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

Phase 3
18 Years
70 Years
Open (Enrolling)
Breast Cancer

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Trial Information

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

Inclusion Criteria:

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

- 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

- 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

- 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

- 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

- 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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

to compare the 3-year DFS of adjuvant TC versus TAC as treatment for early stage HER2-negative breast cancer.

Outcome Time Frame:


Safety Issue:


Principal Investigator

Joanne L Blum, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

US Oncology Research


United States: Institutional Review Board

Study ID:




Start Date:

May 2007

Completion Date:

May 2015

Related Keywords:

  • Breast Cancer
  • Breast Neoplasms



Texas Oncology, P.A. Dallas, Texas  75246
Virginia Oncology Associates Newport News, Virginia  23606
Ocala Oncology Center Ocala, Florida  34474
Cancer Centers of the Carolinas Greenville, South Carolina  29605
Missouri Cancer Associates Columbia, Missouri  65201
Comprehensive Blood and Cancer Center Bakersfield, California  93309
Pacific Shores Medical Group Long Beach, California  90813
New Mexico Cancer Care Associates Santa Fe, New Mexico  87505-7670
Tyler Cancer Center Tyler, Texas  75702
Hope Center Terre Haute, Indiana  47809
Rittenhouse Hematology/Oncology Philadelphia, Pennsylvania  19146
Willamette Valley Cancer Center Eugene, Oregon  97401-8122
San Antonio Tumor and Blood Clinic San Antonio, Texas  78217
New York Oncology Hematology, P.C. Albany, New York  12208
Oncology Hematology Care, Inc. Cincinnati, Ohio  45219
Cancer Centers of Florida, P.A. Orlando, Florida  
Texas Oncology Dallas, Texas  
Virginia Cancer Institute Richmond, Virginia  23230
Wilshire Oncology Medical Group Glendora, California  91741
North Valley Hematology/Oncology Medical Group Northridge, California  91328
Northwest Cancer Specialists-Vancouver Vancouver, Washington  98684
Medical Oncology Associates Kingston, Pennsylvania  18704
Florida Cancer Institute New Port Richey, Florida  34652
Central Indiana Cancer Centers Indianapolis, Indiana  46227
Minnesota Oncology Hematology, P.A. Minneapolis, Minnesota  55407
Texas Cancer Center at Medical City Dallas, Texas  75230
Allison Cancer Center Midland, Texas  79701
Texoma Cancer Center Wichita Falls, Texas  76310
Highline Medical Oncology Burien, Washington  98166
Hematology Oncology Associates Phoenix, Arizona  85012
Arch Medical Services, INC. St. Louis, Missouri  63142
Greater Dayton Cancer Center Kettering, Ohio  45409
Birmingham Hematology and Oncology Birmingham, Alabama  35235
Texas Cancer Center Abilene, Texas  79606
Texas Oncology Cancer Center Austin, Texas  78731
Mamie McFaddin Ward Cancer Center Beaumont, Texas  77702
Lake Vista Cancer Center Lewisville, Texas  75067
Longview Cancer Center Longview, Texas  75601
Texas Cancer Center of Mesquite Mesquite, Texas  75150
Comprehensive Cancer Center of Nevada Las Vegas, Nevada  89109
Maryland Oncology Hematology, P.A. Columbia, Maryland  21044
Paris Regional Cancer Center Paris, Texas  75460
Antelope Valley Cancer Center Lancaster, California  93534
Central Hematology Oncology Medical Group, Inc. Alhambra, California  91801
The Sarah Cannon Research Institute Nashville, Tennessee  37203
Central Coast Medical Oncology Corporation Santa Maria, California  93454
Suburban Hematology-Oncology Associates, Pc Lawrenceville, Georgia  30046
South Texas Oncology and Hematology, P.A. San Antonio, Texas  78207
Hematology Oncology Associates of IL Chicago, Illinois  60611
Cancer Care & Hematology Specialists of Chicagoland Niles, Illinois  60714
Yakima Valley Memorial Hospital/North Star Lodge Yakima, Washington  98902
Rocky Mountain Cancer Center-Rose Denver, Colorado  80220
Texas Oncology PA Dallas, Texas  75231
Melbourne Internal Medicine Associates Melbourne, Florida  32901
Hematology-Oncology Associates of NNJ, P.A. Morristown, New Jersey  07960
Interlakes Oncology Hematology, PC Rochester, New York  14623
El Paso Cancer Treatment Ctr El Paso, Texas  79915
South Texas Cancer Center-McAllen McAllen, Texas  78503
Texas Cancer Center-Sherman Sherman, Texas  75090
Texas Oncology Cancer Center-Sugar Land Sugar Land, Texas  77479
Puget Sound Cancer Center-Seattle Seattle, Washington  98133
Cancer Care Northwest-South Spokane, Washington  99202
Yakima Valley Mem Hosp/North Star Lodge Yakima, Washington  98902
Fairfax Northern VA Hem-Onc PC Fairfax, Virginia  22031
Chattanooga Oncology & Hematology Associates, PC Chattanooga, Tennessee  37404
Kansas City Cancer Centers-Southwest Overland Park, Kansas  66210
Alliance Hematology Oncology PA Westminster, Maryland  21157
Northwest Georgia Oncology Centers, PC Marietta, Georgia  30060
Texas Oncology, P.A.-Amarillo Amarillo, Texas  79106
HOAST-Medical Dr. San Antonio, Texas  78229
Cancer Centers of North Carolina Raleigh, North Carolina  27607
Arizona Oncology Associates DBA HOPE Tucson, Arizona  85704
Texas Cancer Center-Abilene (South) Abilene, Texas  79606
Methodist Charlton Cancer Ctr. Dallas, Texas  75237
Texas Oncology-Odessa Odessa, Texas  79761
Texas Oncology Cancer Care and Research Waco, Texas  76712
Northern AZ Hematology Oncology Associates-AOA Sedona, Arizona  86336
St. Jude Hertiage Medical Group Fullerton, California  92835
University of California-Los Angeles Los Angeles, California  90095
Ventura County Hematology-Oncology Specialist Oxnard, California  93030
Santa Barabra Hematology Oncology Medical Group, Inc. Santa Barbara, California  93105
SAMSUM Clinic Santa Barbara, California  93105
Flordia Cancer Specialist Fort Myers, Florida  33916
Advanced Medical Specialist Miami, Florida  33176
Southern New Mexico Cancer Center Las Cruces, New Mexico  88011
Mahoning Valley Hematology Oncology Associates Boardman, Ohio  44514
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Onc and Hem Associates os SW VA, Inc. Salem, Virginia  24153
Pudget Sound Cancer Center-Edmonds Edmonds, Washington  98026
Columbia Basin Hematology and Oncology Kennewick, Washington  99336
Raleigh Regional Cancer Center Beckley, West Virginia  25801