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

Use our guide to learn which trials are right for you!

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
Menomonee Falls, Wisconsin 53051
1720
mi
from 91732
Menomonee Falls, WI
Click here to add this to my saved trials
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...
2377
mi
from 91732
Abington, PA
Click here to add this to my saved trials
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...
1730
mi
from 91732
Chicago, IL
Click here to add this to my saved trials
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas From its...
1225
mi
from 91732
Dallas, TX
Click here to add this to my saved trials
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...
1974
mi
from 91732
Grosse Pointe Woods, MI
Click here to add this to my saved trials
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...
1836
mi
from 91732
Kalamazoo, MI
Click here to add this to my saved trials
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...
2435
mi
from 91732
New York, NY
Click here to add this to my saved trials
401 College Street
Richmond, Virginia 23298
(804) 828-0450
Virginia Commonwealth University Massey Cancer Center Founded in 1974, VCU Massey Cancer Center is a...
2269
mi
from 91732
Richmond, VA
Click here to add this to my saved trials
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...
2244
mi
from 91732
Rochester, NY
Click here to add this to my saved trials
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...
2384
mi
from 91732
Voorhees, NJ
Click here to add this to my saved trials
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...
2124
mi
from 91732
Winston-Salem, NC
Click here to add this to my saved trials
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...
2040
mi
from 91732
Akron, OH
Click here to add this to my saved trials
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...
2038
mi
from 91732
Akron, OH
Click here to add this to my saved trials
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...
1926
mi
from 91732
Ann Arbor, MI
Click here to add this to my saved trials
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...
1932
mi
from 91732
Ann Arbor, MI
Click here to add this to my saved trials
Atlantis, Florida 33462
2307
mi
from 91732
Atlantis, FL
Click here to add this to my saved trials
825
mi
from 91732
Aurora, CO
Click here to add this to my saved trials
900 Caton Ave.
Baltimore, Maryland 21229
410-368-6000
St. Agnes Hospital Cancer Center Saint Agnes Hospital is leading Maryland in the battle against...
2297
mi
from 91732
Baltimore, MD
Click here to add this to my saved trials
2301
mi
from 91732
Baltimore, MD
Click here to add this to my saved trials
Barberton, Ohio 44203
2036
mi
from 91732
Barberton, OH
Click here to add this to my saved trials
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...
2404
mi
from 91732
Basking Ridge, NJ
Click here to add this to my saved trials
300 North Ave
Battle Creek, Michigan 49017
(269) 245-8000
Battle Creek Health System Cancer Care Center As a proud member of the Battle Creek...
1857
mi
from 91732
Battle Creek, MI
Click here to add this to my saved trials
19
mi
from 91732
Burbank, CA
Click here to add this to my saved trials
360 Parrish Street
Canandaigua, New York 14424
2261
mi
from 91732
Canandaigua, NY
Click here to add this to my saved trials
Cincinnati, Ohio 45267
513-584-7698
1878
mi
from 91732
Cincinnati, OH
Click here to add this to my saved trials
Columbia, Maryland 21044
2288
mi
from 91732
Columbia, MD
Click here to add this to my saved trials
Commack, New York 11725
2470
mi
from 91732
Commack, NY
Click here to add this to my saved trials
2368
mi
from 91732
Drexel Hill, PA
Click here to add this to my saved trials
1361
mi
from 91732
Edmonton,
Click here to add this to my saved trials
Flint, Michigan 48532
1934
mi
from 91732
Flint, MI
Click here to add this to my saved trials
2301
mi
from 91732
Glen Burnie, MD
Click here to add this to my saved trials
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...
1840
mi
from 91732
Grand Rapids, MI
Click here to add this to my saved trials
Grand Rapids, Michigan 49503
1840
mi
from 91732
Grand Rapids, MI
Click here to add this to my saved trials
1357
mi
from 91732
Houston, TX
Click here to add this to my saved trials
Hyannis, Massachusetts 02601
2621
mi
from 91732
Hyannis, MA
Click here to add this to my saved trials
Livingston, New Jersey 07039
2416
mi
from 91732
Livingston, NJ
Click here to add this to my saved trials
Long Branch, New Jersey
2435
mi
from 91732
Long Branch, NJ
Click here to add this to my saved trials
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...
2388
mi
from 91732
Marlton, NJ
Click here to add this to my saved trials
1726
mi
from 91732
Mequon, WI
Click here to add this to my saved trials
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,...
1722
mi
from 91732
Milwaukee, WI
Click here to add this to my saved trials
Milwaukee, Wisconsin 53211
1730
mi
from 91732
Milwaukee, WI
Click here to add this to my saved trials
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...
2410
mi
from 91732
New Brunswick, NJ
Click here to add this to my saved trials
333
mi
from 91732
Peoria, AZ
Click here to add this to my saved trials
Philadelphia, Pennsylvania 19141
2376
mi
from 91732
Philadelphia, PA
Click here to add this to my saved trials
Philadelphia, Pennsylvania 19111
2379
mi
from 91732
Philadelphia, PA
Click here to add this to my saved trials
111 S 11th St,
Philadelphia, Pennsylvania 19107
(877) 503-8350
Kimmel Cancer Center at Thomas Jefferson University - Philadelphia The Kimmel Cancer Center at Jefferson...
2375
mi
from 91732
Philadelphia, PA
Click here to add this to my saved trials
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...
1049
mi
from 91732
Rapid City, SD
Click here to add this to my saved trials
Spruce St
Reading, Pennsylvania 19611
(484) 628-4357
McGlinn Family Regional Cancer Center at Reading Hospital and Medical Center Cancer is an unknown...
2335
mi
from 91732
Reading, PA
Click here to add this to my saved trials
2241
mi
from 91732
Rochester, NY
Click here to add this to my saved trials
Rochester, New York 14620
2246
mi
from 91732
Rochester, NY
Click here to add this to my saved trials
2452
mi
from 91732
Rockville Centre, NY
Click here to add this to my saved trials
1962
mi
from 91732
Royal Oak, MI
Click here to add this to my saved trials
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...
1931
mi
from 91732
Saginaw, MI
Click here to add this to my saved trials
Saint Louis, Missouri 63141
1559
mi
from 91732
Saint Louis, MO
Click here to add this to my saved trials
1570
mi
from 91732
Saint Louis, MO
Click here to add this to my saved trials
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...
2439
mi
from 91732
Sleepy Hollow, NY
Click here to add this to my saved trials
Springfield, Illinois 62702
1608
mi
from 91732
Springfield, IL
Click here to add this to my saved trials
5200 Harroun Rd
Sylvania, Ohio 43560
(419) 824-1444
Flower Hospital Cancer Center Established in 1986, ProMedica is a locally owned, nonprofit healthcare organization...
1929
mi
from 91732
Sylvania, OH
Click here to add this to my saved trials