Breast Cancer Clinical Trial
Early Surgery or Standard Palliative Therapy in Treating Patients With Stage IV Breast Cancer
Summary
RATIONALE: Early surgery may have fewer side effects and improve recovery. Palliative surgery or radiation therapy may help patients with advanced breast cancer live more comfortably. It is not yet known whether early surgery is more effective than palliative therapy for advanced breast cancer.
PURPOSE: This randomized phase III trial is studying early surgery to see how well it works compared to standard palliative therapy in treating patients with stage IV breast cancer.
Full Description
OBJECTIVES:
Primary
To evaluate whether early local therapy of intact primary disease in patients with Stage IV breast cancer whose disease does not progress during initial optimal systemic therapy, will result in prolonged survival, compared to patients who receive local therapy for palliation only.
Secondary
To compare the time to uncontrolled chest wall disease between patients who receive early local therapy versus patients who receive palliative local therapy.
To determine whether there is a difference in health-related quality-of-life (HRQOL) between patients who receive early local therapy versus patients who receive palliative local therapy.
To determine whether the absolute value of circulating tumor cells (CTC) burden at 6 months following randomization (time +6) will be lower in the palliative therapy arm than in early local therapy arm, and whether this value is inversely related to survival (lower CTC, longer survival).
Exploratory
To collect tumor and blood specimens for future exploration of the biological interactions between the primary tumor and metastatic lesions and the effect of primary tumor resection.
OUTLINE: This is a multicenter study. Patients are stratified according to hormone receptor and treatment plan (ER+ or PR+, HER2-, endocrine therapy alone vs ER+ or PR+, and HER2-, chemotherapy and/or endocrine therapy vs ER- or PR-, and HER2- vs HER2+), and number of involved organ systems with distant disease (regional nodes in the axillary, supraclavicular, and internal mammary locations are not considered distant sites) (1 vs > 1). Patients are randomized to 1 of 2 treatment arms in 1:1 ratio.
Arm I: Patients receive standard palliative therapy, if needed, to address symptoms such as tumor ulceration, pain, bulky adenopathy causing arm symptoms, and other similar situations. Therapy may consist of radiotherapy alone, surgery alone, or a combination of both.
Arm II: Patients undergo surgery comprising breast-conserving therapy (BCT) or total mastectomy according to patient and treating physician preference. Surgery is to occur no later than 10 weeks after completion of 32 weeks of systemic therapy. Free surgical margins must be achieved with re-excision or mastectomy for patients undergoing BCT. After completion of BCT, patients undergo radiotherapy once a day, 5 days per week. Patients who had mastectomy undergo radiotherapy at the discretion of treating physician.
Patients may undergo blood and tumor tissue sample collection for circulating tumor cells (CTC) burden and future studies.
Patients complete the Functional Assessment of Cancer Therapy - Breast Trial Outcome Index (FACT- TOI) and FACT - General (22) and the Breast Cancer Subscale (FACT-B) quality-of-life questionnaires at baseline and periodically during study.
After completion of study therapy, patients are followed up periodically for 5 years.
Eligibility Criteria
Inclusion Criteria:
Diagnosis of intact primary (not recurrent) invasive carcinoma of the breast
Stage IV disease
Confirmation of the primary tumor should be by needle biopsy (preferred)
Incisional surgical biopsy allowed as long as there is residual palpable or tumor image in the breast
Patients must be judged to be candidates for complete resection with free margins followed by radiation therapy (if radiation therapy is indicated)
For women not undergoing axillary dissection, sentinel node biopsy should document an axillary nodal burden of 1-2 involved lymph nodes (i.e., ACOSOG Z-11 criteria may be applied)
Prior non-invasive (Ductal Carcinoma In Situ) cancer allowed provided there has been no recurrence
Prior ipsilateral invasive cancer allowed if more than 5 years previous
Patients should have at least one organ system involved with distant metastatic disease
If patient has only one metastatic lesion/focus, this must be proven by biopsy and the pathology report confirming the diagnosis of primary breast cancer, as well as the metastatic site, must be available
Must have available radiologic reports documenting disease status within the past 6 weeks prior to initiating systemic therapy
CNS metastases allowed provided projected survival > 6 months
Patients must have completed at least 16 weeks of optimal systemic therapy (appropriate to the tumor biological profile and the patient's age and menopausal status)
If systemic therapy is discontinued for toxicity, but there is no distant progression and at least 12 weeks of therapy have been delivered, then the patient remains eligible
Radiation therapy (if indicated) must begin within 12 weeks of final therapeutic surgical procedure (including re-excision for free margins and completion of axillary dissection)
Patients may register at any time from the time of diagnosis of stage IV breast cancer (if eligibility criteria met) to the time when a maximum of 30 weeks of induction systemic therapy has been completed
Patients must be randomized within 16-32 weeks after the start of systemic therapy
Patients must not have experienced disease progression since the start of systemic therapy, as evidenced by radiographic documentation of disease status before treatment and within 4 weeks +/- 2 weeks prior to randomization, including:
No new sites of disease
No enlargement of existing sites by 20% or more in longest diameter
No symptomatic deterioration
Patients who require radiotherapy to bone metastases during induction systemic therapy are eligible
Local disease at the primary site must be asymptomatic
Hormone receptor status known
Menopausal status not specified
Patients must have adequate organ function to undergo local therapy 4 weeks +/- 2 weeks prior to randomization per investigator discretion and institutional guidelines
More than 5 years since other primary cancers that were curatively treated
Negative pregnancy test
Fertile patients must use an accepted and effective contraception method
Exclusion criteria:
Synchronous contralateral breast cancer
Pregnant or nursing
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There are 331 Locations for this study
Mobile Alabama, 36604, United States
Anchorage Alaska, 99508, United States
Scottsdale Arizona, 85259, United States
Castro Valley California, 94546, United States
Chico California, 95926, United States
Fairfield California, 94533, United States
Greenbrae California, 94904, United States
Long Beach California, 90806, United States
Martinez California, 94553, United States
Monterey California, 93940, United States
Mountain View California, 94040, United States
Oakland California, 94609, United States
Orange California, 92868, United States
San Pablo California, 94806, United States
Stanford California, 94305, United States
Boulder Colorado, 80301, United States
Colorado Springs Colorado, 80933, United States
Denver Colorado, 80218, United States
Wheat Ridge Colorado, 80033, United States
Hartford Connecticut, 06105, United States
Norwalk Connecticut, 06856, United States
Norwich Connecticut, 06360, United States
Lewes Delaware, 19958, United States
Newark Delaware, 19713, United States
Daytona Beach Florida, 32114, United States
Jacksonville Florida, 32224, United States
Orlando Florida, 32803, United States
Orlando Florida, 32806, United States
Tampa Florida, 33612, United States
Atlanta Georgia, 30303, United States
Atlanta Georgia, 30308, United States
Atlanta Georgia, 30309, United States
Atlanta Georgia, 30322, United States
Atlanta Georgia, 30342, United States
Atlanta Georgia, 30342, United States
Columbus Georgia, 31904, United States
Decatur Georgia, 30033, United States
Marietta Georgia, 30060, United States
Riverdale Georgia, 30274, United States
Savannah Georgia, 31405, United States
'Aiea Hawaii, 96701, United States
'Ewa Beach Hawaii, 96706, United States
Honolulu Hawaii, 96813, United States
Honolulu Hawaii, 96813, United States
Honolulu Hawaii, 96813, United States
Honolulu Hawaii, 96817, United States
Honolulu Hawaii, 96817, United States
Boise Idaho, 83706, United States
Boise Idaho, 83712, United States
Fruitland Idaho, 83619, United States
Meridian Idaho, 83642, United States
Nampa Idaho, 83686, United States
Twin Falls Idaho, 83301, United States
Bloomington Illinois, 61701, United States
Canton Illinois, 61520, United States
Carthage Illinois, 62321, United States
Chicago Illinois, 60611, United States
Chicago Illinois, 60611, United States
Chicago Illinois, 60612, United States
Chicago Illinois, 60612, United States
Chicago Illinois, 60631, United States
Chicago Illinois, 60637, United States
Chicago Illinois, 60640, United States
Decatur Illinois, 62526, United States
Elmhurst Illinois, 60126, United States
Eureka Illinois, 61530, United States
Galesburg Illinois, 61401, United States
Harvey Illinois, 60426, United States
Highland Park Illinois, 60035, United States
Hinsdale Illinois, 60521, United States
Kankakee Illinois, 60901, United States
Libertyville Illinois, 60048, United States
Macomb Illinois, 61455, United States
Maywood Illinois, 60153, United States
Moline Illinois, 61265, United States
Niles Illinois, 60714, United States
Normal Illinois, 61761, United States
Normal Illinois, 61761, United States
Ottawa Illinois, 61350, United States
Ottawa Illinois, 61350, United States
Pekin Illinois, 61554, United States
Peoria Illinois, 61614, United States
Peoria Illinois, 61615, United States
Peoria Illinois, 61615, United States
Peoria Illinois, 61636, United States
Peoria Illinois, 61637, United States
Peru Illinois, 61354, United States
River Forest Illinois, 60305, United States
Rockford Illinois, 61104, United States
Skokie Illinois, 60076, United States
Springfield Illinois, 62781, United States
Beech Grove Indiana, 46107, United States
Elkhart Indiana, 46515, United States
Goshen Indiana, 46526, United States
Indianapolis Indiana, 46202, United States
Indianapolis Indiana, 46202, United States
Kokomo Indiana, 46904, United States
La Porte Indiana, 46350, United States
Mishawaka Indiana, 46545, United States
Mishawaka Indiana, 46545, United States
Richmond Indiana, 47374, United States
South Bend Indiana, 46601, United States
South Bend Indiana, 46601, United States
Ames Iowa, 50010, United States
Clive Iowa, 50325, United States
Des Moines Iowa, 50309, United States
Des Moines Iowa, 50309, United States
Des Moines Iowa, 50309, United States
Des Moines Iowa, 50314, United States
Des Moines Iowa, 50314, United States
Des Moines Iowa, 50316, United States
Ottumwa Iowa, 52501, United States
Sioux City Iowa, 51101, United States
Sioux City Iowa, 51102, United States
Sioux City Iowa, 51104, United States
Chanute Kansas, 66720, United States
Dodge City Kansas, 67801, United States
El Dorado Kansas, 67042, United States
Fort Scott Kansas, 66701, United States
Independence Kansas, 67301, United States
Kingman Kansas, 67068, United States
Lawrence Kansas, 66044, United States
Liberal Kansas, 67901, United States
McPherson Kansas, 67460, United States
Newton Kansas, 67114, United States
Parsons Kansas, 67357, United States
Prairie Village Kansas, 66208, United States
Pratt Kansas, 67124, United States
Salina Kansas, 67401, United States
Wellington Kansas, 67152, United States
Wichita Kansas, 67208, United States
Wichita Kansas, 67214, United States
Wichita Kansas, 67214, United States
Wichita Kansas, 67214, United States
Winfield Kansas, 67156, United States
Edgewood Kentucky, 41017, United States
Lexington Kentucky, 40536, United States
Alexandria Louisiana, 71315, United States
Annapolis Maryland, 21401, United States
Baltimore Maryland, 21204, United States
Baltimore Maryland, 21229, United States
Baltimore Maryland, 21231, United States
Easton Maryland, 21601, United States
Elkton Maryland, 21921, United States
Adrian Michigan, 49221, United States
Ann Arbor Michigan, 48106, United States
Ann Arbor Michigan, 48106, United States
Dearborn Michigan, 48123, United States
Detroit Michigan, 48201, United States
Escanaba Michigan, 49431, United States
Flint Michigan, 48503, United States
Flint Michigan, 48503, United States
Grand Rapids Michigan, 49503, United States
Grosse Pointe Woods Michigan, 48236, United States
Iron Mountain Michigan, 49801, United States
Jackson Michigan, 49201, United States
Kalamazoo Michigan, 49001, United States
Kalamazoo Michigan, 49007, United States
Kalamazoo Michigan, 49007, United States
Lansing Michigan, 48912, United States
Livonia Michigan, 48154, United States
Midland Michigan, 48670, United States
Monroe Michigan, 48162, United States
Monroe Michigan, 48162, United States
Muskegon Michigan, 49444, United States
Pontiac Michigan, 48341, United States
Port Huron Michigan, 48060, United States
Reed City Michigan, 49677, United States
Royal Oak Michigan, 48073, United States
Saginaw Michigan, 48601, United States
Saint Joseph Michigan, 49085, United States
Saint Joseph Michigan, 49085, United States
Southfield Michigan, 48075, United States
Traverse City Michigan, 49684, United States
Warren Michigan, 48093, United States
Burnsville Minnesota, 55337, United States
Coon Rapids Minnesota, 55433, United States
Edina Minnesota, 55435, United States
Fridley Minnesota, 55432, United States
Hutchinson Minnesota, 55350, United States
Mankato Minnesota, 56002, United States
Maplewood Minnesota, 55109, United States
Maplewood Minnesota, 55109, United States
Minneapolis Minnesota, 55407, United States
Minneapolis Minnesota, 55415, United States
New Ulm Minnesota, 56073, United States
Robbinsdale Minnesota, 55422, United States
Rochester Minnesota, 55905, 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
Shakopee Minnesota, 55379, United States
Stillwater Minnesota, 55082, United States
Waconia Minnesota, 55387, United States
Willmar Minnesota, 56201, United States
Woodbury Minnesota, 55125, United States
Jackson Mississippi, 39216, United States
Pascagoula Mississippi, 39581, United States
Cape Girardeau Missouri, 63703, United States
Kansas City Missouri, 64111, United States
Kansas City Missouri, 64132, United States
Rolla Missouri, 65401, United States
Saint Joseph Missouri, 64506, United States
Saint Joseph Missouri, 64507, United States
Saint Louis Missouri, 63128, United States
Saint Louis Missouri, 63141, United States
Springfield Missouri, 65804, United States
Springfield Missouri, 65807, United States
Billings Montana, 59101, United States
Billings Montana, 59107, United States
Great Falls Montana, 59405, United States
Great Falls Montana, 59405, United States
Great Falls Montana, 59405, United States
Lincoln Nebraska, 68510, United States
Omaha Nebraska, 68106, United States
Omaha Nebraska, 68122, United States
Omaha Nebraska, 68130, United States
Omaha Nebraska, 68131, United States
Lebanon New Hampshire, 03756, United States
Manchester New Hampshire, 03102, United States
Flemington New Jersey, 08822, United States
Marlton New Jersey, 08053, United States
Newark New Jersey, 07112, United States
Sewell New Jersey, 08080, United States
Toms River New Jersey, 08755, United States
Voorhees New Jersey, 08043, United States
Voorhees New Jersey, 08043, United States
Albuquerque New Mexico, 87102, United States
Albuquerque New Mexico, 87131, United States
Las Cruces New Mexico, 88011, United States
Buffalo New York, 14263, United States
Cooperstown New York, 13326, United States
Mineola New York, 11501, United States
New York New York, 10003, United States
New York New York, 10025, United States
New York New York, 10029, United States
New York New York, 10065, United States
Poughkeepsie New York, 12601, United States
Rochester New York, 14620, United States
Rochester New York, 14642, United States
Staten Island New York, 10305, United States
White Plains New York, 10601, United States
Charlotte North Carolina, 28232, United States
Concord North Carolina, 28025, United States
Statesville North Carolina, 28677, United States
Winston-Salem North Carolina, 27157, United States
Bismarck North Dakota, 58501, United States
Bismarck North Dakota, 58501, United States
Bismarck North Dakota, 58502, United States
Fargo North Dakota, 58122, United States
Minot North Dakota, 58701, United States
Akron Ohio, 44307, United States
Akron Ohio, 44309, United States
Bowling Green Ohio, 43402, United States
Cleveland Ohio, 44106, United States
Columbus Ohio, 43214, United States
Columbus Ohio, 43215, United States
Columbus Ohio, 43215, United States
Columbus Ohio, 43222, United States
Columbus Ohio, 43228, United States
Dayton Ohio, 45406, United States
Dayton Ohio, 45409, United States
Dayton Ohio, 45415, United States
Delaware Ohio, 43015, United States
Elyria Ohio, 44035, United States
Elyria Ohio, 44035, United States
Findlay Ohio, 45840, United States
Franklin Ohio, 45005, United States
Lancaster Ohio, 43130, United States
Lima Ohio, 45804, United States
Marietta Ohio, 45750, United States
Maumee Ohio, 43537, United States
Mount Vernon Ohio, 43050, United States
Newark Ohio, 43055, United States
Oregon Ohio, 43616, United States
Oregon Ohio, 43616, United States
Portsmouth Ohio, 45662, United States
Springfield Ohio, 45505, United States
Sylvania Ohio, 43560, United States
Tiffin Ohio, 44883, United States
Toledo Ohio, 43606, United States
Toledo Ohio, 43608, United States
Toledo Ohio, 43614, United States
Toledo Ohio, 43617, United States
Toledo Ohio, 43623, United States
Toledo Ohio, 43623, United States
Troy Ohio, 45373, United States
Wauseon Ohio, 43567, United States
Westerville Ohio, 43081, United States
Zanesville Ohio, 43701, United States
Oklahoma City Oklahoma, 73104, United States
Bethlehem Pennsylvania, 18015, United States
Easton Pennsylvania, 18042, United States
Hanover Pennsylvania, 17331, United States
Hershey Pennsylvania, 17033, United States
Lancaster Pennsylvania, 17604, United States
Langhorne Pennsylvania, 19047, United States
Lewistown Pennsylvania, 17044, United States
Meadowbrook Pennsylvania, 19046, United States
Philadelphia Pennsylvania, 19107, United States
Philadelphia Pennsylvania, 19111, United States
Pittsburgh Pennsylvania, 15232, United States
State College Pennsylvania, 16803, United States
Williamsport Pennsylvania, 17701, United States
York Pennsylvania, 17405, United States
Charleston South Carolina, 29401, United States
Charleston South Carolina, 29425, United States
Spartanburg South Carolina, 29303, United States
Spartanburg South Carolina, 29303, United States
Sioux Falls South Dakota, 57105, United States
Sioux Falls South Dakota, 57117, United States
Jackson Tennessee, 38301, United States
Galveston Texas, 77555, United States
Houston Texas, 77030, United States
Houston Texas, 77030, United States
Irving Texas, 75061, United States
Laredo Texas, 78045, United States
Temple Texas, 76508, United States
Salt Lake City Utah, 84112, United States
Fredericksburg Virginia, 22401, United States
Richmond Virginia, 23298, United States
Bellingham Washington, 98225, United States
Bremerton Washington, 98310, United States
Seattle Washington, 98122, United States
Seattle Washington, 98195, United States
Walla Walla Washington, 99362, United States
Huntington West Virginia, 25702, United States
Antigo Wisconsin, 54409, United States
Appleton Wisconsin, 54911, United States
Appleton Wisconsin, 54911, United States
Appleton Wisconsin, 54911, United States
Chippewa Falls Wisconsin, 54729, United States
Eau Claire Wisconsin, 54701, United States
Eau Claire Wisconsin, 54701, United States
Green Bay Wisconsin, 54301, United States
Green Bay Wisconsin, 54303, United States
Green Bay Wisconsin, 54303, United States
Green Bay Wisconsin, 54307, United States
Green Bay Wisconsin, 54311, United States
Johnson Creek Wisconsin, 53038, United States
La Crosse Wisconsin, 54601, United States
Madison Wisconsin, 53792, United States
Manitowoc Wisconsin, 54221, United States
Marinette Wisconsin, 54143, United States
Marinette Wisconsin, 54143, United States
Marshfield Wisconsin, 54449, United States
Milwaukee Wisconsin, 53226, United States
Minocqua Wisconsin, 54548, United States
Oconomowoc Wisconsin, 53066, United States
Oconto Falls Wisconsin, 54154, United States
Oshkosh Wisconsin, 54904, United States
Rhinelander Wisconsin, 54501, United States
Rice Lake Wisconsin, 54868, United States
Sheboygan Wisconsin, 53081, United States
Sheboygan Wisconsin, 53081, United States
Stevens Point Wisconsin, 54481, United States
Stevens Point Wisconsin, 54481, United States
Sturgeon Bay Wisconsin, 54235, United States
Summit Wisconsin, 53066, United States
Two Rivers Wisconsin, 54241, United States
Waukesha Wisconsin, 53188, United States
Wausau Wisconsin, 54401, United States
Wausau Wisconsin, 54401, United States
Wauwatosa Wisconsin, 53226, United States
Weston Wisconsin, 54476, United States
Weston Wisconsin, 54476, United States
Wisconsin Rapids Wisconsin, 54494, United States
Wisconsin Rapids Wisconsin, 54494, United States
Edmonton Alberta, T6G 1, Canada
Winnipeg Manitoba, R3E 0, Canada
Saint John New Brunswick, E2L 4, Canada
London Ontario, N6A 4, Canada
Montreal Quebec, H2W 1, Canada
Tel Aviv , 64239, Israel
Riyadh , 11211, Saudi Arabia
Pretoria , 0002, South Africa
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