S0221 Adjuvant Doxorubicin, Cyclophosphamide, and Paclitaxel in Treating Patients With Breast Cancer



Status:Active, not recruiting
Conditions:Breast Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:12/27/2018
Start Date:November 2003
End Date:January 2027

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Phase III Trial of Continuous Schedule AC + G vs. Q 2 Week Schedule AC, Followed by Paclitaxel Given Either Every 2 Weeks or Weekly for 12 Weeks as Post-Operative Adjuvant Therapy in Node-Positive or High-Risk Node-Negative Breast Cancer

RATIONALE: Drugs used in chemotherapy, such as doxorubicin, cyclophosphamide, and paclitaxel,
use different ways to stop tumor cells from dividing so they stop growing or die. Combining
more than one drug and giving them after surgery may kill any remaining tumor cells. It is
not yet known which combination chemotherapy regimen is more effective in treating resected
breast cancer.

PURPOSE: This randomized phase III trial is comparing 2 different regimens of combination
chemotherapy to see how well they work in treating patients who have undergone surgery for
stage I, stage II, or stage III breast cancer.

OBJECTIVES:

- Compare the disease-free survival of patients with node-positive or high-risk
node-negative breast cancer treated with 2 different schedules of adjuvant doxorubicin,
cyclophosphamide, and paclitaxel.

- Compare the overall survival of patients treated with these regimens.

- Compare the toxic effects of these regimens in these patients.

- Correlate outcome with putative prognostic markers in patients treated with these
regimens.

OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2 treatment
arms (arms V and VI) (arms I-IV closed 11/10/10).

- Arm I: (closed 11/10/10) Patients receive doxorubicin IV and cyclophosphamide IV on day
1 and pegfilgrastim subcutaneously (SC) on day 2 or filgrastim (G-CSF) SC on days 3-10.
Treatment repeats every 14 days for 6 courses.

Beginning 2 weeks after completion of doxorubicin and cyclophosphamide, patients receive
paclitaxel IV over 3 hours on day 1 and pegfilgrastim SC on day 2. Treatment repeats every 14
days for 6 courses.

- Arm II: (closed 11/10/10) Patients receive doxorubicin IV on day 1, oral
cyclophosphamide on days 1-7, and G-CSF SC on days 2-7. Treatment repeats every 7 days
for 15 courses.

Beginning 2 weeks after completion of cyclophosphamide, patients receive paclitaxel and
pegfilgrastim as in arm I.

- Arm III: (closed 11/10/10) Patients receive doxorubicin, cyclophosphamide, and
pegfilgrastim or G-CSF as in arm I.

Beginning 2 weeks after completion of doxorubicin and cyclophosphamide, patients receive
paclitaxel IV over 1 hour on day 1. Treatment repeats every 7 days for 12 courses.

- Arm IV: (closed 11/10/10) Patients receive doxorubicin, cyclophosphamide, and G-CSF as
in arm II.

Beginning 2 weeks after completion of cyclophosphamide, patients receive paclitaxel as in arm
III.

- Arm V: Patients receive doxorubicin IV and cyclophosphamide IV on day 1 and
pegfilgrastim SC on day 2. Treatment repeats every 14 days for 4 courses. Patients
receive doxorubicin IV and cyclophosphamide IV on day 1 and pegfilgrastim SC on day 2.
Treatment repeats every 14 days for 6 courses.

Beginning 2 weeks after completion of doxorubicin and cyclophosphamide, patients receive
paclitaxel IV over 3 hours on day 1 and pegfilgrastim SC on day 2. Treatment repeats every 14
days for 6 courses.

- Arm VI: Patients receive doxorubicin, cyclophosphamide, and pegfilgrastim as in arm V.

Beginning 2 weeks after completion of doxorubicin and cyclophosphamide, patients receive
paclitaxel IV over 1 hour on day 1. Treatment repeats every 7 days for 12 courses.

In all arms, treatment continues in the absence of disease progression or unacceptable
toxicity.

In all arms patients with HER2/neu-positive tumors also receive trastuzumab (Herceptin®)
weekly or every 3 weeks beginning concurrently with paclitaxel OR 3 months after the last
dose of paclitaxel and continuing for up to 52 weeks.

In all arms, patients with estrogen-receptor or progesterone-receptor positive tumors receive
hormonal therapy beginning within 28 days of the completion of adjuvant chemotherapy or
radiotherapy (if given).

After finishing study treatment patients are followed up every 6 months for 5 years and then
once a year for up to 15 years.

PROJECTED ACCRUAL: A total of 3,250 patients will be accrued for this study.

DISEASE CHARACTERISTICS:

- Histologically confirmed stage I-III invasive breast cancer

- Operable disease

- Stage I, II, IIIA, and IIIC (T1-3, N3a only)

- No T4 tumors

- High-risk disease, defined by 1 of the following:

- Tumor ≥ 2 cm in greatest diameter (includes both invasive and intraductal
component)

- Patients with nodal status of N0+ (i.e., no cluster of tumor cells in any
node greater than 0.2 mm) are considered to be node negative and must have a
primary tumor ≥ 2 cm in size or have a tumor ≥ 1 cm with high risk features

- Patients who are node negative on the basis of a sentinel node procedure and
fewer than 6 axillary nodes are removed are eligible OR at least 6 axillary
or intramammary nodes must be negative

- Tumor ≥ 1 cm in diameter and meeting 1 of the following criteria:

- ER-negative and PgR-negative

- ER-positive or PgR-positive with a Genomic Health Recurrence Score of ≥ 26

- One or more axillary or intramammary nodes are involved by metastatic breast
cancer

- If one or more nodes is involved, a minimum of 6 axillary or intramammary
nodes must have been examined histologically

- Patients with N0(I+) disease will be considered node negative

- HER2/neu-positive tumors (3+ by immunohistochemical staining or amplified by
fluorescence in-situ hybridization) allowed

- Bilateral synchronous breast cancer diagnosed within 1 month of each other allowed
provided the higher TNM stage primary tumor meets the eligibility criteria

- Prior modified radical mastectomy OR local excision of all tumors with axillary lymph
node dissection or sentinel node resection required

- No more than 84 days since prior surgery for the primary tumor and/or axilla

- Final resection margins for the primary tumor must be histologically negative for
invasive cancer and ductal carcinoma in situ

- Resection margins positive for lobular carcinoma in situ are allowed

- Hormone receptor status:

- Estrogen receptor status known

- Progesterone receptor status known

PATIENT CHARACTERISTICS:

Age

- 18 and over

Sex

- Male or female

Menopausal status

- Not specified

Performance status

- Zubrod 0-2

Life expectancy

- Not specified

Hematopoietic

- Absolute neutrophil count at least 1,200/mm^3

- Platelet count at least 100,000/mm^3

Hepatic

- Bilirubin no greater than upper limit of normal (ULN)

- Alkaline phosphatase no greater than 2 times ULN

- SGOT or SGPT no greater than 2 times ULN

Renal

- Creatinine no greater than ULN

Cardiovascular

- No congestive heart failure

- No active angina pectoris

- LVEF greater than or equal to the lower limit of normal* by MUGA or echocardiogram
NOTE: Patients age 60 and over OR with a history of hypertension

Other

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- No other malignancy within the past 5 years except adequately treated basal cell or
squamous cell skin cancer, in situ cervical carcinoma, or lobular carcinoma in situ of
the breast

- Prior invasive breast cancer or ductal carcinoma in situ allowed if disease-free
for 5 years

- HIV negative

PRIOR CONCURRENT THERAPY:

Biologic therapy

- Not specified

Chemotherapy

- No prior cytotoxic chemotherapy for this breast cancer

- No prior chemotherapy with an anthracycline, anthracenedione, or taxane

Endocrine therapy

- Not specified

Radiotherapy

- No prior radiotherapy for this malignancy

- At least 2 weeks since prior radiotherapy for ductal carcinoma in situ

Surgery

- See Disease Characteristics
We found this trial at
542
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100 Provena Way
Kankakee, Illinois 60914
815.937.8780
Provena St. Mary's Regional Cancer Center - Kankakee For over 20 years, Presence St. Mary's...
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1201 Camino de Salud Northeast
Albuquerque, New Mexico 87131
(505) 272-4946
University of New Mexico Cancer Center It’s been 40 years since the New Mexico State...
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2401 West Belvedere Avenue
Baltimore, Maryland 21215
(410) 601-4688
Alvin and Lois Lapidus Cancer Institute at Sinai Hospital The Alvin & Lois Lapidus Cancer...
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1802 6th Avenue South
Birmingham, Alabama 35294
(205) 934-4011
UAB Comprehensive Cancer Center One of the nation’s leading cancer research and treatment centers, the...
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2720 Clare Avenue
Bremerton, Washington 98310
360-479-6154
Olympic Hematology and Oncology We provide outpatient cancer services in a refined environment designed specifically...
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666 Elm Street
Buffalo, New York 14263
(716) 845-2300
Roswell Park Cancer Institute Welcome to Roswell Park Cancer Institute (RPCI), America's first cancer center...
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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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2010 E 90th St
Cleveland, Ohio 44195
(866) 223-8100
Cleveland Clinic Taussig Cancer Center At Taussig Cancer Institute, more than 250 highly skilled doctors,...
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166 Stoneridge Drive
Columbia, South Carolina 29210
803-461-3000
South Carolina Oncology Associates, PA South Carolina Oncology Associates (SCOA) is the only comprehensive cancer...
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3535 Olentangy River Road
Columbus, Ohio 43214
(614) 566-5000
Riverside Methodist Hospital Cancer Care Serving central Ohio since 1892, Riverside Methodist is consistently ranked...
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4100 John R
Detroit, Michigan 48201
800-527-6266
Barbara Ann Karmanos Cancer Institute Karmanos is based in southeast Michigan, in midtown Detroit, and...
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1 Hurley Plaza
Flint, Michigan 48503
(810) 262-9000
Hurley Medical Center From its founding in 1908, Hurley Medical Center has devoted itself to...
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4725 North Federal Highway
Fort Lauderdale, Florida 33308
(954) 492-5764
Michael and Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital Holy Cross Hospital's Michael...
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11143 Parkview Plaza Dr # 100
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(260) 484-8830
Fort Wayne Medical Oncology and Hematology Fort Wayne Medical Oncology and Hematology provides state-of-the-art cancer...
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301 University Blvd
Galveston, Texas 77555
(409) 772-1011
University of Texas Medical Branch Established in 1891 as the University of Texas Medical Department,...
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900 West Faris Road
Greenville, South Carolina 29605
(864) 679-3900
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3 Butternut Drive, Suite B
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(864) 241-7272
Cancer Centers of the Carolinas - Grove Commons Cancer Centers of the Carolinas is now...
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701 Grove Rd # 1
Greenville, South Carolina 29605
(864) 455-7000
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33 Villa Road, Suite 400
Greenville, South Carolina 29615
(864) 404-2045
CCOP - Greenville Cancer care in the last decade has made many advances. Most of...
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340 Medical Pkwy
Greer, South Carolina 29650
(864) 334-4900
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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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500 University Drive
Hershey, Pennsylvania 17033
(717) 531-8521
Penn State Hershey Cancer Institute at Milton S. Hershey Medical Center Penn State Milton S....
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701 Ilalo Street Suite 600
Honolulu, Hawaii 96813
808-586-3010
Cancer Research Center of Hawaii The University of Hawaii Cancer Center is the only National...
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1240 S Old Dixie Hwy
Jupiter, Florida 33458
(561) 263-4400
Ella Milbank Foshay Cancer Center at Jupiter Medical Center The Foshay Cancer Center is one...
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524 South Park Street
Kalamazoo, Michigan 49007
(269) 341-7654
Bronson Methodist Hospital Our healthcare system serves patients and families throughout southwest Michigan and northern...
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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 Doctors Dr
Kinston, North Carolina 28504
(252) 559-2200
Kinston Medical Specialists offers comprehensive medical services for all ages. Whether it’s a case of...
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1900 South Avenue
La Crosse, Wisconsin 54601
(608) 782-7300
Gundersen Lutheran Center for Cancer and Blood Gundersen Health System is where caring meets excellence...
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1800 West Charleston Boulevard
Las Vegas, Nevada 89102
(702) 383-2000
University Medical Center of Southern Nevada University Medical Center is dedicated to providing the highest...
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One Medical Center Drive
Lebanon, New Hampshire 03756
(603) 653-9000
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center Norris Cotton Cancer Center at DHMC in...
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4300 Alton Road
Miami Beach, Florida 33140
(305) 674-2625
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1415 E. Kincaid
Mount Vernon, Washington 98273
360-424-4111
Skagit Valley Hospital Cancer Care Center We know that treatment takes its toll physically, emotionally...
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1300 York Avenue # A421
New York, New York 10065
New York Weill Cornell Cancer Center at Cornell University Welcome to the Division of Hematology...
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19500 10th Ave NE # 100
Poulsbo, Washington 98370
(360) 598-7500
Harrison Poulsbo Hematology and Onocology Harrison Poulsbo's new Hematology & Oncology center provides outpatient cancer...
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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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2279 45th Street
Sacramento, California 95817
(916) 734-5800
University of California Davis Cancer Center At UC Davis Comprehensive Cancer Center, specialized teams of...
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4502 Medical Drive
San Antonio, Texas 78284
(210) 567-7000
University of Texas Health Science Center at San Antonio The University of Texas Health Science...
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1600 Divisadero Street
San Francisco, California 94115
888.689.8273
UCSF Helen Diller Family Comprehensive Cancer Center UCSF’s long tradition of excellence in cancer research...
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1100 Fairview Avenue North
Seattle, Washington 98109
(206) 667-5000
Fred Hutchinson Cancer Research Center At Fred Hutchinson Cancer Research Center, our interdisciplinary teams of...
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201 16th Avenue East
Seattle, Washington 98112
(206) 326-3000
Group Health Central Hospital Group Health Cooperative is a member-governed, nonprofit health care system that...
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747 Broadway
Seattle, Washington 98122
206-386-6000
Swedish Cancer Institute at Swedish Medical Center - First Hill Campus Since 1910, Swedish has...
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1959 NE Pacific St
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(206) 598-4100
University Cancer Center at University of Washington Medical Center The Division of Radiation Oncology's work...
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131 Lila Doyle Drive
Seneca, South Carolina 29672
(864) 888-3717
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120 Dillon Dr
Spartanburg, South Carolina 29307
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601 South Sherman Street
Spokane, Washington 99202
(509) 228-1000
Cancer Care Northwest - Spokane South Cancer Care Northwest is the Inland Northwest’s premier cancer...
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105 West 8th Avenue
Spokane, Washington 99220
(509) 474-3131
Providence Cancer Center at Sacred Heart Medical Center When Mother Joseph and the Sisters of...
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1717 S J St
Tacoma, Washington 98405
(253) 426-4101
Franciscan Cancer Center at St. Joseph Medical Center St. Joseph Medical Center is a 361-bed...
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1501 North Campbell Avenue
Tucson, Arizona 85719
(520) 694-CURE (2873)
Arizona Cancer Center at University of Arizona Health Sciences Center Since being established in 1976,...
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820 North Chelan Avenue
Wenatchee, Washington 98801
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Wenatchee Valley Medical Center Established on July 21, 2013, Confluence Health is an affiliation between...
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825 N Emporia Ave
Wichita, Kansas 67214
(316) 261-3200
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808 North 39th Avenue
Yakima, Washington 98902
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98-1079 Moanalua Road
'Aiea, Hawaii 96701
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777 Kimole Ln
Adrian, Michigan 49221
517-265-0900
Hickman Cancer Center at Bixby Medical Center At ProMedica Bixby Hospital, we
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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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161 North Forge Street
Akron, Ohio 44304
(330) 375-7280
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Alamosa, Colorado 81101
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Albuquerque, New Mexico 87106
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1415 Tulane Ave., HC-62
Alexandria, Louisiana 70112
504-988-6121
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American Fork, Utah 84003
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Ames, Iowa 50010
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1211 24th Street
Anacortes, Washington 98221
(360) 299-1300
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Anchorage, Alaska 99508
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5301 East Huron River Drive
Ann Arbor, Michigan 48106
1.877.590.5995
CCOP - Michigan Cancer Research Consortium The Community Clinical Oncology Program (CCOP) is a comprehensive...
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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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5301 McAuley Drive
Ann Arbor, Michigan 48197
734-712-4673
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Anniston, Alabama 36207
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Antigo, Wisconsin 54409
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Asheville, North Carolina 28816
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Atlanta, Georgia 30342
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5665 Peachtree Dunwoody Rd NE
Atlanta, Georgia 30342
(678) 843-7001
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1968 Peachtree Rd NW
Atlanta, Georgia 30309
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Atlanta, Georgia 30342
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Aurora, Illinois 60507
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Austell, Georgia 30106
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900 Caton Ave.
Baltimore, Maryland 21229
410-368-6000
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Baton Rouge, Louisiana 70809
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300 North Ave
Battle Creek, Michigan 49017
(269) 245-8000
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Bay City, Michigan 48708
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8111 South Emerson Avenue
Beech Grove, Indiana 46237
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Bellefontaine, Ohio 43311
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3301 Squalicum Parkway
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(360) 788-8222
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Bennington, Vermont 05201
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2450 Ashby Ave.
Berkeley, California 94705
(510) 204-4444
Alta Bates Summit Comprehensive Cancer Center Our Comprehensive Cancer Services are comprised of exceptional, state-of-the-art...
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1351 Kimberly Rd
Bettendorf, Iowa 52722
(563) 355-7733
Hematology Oncology Associates of the Quad Cities
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605 Oak St
Big Rapids, Michigan 49307
(231) 796-8691
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Billings, Montana 59107
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1101 N 27th St # 201
Billings, Montana 59101
(406) 237-3585
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2900 12th Ave N Ste 160W
Billings, Montana 59101
(406) 238-6290
Hematology-Oncology Centers of the Northern Rockies - Billings The physicians and staff of Hematology-Oncology Centers...
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500 N 8th St
Bismarck, North Dakota 58501
(701) 222-6100
Bismarck Cancer Center The Bismarck Cancer Center (BCC) is a joint venture between Sanford Health...
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720 E Rosser Ave
Bismarck, North Dakota 58501
(701) 323-6741
Medcenter One Hospital Cancer Care Center Sanford Health is an integrated health system headquartered in...
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900 E Broadway Ave
Bismarck, North Dakota 58501
(701) 530-5550
Mid Dakota Clinic, PC We're your family clinic, with the doctors you know and trust...
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900 East Broadway
Bismarck, North Dakota 58501
701.530.7000
St. Alexius Medical Center Cancer Center Throughout the healing continuum we are dedicated to our...
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