Breast Cancer Clinical Trial
Radiation Therapy (WBI Versus PBI) in Treating Women Who Have Undergone Surgery For Ductal Carcinoma In Situ or Stage I or Stage II Breast Cancer
Summary
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Giving radiation therapy in different ways may kill any tumor cells that remain after surgery. It is not yet known whether whole breast radiation therapy is more effective than partial breast radiation therapy in treating breast cancer.
PURPOSE: This randomized phase III trial is studying whole breast radiation therapy to see how well it works compared to partial breast radiation therapy in treating women who have undergone surgery for ductal carcinoma in situ or stage I or stage II breast cancer.
Full Description
OBJECTIVES:
Primary
Compare local tumor control in women with ductal carcinoma in situ or stage I or II breast cancer treated with adjuvant whole breast vs partial breast irradiation following lumpectomy.
Secondary
Compare overall survival, recurrence-free survival, and distant disease-free survival in patients treated with these regimens.
Compare the cosmetic result in patients treated with these regimens.
Compare fatigue and treatment-related symptoms in patients treated with these regimens.
Compare perceived convenience of care in patients treated with these regimens.
Compare acute and late toxic effects of these regimens in these patients.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to disease stage (ductal carcinoma in situ [DCIS] only vs invasive and node negative vs invasive with 1-3 positive nodes), menopausal status (premenopausal vs postmenopausal), hormone receptor status (estrogen receptor [ER]-positive and/or progesterone receptor [PR]-positive vs ER-negative and PR-negative), intention to receive chemotherapy (yes vs no). Patients are randomized to 1 of 2 treatment arms. (Patients who are 50 years of age and over with DCIS regardless of hormone receptor status AND patients with invasive breast cancer meeting all of the following criteria: ≥ 50 years of age, node-negative, and hormone-receptor positive status will not be enrolled in study after 12/30/2006.)
Group 1: Patients undergo whole-breast irradiation (WBI) once daily, 5 days a week, for 5-7 weeks.
Group 2: Patients undergo partial-breast irradiation (PBI) twice daily on 5 days over a period of 5-10 days. This may be delivered by multi-catheter brachytherapy, single-entry intracavitary brachytherapy, or 3-D conformal radiotherapy.
Patients in both arms may receive adjuvant chemotherapy at least 2 weeks prior to initiation of WBI OR at least 2 weeks after completion of PBI at the discretion of the treating physician. Patients with ER-positive or PR-positive tumors may also receive hormonal therapy, beginning 3-12 weeks after completion of adjuvant chemotherapy (or before, during, or after completion of WBI or PBI for patients not receiving adjuvant chemotherapy) and continuing for at least 5 years.
After completion of study treatment, patients are followed at 1 and 6 months, every 6 months for 4.5 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 4,300 patients (2,150 per treatment arm) will be accrued for this study within 4.6 years. Note: Accrual closed on April 16, 2013, following approval of the Data Monitoring Committee to reduce the sample size from 4,300 to 4,214 patients.
Eligibility Criteria
DISEASE CHARACTERISTICS:
Histologically confirmed ductal carcinoma in situ (DCIS*) or invasive* adenocarcinoma of the breast
Stage 0, I, or II disease
Stage II tumors must be ≤ 3 cm
Gross disease must be unifocal
Microscopic multifocality allowed provided total pathological tumor size is ≤ 3 cm
No proven multicentric carcinoma in more than 1 quadrant or separated by ≥ 4 cm
No non-epithelial breast malignancies (e.g., sarcoma or lymphoma) NOTE: *Patients who are 50 years of age and over with DCIS regardless of hormone receptor status AND patients with invasive breast cancer meeting all of the following criteria: ≥ 50 years of age, node-negative, and hormone-receptor positive status will not be enrolled in study after 12/30/2006
Prior axillary staging required for patients with invasive breast cancer, including 1 of the following:
Sentinel node biopsy alone (if sentinel node is negative)
Sentinel node biopsy followed by axillary dissection or sampling with ≥ 6 axillary nodes (if sentinel node is positive)
Axillary dissection alone with ≥ 6 axillary nodes
No more than 3 positive axillary nodes
No axillary nodes with definite evidence of microscopic or macroscopic extracapsular extension
No positive non-axillary sentinel nodes (intramammary nodes are staged as axillary nodes)
No palpable or radiographically suspicious ipsilateral or contralateral axillary, supraclavicular, infraclavicular, or internal mammary nodes unless there is histologic confirmation that these nodes are negative for tumor
Must have undergone lumpectomy
Resected margins histologically free of tumor
Re-excision of surgical margins allowed
Target lumpectomy cavity clearly delineated AND target lumpectomy/whole breast reference volume ≤ 30% based on postoperative pre-randomization CT scan
Final surgery (i.e., lumpectomy, re-excision of margins, or axillary staging procedure) within the past 42 days
No suspicious microcalcifications, densities, or palpable abnormalities in the ipsilateral or contralateral breast unless biopsied and found to be benign
No Paget's disease of the nipple
No history of invasive breast cancer or DCIS
Prior lobular carcinoma in situ treated by surgery alone allowed
No synchronous bilateral invasive or non-invasive breast cancer
Partial breast irradiation deemed technically deliverable by radiation oncologist at a credentialed facility
Must have undergone a history and physical exam within the past 4 months AND a bilateral mammogram within the past 6 months
Hormone receptor status:
Estrogen receptor (ER) status known
Progesterone status known if ER analysis is negative
Marginal or borderline results are considered positive
PATIENT CHARACTERISTICS:
Age
18 and over
Sex
Female
Menopausal status
Premenopausal or postmenopausal
Performance status
Not specified
Life expectancy
At least 10 years, excluding diagnosis of breast cancer
Hematopoietic
Not specified
Hepatic
Not specified
Renal
Not specified
Other
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective non-hormonal contraception
No other malignancy within the past 5 years except previously treated carcinoma in situ of the cervix or colon, melanoma in situ, or basal cell or squamous cell skin cancer
Deemed to be at low risk for recurrence
No collagen vascular disease (e.g., systemic lupus erythematosus or scleroderma), specifically dermatomyositis with a creatine phosphokinase (CPK) level above normal, or active skin rash
No psychiatric or addictive disorder that would preclude study therapy
PRIOR CONCURRENT THERAPY:
Biologic therapy
No prior biologic therapy for this malignancy
Chemotherapy
No prior chemotherapy for this malignancy
No concurrent chemotherapy during study radiotherapy
Endocrine therapy
No prior hormonal therapy for this malignancy unless total duration of hormonal therapy was no more than 28 days before randomization
Concurrent hormonal therapy allowed provided it is not administered during chemotherapy
No concurrent raloxifene, tamoxifen, or other selective estrogen receptor modulating drugs
No concurrent hormone replacement therapy
No concurrent Femring^®
Radiotherapy
No prior radiotherapy for this malignancy
No prior breast or thoracic radiotherapy
No concurrent brachytherapy boosts
No concurrent intensity modulated radiotherapy
No concurrent regional nodal irradiation
Surgery
See Disease Characteristics
No prior breast implants
Patients who have had implants removed are eligible
Other
No other concurrent anticancer therapy
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There are 366 Locations for this study
Birmingham Alabama, 35294, United States
Peoria Arizona, 85381, United States
Phoenix Arizona, 85013, United States
Scottsdale Arizona, 85258, United States
Scottsdale Arizona, 85259, United States
Little Rock Arkansas, 72205, United States
Auburn California, 95603, United States
Berkeley California, 94704, United States
Burlingame California, 94010, United States
Cameron Park California, 95682, United States
Carmichael California, 95608, United States
Chico California, 95926, United States
Concord California, 94524, United States
Duarte California, 91010, United States
Fairfield California, 94533, United States
Fresno California, 93720, United States
Hayward California, 94545, United States
La Jolla California, 92093, United States
Los Angeles California, 90095, United States
Monterey California, 93940, United States
Novato California, 94945, United States
Oakland California, 94609, United States
Orange California, 92868, United States
Palm Springs California, 92262, United States
Paradise California, 95969, United States
Pomona California, 91767, United States
Redding California, 96049, United States
Roseville California, 95661, United States
Sacramento California, 95815, United States
Sacramento California, 95817, United States
Sacramento California, 95819, United States
San Diego California, 92108, United States
San Diego California, 92123, United States
San Francisco California, 94118, United States
San Pablo California, 94806, United States
Stanford California, 94305, United States
Vacaville California, 95687, United States
Vallejo California, 94589, United States
Vallejo California, 94589, United States
Walnut Creek California, 94598, United States
Whittier California, 90602, United States
Aurora Colorado, 80012, United States
Aurora Colorado, 80045, United States
Boulder Colorado, 80301, United States
Colorado Springs Colorado, 80909, United States
Colorado Springs Colorado, 80933, United States
Denver Colorado, 80210, United States
Englewood Colorado, 80110, United States
Fort Collins Colorado, 80528, United States
Greeley Colorado, 80631, United States
Lone Tree Colorado, 80124, United States
Longmont Colorado, 80501, United States
Loveland Colorado, 80539, United States
Pueblo Colorado, 81004, United States
Thornton Colorado, 80229, United States
Bridgeport Connecticut, 06610, United States
Hartford Connecticut, 06102, United States
New Haven Connecticut, 06511, United States
New Haven Connecticut, 06520, United States
Norwalk Connecticut, 06856, United States
Torrington Connecticut, 06790, United States
Newark Delaware, 19713, United States
Washington District of Columbia, 20010, United States
Boca Raton Florida, 33486, United States
Gainesville Florida, 32610, United States
Jacksonville Beach Florida, 32250, United States
Jacksonville Florida, 32207, United States
Jacksonville Florida, 32207, United States
Jacksonville Florida, 32224, United States
Jacksonville Florida, 32258, United States
Jupiter Florida, 33458, United States
Lakeland Florida, 33805, United States
Miami Beach Florida, 33140, United States
Orange Park Florida, 32073, United States
Palatka Florida, 32177, United States
Saint Augustine Florida, 32086, United States
Atlanta Georgia, 30342, United States
Atlanta Georgia, 30342, United States
Decatur Georgia, 30033, United States
Marietta Georgia, 30060, United States
Honolulu Hawaii, 96813, United States
Honolulu Hawaii, 96813, United States
Honolulu Hawaii, 96813, United States
Boise Idaho, 83712, United States
Coeur d'Alene Idaho, 83814, United States
Aurora Illinois, 60504, United States
Barrington Illinois, 60010, United States
Bloomington Illinois, 61701, United States
Canton Illinois, 61520, United States
Carthage Illinois, 62321, United States
Chicago Illinois, 60657, United States
Downers Grove Illinois, 60515, United States
Elk Grove Village Illinois, 60007, United States
Eureka Illinois, 61530, United States
Galesburg Illinois, 61401, United States
Galesburg Illinois, 61401, United States
Havana Illinois, 62644, United States
Kewanee Illinois, 61443, United States
Macomb Illinois, 61455, United States
Maywood Illinois, 60153, United States
Moline Illinois, 61265, United States
Monmouth Illinois, 61462, United States
Monmouth Illinois, 61462, United States
Naperville Illinois, 60540, United States
Normal Illinois, 61761, United States
Normal Illinois, 61761, United States
Ottawa Illinois, 61350, United States
Park Ridge Illinois, 60068, United States
Pekin Illinois, 61554, United States
Pekin Illinois, 61603, United States
Peoria Illinois, 61615, United States
Peoria Illinois, 61615, United States
Peoria Illinois, 61615, United States
Peoria Illinois, 61636, United States
Peru Illinois, 61354, United States
Princeton Illinois, 61356, United States
Spring Valley Illinois, 61362, United States
Springfield Illinois, 62702, United States
Urbana Illinois, 61801, United States
Warrenville Illinois, 60555, United States
Anderson Indiana, 46016, United States
Elkhart Indiana, 46515, United States
Fort Wayne Indiana, 46804, United States
Fort Wayne Indiana, 46805, United States
Goshen Indiana, 46526, United States
Indianapolis Indiana, 46202, United States
Indianapolis Indiana, 46219, United States
Indianapolis Indiana, 46260, United States
South Bend Indiana, 46601, United States
Davenport Iowa, 52803, United States
Des Moines Iowa, 50309, United States
Iowa City Iowa, 52242, United States
Prairie Village Kansas, 66208, United States
Lexington Kentucky, 40503, United States
Lexington Kentucky, 40536, United States
Louisville Kentucky, 40202, United States
Louisville Kentucky, 40202, United States
Baton Rouge Louisiana, 70809, United States
Baton Rouge Louisiana, 70809, United States
New Orleans Louisiana, 70121, United States
Bangor Maine, 04401, United States
Lewiston Maine, 04240, United States
Annapolis Maryland, 21401, United States
Baltimore Maryland, 21201, United States
Baltimore Maryland, 21229, United States
Baltimore Maryland, 21231, United States
Baltimore Maryland, 21237, United States
Columbia Maryland, 21044, United States
Easton Maryland, 21601, United States
Elkton Maryland, 21921, United States
Salisbury Maryland, 21801, United States
Silver Spring Maryland, 20910, United States
Boston Massachusetts, 02114, United States
Boston Massachusetts, 02118, United States
Burlington Massachusetts, 01805, United States
Danvers Massachusetts, 01923, United States
Framingham Massachusetts, 01702, United States
Hyannis Massachusetts, 02601, United States
Ann Arbor Michigan, 48106, United States
Battle Creek Michigan, 49017, United States
Clinton Township Michigan, 48038, United States
Dearborn Michigan, 48123, United States
Detroit Michigan, 48201, United States
Detroit Michigan, 48202, United States
Flint Michigan, 48503, United States
Flint Michigan, 48532, United States
Grand Rapids Michigan, 49503, United States
Grand Rapids Michigan, 49503, United States
Grosse Pointe Woods Michigan, 48236, United States
Kalamazoo Michigan, 49001, United States
Kalamazoo Michigan, 49007, United States
Kalamazoo Michigan, 49007, United States
Lansing Michigan, 48910, United States
Pontiac Michigan, 48341, United States
Royal Oak Michigan, 48073, United States
Saginaw Michigan, 48601, United States
Warren Michigan, 48093, United States
Bemidji Minnesota, 56601, United States
Burnsville Minnesota, 55337, United States
Coon Rapids Minnesota, 55433, United States
Duluth Minnesota, 55805, United States
Edina Minnesota, 55435, United States
Fridley Minnesota, 55432, United States
Mankato Minnesota, 56002, United States
Maplewood Minnesota, 55109, United States
Minneapolis Minnesota, 55407, United States
Robbinsdale Minnesota, 55422, United States
Rochester Minnesota, 55905, United States
Saint Cloud Minnesota, 56303, United States
Saint Louis Park Minnesota, 55416, United States
Saint Louis Park Minnesota, 55416, United States
Saint Paul Minnesota, 55101, United States
Saint Paul Minnesota, 55102, United States
Waconia Minnesota, 55387, United States
Woodbury Minnesota, 55125, United States
Jackson Mississippi, 39216, United States
Kansas City Missouri, 64154, United States
Billings Montana, 59107, United States
Great Falls Montana, 59405, United States
Great Falls Montana, 59405, United States
Missoula Montana, 59807, United States
Kearney Nebraska, 68848, United States
Omaha Nebraska, 68114, United States
Omaha Nebraska, 68122, United States
Omaha Nebraska, 68124, United States
Omaha Nebraska, 68131, United States
Las Vegas Nevada, 89106, United States
Reno Nevada, 89502, United States
Reno Nevada, 89503, United States
Concord New Hampshire, 03301, United States
Dover New Hampshire, 03820, United States
Exeter New Hampshire, 03833, United States
Lebanon New Hampshire, 03756, United States
Manchester New Hampshire, 03103, United States
Basking Ridge New Jersey, 07920, United States
Elizabeth New Jersey, 07207, United States
Englewood New Jersey, 07631, United States
Livingston New Jersey, 07039, United States
Marlton New Jersey, 08053, United States
New Brunswick New Jersey, 08901, United States
Newark New Jersey, 07112, United States
Sparta New Jersey, 07871, United States
Toms River New Jersey, 08755, United States
Trenton New Jersey, 08629, United States
Voorhees New Jersey, 08043, United States
Albuquerque New Mexico, 87131, United States
Albany New York, 12206, United States
Buffalo New York, 14263, United States
Canandaigua New York, 14424, United States
Commack New York, 11725, United States
Cooperstown New York, 13326, United States
East Syracuse New York, 13057, United States
Ithaca New York, 14850, United States
Jamaica New York, 11432, United States
Manhasset New York, 11030, United States
New Hyde Park New York, 11040, United States
Poughkeepsie New York, 12601, United States
Poughkeepsie New York, 12601, United States
Rochester New York, 14620, United States
Rochester New York, 14621, United States
Rochester New York, 14626, United States
Rochester New York, 14642, United States
Sleepy Hollow New York, 10591, United States
Syracuse New York, 13210, United States
Asheville North Carolina, 28801, United States
Asheville North Carolina, 28816, United States
Charlotte North Carolina, 28232, United States
Charlotte North Carolina, 28233, United States
Durham North Carolina, 27710, United States
Hendersonville North Carolina, 28791, United States
High Point North Carolina, 27261, United States
Raleigh North Carolina, 27607, United States
Wilmington North Carolina, 28401, United States
Winston-Salem North Carolina, 27103, United States
Fargo North Dakota, 58102, United States
Grand Forks North Dakota, 58201, United States
Akron Ohio, 44307, United States
Akron Ohio, 44309, United States
Barberton Ohio, 44203, United States
Canton Ohio, 44710, United States
Cleveland Ohio, 44106, United States
Cleveland Ohio, 44111, United States
Cleveland Ohio, 44195, United States
Columbus Ohio, 43210, United States
Columbus Ohio, 43215, United States
Independence Ohio, 44131, United States
Lima Ohio, 45801, United States
Lima Ohio, 45804, United States
Mansfield Ohio, 44903, United States
Mayfield Heights Ohio, 44124, United States
Springfield Ohio, 45505, United States
Sylvania Ohio, 43560, United States
Toledo Ohio, 43614, United States
Toledo Ohio, 43623, United States
Wooster Ohio, 44691, United States
Tulsa Oklahoma, 74136, United States
Clackamas Oregon, 97015, United States
Eugene Oregon, 97401, United States
Grants Pass Oregon, 97527, United States
Gresham Oregon, 97030, United States
Medford Oregon, 97504, United States
Medford Oregon, 97504, United States
Milwaukie Oregon, 97222, United States
Portland Oregon, 97210, United States
Portland Oregon, 97213, United States
Portland Oregon, 97225, United States
Portland Oregon, 97225, United States
Portland Oregon, 97227, United States
Portland Oregon, 97239, United States
Salem Oregon, 97309, United States
Tualatin Oregon, 97062, United States
Beaver Pennsylvania, 15009, United States
Bethlehem Pennsylvania, 18015, United States
Danville Pennsylvania, 17822, United States
Drexel Hill Pennsylvania, 19026, United States
Dunmore Pennsylvania, 18512, United States
Erie Pennsylvania, 16505, United States
Harrisburg Pennsylvania, 17110, United States
Monroeville Pennsylvania, 15146, United States
Norristown Pennsylvania, 19401, United States
Philadelphia Pennsylvania, 19102, United States
Philadelphia Pennsylvania, 19107, United States
Philadelphia Pennsylvania, 19111, United States
Philadelphia Pennsylvania, 19114, United States
Pittsburgh Pennsylvania, 15212, United States
Pittsburgh Pennsylvania, 15213, United States
Pittsburgh Pennsylvania, 15224, United States
Reading Pennsylvania, 19612, United States
State College Pennsylvania, 16803, United States
Upland Pennsylvania, 19013, United States
Wilkes-Barre Pennsylvania, 18711, United States
York Pennsylvania, 17405, United States
Providence Rhode Island, 02903, United States
Providence Rhode Island, 02904, United States
Charleston South Carolina, 29401, United States
Charleston South Carolina, 29425, United States
Georgetown South Carolina, 29440, United States
Rapid City South Dakota, 57701, United States
Sioux Falls South Dakota, 57117, United States
Knoxville Tennessee, 37916, United States
Nashville Tennessee, 37232, United States
Bedford Texas, 76022, United States
Dallas Texas, 75390, United States
Denton Texas, 76210, United States
Fort Worth Texas, 76104, United States
Houston Texas, 77030, United States
Irving Texas, 75061, United States
Lewisville Texas, 75067, United States
Lubbock Texas, 79410, United States
Round Rock Texas, 78681, United States
San Antonio Texas, 78217, United States
San Antonio Texas, 78229, United States
Sherman Texas, 75090, United States
Sugar Land Texas, 77479, United States
Cedar City Utah, 84720, United States
Ogden Utah, 84403, United States
Provo Utah, 84604, United States
Saint George Utah, 84770, United States
Salt Lake City Utah, 84106, United States
Salt Lake City Utah, 84112, United States
Salt Lake City Utah, 84143, United States
Burlington Vermont, 05401, United States
Charlottesville Virginia, 22908, United States
Portsmouth Virginia, 23708, United States
Richmond Virginia, 23298, United States
Bellingham Washington, 98225, United States
Seattle Washington, 98109, United States
Seattle Washington, 98195, United States
Spokane Washington, 99204, United States
Vancouver Washington, 98664, United States
Charleston West Virginia, 25304, United States
Huntington West Virginia, 25702, United States
Wheeling West Virginia, 26003, United States
Eau Claire Wisconsin, 54701, United States
Green Bay Wisconsin, 54307, United States
Green Bay Wisconsin, 54311, United States
La Crosse Wisconsin, 54601, United States
Madison Wisconsin, 53717, United States
Madison Wisconsin, 53792, United States
Marshfield Wisconsin, 54449, United States
Menomonee Falls Wisconsin, 53051, United States
Mequon Wisconsin, 53097, United States
Milwaukee Wisconsin, 53211, United States
Milwaukee Wisconsin, 53215, United States
Milwaukee Wisconsin, 53226, United States
Oconomowoc Wisconsin, 53066, United States
Oshkosh Wisconsin, 54904, United States
Racine Wisconsin, 53405, United States
Stevens Point Wisconsin, 54481, United States
Summit Wisconsin, 53066, United States
Waukesha Wisconsin, 53188, United States
Wausau Wisconsin, 54401, United States
West Allis Wisconsin, 53227, United States
Weston Wisconsin, 54476, United States
Edmonton Alberta, T6G 1, Canada
Victoria British Columbia, V8R 6, Canada
Winnipeg Manitoba, R3E 0, Canada
London Ontario, N6A 4, Canada
Toronto Ontario, M4N 3, Canada
Montreal Quebec, H2L 4, Canada
Montreal Quebec, H3A 1, Canada
Montreal Quebec, H3G 1, Canada
Montreal Quebec, H3T 1, Canada
Quebec City Quebec, G1S 4, Canada
Saskatoon Saskatchewan, S7N 4, Canada
Galway , , Ireland
Tel Aviv , 64239, Israel
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