Docetaxel and Cyclophosphamide Compared to Anthracycline-Based Chemotherapy in Treating Women With HER2-Negative Breast Cancer



Status:Active, not recruiting
Conditions:Breast Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:April 2012
End Date:May 2019

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A Phase III Clinical Trial Comparing the Combination of Docetaxel Plus Cyclophosphamide to Anthracycline-Based Chemotherapy Regimens for Women With Node-Positive or High-Risk Node-Negative, HER2-Negative Breast Cancer

RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of breast
cancer cells, either by killing the cells or by stopping them from dividing. Giving the
drugs in different combinations may kill more breast cancer cells. Giving combination
chemotherapy after surgery may kill any tumor cells that remain after surgery.

PURPOSE: This randomized phase III trial is studying different combination chemotherapy
regimens and their side effects and comparing how well they work in treating women with
non-metastatic breast cancer.

OBJECTIVES:

Primary

- To determine if the docetaxel and cyclophosphamide (TC) regimen is non-inferior to the
anthracycline-based chemotherapy regimens in terms of invasive disease-free survival
(DFS) by combining B-49 data with the docetaxel, doxorubicin, and cyclophosphamide
(TAC) and TC arms of NSABP B-46-I/US Oncology Research, Inc.(USOR) 07132 and the data
from USOR 06-090.

Secondary

- To determine rates of DFS-ductal carcinoma in situ (DCIS) for the TC and
anthracycline-based chemotherapy regimens.

- To determine rates of overall survival (OS) for the TC and anthracycline-based
chemotherapy regimens.

- To determine rates of recurrence-free interval (RFI) for the TC and anthracycline-based
chemotherapy regimens.

- To evaluate the toxicity associated with each of the regimens.

- To determine the role of TOP2A in prognosis and prediction of degree of benefit from
anthracycline-based chemotherapy over TC. (exploratory)

- To develop predictive markers for benefit from doxorubicin. (exploratory)

OUTLINE: This is a multicenter randomized study. Patients are stratified according to number
of positive nodes (0 vs 1-3 vs 4-9 vs 10+) and hormone-receptor status (estrogen receptor
[ER] and/or progesterone receptor [PgR] positive vs ER and PgR negative). Patients are
randomized to 1 of 2 treatment arms.

Inclusion Criteria:

- The patient must have an Eastern Cooperative Oncology Group (ECOG) performance status
of 0 or 1.

- The tumor must be unilateral invasive adenocarcinoma of the breast on histologic
examination.

- The breast cancer must be Human Epidermal Growth Factor Receptor 2 (HER2)-negative
based on current American Society of Clinical Oncology (ASCO)/CAP Guideline
Recommendations for Human Epidermal Growth Factor Receptor 2 Testing in Breast
Cancer. If the result of the in situ hybridization testing (FISH, chromagen in situ
hybridization [CISH], or other) is equivocal, the patient is eligible if there is no
plan to administer HER2-targeted therapy.

- All of the following staging criteria must be met according to American Joint
Committee on Cancer (AJCC) criteria:

- By pathologic evaluation, primary tumor must be pT1-3;

- By pathologic evaluation, ipsilateral nodes must be pN0, pN1 (pN1mi, pN1a, pN1b,
pN1c), pN2a, pN3a, or pN3b.

- If pN0, at least one of the following criteria must be met:

- ER negative and PgR negative; or

- Pathologic tumor size greater than 2.0 cm; or

- T1c (pathologic tumor size greater than 1.0 cm but less than or equal to 2.0 cm)
and ER positive (PgR status may be positive or negative) and either grade 3
histology or Oncotype DX® Recurrence Score of greater than or equal to 25.

- Patients must have undergone either a total mastectomy or breast-conserving surgery
(lumpectomy).

- For patients who undergo lumpectomy, the margins of the resected specimen must be
histologically free of invasive tumor and ductal carcinoma in situ (DCIS) as
determined by the local pathologist. If pathologic examination demonstrates tumor at
the line of resection, additional operative procedures must be performed to obtain
clear margins. If tumor is still present at the resected margin after re-excision(s),
the patient must undergo total mastectomy to be eligible. (Patients with margins
positive for lobular carcinoma in situ [LCIS] are eligible without additional
resection.)

- For patients who undergo mastectomy, margins must be histologically free of invasive
tumor and DCIS.

- Patients must have completed one of the following procedures for evaluation of
pathologic nodal status:

- Sentinel lymphadenectomy alone if pathologic nodal staging based on sentinel
lymphadenectomy is pN0, pN1mi, or pN1b;

- Sentinel lymphadenectomy alone if pathologic nodal staging based on sentinel
lymphadenectomy is pN1a limited to 1 or 2 positive nodes and primary tumor is T1
or T2 by pathologic evaluation;

- Sentinel lymphadenectomy followed by removal of additional non-sentinel lymph
nodes if the sentinel node (SN) is positive; or

- Axillary lymphadenectomy with or without SN isolation procedure.

- The interval between the last surgery for breast cancer (treatment or staging) and
randomization must be no more than 84 days.

- Patients must have ER analysis performed on the primary tumor prior to randomization.
Breast cancer must be assessed for ER status by current ASCO/CAP Guideline
Recommendations for hormone receptor testing. If negative for ER, assessment of PgR
must also be performed according to current ASCO/CAP Guideline Recommendations for
hormone receptor testing. (Either a core biopsy or surgical resection specimen can be
used for ER/PgR testing.)

- The most recent postoperative blood counts, performed within 6 weeks prior to
randomization, must meet the following criteria:

- absolute neutrophil count (ANC) must be greater than or equal to 1200/mm3;

- platelet count must be greater than or equal to 100,000/mm3; and

- hemoglobin must be greater than or equal to 10 g/dL.

- The following criteria for evidence of adequate hepatic function must be met based on
the results of the most recent postoperative tests performed within 6 weeks prior to
randomization:

- total bilirubin must be less than or equal to upper limit of normal (ULN) for
the lab unless the patient has a bilirubin elevation greater than ULN to 1.5 x
ULN due to Gilbert's disease or similar syndrome involving slow conjugation of
bilirubin; and

- alkaline phosphatase must be less than or equal to 2.5 x ULN for the lab; and

- aspartate transaminase (AST) must be less than or equal to 1.5 x ULN for the
lab.

- Alkaline phosphatase and AST may not both be greater than the ULN. For example,
if the alkaline phosphatase is greater than the ULN but less than or equal to
2.5 x ULN, then the AST must be less than or equal to the ULN. If the AST is
greater than the ULN but less than or equal to 1.5 x ULN, then the alkaline
phosphatase must be less than or equal to ULN.

- Note: If alanine aminotransferase (ALT) is performed instead of AST (per
institution's standard practice), the ALT value must be less than or equal to
1.5 x ULN; if both were performed, the AST must be less than or equal to 1.5 x
ULN.

- Patients with AST or alkaline phosphatase greater than ULN are eligible for inclusion
in the study if liver imaging (CT, MRI, PET-CT, or PET scan performed within 90 days
prior to randomization) does not demonstrate metastatic disease and the requirements
for adequate hepatic function as described above are met.

- Patients with alkaline phosphatase that is greater than ULN but less than or equal to
2.5 x ULN are eligible for inclusion in the study if a bone scan, PET-CT scan, or PET
scan performed within 90 days prior to randomization does not demonstrate metastatic
disease.

- The most recent postoperative serum creatinine performed within 6 weeks prior to
randomization must be less than or equal to ULN for the lab.

- Left ventricular ejection fraction (LVEF) assessment by 2-D echocardiogram or
multigated acquisition (MUGA) scan must be performed within 90 days prior to
randomization. The LVEF must be greater than or equal to 50% regardless of the
facility's lower limit of normal (LLN). (If the facility performing the assessment
has not reported the LVEF as a whole number, decimals reported as greater than or
equal to 5 should be rounded up and decimals reported as less than 5 should be
rounded down.)

Exclusion criteria:

Patients with one or more of the following conditions are ineligible for this study.

- T4 tumors including inflammatory breast cancer.

- Definitive clinical or radiologic evidence of metastatic disease. (Chest imaging
[mandatory for all patients] and other imaging [if required] must have been performed
within 90 days prior to randomization.)

- Synchronous or previous contralateral invasive breast cancer. (Patients with
synchronous and/or previous contralateral DCIS are eligible.)

- Any history of ipsilateral invasive breast cancer or ipsilateral DCIS.

- History of non-breast malignancies within 5 years prior to randomization, except for
the following: carcinoma in situ of the cervix, colorectal carcinoma in situ,
melanoma in situ, and basal cell and squamous cell carcinomas of the skin.

- Previous therapy with anthracyclines or taxanes for any malignancy.

- Chemotherapy administered for the currently diagnosed breast cancer prior to
randomization.

- Continued endocrine therapy such as raloxifene or tamoxifen (or other SERM) or an
aromatase inhibitor. Patients are eligible if these medications are discontinued
prior to randomization.

- Any sex hormonal therapy, e.g., birth control pills, ovarian hormone replacement
therapy. Patients are eligible if these medications are discontinued prior to
randomization.

- Known active hepatitis B or hepatitis C with abnormal liver function tests.

- Cardiac disease (history of and/or active disease) that would preclude the use of the
drugs included in the treatment regimens. This includes but is not confined to:

- Active cardiac disease

- angina pectoris that requires the use of anti-anginal medication;

- ventricular arrhythmias except for benign premature ventricular contractions;

- supraventricular and nodal arrhythmias requiring a pacemaker or not controlled
with medication;

- conduction abnormality requiring a pacemaker;

- valvular disease with documented compromise in cardiac function;

- symptomatic pericarditis.

- History of cardiac disease

- myocardial infarction documented by elevated cardiac enzymes or persistent
regional wall abnormalities on assessment of left ventricular function;

- history of documented congestive heart failure (CHF);

- documented cardiomyopathy.

- Whole breast radiation therapy (RT) prior to randomization or partial breast RT that
cannot be completed on or before the date of randomization.

- Intrinsic lung disease resulting in dyspnea.

- Unstable diabetes mellitus.

- Active infection or chronic infection requiring suppressive antibiotics.

- History of a major organ allograft or condition requiring chronic immunosuppression,
e.g., kidney, liver, lung, heart, bone marrow transplant, or autoimmune diseases.
(Patients who have received corneal transplants, cadaver skin, or bone transplants
are eligible.)

- Nervous system disorder (paresthesia, peripheral motor neuropathy, or peripheral
sensory neuropathy) greater than or equal to grade 2, per the NCI CTCAE v4.0.

- Conditions that would prohibit administration of corticosteroids.

- Chronic daily treatment with corticosteroids (dose of greater than or equal to 10
mg/day methylprednisolone equivalent) (excluding inhaled steroids).

- History of hypersensitivity reaction to drugs formulated with polysorbate 80.

- Pregnancy or lactation at the time of study entry. (Note: Pregnancy testing must be
performed within 2 weeks prior to randomization according to institutional standards
for women of childbearing potential.)

- Other non-malignant systemic disease that would preclude the patient from receiving
study treatment or would prevent required follow-up.

- Psychiatric or addictive disorders or other conditions that, in the opinion of the
investigator, would preclude the patient from meeting the study requirements.

- Use of any investigational product within 30 days prior to randomization.
We found this trial at
916
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Anchorage, Alaska 99508
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361 Old Belgrade Road
Augusta, Maine 04330
(207) 621-6100
Harold Alfond Center for Cancer Care MaineGeneral's Harold Alfond Center for Cancer Care (HACCC) is...
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3400 N Charles St
Baltimore, Maryland 21205
410-516-8000
Johns Hopkins University The Johns Hopkins University opened in 1876, with the inauguration of its...
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2545 Schoenersville Rd
Bethlehem, Pennsylvania 18017
(484) 884-2200
Lehigh Valley Hospital - Muhlenberg At Lehigh Valley Health Network, we continually go the extra...
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800 Washington St
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Tufts Medical Center Tufts Medical Center is an internationally-respected academic medical center – a teaching...
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Bremerton, Washington 98310
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3550 Jerome Avenue
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Montefiore Medical Center As the academic medical center and University Hospital for Albert Einstein College...
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666 Elm Street
Buffalo, New York 14263
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Roswell Park Cancer Institute Welcome to Roswell Park Cancer Institute (RPCI), America's first cancer center...
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85 S Prospect St
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University of Vermont The University of Vermont combines faculty-student relationships most commonly found in a...
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1000 Blythe Blvd
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5050 Anthony Wayne Dr
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1 Hurley Plaza
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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
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Holy Cross Hospital While spirituality plays an essential role in the way that we minister...
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3 Butternut Drive, Suite B
Greenville, South Carolina 29605
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340 Medical Pkwy
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2500 Campus Rd
Honolulu, Hawaii 96822
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1200 Moursund Street
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Baylor College of Medicine Baylor College of Medicine in Houston, the only private medical school...
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2500 N State St
Jackson, Mississippi 39216
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Jupiter, Florida 33458
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524 South Park Street
Kalamazoo, Michigan 49007
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Bronson Methodist Hospital Our healthcare system serves patients and families throughout southwest Michigan and northern...
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200 North Park Street
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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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3525
Lakeland, Florida 33805
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1800 West Charleston Boulevard
Las Vegas, Nevada 89102
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University Medical Center of Southern Nevada University Medical Center is dedicated to providing the highest...
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8700 Beverly Blvd # 8211
Los Angeles, California 90048
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300 Community Drive
Manhasset, New York 11030
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North Shore University Hospital North Shore-LIJ Health System includes 16 award-winning hospitals and nearly 400...
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1 Gustave L Levy Pl # 271
New York, New York 10029
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433 Southwest 10th Street
Ocala, Florida 34471
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4200 Fifth Ave
Pittsburgh, Pennsylvania 15260
(412) 624-4141
University of Pittsburgh The University of Pittsburgh is a state-related research university, founded as the...
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4805 Northeast Glisan Street
Portland, Oregon 97213
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Providence Portland Medical Center We strive to give those we serve exceptional, compassionate health care...
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593 Eddy Street
Providence, Rhode Island 02903
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60 Crittenden Blvd # 70
Rochester, New York 14642
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4502 Medical Drive
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34800 Bob Wilson Dr,
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100 Campus Dr # 108
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1100 Fairview Avenue North
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131 Lila Doyle Drive
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3900 W Avera Drive
Sioux Falls, South Dakota 57108
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120 Dillon Dr
Spartanburg, South Carolina 29307
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601 South Sherman Street
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820 North Chelan Avenue
Wenatchee, Washington 98801
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808 North 39th Avenue
Yakima, Washington 98902
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1200 Old York Road
Abington, Pennsylvania 19001
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Adrian, Michigan 49221
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818 Riverside Ave.
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1 Akron General Ave
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525 E Market St
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Albuquerque, New Mexico 87131
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Albuquerque, New Mexico 87106
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Albuquerque, New Mexico 87109
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Alexandria, Louisiana 71301
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1200 S Cedar Crest Blvd
Allentown, Pennsylvania 18103
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Anderson, South Carolina 29621
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2000 E Greenville St
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500 S State St
Ann Arbor, Michigan 48109
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5301 McAuley Drive
Ann Arbor, Michigan 48197
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364 White Oak St
Asheboro, North Carolina 27203
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Asheville, North Carolina 28801
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Asheville, North Carolina 28816
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1968 Peachtree Rd NW
Atlanta, Georgia 30309
(404) 605-5000
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1501 S Potomac St
Aurora, Colorado 80012
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2000 Ogden Ave
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6701 N Charles St
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489 State St
Bangor, Maine 04401
(207) 973-7000
Eastern Maine Medical Center Located in Bangor, Eastern Maine Medical Center (EMMC) serves communities throughout...
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Bangor, ME
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155 5th St NE
Barberton, Ohio 44203
(330) 615-3000
Summa Barberton Hospital Summa Barberton Hospital is a full member of Summa Health System and...
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Barberton, OH
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Baton Rouge, Louisiana 70806
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Baton Rouge, LA
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Baton Rouge, Louisiana 70809
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Baton Rouge, LA
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Baton Rouge, Louisiana 70809
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Baton Rouge, LA
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265 Fremont St
Battle Creek, Michigan 49017
(269) 245-8166
Bronson Battle Creek As a proud member of the Battle Creek community, we believe everyone...
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Battle Creek, MI
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Bay City, Michigan 48708
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Bay City, MI
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Beachwood, OH
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Beaufort, South Carolina 29902
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Beaufort, SC
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Beaumont, Texas 77702
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Beaumont, TX
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Bedford, Texas 76022
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Bedford, TX
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1600 Albany Street
Beech Grove, Indiana 46107
(317) 787–3311
Saint Francis Hospital and Health Centers St. Francis Hospital and Health Centers is a general...
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Beech Grove, IN
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