Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Trial Description

Summary

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.

Further Study Information

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 at 1 year and at any time of this regimen in these patients.

• 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.

Eligibility Criteria

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

• No Paget disease of the nipple

• Initial lumpectomy followed by whole-breast radiotherapy performed over 1 year ago

• Repeat lumpectomy performed within the past 42 days

• 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

• Histopathologic confirmation via lumpectomy of local in-breast ipsilateral recurrence within the past 120 days and the following must be true:

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

• Negative histologic margins of resection and no tumor on ink following breast-preserving surgery

• Re-excision to achieve negative margins allowed

• 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

• No more than 120 days since whole-body 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

Trial Contact Information

Trial Lead Organizations/Sponsors

Radiation Therapy Oncology Group

Douglas W. Arthur

Principal Investigator

U.S.A.
Arizona
	Peoria
	Arizona Center for Cancer Care - Peoria
		Daniel R Reed	Ph: 623-773-2873
Colorado
	Aurora
	University of Colorado Cancer Center at UC Health Sciences Center
		Rachel A. Rabinovitch	Ph: 720-848-0650
Florida
	Atlantis
	JFK Medical Center
		Georges F Hatoum	Ph: 866-574-5124
			Email: Sylvester@emergingmed.com
Illinois
	Chicago
	Robert H. Lurie Comprehensive Cancer Center at Northwestern University
		William Small	Ph: 312-695-1301
			Email: cancer@northwestern.edu
	Springfield
	Cancer Institute at St. John's Hospital
		Cathy L. Clausen	Ph: 217-525-5666
			Email: diana.weyhenmeyer@st-johns.org
Maryland
	Baltimore
	Greenebaum Cancer Center at University of Maryland Medical Center
		Steven Feigenberg	Ph: 800-888-8823
	Columbia
	Central Maryland Oncology Center
		Steven Feigenberg	Ph: 800-888-8823
	Glen Burnie
	Tate Cancer Center at Baltimore Washington Medical Center
		Steven Feigenberg	Ph: 800-888-8823
Massachusetts
	Hyannis
	Davenport-Mugar Cancer Center at Cape Cod Hospital
		Daniel J Canaday	Ph: 508-862-5799
	Lowell
	Lowell General Hospital
		Matthew S Katz	Ph: 978-788-7084
			Email: ghincks@lowellgeneral.org
Michigan
	Ann Arbor
	Saint Joseph Mercy Cancer Center
		Samir Narayan	Ph: 734-712-3456
	University of Michigan Comprehensive Cancer Center
		Reshma Jagsi	Ph: 800-865-1125
	Battle Creek
	Battle Creek Health System Cancer Care Center
		Gilbert D Padula	Ph: 616-685-5225
	Detroit
	Van Elslander Cancer Center at St. John Hospital and Medical Center
		Samir Narayan	Ph: 734-712-3456
	Farmington
	Botsford Oncology Practice at Botsford General Hospital
		John M. Robertson	Ph: 248-551-7695
	Flint
	McLaren Cancer Institute
		Hesham E. Gayar	Ph: 810-342-4071
	Grand Rapids
	Butterworth Hospital at Spectrum Health
		Gilbert D Padula	Ph: 616-685-5225
	Lacks Cancer Center at Saint Mary's Health Care
		Gilbert D Padula	Ph: 616-685-5225
	Kalamazoo
	West Michigan Cancer Center
		Raymond Sterling Lord	Ph: 269-373-7458
	Pontiac
	St. Joseph Mercy Oakland
		Samir Narayan	Ph: 734-712-3456
	Royal Oak
	William Beaumont Hospital - Royal Oak Campus
		John M. Robertson	Ph: 248-551-7695
	Saginaw
	Seton Cancer Institute at Saint Mary's - Saginaw
		Samir Narayan	Ph: 734-712-3456
Minnesota
	Minneapolis
	Virginia Piper Cancer Institute at Abbott - Northwestern Hospital
		Paul Sperduto	Ph: 952-993-1517
			Email: MMCCOP@parknicollet.com
Missouri
	Saint Louis
	Barnes-Jewish West County Hospital
		Imran Zoberi	Ph: 800-600-3606
			Email: info@ccadmin.wustl.edu
	Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
		Imran Zoberi	Ph: 800-600-3606
			Email: info@ccadmin.wustl.edu
Montana
	Billings
	Billings Clinic Cancer Center - 801 N 29th Street
		Benjamin Thomas Marchello	Ph: 800-648-6274
New Jersey
	Basking Ridge
	Memorial Sloan-Kettering Cancer Center - Basking Ridge
		Beryl McCormick	Ph: 212-639-7202
	Camden
	Cancer Institute of New Jersey at Cooper University Hospital - Camden
		Noel M Kramer	Ph: 856-325-6757
	Livingston
	St. Barnabas Medical Center Cancer Center
		Alison Grann	Ph: 973-322-2470
	Long Branch
	Monmouth Medical Center
		Sang Eui Sim	Ph: 732-923-7689
	Mount Holly
	Virtua Fox Chase Health Cancer Program at Virtua Memorial Hospital Burlington County
		Lemuel S. Ariaratnam	Ph: 888-847-8823
	New Brunswick
	Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
		Molly Gabel	Ph: 732-235-8675
	Voorhees
	Cancer Institute of New Jersey at Cooper - Voorhees
		Noel M Kramer	Ph: 856-325-6757
New York
	Buffalo
	Roswell Park Cancer Institute
		David M Mattson	Ph: 877-275-7724
	Canandiaqua
	Sands Cancer Center
		Yuhchyau Chen	Ph: 585-275-5830
	Commack
	Memorial Sloan-Kettering Cancer Center
		Beryl McCormick	Ph: 212-639-7202
	New York
	Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center
		Daniela Gidea-Addeo	Ph: 212-305-8615
	Memorial Sloan-Kettering Cancer Center
		Beryl McCormick	Ph: 212-639-7202
	Rochester
	Daisy Marquis Jones Radiation Oncology Center at Highland Hospital of Rochester
		Yuhchyau Chen	Ph: 585-275-5830
	James P. Wilmot Cancer Center at University of Rochester Medical Center
		Yuhchyau Chen	Ph: 585-275-5830
	University Radiation Oncology at Parkridge Hospital
		Yuhchyau Chen	Ph: 585-275-5830
	Rockville Centre
	Memorial Sloan-Kettering Cancer Center - Rockville Centre
		Beryl McCormick	Ph: 212-639-7202
	Sleepy Hollow
	Memorial Sloan-Kettering Cancer Center at Phelps Memorial Hospital Center
		Beryl McCormick	Ph: 212-639-7202
North Carolina
	Statesville
	Iredell Memorial Hospital
		Ruby A. Grimm	Ph: 704-873-5661
Ohio
	Akron
	McDowell Cancer Center at Akron General Medical Center
		Mitchell Lee Fromm	Ph: 330-344-6348
	Summa Center for Cancer Care at Akron City Hospital
		Charles A Kunos	Ph: 800-641-2422
	Barberton
	Barberton Citizens Hospital
		Charles A Kunos	Ph: 800-641-2422
	Cincinnati
	University of Cincinnati
		Kevin P. Redmond	Ph: 513-558-4553
			Email: uchealthnews@uc.edu
	Ravenna
	Robinson Radiation Oncology
		Mitchell Lee Fromm	Ph: 330-344-6348
	Sylvania
	Flower Hospital Cancer Center
		Rex B Mowat	Ph: 517-265-0116
Pennsylvania
	Abington
	Rosenfeld Cancer Center at Abington Memorial Hospital
		Wayne H Pinover	Ph: 215-481-2402
	Drexel Hill
	Delaware County Regional Cancer Center at Delaware County Memorial Hospital
		Deborah A. Markiewicz	Ph: 610-284-8237
			Email: jolene.garney@crozer.org
	Philadelphia
	American College of Radiology Imaging Network
		Douglas W Arthur
	Fox Chase Cancer Center - Philadelphia
		Penny R Anderson	Ph: 215-728-4790
	Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
		Pramila Rani Anne	Ph: 215-955-6084
	West Reading
	McGlinn Family Regional Cancer Center at Reading Hospital and Medical Center
		Albert Yuen	Ph: 610-988-9323
South Dakota
	Rapid City
	Rapid City Regional Hospital
		Michael J Swartz	Ph: 605-716-3982
			Email: research@rcrh.org
Texas
	Dallas
	Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
		Ann E. Spangler	Ph: 214-648-7097
	Houston
	M. D. Anderson Cancer Center at University of Texas
		Wendy A Woodward
			Email: wwoodward@mdanderson.org
	Univeristy of Texas M.D. Anderson Cancer Center
		Wendy A Woodward	Ph: 713-792-3245
Virginia
	Richmond
	Virginia Commonwealth University Massey Cancer Center
		Douglas W Arthur	Ph: 804-628-1939
Wisconsin
	Menomonee Falls
	Community Memorial Hospital Cancer Care Center
		Adam D Currey	Ph: 414-805-4380
	Mequon
	Columbia Saint Mary's Hospital - Ozaukee
		Craig A Schulz	Ph: 414-326-2675
			Email: clinicaltrials@columbia-stmarys.org
	Milwaukee
	Columbia-Saint Mary's Cancer Care Center
		Craig A Schulz	Ph: 414-326-2675
			Email: clinicaltrials@columbia-stmarys.org
	Froedtert Hospital and Medical College of Wisconsin
		Adam D Currey	Ph: 414-805-4380
	Oconomowoc
	Regional Cancer Center at Oconomowoc Memorial Hospital
		Wingate F. Clapper	Ph: 262-928-7632
	Waukesha
	Waukesha Memorial Hospital Regional Cancer Center
		Wingate F. Clapper	Ph: 262-928-7632
Canada
Alberta
	Edmonton
	Cross Cancer Institute at University of Alberta
		Susan Chafe	Ph: 780-432-8500

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT01082211
Information obtained from ClinicalTrials.gov on November 20, 2012