Adj TC + Herceptin Early Stage Breast Cancer

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2010 by US Oncology Research.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Sanofi
Information provided by:
US Oncology Research
ClinicalTrials.gov Identifier:
NCT00493649
First received: June 27, 2007
Last updated: April 22, 2010
Last verified: April 2010
  Purpose

The purpose of this research study is to find out what effects (good and bad) docetaxel/cyclophosphamide (brand names: Taxotere and Cytoxan, or TC) plus trastuzumab (brand name: Herceptin, or H) has on you and your HER2+ breast cancer.


Condition Intervention Phase
Breast Cancer
Drug: Taxotere
Drug: Cytoxan
Drug: Herceptin
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Trial of Adjuvant TC (Docetaxel/Cyclophosphamide) Plus Trastuzumab in HER2-Positive Early Stage Breast Cancer Patients

Resource links provided by NLM:


Further study details as provided by US Oncology Research:

Primary Outcome Measures:
  • To determine the DFS at 2 years in TOP2A-amplified and in TOP2A-nonamplified HER2+ ESBC patients treated with TC+H. [ Time Frame: To determine the DFS at 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To determine the overall safety and cardiac safety of 4 cycles of TC+H in HER2+ ESBC patients. [ Time Frame: To determine the overall survival at 2 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 493
Study Start Date: June 2007
Estimated Study Completion Date: February 2011
Estimated Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Taxotere
    On Day 1 of each 21-day cycle for a total of 4 cycles, patients will receive, in this order: docetaxel 75 mg/m2 IV (over 1 hour), plus cyclophosphamide 600 mg/m2 IV (over 15-30 minutes), plus weekly trastuzumab 4 mg/kg IV (loading dose, over 90 minutes Day 1, Cycle 1 only) and 2 mg/kg IV (over 30-60 minutes on Days 1, 8, and 15) thereafter. Once 4 cycles of TC+H have been received, patients will continue with trastuzumab 6 mg/kg every 3 weeks to complete 1 year of anti-HER2 therapy as per the current standard of care. The anticipated time to study completion is 5 years.
    Other Name: docetaxel
    Drug: Cytoxan
    On Day 1 of each 21-day cycle for a total of 4 cycles, patients will receive, in this order: docetaxel 75 mg/m2 IV (over 1 hour), plus cyclophosphamide 600 mg/m2 IV (over 15-30 minutes), plus weekly trastuzumab 4 mg/kg IV (loading dose, over 90 minutes Day 1, Cycle 1 only) and 2 mg/kg IV (over 30-60 minutes on Days 1, 8, and 15) thereafter. Once 4 cycles of TC+H have been received, patients will continue with trastuzumab 6 mg/kg every 3 weeks to complete 1 year of anti-HER2 therapy as per the current standard of care. The anticipated time to study completion is 5 years.
    Other Name: cyclophosphamide
    Drug: Herceptin
    On Day 1 of each 21-day cycle for a total of 4 cycles, patients will receive, in this order: docetaxel 75 mg/m2 IV (over 1 hour), plus cyclophosphamide 600 mg/m2 IV (over 15-30 minutes), plus weekly trastuzumab 4 mg/kg IV (loading dose, over 90 minutes Day 1, Cycle 1 only) and 2 mg/kg IV (over 30-60 minutes on Days 1, 8, and 15) thereafter. Once 4 cycles of TC+H have been received, patients will continue with trastuzumab 6 mg/kg every 3 weeks to complete 1 year of anti-HER2 therapy as per the current standard of care. The anticipated time to study completion is 5 years.
    Other Name: trastuzumab
  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

  • Has HER2+ (IHC staining of 3+ [uniform, intense membrane staining of >30% of invasive tumor cells], or a FISH result of .6 HER2 gene copies per nucleus or a FISH ratio [HER2 gene signals to chromosome 17 signals] of >2.2; patients with equivocal FISH ratio results 1.8-2.2 are also eligible if 3+ IHC) (Appendix IX); Stage I, IIA, IIB, or IIIA T1-3N1-3M0 disease. At the discretion of the Treating Physician, patients with 4+ nodes with other factors such as patient choice, older age, preexisting cardiac disease with normal MUGA or ECHO may be enrolled into a separate subgroup.
  • Has operable, histologically confirmed, invasive carcinoma of the breast.
  • Has known ER and PR status
  • Has adequate tumor specimen available for FISH analysis of TOP2A status (See Appendix VII)
  • Has had no prior chemotherapy unless it was given >5 years ago for breast cancer or other cancer
  • Has an ECOG Performance Status (PS) 0-1
  • Age >18 to <70 years old.
  • 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 complete surgical resection of the primary breast tumor: either lumpectomy or mastectomy with sentinel lymph node or axillary dissection.
  • It has been <84 days since the date of definitive surgery, and there is adequate wound healing as determined by the Treating Physician
  • Has no evidence of metastatic disease by physical examination and x-ray; appropriate scans as needed by each individual patient (eg, bone scan; abdominal, chest CT; PET or PET/CT; ultrasound; or MRI should indicate no evidence of metastatic disease.
  • Has normal cardiac function as evidenced by a LVEF >50%, but must be within normal limits (WNL) by institutional standard, as determined by multiple gated acquisition (MUGA) scan. An echocardiogram (ECHO). The same modality must be used throughout the study to evaluate LVEF. Ejection fraction (EF) as determined by ECHO must be WNL by institutional standard.
  • 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) to avoid pregnancy for the duration of the study and for a period of 3 months thereafter
  • 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 disease following complete surgical resection of the primary tumor and metastatic workup
  • Has Stage IIIB breast cancer (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)
  • Had prior chemotherapy for breast cancer or other cancer within the last 5 years (no neoadjuvant chemotherapy in this study is permitted)
  • Has a history of severe hypersensitivity reaction to drugs formulated with polysorbate 80
  • Has had a myocardial infarction (MI) within 6 months of trial enrollment, or has New York Heart Association (NYHA) Class II or greater heart failure (see Appendix III), uncontrolled angina, severe uncontrolled ventricular arrhythmias, clinically significant pericardial disease, or electrocardiographic evidence of acute ischemic changes
  • Has abnormal baseline MUGA (or ECHO) (<50%, or less than institutional LLN)
  • Is receiving concurrent immunotherapy, hormonal therapy, or radiation therapy. Adjuvant hormonal therapy, if needed, may be given during radiation therapy and during treatment with trastuzumab after completion of chemotherapy.
  • Is receiving concurrent investigational therapy or has received such therapy within the past 30 calendar days
  • Has peripheral neuropathy >Grade 1
  • 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 and carcinoma in situ of uterine cervix), which could affect the diagnosis or assessment of any of the study drugs
  • Is 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 a pregnant or breastfeeding woman
  • Is deemed unable to comply with requirements of study
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00493649

  Hide Study Locations
Locations
United States, Alabama
Birmingham Hematology and Oncology
Birmingham, Alabama, United States, 35205
United States, Arizona
Hematology Oncology Associates
Phoenix, Arizona, United States, 85012
Northern AZ Hematology & Oncology Associates
Sedona, Arizona, United States, 86336
Arizona Oncology Associates DBA HOPE
Tucson, Arizona, United States, 85704
United States, Colorado
Rocky Mountain Cancer Center-Rose
Denver, Colorado, United States, 80220
United States, Connecticut
Connecticut Oncology & Hematology, LLP
Torrington, Connecticut, United States, 06790
United States, Florida
Florida Cancer Institute
New Port richey, Florida, United States, 34655
Ocala Oncology Center
Ocala, Florida, United States, 34474
Cancer Centers of Florida, P.A.
Ocoee, Florida, United States, 34761
United States, Illinois
Hematology Oncology Associates of IL
Chicago, Illinois, United States, 60611
Cancer Care & Hematology Specialists of Chicagoland
Niles, Illinois, United States, 60714
United States, Indiana
Central Indiana Cancer Centers
Indianapolis, Indiana, United States, 46227
Hope Center
Terre Haute, Indiana, United States, 47802
United States, Kansas
Kansas City Cancer Centers-Southwest
Overland Park, Kansas, United States, 66210
United States, Maryland
Maryland Oncology Hematology, P.A.
Columbia, Maryland, United States, 21044
Alliance Hematology Oncology P.A.
Westminster, Maryland, United States, 21157
United States, Minnesota
Minnesota Oncology Hematology, P.A.
Minneapolis, Minnesota, United States, 55404
United States, Missouri
Missouri Cancer Associates
Columbia, Missouri, United States, 65201
Arch Medical Services, Inc.
St. Louis, Missouri, United States, 63141
United States, Nevada
Comprehensive Cancer Centers of Nevada
Henderson, Nevada, United States, 89052
United States, New Jersey
Hematology-Oncology Associates of NNJ, P.A.
Morristown, New Jersey, United States, 07960
United States, New Mexico
New Mexico Cancer Care Associates
Santa Fe, New Mexico, United States, 87505
United States, New York
New York Oncology Hematology, P.C.
Albany, New York, United States, 12006
Ruth Oratz MD
New York, New York, United States, 10016
Interlakes Oncology Hematology, PC
Rochester, New York, United States, 14623
United States, North Carolina
Cancer Centers of North Carolina
Raleigh, North Carolina, United States, 27607
United States, Ohio
Greater Dayton Cancer Center
Kettering, Ohio, United States, 45409
United States, Oregon
Willamette Valley Cancer Center
Eugene, Oregon, United States, 97401
United States, Pennsylvania
Medical Oncology Associates
Kingston, Pennsylvania, United States, 18704
United States, South Carolina
Cancer Centers of the Carolinas
Greenville, South Carolina, United States, 29605
United States, Texas
Texas Cancer Center-Abilene (South)
Abilene, Texas, United States, 79606
Texas Oncology, P.A.-Amarillo
Amarillo, Texas, United States, 79106
Texas Cancer Center
Arlington, Texas, United States, 76014
Texas Oncology Cancer Center
Austin, Texas, United States, 78731
Mamie McFaddin Ward Cancer Center
Beaumont, Texas, United States, 77702
Texas Oncology, P.A.-Bedford
Bedford, Texas, United States, 76022
Methodist Charlton Cancer Ctr.
Dallas, Texas, United States, 75237
Texas Oncology, P.A.
Dallas, Texas, United States, 75231
Texas Cancer Center at Medical City
Dallas, Texas, United States, 75230
Texas Oncology, P.A.
Dallas, Texas, United States, 75246
Texas Cancer Center
Denton, Texas, United States, 76210
El Paso Cancer Treatment Ctr
EL Paso, Texas, United States, 79915
Texas Oncology, P.A.
Fort Worth, Texas, United States, 76104
Texas Oncology, P.A.
Garland, Texas, United States, 75042
Texas Oncology, P.A.
Houston, Texas, United States, 77024
Lake Vista Cancer Center
Lewisville, Texas, United States, 75067
Longview Cancer Center
Longview, Texas, United States, 75601
South Texas Cancer Center-McAllen
McAllen, Texas, United States, 78503
Texas Cancer Center of Mesquite
Mesquite, Texas, United States, 75150
Allison Cancer Center
Midland, Texas, United States, 79701
Texas Oncology-Odessa
Odessa, Texas, United States, 79761
Paris Regional Cancer Center
Paris, Texas, United States, 75460
HOAST-Medical Dr.
San Antonio, Texas, United States, 78229
San Antonio Tumor and Blood Clinic
San Antonio, Texas, United States, 78217
Texas Cancer Center-Sherman
Sherman, Texas, United States, 75090
Texas Oncology Cancer Center-Sugar Land
Sugar Land, Texas, United States, 77479
Tyler Cancer Center
Tyler, Texas, United States, 75702
Texas Oncology Cancer Care and Research
Waco, Texas, United States, 76712
Texas Oncology PA
Webster, Texas, United States, 77598
Texoma Cancer Center
Wichita Falls, Texas, United States, 76310
United States, Virginia
Fairfax Northern VA Hem-Onc PC
Fairfax, Virginia, United States, 22031
Virginia Oncology Associates
Norfolk, Virginia, United States, 23502
Onc and Hem Associates of SW VA, Inc.
Salem, Virginia, United States, 24153
United States, Washington
Highline Medical Oncology
Burien, Washington, United States, 98166
Puget Sound Cancer Center-Edmonds
Edmonds, Washington, United States, 98026
Puget Sound Cancer Center-Seattle
Seattle, Washington, United States, 98133
Cancer Care Northwest-South
Spokane, Washington, United States, 99202
Northwest Cancer Specialists-Vancouver
Vancouver, Washington, United States, 98684
Yakima Valley Mem Hosp/North Star Lodge
Yakima, Washington, United States, 98902
Sponsors and Collaborators
US Oncology Research
Sanofi
Investigators
Principal Investigator: Stephen E Jones, MD US Oncology Research
  More Information

No publications provided

Responsible Party: Steven Jones, Principal Investigator, US Oncology, Inc.
ClinicalTrials.gov Identifier: NCT00493649     History of Changes
Other Study ID Numbers: 06-038
Study First Received: June 27, 2007
Last Updated: April 22, 2010
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Cyclophosphamide
Docetaxel
Trastuzumab
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists

ClinicalTrials.gov processed this record on April 17, 2014