical Center | Hackensack | New Jersey |
| United States | Memorial Cancer Institute | Hollywood | Florida |
| United States | Genesis Cancer Center | Hot Springs | Arkansas |
| United States | Texas Oncology - Houston (Gessner) | Houston | Texas |
| United States | University of Iowa | Iowa City | Iowa |
| United States | Jackson Oncology Associates, PLLC | Jackson | Mississippi |
| United States | Baptist - MD Anderson Cancer Center | Jacksonville | Florida |
| United States | Florida Oncology Associates | Jacksonville | Florida |
| United States | Queens Hospital Center | Jamaica | New York |
| United States | Jefferson City Medical Group | Jefferson City | Missouri |
| United States | NEA Baptist Clinic | Jonesboro | Arkansas |
| United States | West Michigan Cancer Center | Kalamazoo | Michigan |
| United States | Research Medical Center; Pharmacy | Kansas City | Missouri |
| United States | Kingsport Hematology Oncology Associates | Kingsport | Tennessee |
| United States | Center for Biomedical Research LLC | Knoxville | Tennessee |
| United States | Lafayette General Medical Center | Lafayette | Louisiana |
| United States | Lakeland Regional Cancer Center | Lakeland | Florida |
| United States | Lancaster Cancer Center, Ltd. | Lancaster | Pennsylvania |
| United States | Comprehensive Cancer Centers of Nevada | Las Vegas | Nevada |
| United States | Dartmouth Hitchcock Medical Center; Gastroenterology Section | Lebanon | New Hampshire |
| United States | Southeast Nebraska Cancer Center;; Southeast Nebraska Hematology and Oncology | Lincoln | Nebraska |
| United States | Hematology Oncology Services of Arkansas | Little Rock | Arkansas |
| United States | Mile High Oncology | Littleton | Colorado |
| United States | UCLA School of Medicine | Los Angeles | California |
| United States | University of Southern California | Los Angeles | California |
| United States | Baptist Hospital East | Louisville | Kentucky |
| United States | James Graham Brown Cancer Center, University of Louisville | Louisville | Kentucky |
| United States | Southeastern Regional Medical Center | Lumberton | North Carolina |
| United States | Lynchburg Hem Onc Clinic Inc | Lynchburg | Virginia |
| United States | University of Wisconsin | Madison | Wisconsin |
| United States | Northwest Georgia Oncology Centers PC - Marietta | Marietta | Georgia |
| United States | Mercy Medical Ctr-North Iowa ; Mercy Cancer Center | Mason City | Iowa |
| United States | Texas Oncology, P.A. - McAllen; South Texas Cancer Center-McAllen | McAllen | Texas |
| United States | Connecticut Oncology Group | Middletown | Connecticut |
| United States | Signal Point Clinical; Research Center, LLC | Middletown | Ohio |
| United States | Columbia Saint Mary's; Medical Oncology | Milwaukee | Wisconsin |
| United States | Minnesota Oncology Hematology, Pa | Minneapolis | Minnesota |
| United States | Montana Cancer Specialists | Missoula | Montana |
| United States | University of South Alabama; Mitchell Cancer Institute | Mobile | Alabama |
| United States | West Virginia University Hospitals Inc | Morgantown | West Virginia |
| United States | Hematology Oncology Associates; Carol G. Simon Ctr | Morristown | New Jersey |
| United States | Boston Baskin Cancer Foundation | Nashville | Tennessee |
| United States | Sarah Cannon Research Inst. | Nashville | Tennessee |
| United States | Yale Cancer Center | New Haven | Connecticut |
| United States | Beth Israel Comprehensive Cancer Center Pharmacy | New York | New York |
| United States | Herbert Irving Comprehensive Cancer Center; Herbert Irving Pavillion | New York | New York |
| United States | Peninsula Cancer Institute | Newport News | Virginia |
| United States | Mid-Illinois Hematology | Normal | Illinois |
| United States | Northern Utah Associates | Ogden | Utah |
| United States | Mercy Clinic Oklahoma Communties, Inc | Oklahoma City | Oklahoma |
| United States | Cancer Alliance of Nebraska | Omaha | Nebraska |
| United States | Md Anderson Cancer Center Orlando | Orlando | Florida |
| United States | Comprehensive Cancer Care | Palm Springs | California |
| United States | Luckow Pavillion, Valley Hosp; Office of Clinical Trials | Paramus | New Jersey |
| United States | Texas Oncology - Paris | Paris | Texas |
| United States | Oncology Specialists, S.C. | Park Ridge | Illinois |
| United States | Temple University Hospital | Philadelphia | Pennsylvania |
| United States | First Health of the Carolinas | Pinehurst | North Carolina |
| United States | Allegheny General Hospital; Transplantation Services | Pittsburgh | Pennsylvania |
| United States | Univ of Pittsburgh Sch of Med; Magee-Womens Hospital | Pittsburgh | Pennsylvania |
| United States | Berkshire Hematology, Oncology Pc | Pittsfield | Massachusetts |
| United States | Florida Cancer Research Institute | Plantation | Florida |
| United States | Mercy Oncology / Hematology Center; Oncology | Portland | Maine |
| United States | Providence Cancer Center | Portland | Oregon |
| United States | Portsmouth Regional Hospital; Hem/Onc Clinic | Portsmouth | New Hampshire |
| United States | Kootenai Cancer Center | Post Falls | Idaho |
| United States | Virginia Cancer Institute | Richmond | Virginia |
| United States | Associates in Oncology/Hematology P.C. | Rockville | Maryland |
| United States | Highlands Oncology Group | Rogers | Arkansas |
| United States | Christian Hospital; Outpatient Cancer and Infusion Center | Saint Louis | Missouri |
| United States | St. John'S Mercy Medical Center; David C. Pratt Cancer Center | Saint Louis | Missouri |
| United States | Park Nicollet Clinic Cancer Center | Saint Louis Park | Minnesota |
| United States | Florida Cancer Specialists (St. Petersburg - St. Anthony's Professional Building) | Saint Petersburg | Florida |
| United States | Huntsman Cancer Institute; Oncology | Salt Lake City | Utah |
| United States | Univ of Calif, San Francisco; Breast Cancer Center | San Francisco | California |
| United States | Coastal Integrative Cancer Care | San Luis Obispo | California |
| United States | Central Coast Medical Oncology | Santa Maria | California |
| United States | Sutter Pacific Medical Foundation | Santa Rosa | California |
| United States | Summit Cancer Care PC | Savannah | Georgia |
| United States | Guthrie Clinic | Sayre | Pennsylvania |
| United States | Virginia Mason Medical Center | Seattle | Washington |
| United States | Arizona Oncology Associates, PC - NAHOA | Sedona | Arizona |
| United States | Capitol Hematology & Oncology | Silver Spring | Maryland |
| United States | Orchard Healthcare Research Inc. | Skokie | Illinois |
| United States | Hematology Oncology P.C. | Stamford | Connecticut |
| United States | Flower Memorial Hospital | Sylvania | Ohio |
| United States | Space Coast Medical Associates | Titusville | Florida |
| United States | St. Joseph Medical Center | Towson | Maryland |
| United States | Arizona Oncology | Tucson | Arizona |
| United States | Cancer Care Assoc-15th St | Tulsa | Oklahoma |
| United States | Tyler Hematololgy Oncology, PA | Tyler | Texas |
| United States | Carle Cancer Center | Urbana | Illinois |
| United States | Texas Oncology, PA | Waco | Texas |
| United States | MedStar Washington Hosp Center | Washington | District of Columbia |
| United States | Texas Oncology, P.A.; Duke Slayton Cancer Center | Webster | Texas |
| United States | Carroll County Cancer Center | Westminster | Maryland |
| United States | Cancer Center of Kansas | Wichita | Kansas |
| United States | Shenandoah Oncology Associates | Winchester | Virginia |
| Lead Sponsor | Collaborator |
|---|---|
| Genentech, Inc. |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Distribution of patients receiving unique treatment regimen/sequence of treatment regimens | Up to 8 years | ||
| Secondary | Progression-free survival (PFS) | Up to 8 years | ||
| Secondary | Overall survival (OS) | Up to 8 years | ||
| Secondary | Post-progression survival (PPS) | Up to 8 years | ||
| Secondary | Time-to-treatment failure (TTF) | Up to 8 years | ||
| Secondary | Response rate (RR) | Up to 8 years | ||
| Secondary | Safety: Incidence of adverse events | Up to 8 years | ||
| Secondary | Patient-reported outcome assessment (PRO) | Up to 8 years |
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