Standard of Care Therapy With or Without Stereotactic Radiosurgery and/or Surgery in Treating Patients With Limited Metastatic Breast Cancer



Status:Recruiting
Conditions:Breast Cancer, Cancer, Chronic Pain, Other Indications, Pulmonary
Therapuetic Areas:Musculoskeletal, Oncology, Pulmonary / Respiratory Diseases, Other
Healthy:No
Age Range:18 - Any
Updated:1/30/2019
Start Date:December 24, 2014
End Date:December 31, 2027

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A Phase IIR/III Trial of Standard of Care Therapy With or Without Stereotactic Body Radiotherapy (SBRT) and/or Surgical Ablation for Newly Oligometastatic Breast Cancer

This randomized phase II/III trial studies how well standard of care therapy with
stereotactic radiosurgery and/or surgery works and compares it to standard of care therapy
alone in treating patients with breast cancer that has spread to one or two locations in the
body (limited metastatic) that are previously untreated. Standard of care therapy comprising
chemotherapy, hormonal therapy, biological therapy, and others may help stop the spread of
tumor cells. Radiation therapy and/or surgery is usually only given with standard of care
therapy to relieve pain; however, in patients with limited metastatic breast cancer,
stereotactic radiosurgery, also known as stereotactic body radiation therapy, may be able to
send x-rays directly to the tumor and cause less damage to normal tissue and surgery may be
able to effectively remove the metastatic tumor cells. It is not yet known whether standard
of care therapy is more effective with stereotactic radiosurgery and/or surgery in treating
limited metastatic breast cancer.

PRIMARY OBJECTIVES:

I. To determine whether ablation (through stereotactic body radiation therapy [SBRT]
[stereotactic radiosurgery] and/or surgical resection of all known metastases) in
oligometastatic breast cancer patients provides a sufficient signal for improved
progression-free survival (PFS) to warrant full accrual to the Phase III portion of the
trial. (Phase II-R) II. To determine whether ablation (through SBRT and/or surgical resection
of all known metastases) in oligometastatic breast cancer patients significantly improves
overall survival (OS). (Phase III)

SECONDARY OBJECTIVES:

I. To evaluate treated metastasis control according to tumor receptor status (estrogen
receptor [ER], progesterone receptor [PR], human epidermal growth factor receptor [HER]-2),
use of chemotherapy, surgery vs. ablative therapy, and solitary metastasis vs. 2 metastasis
(may expand to >= 2 to =< 4 following completion of a Phase I trial).

II. To evaluate whether the addition of ablative metastasis directed therapy significantly
reduces the number of distant recurrences (new metastases) in patients who progress according
to tumor receptor status (ER, PR, HER-2); use of chemotherapy, and solitary metastasis vs. 2
metastases (may expand to >= 2 to =< 4 following completion of the Phase I NRG-BR001 trial).

III. To evaluate adverse events in patients who receive ablative metastasis-directed therapy
to all known metastases in addition to standard medical therapy alone.

IV. To explore the most appropriate and clinically relevant technological parameters to
ensure quality and effectiveness throughout the radiation therapy processes, including
imaging, simulation, target and critical structure definition, treatment planning, image
guidance, and delivery.

TERTIARY OBJECTIVES:

I. To determine whether < 5 circulating tumor cells (CTCs) (per 7.5 ml of blood) is an
independent prognostic (outcome) marker for improved PFS and OS in oligometastatic breast
cancer.

II. To determine whether < 5 CTCs (per 7.5 ml of blood) is an independent predictive
(response to therapy) marker for improved PFS and OS in oligometastatic breast cancer.

III. To determine whether eliminating CTCs (0/7.5 ml of blood in patients with at least 2
CTCs at registration) is both a prognostic and predictive marker for improved PFS and OS.

IV. To evaluate the prognostic and predictive properties of CTC count as a continuous measure
of PFS and OS.

V. To store material for retrospective analysis of circulating tumor deoxyribonucleic acid
(ctDNA).

VI. To store material for retrospective analysis of circulating micro-ribonucleic acid (RNA).

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM 1: Patients continue to receive their current planned systemic therapy at the discretion
of the treating physician.

ARM 2: Patients continue to receive their current planned systemic therapy at the discretion
of the treating physician. Patients also undergo stereotactic radiosurgery in 1, 3, or 5
fractions within 3 weeks and/or surgery at the discretion of the treating physician.

ARM 1: Patients are followed every 3 months from randomization to 2 years. ARM 2: Patients
are followed 25-35 days post-ablation, every 3 months from randomization to 2 years, and then
yearly thereafter.

Inclusion Criteria:

- Pathologically confirmed metastatic breast cancer

- Known estrogen, progesterone, and HER2 status of either primary tumor or metastasis

- ≤ 4 metastases seen on standard imaging within 60 days prior to registration when all
metastatic disease is located within the following sites:

- peripheral lung

- osseous (bone)

- spine

- central lung

- abdominal-pelvic(lymph node/adrenal gland)

- liver

- mediastinal/cervical lymph node

- All known disease amenable to metastasis-directed therapy with either SBRT or
resection

- NOTE: Symptomatic bone metastasis are allowed if ablative therapy can be
delivered

- NOTE: Sites for possible surgical excision include lung, liver, adrenal gland,
bone, small intestine, large intestine, ovary, and amenable nodal disease sites

- NOTE: Surgical stabilization is allowed for a metastasis if it is followed by
conventionally fractionated external beam radiotherapy

- Maximum diameter of individual metastasis in any dimension ≤ 5 cm

- There are no restrictions on distance between the metastases

- Patients must be registered within 365 days of the initial metastatic breast cancer
diagnosis. First-line standard systemic therapy (chemotherapy, anti-endocrine therapy,
anti-HER2 or other standard targeted therapy) for metastatic breast cancer must be
given or planned to be given. If given before study entry, it cannot have exceeded a
duration of 12 months at the time of registration. (Note: Sequencing of ablative
therapy (surgery or SBRT) relative to systemic therapy, for patients randomized to Arm
2, is at the discretion of the treating physician.)

- The primary tumor site must be controlled prior to registration

- For those who present with synchronous primary and oligometastatic disease:

Primary must be controlled prior to registration. The definition of control is definitive
surgery by excision or mastectomy (+/- radiotherapy) per institution preference

- For those who present with local recurrence and oligometastatic disease, local
recurrence must be controlled prior to registration The definition of control is
definitive surgery by excision or mastectomy (+/- radiotherapy) per institution
preference

- Appropriate stage for study entry based on the following diagnostic workup:

- History/physical examination within 60 days prior to registration

- Clinical grade computed tomography (CT) scans of the chest, abdomen, and pelvis with
radionuclide bone scan OR whole body positron emission tomography (PET)/CT within 60
days prior to study registration

- Zubrod performance status ≤ 2 within 60 days prior to registration

- Absolute neutrophil count (ANC) ≥ 500 cells/mm^3

- Platelets ≥ 50,000 cells/mm^3

- Hemoglobin ≥ 8.0 g/dl (note: the use of transfusion or other intervention to
achieve hemoglobin [Hgb] ≥ 8.0 g/dl is acceptable)

- For females of child-bearing potential, negative serum or urine pregnancy test
within 14 days prior to study registration

Exclusion Criteria:

- Pathologic evidence of local/regional breast tumor recurrence at the time of
registration

- Co-existing or prior invasive malignancy (except non-melanomatous skin cancer), unless
disease free for a minimum of 3 years; previous RT dose, date, fraction size, must be
reported

- Metastases with indistinct borders making targeting not feasible

- NOTE: A potential issue with bone metastases is that they often are not discrete.
Since many patients on this protocol will have bone metastases, this will be an
important issue. Theoretically, Houndsfield units might provide an appropriate
measure; however, a sclerotic lesion against dense cortical bone will not have a
sharp demarcation based on Houndsfield units (HU). Therefore, we acknowledge that
such determinations will pose a challenge and thus the physician's judgment will
be required

- Prior palliative radiation treatment for metastatic disease (including
radiopharmaceuticals)

- Metastases located within 3 cm of the previously irradiated structures:

- Spinal cord previously irradiated to > 40 Gy (delivered in ≤ 3 Gy/fraction)

- Brachial plexus previously irradiated to > 50 Gy (delivered in ≤ 3 Gy/fraction)

- Small intestine, large intestine, or stomach previously irradiated to > 45 Gy
(delivered in ≤ 3 Gy/fraction)

- Brainstem previously irradiated to > 50 Gy (delivered in ≤ 3 Gy/fraction)

- Whole lung previously irradiated with prior V20Gy > 30% (delivered in ≤ 3
Gy/fraction)

- Primary tumor irradiated with SBRT

- Metastasis irradiated with SBRT

- Brain metastases

- Exudative, bloody, or cytological proven malignant effusions

- Severe, active co-morbidity defined as follows:

- Unstable angina and/or congestive heart failure requiring hospitalization within
the last 6 months

- Transmural myocardial infarction within the last 6 months

- Acute bacterial or fungal infection requiring intravenous antibiotics at the time
of registration

- Chronic obstructive pulmonary disease exacerbation or other respiratory illness
requiring hospitalization or precluding study therapy at the time of registration

- Pregnancy; lactating females must cease expression of milk prior to signing consent to
be eligible

- Human immunodeficiency virus (HIV) positive with cluster of differentiation (CD)4
count < 200 cells/microliter; note that patients who are HIV positive are eligible,
provided they are under treatment with highly active antiretroviral therapy (HAART)
and have a CD4 count ≥ 200 cells/microliter within 30 days prior to registration; note
also that HIV testing is not required for eligibility for this protocol
We found this trial at
136
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Greer, South Carolina 29651
Principal Investigator: Steven W. Corso
Phone: 864-560-6104
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1201 Camino de Salud Northeast
Albuquerque, New Mexico 87131
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University of New Mexico Cancer Center It’s been 40 years since the New Mexico State...
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3300 Gallows Road
Falls Church, Virginia 22042
(703) 776-4001
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Inova Fairfax Hospital Inova Fairfax Hospital, Inova's flagship hospital, is an 833-bed, nationally recognized regional...
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8700 Beverly Blvd # 8211
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4805 Northeast Glisan Street
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60 Crittenden Blvd # 70
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34800 Bob Wilson Dr,
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1 Akron General Avenue
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Albuquerque, New Mexico 87109
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Albuquerque, New Mexico 87102
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4650 Jefferson Lane Northeast
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150 Parkway Office Court
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303 East Superior Street
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1200 West Harrison Stree
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1653 W. Congress Parkway
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5841 S Maryland Ave
Chicago, Illinois 60637
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Clarkston, Michigan 48346
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10900 Euclid Ave
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Clinton Township, Michigan 48038
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6001 E Woodmen Rd
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4050 Coon Rapids Blvd NW
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2300 N Edward St
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2301 Erwin Rd
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1024 S Lemay Ave
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Fort Wayne, Indiana 46845
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1600 Southwest Archer Road
Gainesville, Florida 32610
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1117 29th St S
Great Falls, Montana 59405
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835 S Van Buren St
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1726 Shawano Avenue
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Greenwood, South Carolina 29646
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24800 SE Stark St
Gresham, Oregon 97030
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Hollywood, Florida 33021
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1301 Punchbowl St
Honolulu, Hawaii 96813
(808) 538-9011
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Queen's Medical Center The Queen's Medical Center, located in downtown Honolulu, Hawaii, is a private,...
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Houston, Texas 77030
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Huntington, West Virginia 25701
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4500 San Pablo Rd S
Jacksonville, Florida 32224
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310 Sunnyview Ln
Kalispell, Montana 59901
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3855 Health Sciences Dr,
La Jolla, California 92093
(858) 822-6100
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1 Medical Center Dr
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1441 Eastlake Ave
Los Angeles, California 90033
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2000 N Boise Ave
Loveland, Colorado 80538
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295 Varnum Ave
Lowell, Massachusetts 01854
(978) 937-6000
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2160 South 1st Avenue
Maywood, Illinois 60153
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9200 W Wisconsin Ave
Milwaukee, Wisconsin 53226
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Morgantown, West Virginia 26505
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Mount Holly, New Jersey 08060
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Muncie, Indiana 47303
Principal Investigator: Yunjie X. Lin
Phone: 765-751-5850
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Muncie, IN
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New York, New York 10032
Principal Investigator: Eileen P. Connolly
Phone: 212-305-6361
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New York, NY
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Newark, Delaware 19713
Principal Investigator: Gregory A. Masters
Phone: 302-623-4450
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Newark, DE
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5475 South 500 East
Ogden, Utah 84405
Principal Investigator: Brandon J. Fisher
Phone: 412-339-5294
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Ogden, UT
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940 NE 13th St
Oklahoma City, Oklahoma 73190
(405) 271-6458
Principal Investigator: J. S. Thompson
Phone: 405-271-8777
University of Oklahoma Health Sciences Center The OU Health Sciences Center is composed of seven...
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Oklahoma City, OK
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Emile St
Omaha, Nebraska 68198
(402) 559-4000
Principal Investigator: Andrew O. Wahl
Phone: 402-559-6941
Univ of Nebraska Med Ctr A vital enterprise in the nation’s heartland, the University of...
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Omaha, NE
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Orange, California 92868
Principal Investigator: Parima Daroui
Phone: 877-827-8839
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Orange, CA
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Orlando, Florida 32806
Principal Investigator: Patrick Kelly
Phone: 321-841-7246
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Orlando, FL
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Owensboro, KY
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Pembroke Pines, Florida 33028
Principal Investigator: Srinath Sundararaman
Phone: 954-265-4325
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Pembroke Pines, FL
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Peoria, AZ
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Philadelphia, Pennsylvania 19104
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Philadelphia, PA
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320 E North Ave
Pittsburgh, Pennsylvania 15212
(412) 359-3131
Principal Investigator: Mark G. Trombetta
Phone: 877-284-2000
Allegheny General Hospital At Allegheny General Hospital, our physicians and healthcare staff have earned an...
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Pittsburgh, PA
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Pontiac, Michigan 48341
Principal Investigator: Samir Narayan
Phone: 734-712-3671
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Pontiac, MI
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Portland, Maine 04102
Principal Investigator: Matthew D. Cheney
Phone: 207-885-7565
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Portland, ME
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1015 NW 22nd Ave
Portland, Oregon 97210
(503) 413-7711
Principal Investigator: Andrew Y. Kee
Phone: 800-220-4937
Legacy Good Samaritan Hospital and Medical Center Located in the heart of Northwest Portland, Legacy...
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Portland, OR
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Portland, Oregon 97225
Principal Investigator: Benjamin B. Bridges
Phone: 503-215-2614
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Portland, OR
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Raleigh, North Carolina 27609
Principal Investigator: Achilles J. Fakiris
Phone: 919-784-7209
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Raleigh, NC
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2605 Blue Ridge Road
Raleigh, North Carolina 27607
Principal Investigator: Achilles J. Fakiris
Phone: 919-784-7209
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Raleigh, NC
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Raleigh, North Carolina 27614
Principal Investigator: Achilles J. Fakiris
Phone: 919-784-7209
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Raleigh, NC
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Reno, Nevada 89502
Principal Investigator: Michael C. Hardacre
Phone: 702-384-0013
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Reno, NV
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Richmond, Virginia 23226
Principal Investigator: William J. Irvin
Phone: 412-339-5294
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Richmond, VA
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Rochester, Minnesota 55905
Principal Investigator: Kimberly S. Corbin
Phone: 855-776-0015
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Rochester, MN
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Roseville, California 95678
Principal Investigator: Samantha A. Seaward
Phone: 877-642-4691
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Roseville, CA
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