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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)
Female
Breast Cancer

Thank you

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
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

Type of Study:

Interventional

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:

3-year

Safety Issue:

No

Principal Investigator

Joanne L Blum, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

US Oncology Research

Authority:

United States: Institutional Review Board

Study ID:

11271

NCT ID:

NCT00493870

Start Date:

May 2007

Completion Date:

May 2015

Related Keywords:

  • Breast Cancer
  • Breast Neoplasms

Name

Location

Texas Oncology, P.A.Dallas, Texas  75246
Virginia Oncology AssociatesNewport News, Virginia  23606
Ocala Oncology CenterOcala, Florida  34474
Cancer Centers of the CarolinasGreenville, South Carolina  29605
Missouri Cancer AssociatesColumbia, Missouri  65201
Comprehensive Blood and Cancer CenterBakersfield, California  93309
Pacific Shores Medical GroupLong Beach, California  90813
New Mexico Cancer Care AssociatesSanta Fe, New Mexico  87505-7670
Tyler Cancer CenterTyler, Texas  75702
Hope CenterTerre Haute, Indiana  47809
Rittenhouse Hematology/OncologyPhiladelphia, Pennsylvania  19146
Willamette Valley Cancer CenterEugene, Oregon  97401-8122
San Antonio Tumor and Blood ClinicSan 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 OncologyDallas, Texas  
Virginia Cancer InstituteRichmond, Virginia  23230
Wilshire Oncology Medical GroupGlendora, California  91741
North Valley Hematology/Oncology Medical GroupNorthridge, California  91328
Northwest Cancer Specialists-VancouverVancouver, Washington  98684
Medical Oncology AssociatesKingston, Pennsylvania  18704
Florida Cancer InstituteNew Port Richey, Florida  34652
Central Indiana Cancer CentersIndianapolis, Indiana  46227
Minnesota Oncology Hematology, P.A.Minneapolis, Minnesota  55407
Texas Cancer Center at Medical CityDallas, Texas  75230
Allison Cancer CenterMidland, Texas  79701
Texoma Cancer CenterWichita Falls, Texas  76310
Highline Medical OncologyBurien, Washington  98166
Hematology Oncology AssociatesPhoenix, Arizona  85012
Arch Medical Services, INC.St. Louis, Missouri  63142
Greater Dayton Cancer CenterKettering, Ohio  45409
Birmingham Hematology and OncologyBirmingham, Alabama  35235
Texas Cancer CenterAbilene, Texas  79606
Texas Oncology Cancer CenterAustin, Texas  78731
Mamie McFaddin Ward Cancer CenterBeaumont, Texas  77702
Lake Vista Cancer CenterLewisville, Texas  75067
Longview Cancer CenterLongview, Texas  75601
Texas Cancer Center of MesquiteMesquite, Texas  75150
Comprehensive Cancer Center of NevadaLas Vegas, Nevada  89109
Maryland Oncology Hematology, P.A.Columbia, Maryland  21044
Paris Regional Cancer CenterParis, Texas  75460
Antelope Valley Cancer CenterLancaster, California  93534
Central Hematology Oncology Medical Group, Inc.Alhambra, California  91801
The Sarah Cannon Research InstituteNashville, Tennessee  37203
Central Coast Medical Oncology CorporationSanta Maria, California  93454
Suburban Hematology-Oncology Associates, PcLawrenceville, Georgia  30046
South Texas Oncology and Hematology, P.A.San Antonio, Texas  78207
Hematology Oncology Associates of ILChicago, Illinois  60611
Cancer Care & Hematology Specialists of ChicagolandNiles, Illinois  60714
Yakima Valley Memorial Hospital/North Star LodgeYakima, Washington  98902
Rocky Mountain Cancer Center-RoseDenver, Colorado  80220
Texas Oncology PADallas, Texas  75231
Melbourne Internal Medicine AssociatesMelbourne, Florida  32901
Hematology-Oncology Associates of NNJ, P.A.Morristown, New Jersey  07960
Interlakes Oncology Hematology, PCRochester, New York  14623
El Paso Cancer Treatment CtrEl Paso, Texas  79915
South Texas Cancer Center-McAllenMcAllen, Texas  78503
Texas Cancer Center-ShermanSherman, Texas  75090
Texas Oncology Cancer Center-Sugar LandSugar Land, Texas  77479
Puget Sound Cancer Center-SeattleSeattle, Washington  98133
Cancer Care Northwest-SouthSpokane, Washington  99202
Yakima Valley Mem Hosp/North Star LodgeYakima, Washington  98902
Fairfax Northern VA Hem-Onc PCFairfax, Virginia  22031
Chattanooga Oncology & Hematology Associates, PCChattanooga, Tennessee  37404
Kansas City Cancer Centers-SouthwestOverland Park, Kansas  66210
Alliance Hematology Oncology PAWestminster, Maryland  21157
Northwest Georgia Oncology Centers, PCMarietta, Georgia  30060
Texas Oncology, P.A.-AmarilloAmarillo, Texas  79106
HOAST-Medical Dr.San Antonio, Texas  78229
Cancer Centers of North CarolinaRaleigh, North Carolina  27607
Arizona Oncology Associates DBA HOPETucson, Arizona  85704
Texas Cancer Center-Abilene (South)Abilene, Texas  79606
Methodist Charlton Cancer Ctr.Dallas, Texas  75237
Texas Oncology-OdessaOdessa, Texas  79761
Texas Oncology Cancer Care and ResearchWaco, Texas  76712
Northern AZ Hematology Oncology Associates-AOASedona, Arizona  86336
St. Jude Hertiage Medical GroupFullerton, California  92835
University of California-Los AngelesLos Angeles, California  90095
Ventura County Hematology-Oncology SpecialistOxnard, California  93030
Santa Barabra Hematology Oncology Medical Group, Inc.Santa Barbara, California  93105
SAMSUM ClinicSanta Barbara, California  93105
Flordia Cancer SpecialistFort Myers, Florida  33916
Advanced Medical SpecialistMiami, Florida  33176
Southern New Mexico Cancer CenterLas Cruces, New Mexico  88011
Mahoning Valley Hematology Oncology AssociatesBoardman, Ohio  44514
Texas Oncology -BedfordBedford, Texas  76022
Onc and Hem Associates os SW VA, Inc.Salem, Virginia  24153
Pudget Sound Cancer Center-EdmondsEdmonds, Washington  98026
Columbia Basin Hematology and OncologyKennewick, Washington  99336
Raleigh Regional Cancer CenterBeckley, West Virginia  25801