A Randomized Trial of Ixempra Versus Taxol in Adjuvant Therapy of Triple Negative Breast Cancer



Status:Active, not recruiting
Conditions:Breast Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:6/3/2016
Start Date:January 2009
End Date:December 2016

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Phase III Study of Doxorubicin/Cyclophosphamide (AC) Followed by Ixabepilone vs. AC Followed by Paclitaxel in Patients With Triple-Negative Early-Stage Breast Cancer

This is a randomized, Phase III, open-label, multicenter study.

Patients will be randomized in a 1:1 ratio to receive one of two different treatment arms.
Patients in treatment arm 1 will receive AC followed by ixabepilone. Patients in treatment
arm 2 will receive AC followed by weekly paclitaxel.

Inclusion Criteria:

1. Female patients greater than or equal to18 years of age.

2. Histologically confirmed invasive unilateral breast cancer (regardless of

histology).

3. Early-stage breast cancer, defined as:

- Node-positive disease: >0.2-mm metastasis in at least one lymph node
(pN1mipN2b)OR

- Node-negative, with primary tumor >1.0 cm (T1c-T3).

4. Definitive loco-regional surgery must have been completed as specified

below:

- Patients must have undergone either breast conservation surgery

(i.e., lumpectomy) or total mastectomy.

- Surgical margins of the resected section must be histologically free of

invasive adenocarcinoma and ductal carcinoma in situ.

- Surgical margins involved with lobular carcinoma in situ (LCIS) will not

be considered as a positive margin; therefore, such patients will be eligible for
this study without additional resection.

- Patients must have completed axillary lymph node sampling for the pathologic
evaluation of axillary lymph nodes as specified below:

Sentinel node biopsy and/or either lymph node sampling procedure or axillary
dissection.

5. Multicentric and multifocal invasive breast cancer is eligible if loco-regional
surgery has been completed as described above.

6. Patients with synchronous bilateral cancers are eligible only if:

- All cancers are of triple-negative phenotype, defined as ER-, PR-, HER2-.

- Eligibility based on the highest stage grouping.

7. HER2 negative tumors. HER2 negativity must be confirmed by one of the

following:

- FISH-negative (FISH ratio <2.2), or

- IHC 0-1+, or

- IHC 2-3+ AND FISH-negative (FISH ratio <2.2).

8. Estrogen receptor negative (<10% staining by IHC for estrogen receptor).

9. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.

10. Patient must be <= 84 days from having completed definitive primary breast surgery
(either lumpectomy or mastectomy).

11. MammoSite brachytherapy radiation is acceptable if it is performed

immediately following surgery and prior to chemotherapy. It is recommended that
chemotherapy be started no earlier than 2 weeks following the removal of the
MammoSite balloon catheter.

12. Adequate hematologic function, defined by:

- Absolute neutrophil count (ANC) >1500/mm3

- Platelet count >=100,000/mm3

- Hemoglobin >9 g/dL

13. Adequate liver function, defined by:

- AST and ALT <=2.5 x the upper limit of normal (ULN)

- Total bilirubin <=1.5 x ULN (unless the patient has grade 1 bilirubin

elevation due to Gilbert's disease or a similar syndrome involving slow

conjugation of bilirubin).

14. Adequate renal function, defined by:

- Serum creatinine <=1.5 x ULN

15. Complete staging work-up <=12 weeks prior to initiation of study treatment

with computed tomography (CT) scans of the chest and abdomen/pelvis (abdomen/pelvis
preferred; abdomen accepted), and either a positron emission tomography (PET) scan or
a bone scan.

16. Adequate cardiac function, defined by a left ventricular ejection fraction

(LVEF) value of >50% (or normal per institutional guidelines) by MUGA scan or
echocardiogram (ECHO).

17. Adequate recovery from recent surgery. At least 1 week must have elapsed from the
time of a minor surgery (i.e., sentinel node biopsy, port-acath (placement); at least
3 weeks must have elapsed from the time of a major surgery (i.e., lumpectomy, partial
or total mastectomy, axillary lymph node dissection, breast reconstruction
procedure).

18. Patients with previous history of invasive cancers (including breast cancer)

are eligible if definitive treatment was completed more than 5 years prior to

initiating current study treatment, and there is no evidence of recurrent disease.

19. Women of childbearing potential must have a negative serum or urine pregnancy test
performed within 7 days prior to start of treatment. If a woman becomes pregnant or
suspects she is pregnant while participating in this study, she must agree to inform
her treating physician immediately.

20. Patient must be accessible for treatment and follow-up.

21. Women of childbearing potential must agree to use an acceptable method of birth
control to avoid pregnancy for the duration of study treatment, and for 3 months
thereafter.

22. All patients must be able to understand the investigational nature of the

study and give written informed consent prior to study entry.

Exclusion Criteria:

1. Women who are pregnant or breastfeeding.

2. History of previous diagnosis of invasive breast cancer (unless treated >5 years
previously with no recurrence). History of previously treated ductal carcinoma in
situ (DCIS) is acceptable.

3. Any evidence or suspicion of metastatic disease other than ipsilateral

axillary lymph nodes.

4. Any tumor >=T4 (cutaneous invasion, deep adherence, inflammatory breast cancer).

5. Previous anthracycline chemotherapy.

6. Concurrent use of CYP3A4 inhibitors from 72 hours prior to initiation of

study treatment until the end of treatment with ixabepilone.

7. Previous treatment for this breast cancer (including neoadjuvant

chemotherapy).

8. Previous cancer (with the exception of non-melanoma skin cancer or cervical carcinoma
in situ) in the past 5 years (including invasive contralateral breast cancer).

9. Peripheral neuropathy of > grade 1 per NCI CTCAE v3.0.

10. Cardiac disease, including: congestive heart failure (CHF) > Class II per

New York Heart Association (NYHA) classification; unstable angina (anginal symptoms
at rest) or new-onset angina (i.e., began within the last 3 months), or myocardial
infarction within the past 6 months; symptomatic CHF, unstable angina pectoris,
cardiac arrhythmia, or cardiac ventricular arrhythmias requiring anti-arrhythmic
therapy.

11. History of hypersensitivity to CremophorEL (polyoxyethylated castor oil) or

a drug formulated in CremophorEL such as paclitaxel.

12. Use of any investigational agent within 30 days of administration of the first dose
of study drug.

13. Patients may not receive any other investigational or anti-cancer treatments while
participating in this study.

14. Concurrent severe, uncontrolled infection or intercurrent illness including,

but not limited to, ongoing or active infection, or psychiatric illness/social

situations that would limit compliance with study requirements.

15. Mental condition that would prevent patient comprehension of the nature of, and risk
associated with, the study.

16. Inability to comply with study and/or follow-up procedures.
We found this trial at
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Jonesboro, Arkansas 72401
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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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Davie, Florida 33328
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3840 Broadway
Fort Myers, Florida 33901
(239) 275-6400
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850 Century Medical Drive
Titusville, Florida 32796
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Albuquerque, New Mexico 87109
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Aventura, Florida 33180
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Baton Rouge, Louisiana 70806
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6410 Rockledge Dr #660
Bethesda, Maryland 20817
(301) 571-0019
Center for Cancer & Blood Disorders Widely recognized for its compassionate, expert care, the Center...
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Boca Raton, Florida 33486
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Burlington, North Carolina 27215
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171 Ashley Avenue
Charleston, South Carolina 29425
843-792-1414
Medical University of South Carolina The Medical University of South Carolina (MUSC) has grown from...
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Chattanooga, Tennessee 37404
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Chattanooga, Tennessee 37404
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Chesterfield, Missouri 63017
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5053 Wooster Rd
Cincinnati, Ohio 45226
(513) 751-2273
Oncology Hematology Care Our more than 60 physicians and advanced practice providers throughout neighborhood offices...
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Collierville, Tennessee 38017
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Corpus Christi, Texas 78463
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Edina, Minnesota 55436
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Elyria, Ohio 44035
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Ft. Lauderdale, Florida 33308
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743 Spring St NE
Gainesville, Georgia 30501
770-219-9000
Northeast Georgia Medical Center Northeast Georgia Health System (NGHS) is a not-for-profit community health system...
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25 Michigan St. NE, Suite 3100
Grand Rapids, Michigan 49503
(616) 391-1230
Grand Rapids Clinical Oncology Program GRCOP initially formed to develop community cancer patient management guidelines....
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Hollywood, Florida 33021
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Huntsville, Alabama 35805
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Indianapolis, Indiana 46260
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Jacksonville, Florida 32256
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2316 E Meyer Blvd
Kansas City, Missouri 64132
(816) 276-4000
Research Medical Center Research Medical Center offers hospital and health clinic services across three Kansas...
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Lawrenceville, Georgia 30045
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Mobile, Alabama 36604
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Morristown, New Jersey 07960
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Mt. Pleasant, South Carolina 29464
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Myrtle Beach, South Carolina 29572
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250 25th Ave N, Ste 100
Nashville, Tennessee 37023
615-320-5090
Tennessee Oncology, PLLC Since 1976 Tennessee Oncology has been providing quality cancer care. In 2013,...
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Newport News, Virginia 23601
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Normal, Illinois 61761
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Norwich, Connecticut 06360
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Omaha, Nebraska 68114
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Overland Park, Kansas 66210
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200 Lothrop St
Pittsburgh, Pennsylvania 15213
University of Pittsburgh Medical Center UPMC is one of the leading nonprofit health systems in...
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Pomona, California 91767
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Portland, Maine 04101
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Richmond, Virginia 23235
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Rockledge, Pennsylvania 18960
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San Antonio, Texas 78229
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San Juan, 45150
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101 E Wood St
Spartanburg, South Carolina 29303
(864) 560-6000
Spartanburg Regional Medical Center Spartanburg Regional is an integrated healthcare delivery system that provides care...
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Springfield, Missouri 65807
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Terre Haute, Indiana 47802
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1414 SW 8th Ave
Topeka, Kansas 66606
(785) 354-5300
Cotton-O'Neil Cancer Center The state-of-the-art Stormont-Vail Cancer Center is one of the specialty medical centers...
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Vineland, New Jersey 08360
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Worchester, Massachusetts 01608
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