Doxorubicin Hydrochloride, Cyclophosphamide, and Paclitaxel With or Without Bevacizumab in Treating Patients With Lymph Node-Positive or High-Risk, Lymph Node-Negative Breast Cancer
Launched by NATIONAL CANCER INSTITUTE (NCI) · Feb 8, 2007
Trial Information
Current as of May 29, 2025
Active, not recruiting
Keywords
ClinConnect Summary
This clinical trial is looking at how effective a combination of chemotherapy drugs—doxorubicin, cyclophosphamide, and paclitaxel—are in treating certain types of breast cancer, specifically those that have spread to the lymph nodes or are at high risk of returning. The trial is also testing whether adding a drug called bevacizumab, which helps block blood flow to tumors, makes the treatment more effective. Participants will receive chemotherapy after their surgery to kill any remaining cancer cells and reduce the chance of the cancer coming back.
To be eligible for this trial, patients must have a confirmed diagnosis of breast cancer that meets specific criteria, such as having cancer in the lymph nodes or certain tumor characteristics. They should have completed surgery for their breast cancer and have no signs of active disease. Patients will be monitored closely during the trial, and the treatment will focus on ensuring their health and safety throughout the process. This trial is currently active but not recruiting new participants, and it aims to determine the best treatment approach for those facing these challenging breast cancer types.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- * Patients must have histologically confirmed adenocarcinoma of the breast at significant risk of distant recurrence based on at least one of the following criteria:
- * For axillary lymph node positive disease:
- • Involvement of at least one sentinel or axillary lymph node on routine histologic examination; patients with negative sentinel nodes and negative axillary nodes or involvement only demonstrated by immunohistochemistry are not eligible unless they meet one of the other eligibility criteria below
- • NOTE: consider intramammary nodes as equivalent to axillary nodes for the purposes of eligibility and stratification
- * For axillary lymph node negative disease:
- • Estrogen receptor (ER) negative tumor \>= 1 cm
- • ER+ tumor \>= 5 cm regardless of recurrence score
- • ER+ tumor \>= 1 cm but \< 5 cm with a recurrence score \>= 11 (patients enrolled in the TAILORx trial are eligible)
- • NOTE: axillary dissection is strongly encouraged in patients with lymph node involvement identified on sentinel node biopsy
- • Patients must have completed definitive breast surgery including total mastectomy and axillary dissection (modified radical mastectomy), total mastectomy and sentinel node biopsy, breast conservation surgery and axillary dissection or breast conservation surgery and sentinel node biopsy
- • NOTE: breast conservation surgery includes lumpectomy, partial mastectomy, and excisional biopsy
- • Margins of breast conservation surgery or mastectomy must be histologically free of invasive breast cancer and ductal carcinoma in situ (DCIS); patients with resection margins positive for lobular carcinoma in situ (LCIS) are eligible
- • Time from last surgery for breast cancer (breast conservation surgery, mastectomy, sentinel node biopsy, axillary dissection or re-excision of breast conservation surgery margins) to planned treatment start date must be \> 28 days and =\< 84 days
- • Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- • Within =\< 8 weeks prior to randomization: Absolute neutrophil count \>= 1,000/mm\^3
- • Within =\< 8 weeks prior to randomization: Platelet count \>= 100,000/mm\^3
- • Within =\< 8 weeks prior to randomization: Total bilirubin =\< 1.5 mg/dL
- • Within =\< 8 weeks prior to randomization: Aspartate aminotransferase (AST) =\< 2 times upper limit of normal(ULN)
- • Within =\< 8 weeks prior to randomization: Serum creatinine =\< 1.5 mg/dL
- • Within =\< 8 weeks prior to randomization: Urine protein:creatinine ratio \< 1.0 or 24-hour protein
- • Within =\< 8 weeks prior to randomization: Partial thromboplastin time (PTT) =\< 1.5 times ULN
- • Within =\< 8 weeks prior to randomization: Left ventricle ejection fraction (LVEF) \>= institutional limits of normal by multigated acquisition scan (MUGA) or echocardiogram (ECHO)
- * Patients who have undergone breast conservation surgery must receive radiation; prior to randomization, the investigator must specify the planned radiation technique:
- • Whole breast radiation (WBRT) after chemotherapy
- • Accelerated partial breast radiation (APBI) after chemotherapy
- • Accelerated partial breast radiation (APBI) prior to chemotherapy
- • NOTE: if APBI was completed prior to study entry, day 1 of protocol therapy must be at least 4 weeks after the completion of APBI
- • Post-mastectomy radiation therapy (RT) is required for all patients with a primary tumor of \>= 5 cm or involvement of 4 or more lymph nodes; post-mastectomy RT may be administered at the investigator's discretion for all other mastectomy patients
- • Patients with human epidermal growth factor receptor (HER)2 + (3+ by immunohistochemistry \[IHC\] or fluorescent in situ hybridization \[FISH\] ratio \>= 2) breast cancer are not eligible
- • Patients with synchronous bilateral breast cancer (diagnosed within one month) are eligible if the higher tumor, node, metastasis (TNM) stage tumor meets the eligibility criteria for this trial
- • Patients must not have clinical evidence of inflammatory disease or fixed axillary nodes at diagnosis
- • Patients must not have received prior cytotoxic chemotherapy or hormonal therapy for this breast cancer; prior treatment with an anthracycline, anthracenedione or taxane for any condition is not allowed
- • NOTE: prior use of tamoxifen for chemoprevention is allowed but must be discontinued at study entry; similarly, prior raloxifene use is allowed but must be discontinued at study entry
- • Patients must not have had any major surgical procedure within 28 days of planned treatment start date
- • NOTE: non-operative biopsy or placement of a vascular access device is not considered a major surgery
- • Patients may not have had placement of a vascular access device within 24 hours of planned day 1 of treatment
- * Patients must not have clinically significant cardiovascular or cerebrovascular disease, including:
- • Any history of
- • Cerebrovascular disease including transient ischemic attack (TIA), stroke or subarachnoid hemorrhage
- • Ischemic bowel
- • Within the last 12 months
- • Myocardial infarction
- • Unstable angina
- • New York Heart Association (NYHA) class II or greater congestive heart failure
- • Grade II or greater peripheral vascular disease
- • Uncontrolled hypertension defined as systolic blood pressure (SBP) \> 160 or diastolic blood pressure (DBP) \> 90
- • Uncontrolled or clinically significant arrhythmia
- • NOTE: blood pressure must be obtained within =\< 8 weeks prior to randomization
- • NOTE: patients with controlled atrial fibrillation are eligible
- * Patients who require full-dose anticoagulation may enroll provided they meet the following criteria:
- • The patient must have an in-range international normalized ratio (INR) (usually between 2 and 3) on a stable dose of warfarin or be on stable dose of low molecular weight (LMW) heparin
- • The patient must not have active bleeding or pathological conditions that carry high risk of bleeding (e.g. varices)
- • NOTE: prophylactic use of anticoagulants to maintain patency of a vascular access device is permitted
- • Patients must not have a bleeding diathesis, hereditary or acquired bleeding disorder or coagulopathy
- • Patients must not have a non-healing wound or fracture; patients with an abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to randomization are not eligible
- • Patients must not have hypersensitivity to paclitaxel or drugs using the vehicle Cremophor, Chinese hamster ovary cell products or other recombinant human antibodies
- • Women must not be pregnant or breast-feeding; all females of childbearing potential must have a blood or urine test within 7 days prior to randomization to rule out pregnancy
- • Women of childbearing potential and sexually active males must use an accepted and effective method of contraception
About National Cancer Institute (Nci)
The National Cancer Institute (NCI) is a prominent component of the National Institutes of Health (NIH), dedicated to advancing cancer research and improving patient outcomes through innovative clinical trials. As a leading sponsor of cancer-related studies, NCI focuses on facilitating the development of new therapies, enhancing prevention strategies, and understanding the biology of cancer. The institute collaborates with academic institutions, healthcare providers, and industry partners to conduct rigorous clinical trials that aim to translate scientific discoveries into effective treatments. NCI’s commitment to fostering a robust research environment supports the mission to eliminate cancer as a major health problem.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
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Marietta, Ohio, United States
Newark, Ohio, United States
Springfield, Ohio, United States
Westerville, Ohio, United States
Zanesville, Ohio, United States
Langhorne, Pennsylvania, United States
York, Pennsylvania, United States
Chattanooga, Tennessee, United States
Nashville, Tennessee, United States
Tacoma, Washington, United States
Huntington, West Virginia, United States
Antigo, Wisconsin, United States
Madison, Wisconsin, United States
Wausau, Wisconsin, United States
Nashua, New Hampshire, United States
Oklahoma City, Oklahoma, United States
Joliet, Illinois, United States
Libertyville, Illinois, United States
Naperville, Illinois, United States
Niles, Illinois, United States
Skokie, Illinois, United States
Skokie, Illinois, United States
York, Maine, United States
Livonia, Michigan, United States
East Syracuse, New York, United States
Rochester, New York, United States
Winston Salem, North Carolina, United States
Florence, South Carolina, United States
Sioux Falls, South Dakota, United States
Oshkosh, Wisconsin, United States
Munster, Indiana, United States
Boise, Idaho, United States
Charleston, West Virginia, United States
Saint Helena, California, United States
Shreveport, Louisiana, United States
Castro Valley, California, United States
Marysville, California, United States
Pleasanton, California, United States
San Pablo, California, United States
Danbury, Connecticut, United States
Lakeland, Florida, United States
Leesburg, Florida, United States
Moline, Illinois, United States
Merrillville, Indiana, United States
Mansfield, Louisiana, United States
Kensington, Maryland, United States
Norwood, Massachusetts, United States
Duluth, Minnesota, United States
Saint Charles, Missouri, United States
Laconia, New Hampshire, United States
Brick, New Jersey, United States
Las Cruces, New Mexico, United States
Utica, New York, United States
Hendersonville, North Carolina, United States
Lemoyne, Pennsylvania, United States
Norton, Virginia, United States
Elkhart, Indiana, United States
Elkhart, Indiana, United States
Mishawaka, Indiana, United States
Plymouth, Indiana, United States
Westville, Indiana, United States
Saint Joseph, Michigan, United States
Boca Raton, Florida, United States
Olathe, Kansas, United States
Elgin, Illinois, United States
Grand Junction, Colorado, United States
Torrington, Connecticut, United States
Boca Raton, Florida, United States
Athens, Georgia, United States
Council Bluffs, Iowa, United States
Baton Rouge, Louisiana, United States
Waterville, Maine, United States
Goldsboro, North Carolina, United States
Chippewa Falls, Wisconsin, United States
Canton, Illinois, United States
Carthage, Illinois, United States
Eureka, Illinois, United States
Havana, Illinois, United States
Kewanee, Illinois, United States
Macomb, Illinois, United States
Monmouth, Illinois, United States
Monmouth, Illinois, United States
Normal, Illinois, United States
Peru, Illinois, United States
Princeton, Illinois, United States
Spring Valley, Illinois, United States
Saint Joseph, Michigan, United States
Boise, Idaho, United States
Elk Grove Village, Illinois, United States
Indianapolis, Indiana, United States
Waterloo, Iowa, United States
Middletown, New York, United States
New York, New York, United States
Fargo, North Dakota, United States
Lancaster, Pennsylvania, United States
Lynchburg, Virginia, United States
Appleton, Wisconsin, United States
La Jolla, California, United States
Denver, Colorado, United States
Warrenville, Illinois, United States
Shreveport, Louisiana, United States
Niles, Michigan, United States
Joplin, Missouri, United States
Walla Walla, Washington, United States
Bloomington, Indiana, United States
Waterloo, Iowa, United States
Huntington, West Virginia, United States
San Diego, California, United States
Glendale, Wisconsin, United States
Atlanta, Georgia, United States
La Grange, Illinois, United States
Columbia, Missouri, United States
Mount Kisco, New York, United States
Memphis, Tennessee, United States
Fort Smith, Arkansas, United States
Burlingame, California, United States
Truckee, California, United States
Vallejo, California, United States
Colorado Springs, Colorado, United States
Dover, Delaware, United States
Deerfield Beach, Florida, United States
Lakeland, Florida, United States
Weston, Florida, United States
Post Falls, Idaho, United States
Bloomington, Illinois, United States
Chicago, Illinois, United States
Galesburg, Illinois, United States
Pekin, Illinois, United States
Winfield, Illinois, United States
Liberal, Kansas, United States
Covington, Louisiana, United States
Monroe, Louisiana, United States
Scarborough, Maine, United States
Brighton, Massachusetts, United States
Mount Clemens, Michigan, United States
Fergus Falls, Minnesota, United States
Mankato, Minnesota, United States
Bolivar, Missouri, United States
Omaha, Nebraska, United States
Manchester, New Hampshire, United States
New York, New York, United States
Cary, North Carolina, United States
Concord, North Carolina, United States
Raleigh, North Carolina, United States
Washington, North Carolina, United States
Lawton, Oklahoma, United States
Erie, Pennsylvania, United States
Harrisburg, Pennsylvania, United States
Kittanning, Pennsylvania, United States
Pottstown, Pennsylvania, United States
Williamsport, Pennsylvania, United States
Warwick, Rhode Island, United States
Franklin, Tennessee, United States
Parkersburg, West Virginia, United States
Burlington, Wisconsin, United States
Franklin, Wisconsin, United States
Germantown, Wisconsin, United States
Green Bay, Wisconsin, United States
Janesville, Wisconsin, United States
Kenosha, Wisconsin, United States
La Crosse, Wisconsin, United States
Marinette, Wisconsin, United States
Milwaukee, Wisconsin, United States
Racine, Wisconsin, United States
Summit, Wisconsin, United States
Two Rivers, Wisconsin, United States
Waukesha, Wisconsin, United States
Wauwatosa, Wisconsin, United States
Wisconsin Rapids, Wisconsin, United States
Rockville, Maryland, United States
Bloomington, Illinois, United States
Muncie, Indiana, United States
Scottsdale, Arizona, United States
Arroyo Grande, California, United States
Fresno, California, United States
Denver, Colorado, United States
Lafayette, Colorado, United States
Daytona Beach, Florida, United States
Chicago, Illinois, United States
Normal, Illinois, United States
River Forest, Illinois, United States
Anderson, Indiana, United States
Goshen, Indiana, United States
Lafayette, Indiana, United States
Ashland, Kentucky, United States
Owensboro, Kentucky, United States
Baltimore, Maryland, United States
Baltimore, Maryland, United States
Pittsfield, Massachusetts, United States
Midland, Michigan, United States
Pennington, New Jersey, United States
San Juan, New Mexico, United States
Albany, New York, United States
Brooklyn, New York, United States
Poughkeepsie, New York, United States
Poughkeepsie, New York, United States
Troy, New York, United States
Oklahoma City, Oklahoma, United States
Erie, Pennsylvania, United States
Meadowbrook, Pennsylvania, United States
Reading, Pennsylvania, United States
Aberdeen, South Dakota, United States
Bristol, Tennessee, United States
Nashville, Tennessee, United States
Berwyn, Illinois, United States
Moline, Illinois, United States
Antioch, California, United States
Gainesville, Florida, United States
Atlanta, Georgia, United States
Louisville, Kentucky, United States
Saint Louis, Missouri, United States
Dover, New Hampshire, United States
Albuquerque, New Mexico, United States
Elmira, New York, United States
Norman, Oklahoma, United States
Oklahoma City, Oklahoma, United States
Wilkes Barre, Pennsylvania, United States
Vancouver, Washington, United States
Stony Brook, New York, United States
Pittsburgh, Pennsylvania, United States
Fort Gordon, Georgia, United States
Manchester, New Hampshire, United States
Mount Kisco, New York, United States
Fairfax, Virginia, United States
Great Falls, Montana, United States
Las Cruces, New Mexico, United States
Sacramento, California, United States
Springfield, Ohio, United States
Medford, Oregon, United States
Bozeman, Montana, United States
Raleigh, North Carolina, United States
Annapolis, Maryland, United States
Greeley, Colorado, United States
Alton, Illinois, United States
Springfield, Illinois, United States
Waterloo, Iowa, United States
Pekin, Illinois, United States
Normal, Illinois, United States
Macon, Georgia, United States
Indianapolis, Indiana, United States
Elk Grove Village, Illinois, United States
Des Moines, Iowa, United States
Anderson, Indiana, United States
Kalispell, Montana, United States
Brick, New Jersey, United States
Bloomington, Indiana, United States
Lebanon, New Hampshire, United States
Wyoming, Michigan, United States
Grand Rapids, Michigan, United States
Muskegon, Michigan, United States
Meadowbrook, Pennsylvania, United States
Pontiac, Michigan, United States
Ann Arbor, Michigan, United States
Decatur, Georgia, United States
Ames, Iowa, United States
Rhinelander, Wisconsin, United States
Stevens Point, Wisconsin, United States
Minocqua, Wisconsin, United States
Columbia, Missouri, United States
Niles, Michigan, United States
Saint Joseph, Michigan, United States
Des Moines, Iowa, United States
Clive, Iowa, United States
Lansing, Michigan, United States
Grand Rapids, Michigan, United States
Loveland, Colorado, United States
Escanaba, Michigan, United States
Saint Joseph, Michigan, United States
Madison, Wisconsin, United States
Kinston, North Carolina, United States
Lynchburg, Virginia, United States
Ridgewood, New Jersey, United States
Washington, North Carolina, United States
Wilmington, Ohio, United States
Manchester, New Hampshire, United States
Madison, Wisconsin, United States
Johnson Creek, Wisconsin, United States
Royal Oak, Michigan, United States
Johnson Creek, Wisconsin, United States
Dearborn, Michigan, United States
Fort Eisenhower, Georgia, United States
Saginaw, Michigan, United States
Wheat Ridge, Colorado, United States
Southfield, Michigan, United States
Detroit, Michigan, United States
Kalamazoo, Michigan, United States
Warren, Michigan, United States
Norton, Virginia, United States
Denver, Colorado, United States
Mount Vernon, Illinois, United States
Clive, Iowa, United States
Des Moines, Iowa, United States
Des Moines, Iowa, United States
Denver, Colorado, United States
Davenport, Iowa, United States
Davenport, Iowa, United States
Westbrook, Maine, United States
Patients applied
Trial Officials
Kathy D Miller
Principal Investigator
ECOG-ACRIN Cancer Research Group
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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