Radiation Therapy in Treating Women With Locally Recurrent Breast Cancer Previously Treated With Repeat Breast-Preserving Surgery



Status:Active, not recruiting
Conditions:Breast Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - 120
Updated:6/20/2018
Start Date:June 2010
End Date:November 2020

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A Phase II Study of Repeat Breast Preserving Surgery and 3D-Conformal Partial Breast Re-Irradiation (PBrI) for Local Recurrence of Breast Carcinoma

RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Giving radiation
therapy after surgery kill any remaining tumor cells and may be an effective treatment for
breast cancer.

PURPOSE: This phase II trial is studying how well radiation therapy works in treating women
with locally recurrent breast cancer previously treated with repeat breast-conserving
surgery.

OBJECTIVES:

Primary

- To evaluate skin, breast, and chest wall adverse events occurring within 1 year after
completion of 3D-conformal partial-breast re-irradiation following repeat
breast-preserving surgery in patients with locally recurrent breast carcinoma.

Secondary

- To evaluate the adverse events occurring after 1 year from the completion of
re-irradiation and at any time.

- To evaluate in-breast control rate in patients treated with this regimen.

- To evaluate freedom-from-mastectomy rate in these patients.

- To evaluate the rate of circulating tumor cells (CTCs) in this patient population and to
document eradication of CTCs by locoregional therapy.

- To determine whether translational objective will correlate with eradication or presence
of CTCs with in-breast recurrence and distant metastasis-free survival.

- To evaluate cosmesis as judged by the patient and independent evaluation.

- To evaluate distant metastasis-free survival, mastectomy-free survival, and overall
survival of patients treated with this regimen.

OUTLINE: This is a multicenter study.

Patients undergo 3-dimensional conformal accelerated partial-breast irradiation twice daily,
5 days a week, for 3 weeks.

Some patients undergo blood sample collection at baseline and within 3 weeks after completion
of radiotherapy for circulating tumor cells analysis.

Some patients complete questionnaires on cosmesis at baseline and at 1 and 3 years following
radiotherapy.

After completion of study therapy, patients are followed up periodically for 4-5 years and
then every year thereafter.

DISEASE CHARACTERISTICS:

- Histologically confirmed locally recurrent breast carcinoma consistent with the
following cell types:

- Invasive ductal breast carcinoma

- Medullary ductal breast carcinoma

- Tubular ductal breast carcinoma

- Mucinous ductal breast carcinoma

- Lobular breast carcinoma

- Ductal carcinoma in situ (DCIS)

- No Paget disease of the nipple

- Target lumpectomy cavity must be clearly defined and the target lumpectomy
cavity/ whole-breast reference volume must be < 30% based on a post-operative,
pre-treatment CT scan

- Tumor size ≤ 3 cm in greatest dimension on pathologic specimen

- Negative histologic margins of resection and no tumor on ink following
breast-preserving surgery of local recurrence (Re-excision is permitted to
achieve negative margins)

- Axilla negative or ≤ 3 positive lymph nodes without extracapsular extension

- If the in-breast recurrence is DCIS and/or microinvasive disease, a sentinel
lymph node (SLN) evaluation is not required, but if performed:

- Patients with a negative sentinal lymph node (SLN) biopsy are eligible for
enrollment

- Patients with a positive SLN biopsy require an axillary lymph node (ALN)
dissection (ALND is not required if the SLN is not identified)

- Patient is eligible if 0-3 positive ALNs without extracapsular extension is
documented

- If the in-breast recurrence is invasive disease and:

- No prior ALN dissection or SLN dissection only:

- Patient is required to undergo axillary evaluation with either a SLN or ALN
dissection

- If the SLN is not identified or if the SLN is positive for metastatic
disease then an ALN dissection is required

- Patient is eligible for enrollment if encounter 0-3 positive lymph nodes
without extracapsular extension

- • Prior ALN dissection: negative clinical exam: patient is eligible for
enrollment

- It is recommended, but not required, that the patient undergo ultrasound
evaluation of the axilla and the lymph node draining regions of the breast;
any suspicious areas are to be biopsied and if positive followed with an ALN
dissection

- Patient is eligible for enrollment if biopsies are negative or 0-3 axillary
lymph nodes without extracapsular extension are encountered

- Prior ALN dissection: positive clinical exam: biopsy required

- If biopsy is negative, patient is eligible for enrollment

- If biopsy is positive an ALN dissection is required

- Patient is eligible for enrollment if biopsies are negative or 0-3 axillary
lymph nodes without extracapsular extension encountered

- Ipsilateral breast mammogram and MRI within 120 days prior to study entry

- Contralateral breast mammogram within 12 months of study entry

- For invasive in-breast recurrence, no more than 120 days since whole-body (positron
emission tomography) PET-CT scan OR CT scan of the chest, abdomen, and pelvis, and
bone scan

- No multicentric ipsilateral breast recurrence or regional recurrence (other than
axilla)

- Patients must have a breast technically amenable to partial-breast irradiation

- No metastatic disease documented by physical exam or radiographic evaluation (for
patients with invasive disease)

- No skin involvement

- No prior contralateral mastectomy

- Estrogen and progesterone status must be known

PATIENT CHARACTERISTICS:

- Zubrod performance status 0-1

- Menopausal status not specified

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- No other invasive malignancy within the past 3 years except ipsilateral breast cancer
and/or nonmelanoma skin cancer

- No collagenous diseases, specifically systemic lupus erythematosus, scleroderma, or
dermatomyositis

- No psychiatric or addictive disorders that would preclude obtaining informed consent

PRIOR CONCURRENT THERAPY:

- See Disease Characteristics

- More than 2 weeks since prior chemotherapy and recovered

- No concurrent intensity-modulated radiotherapy

- No concurrent chemotherapeutic agents, including trastuzumab
We found this trial at
58
sites
353 Fairmont Blvd
Rapid City, South Dakota 57701
(605) 719-1000
Rapid City Regional Hospital Regional Health is an integrated health care system of more than...
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1200 Old York Road
Abington, Pennsylvania 19001
(215) 481-2400
Rosenfeld Cancer Center at Abington Memorial Hospital As one of the most trusted cancer centers...
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Abington, PA
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675 N Saint Clair St # 21-100
Chicago, Illinois 60611
(312) 695-1156
Robert H. Lurie Comprehensive Cancer Center at Northwestern University The cancer center was first established...
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Chicago, IL
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Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas From its...
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19229 Mack Ave
Grosse Pointe Woods, Michigan 48236
(866) 246-4673
Van Elslander Cancer Center at St. John Hospital and Medical Center We built the Van...
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200 North Park Street
Kalamazoo, Michigan 49007
(269) 382-2500
West Michigan Cancer Center In 1994, Borgess Health Alliance and Bronson Healthcare Group opened the...
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701 West 168th Street
New York, New York 10032
(212) 851-4680
Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center The Herbert Irving Comprehensive Cancer...
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401 College Street
Richmond, Virginia 23298
(804) 828-0450
Virginia Commonwealth University Massey Cancer Center Founded in 1974, VCU Massey Cancer Center is a...
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601 Elmwood Avenue
Rochester, New York 14642
(585) 275-5830
James P. Wilmot Cancer Center at University of Rochester Medical Center The Wilmot Cancer Center...
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42 E Laurel Rd # 2545
Voorhees, New Jersey 08043
(800) 826-6737
Cancer Institute of New Jersey at Cooper - Voorhees Cooper University Health Care, the clinical...
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1 Medical Center Blvd
Winston-Salem, North Carolina 27103
(336) 716-2011
Wake Forest University Comprehensive Cancer Center Our newly expanded Comprehensive Cancer Center is the region’s...
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161 North Forge Street
Akron, Ohio 44304
(330) 375-7280
Summa Center for Cancer Care at Akron City Hospital Summa Health System is a leader...
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1 Akron General Ave
Akron, Ohio 44307
(330) 344-6000
McDowell Cancer Center at Akron General Medical Center Learning that you or someone you love...
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5301 McAuley Drive
Ann Arbor, Michigan 48197
734-712-4673
Saint Joseph Mercy Cancer Center Saint Joseph Mercy Health System is one of Michigan's most...
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1500 East Medical Center Drive
Ann Arbor, Michigan 48109
800-865-1125
University of Michigan Comprehensive Cancer Center The U-M Comprehensive Cancer Center's mission is the conquest...
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Atlantis, Florida 33462
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900 Caton Ave.
Baltimore, Maryland 21229
410-368-6000
St. Agnes Hospital Cancer Center Saint Agnes Hospital is leading Maryland in the battle against...
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Barberton, Ohio 44203
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136 Mountainview Blvd
Basking Ridge, New Jersey 7920
(908) 542-3000
Memorial Sloan-Kettering Cancer Center - Basking Ridge At Memorial Sloan Kettering Basking Ridge, we offer...
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300 North Ave
Battle Creek, Michigan 49017
(269) 245-8000
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360 Parrish Street
Canandaigua, New York 14424
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Cincinnati, Ohio 45267
513-584-7698
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Columbia, Maryland 21044
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Commack, New York 11725
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Flint, Michigan 48532
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250 Cherry St SE
Grand Rapids, Michigan 49503
(616) 685-5225
Lacks Cancer Center at Saint Mary's Health Care Mercy Health Lacks Cancer Center was one...
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Grand Rapids, Michigan 49503
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Hyannis, Massachusetts 02601
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Livingston, New Jersey 07039
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Long Branch, New Jersey
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90 Brick Rd
Marlton, New Jersey 08053
(856) 355-6000
Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton Virtua collaborates with Fox...
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Menomonee Falls, Wisconsin 53051
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Milwaukee, Wisconsin 53211
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8800 W. Doyne Avenue
Milwaukee, Wisconsin 53226
(414) 805-6840
Medical College of Wisconsin Cancer Center Cancer touches everyone in our community, and for many,...
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195 Little Albany St
New Brunswick, New Jersey 08903
(732) 235-2465
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School As New...
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Philadelphia, Pennsylvania 19141
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Philadelphia, Pennsylvania 19111
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111 S 11th St,
Philadelphia, Pennsylvania 19107
(877) 503-8350
Kimmel Cancer Center at Thomas Jefferson University - Philadelphia The Kimmel Cancer Center at Jefferson...
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Spruce St
Reading, Pennsylvania 19611
(484) 628-4357
McGlinn Family Regional Cancer Center at Reading Hospital and Medical Center Cancer is an unknown...
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Rochester, New York 14620
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800 S Washington Ave
Saginaw, Michigan 48601
(989) 907-8115
Seton Cancer Institute at Saint Mary's - Saginaw At St. Mary's of Michigan, we continue...
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Saint Louis, Missouri 63141
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701 N Broadway
Sleepy Hollow, New York 10591
(914) 366-3000
Memorial Sloan-Kettering Cancer Center at Phelps Memorial Hospital Center Memorial Sloan Kettering Cancer Center Sleepy...
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Springfield, Illinois 62702
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5200 Harroun Rd
Sylvania, Ohio 43560
(419) 824-1444
Flower Hospital Cancer Center Established in 1986, ProMedica is a locally owned, nonprofit healthcare organization...
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