Serum Tumor Marker Directed Disease Monitoring in Patients With Hormone Receptor Positive Her2 Negative Metastatic Breast Cancer



Status:Recruiting
Conditions:Breast Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:12/23/2018
Start Date:July 16, 2018
End Date:July 15, 2027

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Randomized Non-Inferiority Trial Comparing Overall Survival of Patients Monitored With Serum Tumor Marker Directed Disease Monitoring (STMDDM) Versus Usual Care in Patients With Metastatic Hormone Receptor Positive Breast Cancer

This randomized research trial studies how well serum tumor marker directed disease
monitoring works in monitoring patients with hormone receptor positive Her2 negative breast
cancer that has spread to other places in the body. Using markers to prompt when scans should
be ordered may be as good as the usual approach to monitoring disease.

PRIMARY OBJECTIVES:

I. To assess whether patients with HER-2 negative, hormone receptor positive, metastatic
breast cancer who are monitored with serum tumor marker directed disease monitoring (STMDDM)
have non-inferior overall survival compared to patients monitored with usual care.

SECONDARY OBJECTIVES:

I. To compare cumulative direct healthcare costs through 48 weeks among patients monitored
with STMDDM versus those monitored with usual care in this patient population.

II. To assess whether the patient-reported outcomes (PROs) of anxiety and quality of life
(QOL) are different among patients who are monitored with STMDDM compared with patients who
are monitored with usual care in this patient population.

TERTIARY OBJECTIVES:

I. To assess modality and frequency of disease monitoring testing in the usual care cohort.

II. To assess the association of PROs and patient preferences for disease monitoring testing.

III. To evaluate predictors of physician preferences for disease monitoring testing.

OUTLINE: Patients are randomized into 1 of 2 arms.

ARM I: Patients undergo imaging studies at a minimum frequency of every 12 weeks and continue
with usual care disease monitoring for up to 312 weeks in the absence of disease progression.

ARM II: Patients undergo disease specific serum tumor marker (STM) evaluation every 6 weeks.
Patients with elevated STM, undergo imaging evaluation. Patients continue with STMDDM for up
to 312 weeks in the absence of disease progression.

Inclusion Criteria:

- STEP 1 REGISTRATION

- Patients must have a diagnosis of hormone receptor positive (estrogen receptor
positive [ER+] and/or progesterone receptor positive [PR+]), HER-2 negative,
metastatic (M1) breast cancer and must be receiving or plan to receive first-line
systemic treatment for metastatic disease

- NOTE: Participants are eligible if they have either de-novo metastatic breast
cancer and/or recurrent breast cancer from an earlier stage that is now
metastatic

- Patients must be registered to step 1 between 14 days prior to and 28 days after start
of first-line systemic treatment for metastatic disease

- Patients must have been tested for all of the following breast cancer specific STMs
after diagnosis of metastatic disease and within +/-14 days of initiation of
first-line systemic treatment for metastatic disease:

- CA 15-3

- CA 27.29

- CEA

- At least one of these STMs must have been >= 2 x the institutional upper limit of
normal at this time

- Patients must have systemic radiographic imaging prior to initiation of systemic
therapy for treatment of metastatic breast cancer and prior to step 1 registration
with either:

- A computed tomography (CT) scan of the chest and abdomen with or without CT
pelvis, and with or without bone scan or

- A positron emission tomography (PET) scan with or without CT

- Note: the treating physician can order additional imaging tests at any point
prior to randomization at their discretion

- Patients must be willing to obtain disease monitoring (imaging and/or serum tumor
markers) at their current center for the duration of the study intervention (312 weeks
after step 2 randomization)

- Patients with known cirrhosis, untreated B12 deficiency, thalassemia, or sickle cell
anemia are not eligible as these could cause falsely elevated STM levels

- Patients with known brain metastases are not eligible as they may require regular
radiographic monitoring to assess treatment response

- Patients must not be currently enrolled or plan to participate in a first-line
treatment trial for metastatic breast cancer with a defined monitoring schedule

- Patients who are able to complete questionnaires in English or Spanish must
participate in patient-reported outcome (PRO) assessments

- Patients must not be pregnant due to the potential harm to the fetus from radiation
exposure from radiographic imaging

- Except for breast cancer (and previous history of breast cancer), no other prior
malignancy is allowed except for adequately treated basal (or squamous cell) skin
cancer, in situ cervical cancer or other cancer for which the patient has been disease
free for five years

- Patients must not have received prior systemic therapy for metastatic breast cancer,
except for their current treatment regimen initiated no more than 28 days prior to
registration

- Patients must have decision making capacity and be able to provide informed consent

- Patients must be informed of the investigational nature of this study and must sign
and give written informed consent in accordance with institutional and federal
guidelines; use of legally-authorized representative is not permissible for this study

- As a part of the Oncology Patient Enrollment Network (OPEN) registration process the
treating institution's identity is provided in order to ensure that the current
(within 365 days) date of institutional review board approval for this study has been
entered in the system

- STEP 2 RANDOMIZATION

- Patients must be tested for all of the following breast cancer specific STMs between
56 and 112 days after initiation of first-line systemic therapy for metastatic
disease:

- CA 15-3

- CA 27.29

- CEA

- At least one of the STMs that was previously elevated must have decreased from the
assessment at step 1 by >= 25% at this time

- Patients must not have known progression since registration to step 1

- Patients must be registered to step 2 randomization between 56 days and 112 days after
the initiation of first-line systemic therapy for metastatic disease; patients must
have been eligible for step 1 in order to be eligible for step 2 randomization

- Baseline questionnaires must be completed within 28 days prior to step 2
randomization; (Note: Those patients who cannot complete the PRO questionnaires in
English or Spanish can be registered to step 2 without contributing to PRO research)
We found this trial at
241
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775 South Main Street
Chelsea, Michigan 48118
Principal Investigator: Christopher M. Reynolds
Phone: 734-712-3671
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2545 Schoenersville Rd
Bethlehem, Pennsylvania 18017
(484) 884-2200
Principal Investigator: Christopher M. Reynolds
Phone: 734-712-3671
Lehigh Valley Hospital - Muhlenberg At Lehigh Valley Health Network, we continually go the extra...
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1 Hurley Plaza
Flint, Michigan 48503
(810) 262-9000
Principal Investigator: Christopher M. Reynolds
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Hurley Medical Center From its founding in 1908, Hurley Medical Center has devoted itself to...
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4805 Northeast Glisan Street
Portland, Oregon 97213
(503) 215-1111
Principal Investigator: Gary E. Goodman
Phone: 503-215-2614
Providence Portland Medical Center We strive to give those we serve exceptional, compassionate health care...
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Seattle, Washington 98104
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Aberdeen, Washington 98520
Principal Investigator: Gary E. Goodman
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Adrian, Michigan 49221
Principal Investigator: Rex B. Mowat
Phone: 517-265-0116
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200-298 Avenida Doctor Pedro Albizu Campos
Aguadilla, 00603
Principal Investigator: Luis Baez-Diaz
Phone: 787-997-2222
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Allentown, Pennsylvania 18103
Principal Investigator: Christopher M. Reynolds
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Anaconda, Montana 59711
Principal Investigator: Benjamin T. Marchello
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Anchorage, Alaska 98508
Principal Investigator: Gary E. Goodman
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Anchorage, Alaska 99508
Principal Investigator: Gary E. Goodman
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Anchorage, Alaska 99508
Principal Investigator: Gary E. Goodman
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Anchorage, Alaska 99508
Principal Investigator: Gary E. Goodman
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Anchorage, Alaska 99508
Principal Investigator: Gary E. Goodman
Phone: 907-212-6871
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Anchorage, Alaska 99508
Principal Investigator: Gary E. Goodman
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Anchorage, Alaska 99508
Principal Investigator: Gary E. Goodman
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5301 McAuley Drive
Ann Arbor, Michigan 48197
734-712-3456
Principal Investigator: Christopher M. Reynolds
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Saint Joseph Mercy Hospital St. Joseph Mercy Ann Arbor Hospital is a 537-bed teaching hospital...
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2000 Ogden Ave
Aurora, Illinois 60504
(630) 978-6200
Principal Investigator: Pratima Chalasani
Phone: 630-978-6212
Rush - Copley Medical Center Rush-Copley is proud to be the leading provider of health...
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3325 Pocahontas Road
Baker City, Oregon 97814
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3535 Pentagon Boulevard
Beavercreek, Ohio 45431
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Bellingham, Washington 98225
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800 Farson Street
Belpre, Ohio 45714
(740) 401-0417
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Strecker Cancer Center-Belpre The Memorial Health System's Strecker Cancer Center, Belpre combines the clinical expertise...
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Bend, Oregon 97701
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Billings, Montana 59101
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1505 Eastland Drive
Bloomington, Illinois 61701
309-662-2102
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Illinois CancerCare-Bloomington Illinois CancerCare, P.C. is a comprehensive practice treating patients withcancer andblood diseases. Our...
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Boise, Idaho 83706
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100 E Idaho St
Boise, Idaho 83712
(208) 381-2711
Principal Investigator: Gary E. Goodman
Saint Luke's Mountain States Tumor Institute For more than 100 years, St. Luke
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Bolivar, Missouri 65613
Principal Investigator: Rakesh Gaur
Phone: 913-948-5588
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Bonne Terre, Missouri 63628
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915 Highland Blvd
Bozeman, Montana 59715
(406) 414-5000
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7575 Grand River Avenue
Brighton, Michigan 48114
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7575 Grand River Avenue
Brighton, Michigan 48114
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Burbank, California
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3123 Medical Dr
Caldwell, Idaho 83605
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210 W Walnut St
Canton, Illinois 61520
309-647-5240
Principal Investigator: Bryan A. Faller
Phone: 309-243-3605
Illinois CancerCare - Canton Illinois CancerCare is one of the largest private oncology and hematology...
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1600 South Canton Center Road
Canton, Michigan 48188
Principal Investigator: Christopher M. Reynolds
Phone: 734-712-3671
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1600 South Canton Center Road
Canton, Michigan 48188
Principal Investigator: Christopher M. Reynolds
Phone: 734-712-3671
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211 Saint Francis Drive
Cape Girardeau, Missouri 63703
573-331-3000
Principal Investigator: Bryan A. Faller
Phone: 573-334-2230
Saint Francis Medical Center Saint Francis Medical Center is a 282-bed facility serving more than...
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789 Mt Auburn Rd
Cape Girardeau, Missouri 63703
(573) 519-4725
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Phone: 573-651-5550
Southeast Cancer Center SoutheastHEALTH is a far-reaching network of providers and facilities including Southeast Hospital...
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Cape May Court House, New Jersey 08210
Principal Investigator: Victor G. Vogel
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Carbondale, Illinois 62902
Principal Investigator: Bryan A. Faller
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401 North Hooper Street
Caro, Michigan 48723
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Carterville, Illinois 62918
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160 S Adams St
Carthage, Illinois 62321
(217) 357-6877
Principal Investigator: Bryan A. Faller
Phone: 309-243-3605
Illinois CancerCare - Carthage Illinois CancerCare, P.C. is a comprehensive practice treating patients withcancer andblood...
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Centerville, Ohio 45459
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Centerville, Ohio 45459
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Centralia, Illinois 62801
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Centralia, Washington 98531
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14650 East Old US Highway 12
Chelsea, Michigan 48118
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272 Hospital Rd
Chillicothe, Ohio 45601
740-779-7500
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Phone: 877-779-7585
Adena Regional Medical Center Since 1895, Adena Health System has remained focused on its commitment...
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Cincinnati, Ohio 45236
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Clackamas, Oregon 97015
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9280 SE Sunnybrook Blvd #100
Clackamas, Oregon 97015
(503) 513-3300
Principal Investigator: Gary E. Goodman
Phone: 503-215-2614
Clackamas Radiation Oncology Center State-of-the-art technology and compassionate care come together at Clackamas Radiation Oncology...
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5680 Bow Pointe Drive
Clarkston, Michigan 48346
Principal Investigator: Christopher M. Reynolds
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31500 Telegraph Road
Clarkston, Michigan 48346
Principal Investigator: Christopher M. Reynolds
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Clinton, South Carolina 29325
Principal Investigator: Jeffrey K. Giguere
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Cody, Wyoming 82414
Principal Investigator: Benjamin T. Marchello
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Coeur d'Alene, Idaho 83814
Principal Investigator: Benjamin T. Marchello
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Columbus, Ohio 43213
Principal Investigator: Timothy D. Moore
Phone: 614-488-2118
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810 Jasonway Avenue
Columbus, Ohio 43214
614/442-3130
Principal Investigator: Timothy D. Moore
Phone: 614-488-2118
Columbus Oncology and Hematology Associates Inc Columbus Oncology and Hematology Associates is a group of...
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3535 Olentangy River Rd
Columbus, Ohio 43214
(614) 566-5000
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Riverside Methodist Hospital Serving central Ohio since 1892, Riverside Methodist Hospital is consistently ranked one...
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111 S Grant Ave
Columbus, Ohio 43215
(614) 566-9000
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Grant Medical Center Founded in 1900 in Columbus' downtown, Grant has grown into one of...
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3100 Plaza Properties Blvd
Columbus, Ohio 43219
(614) 383-6000
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The Mark H. Zangmeister Center At The Zangmeister Center, we appreciate that our patients have...
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Columbus, Ohio 43222
Principal Investigator: Timothy D. Moore
Phone: 614-234-5433
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5100 W Broad St
Columbus, Ohio 43228
(614) 544-1000
Principal Investigator: Timothy D. Moore
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Doctors Hospital Nationally recognized for care quality and patient safety and satisfaction, Doctors Hospital is...
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Concord, New Hampshire 03301
Principal Investigator: Douglas J. Weckstein
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Coos Bay, Oregon 97420
Principal Investigator: Gary E. Goodman
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Danville, Illinois 61832
Principal Investigator: Pratima Chalasani
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100 North Academy Avenue
Danville, Pennsylvania 17822
570-271-6211
Principal Investigator: Victor G. Vogel
Phone: 570-271-5251
Geisinger Medical Center Since 1915, Geisinger Medical Center has been known as the region’s resource...
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1 Wyoming St,
Dayton, Ohio 45409
(937) 208-8000
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Dayton, Ohio 45415
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2222 Philadelphia Dr
Dayton, Ohio 45406
(937) 734-2612
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Good Samaritan Hospital - Dayton Good Samaritan Hospital (GSH) is passionate about providing the most...
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9000 N. Main St.
Dayton, Ohio 45415
(937) 734-6784
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Samaritan North Health Center Good Samaritan Hospital (GSH) is passionate about providing the most recent...
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210 West McKinley Avenue
Decatur, Illinois 62526
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2300 N Edward St
Decatur, Illinois 62526
(217) 876-8121
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Decatur Memorial Hospital An American flag bearing only 48 stars waved above Decatur Memorial Hospital...
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561 West Central Avenue
Delaware, Ohio 43015
(740) 615-1000
Principal Investigator: Timothy D. Moore
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Delaware Health Center-Grady Cancer Center As the center of healthcare in Delaware County, Grady Memorial...
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Delaware, Ohio 43015
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561 W. Central Avenue
Delaware, Ohio 43015
(740) 615-1000
Principal Investigator: Timothy D. Moore
Phone: 740-615-2403
Grady Memorial Hospital As the center of healthcare in Delaware County, Grady Memorial Hospital is...
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Detroit, Michigan 48236
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Easley, South Carolina 29640
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17900 23 Mile Road
East China Township, Michigan 48054
Principal Investigator: Christopher M. Reynolds
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East Stroudsburg, Pennsylvania 18301
Principal Investigator: Christopher M. Reynolds
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Edmonds, Washington 98026
Principal Investigator: Gary E. Goodman
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Effingham, Illinois 62401
Principal Investigator: Pratima Chalasani
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Effingham, Illinois 62401
Principal Investigator: Bryan A. Faller
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Egg Harbor Township, New Jersey 08234
Principal Investigator: Victor G. Vogel
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Elmira, New York 14905
Principal Investigator: Serge Dauphin
Phone: 607-271-7000
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1202 East Locust Street
Emmett, Idaho 83617
Principal Investigator: Christopher M. Reynolds
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101 S Major St
Eureka, Illinois 61530
309-467-2371
Principal Investigator: Bryan A. Faller
Phone: 309-243-3605
Illinois CancerCare - Eureka Illinois CancerCare is one of the largest private oncology and hematology...
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1717 13th St
Everett, Washington 98201
(425) 297-5500
Principal Investigator: Gary E. Goodman
Phone: 425-261-3529
Providence Regional Cancer Partnership Founded in 2007, the Providence Regional Cancer Partnership is the result...
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Findlay, Ohio 45840
Principal Investigator: Howard M. Gross
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Findlay, Ohio 45840
Principal Investigator: Howard M. Gross
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1900 S Main St
Findlay, Ohio 45840
(419) 423-4500
Principal Investigator: Howard M. Gross
Phone: 937-775-1350
Blanchard Valley Hospital For more than 100 years, Blanchard Valley Hospital has made quality care...
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Flint, Michigan 48503
Principal Investigator: Christopher M. Reynolds
Phone: 734-712-3671
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Flint, MI
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302 Kensington Avenue
Flint, Michigan 48503
Principal Investigator: Christopher M. Reynolds
Phone: 734-712-3671
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Flint, MI
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302 Kensington Ave
Flint, Michigan 48503
(810) 762-8490
Principal Investigator: Christopher M. Reynolds
Phone: 734-712-3671
Genesys Hurley Cancer Institute Bringing the most advanced cancer treatment services, technologies and programs available...
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Flint, MI
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1600 S Andrews Ave
Fort Lauderdale, Florida 33316
(954) 355-4400
Principal Investigator: Mehmet F. Hepgur
Phone: 954-355-5346
Broward Health Medical Center Broward Health, providing service for more than 75 years, is a...
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Fort Lauderdale, FL
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Franklin, Ohio 45005
Principal Investigator: Howard M. Gross
Phone: 937-775-1350
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Franklin, OH
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One Medical Center Drive
Franklin, Ohio 45005
(513) 424-2111
Principal Investigator: Howard M. Gross
Phone: 937-775-1350
Atrium Medical Center - Middletown Regional Hospital Atrium Medical Center (Atrium) is built on the...
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Franklin, OH
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Fruitland, Idaho 83619
Principal Investigator: Gary E. Goodman
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Fruitland, ID
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