TAC Versus TC for Adjuvant Breast Cancer



Status:Active, not recruiting
Conditions:Breast Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - 70
Updated:10/3/2018
Start Date:May 29, 2007
End Date:May 2019

Use our guide to learn which trials are right for you!

Phase III Trial of TC Versus TAC in HER2-Negative Early Stage Breast Cancer Patients

The purpose of this research study is to find out what effects (good and bad) TC or TAC has
on early stage HER2- breast cancer.

Both TAC (docetaxel, doxorubicin, and cyclophosphamide) and TC (docetaxel and
cyclophosphamide) are established adjuvant chemotherapy regimens for early stage breast
cancer. TAC, however, due to the inclusion of the anthracycline doxorubicin, carries a high
risk of hematologic and cardiotoxic adverse effects. Substantial evidence supports the
concept that early stage HER2-negative breast cancers will benefit similarly from
anthracycline-based adjuvant and non-anthracycline-based chemotherapy.

Further, approximately 0 to 9% of HER2-negative breast cancers have alterations in the TOP2A
gene, which may predict for benefit from anthracycline-based chemotherapy.

We hypothesize that 6 cycles of TC versus 6 cycles of TAC will have similar efficacy in the
treatment of early stage HER2-negative breast cancer and that TC will have less toxicity. If
this hypothesis were upheld and the anthracycline doxorubicin could be eliminated from the
regimen while obtaining similar efficacy in this population of patients, it would not only be
an important advance in the understanding of the biology of cancer, but it would also be of
significant clinical benefit to women with breast cancer.

Inclusion Criteria:

A woman will be eligible for inclusion in this study if she meets all of the following
criteria:

- Age >18 to <70 years old.

- Has known ER and PR status

- Has HER2 nonamplified disease, confirmed by FISH

- Has known menopausal status (see Section 7.3 for criteria)

- Has operable, histologically confirmed, Stage I, IIA, IIB, or IIIA, IIIB, or IIIC
invasive carcinoma of the breast. Bilateral synchronous breast cancer is allowable
provided that 1 primary meets the inclusion criteria.

- Meets 1 of the 3 following criteria:

- T1-3N1-3M0 if ER positive or negative

- T2-3N0M0 if ER positive or negative

- T1N0M0 if ER and PR negative

- Has complete surgical resection of the primary breast tumor: either lumpectomy or
mastectomy with sentinel lymph node biopsy or axillary dissection, with clear margins
for both invasive and ductal carcinoma in situ (DCIS)

- Has had no prior chemotherapy unless >5 years ago

- Has an ECOG Performance Status (PS) 0-1

- Has laboratory values of: See protocol for specific details

- Has aspartate aminotransferase (AST) or alanine aminotransferase (ALT) and alkaline
phosphatase (ALP) within the ranges shown below. In determining eligibility the more
abnormal of the 2 values (AST or ALT) should be used. See protocol for specific
details

- Has normal cardiac function as evidenced by a LVEF >50%, but WNL by institutional
standard by multiple gated acquisition (MUGA) scan. An echocardiogram (ECHO) may be
used if MUGA is not available, but the same modality must be used consistently
throughout the study to evaluate LVEF. Ejection fraction as determined by ECHO must be
WNL by institutional standard.

- Has no evidence of metastatic disease outside of breast by physical examination and
chest x-ray. Other scans if done as needed by the patient (eg, bone scan; abdominal,
chest CT; PET or PET/CT; ultrasound; or MRI should indicate no evidence of metastatic
disease

- Has had baseline bilateral mammography

- It has been <84 days since the date of definitive surgery (eg, mastectomy or, in the
case of a breast-sparing procedure, axillary dissection) with adequate wound healing,
as determined by the Treating Physician

- Has a negative serum pregnancy test within 7 calendar days prior to registration
(female patients of childbearing potential [not surgically sterilized and between
menarche and 1 year postmenopause])

- If fertile, patient has agreed to use an acceptable method of birth control (barrier
contraceptive only) to avoid pregnancy for the duration of the study and for a period
of 3 months thereafter

- Has adequate tumor specimen available for FISH analysis of TOP2A status (See Appendix
VI).

- Has signed a Patient Informed Consent Form

- Has signed a Patient Authorization Form

Exclusion Criteria:

A woman will be excluded from this study if she meets any of the following criteria:

- Has any evidence of metastatic disease following surgical resection of the primary
tumor including: positive surgical margins, staging work-up, or physical examination
suspicious for malignant disease

- Has T4 disease (ie, patients with fixed tumors, peau d'orange skin changes, skin
ulcerations, or inflammatory changes)

- Has Stage IV breast cancer (M1 disease on TNM staging system)

- Has a history of severe hypersensitivity reaction to drugs formulated with polysorbate
80

- Has had neoadjuvant chemotherapy for this breast cancer

- Has ever had a myocardial infarction (MI) or has a history of heart failure,
uncontrolled angina, severe uncontrolled arrhythmias, pericardial disease, or
electrocardiographic evidence of acute ischemic changes

- Is receiving concurrent immunotherapy, hormonal therapy (eg, tamoxifen, hormone
replacement therapy), or radiation therapy. Must discontinue prior to registering on
the study.

- Is receiving concurrent investigational therapy or has received such therapy within
the past 30 calendar days

- Has peripheral neuropathy >Grade 1

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

- Has a serious uncontrolled intercurrent medical or psychiatric illness, including
serious viral (including clinically defined AIDS), bacterial or fungal infection; or
history of uncontrolled seizures, or diabetes, or CNS disorders deemed by the Treating
Physician to be clinically significant, precluding informed consent

- Has active hepatitis B or hepatitis C with abnormal liver function tests (LFTs) or is
known to be HIV positive

- Has a history of other malignancy within the last 5 years (except cured basal cell
carcinoma of skin, carcinoma in situ of uterine cervix, DCIS, which could affect the
diagnosis or assessment of any of the study drugs

- In an obese patient to whom the Treating Physician would not be comfortable
administering full doses of study drugs as calculated by the BSA. Obese patients will
be treated based on actual body weight. Obese patients treated with full doses based
on actual BSA are eligible.

- Is pregnant or breastfeeding

- Is deemed unable to comply with requirements of study
We found this trial at
94
sites
Denver, Colorado 80220
?
mi
from
Denver, CO
Click here to add this to my saved trials
Los Angeles, California 90095
310-825-4321
University of California at Los Angeles The University of California, Los Angeles (UCLA) is an...
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials
?
mi
from
Melbourne, FL
Click here to add this to my saved trials
2102 Trinity Oaks Blvd # 204A Trinity,
New Port Richey, Florida 34655
?
mi
from
New Port Richey, FL
Click here to add this to my saved trials
433 Southwest 10th Street
Ocala, Florida 34471
?
mi
from
Ocala, FL
Click here to add this to my saved trials
Ocoee, Florida 34761
?
mi
from
Ocoee, FL
Click here to add this to my saved trials
220 S Palisade Dr # 204
Santa Maria, California 93454
?
mi
from
Santa Maria, CA
Click here to add this to my saved trials
?
mi
from
Abilene, TX
Click here to add this to my saved trials
Albany, New York 12206
?
mi
from
Albany, NY
Click here to add this to my saved trials
?
mi
from
Alhambra, CA
Click here to add this to my saved trials
Amarillo, Texas 79106
?
mi
from
Amarillo, TX
Click here to add this to my saved trials
Arlington, Texas 76014
?
mi
from
Arlington, TX
Click here to add this to my saved trials
Austin, Texas 78731
?
mi
from
Austin, TX
Click here to add this to my saved trials
Bakersfield, California 93309
?
mi
from
Bakersfield, CA
Click here to add this to my saved trials
Beaumont, Texas 77702
?
mi
from
Beaumont, TX
Click here to add this to my saved trials
Beckley, West Virginia 25801
?
mi
from
Beckley, WV
Click here to add this to my saved trials
Bedford, Texas 76022
?
mi
from
Bedford, TX
Click here to add this to my saved trials
Birmingham, Alabama 35205
?
mi
from
Birmingham, AL
Click here to add this to my saved trials
?
mi
from
Boardman, OH
Click here to add this to my saved trials
Burien, Washington 98166
?
mi
from
Burien, WA
Click here to add this to my saved trials
Chattanooga, Tennessee 37404
?
mi
from
Chattanooga, TN
Click here to add this to my saved trials
?
mi
from
Chicago, IL
Click here to add this to my saved trials
5053 Wooster Rd
Cincinnati, Ohio 45226
(513) 751-2273
Oncology Hematology Care Our more than 60 physicians and advanced practice providers throughout neighborhood offices...
?
mi
from
Cincinnati, OH
Click here to add this to my saved trials
Columbia, Maryland 21044
?
mi
from
Columbia, MD
Click here to add this to my saved trials
Columbia, Missouri 65201
?
mi
from
Columbia, MO
Click here to add this to my saved trials
?
mi
from
Dallas, TX
Click here to add this to my saved trials
Dallas, Texas 75246
?
mi
from
Dallas, TX
Click here to add this to my saved trials
Dallas, Texas 75237
?
mi
from
Dallas, TX
Click here to add this to my saved trials
Denton, Texas 76210
?
mi
from
Denton, TX
Click here to add this to my saved trials
Edmonds, Washington 98026
?
mi
from
Edmonds, WA
Click here to add this to my saved trials
El Paso, Texas 79915
?
mi
from
El Paso, TX
Click here to add this to my saved trials
Eugene, Oregon 97401
?
mi
from
Eugene, OR
Click here to add this to my saved trials
Fairfax, Virginia 22031
?
mi
from
Fairfax, VA
Click here to add this to my saved trials
Fort Myers, Florida 33916
?
mi
from
Fort Myers, FL
Click here to add this to my saved trials
Fort Worth, Texas 76104
?
mi
from
Fort Worth, TX
Click here to add this to my saved trials
Fullerton, California 92835
?
mi
from
Fullerton, CA
Click here to add this to my saved trials
Garland, Texas 75042
?
mi
from
Garland, TX
Click here to add this to my saved trials
Greenville, South Carolina 29605
?
mi
from
Greenville, SC
Click here to add this to my saved trials
Henderson, Nevada 89052
?
mi
from
Henderson, NV
Click here to add this to my saved trials
Houston, Texas 77024
?
mi
from
Houston, TX
Click here to add this to my saved trials
Indianapolis, Indiana 46227
?
mi
from
Indianapolis, IN
Click here to add this to my saved trials
7360 W. Deschutes
Kennewick, Washington 99336
509-783-0144
Columbia Basin Hematology and Oncology Our collaboration with Seattle Cancer Care Alliance gives you convenient...
?
mi
from
Kennewick, WA
Click here to add this to my saved trials
Kettering, Ohio 45409
?
mi
from
Kettering, OH
Click here to add this to my saved trials
Kingston, Pennsylvania 18704
?
mi
from
Kingston, PA
Click here to add this to my saved trials
La Verne, California 91750
?
mi
from
La Verne, CA
Click here to add this to my saved trials
Lancaster, California 93534
?
mi
from
Lancaster, CA
Click here to add this to my saved trials
Las Cruces, New Mexico 88011
?
mi
from
Las Cruces, NM
Click here to add this to my saved trials
Lawrenceville, Georgia 30046
?
mi
from
Lawrenceville, GA
Click here to add this to my saved trials
Lewisville, Texas 75067
?
mi
from
Lewisville, TX
Click here to add this to my saved trials
Long Beach, California 90813
?
mi
from
Long Beach, CA
Click here to add this to my saved trials
Longview, Texas 75601
?
mi
from
Longview, TX
Click here to add this to my saved trials
Marietta, Georgia 30060
?
mi
from
Marietta, GA
Click here to add this to my saved trials
?
mi
from
McAllen, TX
Click here to add this to my saved trials
Mesquite, Texas 75150
?
mi
from
Mesquite, TX
Click here to add this to my saved trials
Miami, Florida 33176
?
mi
from
Miami, FL
Click here to add this to my saved trials
Midland, Texas 79701
?
mi
from
Midland, TX
Click here to add this to my saved trials
Minneapolis, Minnesota 55405
?
mi
from
Minneapolis, MN
Click here to add this to my saved trials
Morristown, New Jersey 07960
?
mi
from
Morristown, NJ
Click here to add this to my saved trials
3322 West End Avenue
Nashville, Tennessee 37203
(615)329-SCRI (7274)
Sarah Cannon Research Institute Sarah Cannon Research Institute (SCRI) is a global strategic research organization...
?
mi
from
Nashville, TN
Click here to add this to my saved trials
?
mi
from
Niles, IL
Click here to add this to my saved trials
5900 Lake Wright Dr
Norfolk, Virginia 23502
(757) 466-8683
Virginia Oncology Associates Virginia Oncology Associates is an oncology and hematology practice of physicians, specializing...
?
mi
from
Norfolk, VA
Click here to add this to my saved trials
Northridge, California 91328
?
mi
from
Northridge, CA
Click here to add this to my saved trials
Odessa, Texas 79761
?
mi
from
Odessa, TX
Click here to add this to my saved trials
12200W. 110th Street
Overland Park, Kansas 66210
913.234.0400
Kansas City Cancer Centers - Southwest Through world-class research and patient care, The University of...
?
mi
from
Overland Park, KS
Click here to add this to my saved trials
?
mi
from
Oxnard, CA
Click here to add this to my saved trials
Paris, Texas 75460
?
mi
from
Paris, TX
Click here to add this to my saved trials
Philadelphia, Pennsylvania 19107
?
mi
from
Philadelphia, PA
Click here to add this to my saved trials
Phoenix, Arizona 85012
?
mi
from
Phoenix, AZ
Click here to add this to my saved trials
Raleigh, North Carolina 27607
?
mi
from
Raleigh, NC
Click here to add this to my saved trials
Richmond, Virginia 23235
?
mi
from
Richmond, VA
Click here to add this to my saved trials
Rochester, New York 14623
?
mi
from
Rochester, NY
Click here to add this to my saved trials
Saint Louis, Missouri 63141
?
mi
from
Saint Louis, MO
Click here to add this to my saved trials
?
mi
from
Salem, VA
Click here to add this to my saved trials
San Antonio, Texas 78229
?
mi
from
San Antonio, TX
Click here to add this to my saved trials
San Antonio, Texas 78217
?
mi
from
San Antonio, TX
Click here to add this to my saved trials
San Antonio, Texas 78229
?
mi
from
San Antonio, TX
Click here to add this to my saved trials
Santa Barbara, California 93105
?
mi
from
Santa Barbara, CA
Click here to add this to my saved trials
?
mi
from
Santa Barbara, CA
Click here to add this to my saved trials
Santa Fe, New Mexico 87505
?
mi
from
Santa Fe, NM
Click here to add this to my saved trials
Seattle, Washington 98133
?
mi
from
Seattle, WA
Click here to add this to my saved trials
?
mi
from
Sedona, AZ
Click here to add this to my saved trials
Sherman, Texas 75090
?
mi
from
Sherman, TX
Click here to add this to my saved trials
Spokane, Washington 99202
?
mi
from
Spokane, WA
Click here to add this to my saved trials
?
mi
from
Sugar Land, TX
Click here to add this to my saved trials
Terre Haute, Indiana 47802
?
mi
from
Terre Haute, IN
Click here to add this to my saved trials
?
mi
from
Tucson, AZ
Click here to add this to my saved trials
Tyler, Texas 75702
?
mi
from
Tyler, TX
Click here to add this to my saved trials
Vancouver, Washington 98684
?
mi
from
Vancouver, WA
Click here to add this to my saved trials
?
mi
from
Waco, TX
Click here to add this to my saved trials
Webster, Texas 77598
?
mi
from
Webster, TX
Click here to add this to my saved trials
Westminster, Maryland 21157
?
mi
from
Westminster, MD
Click here to add this to my saved trials
Wichita Falls, Texas 76310
?
mi
from
Wichita Falls, TX
Click here to add this to my saved trials
2811 Tieton Drive
Yakima, Washington 98902
?
mi
from
Yakima, WA
Click here to add this to my saved trials
2811 Tieton Drive
Yakima, Washington 98902
?
mi
from
Yakima, WA
Click here to add this to my saved trials