Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
493 participants
INTERVENTIONAL
2007-06-30
2013-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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TC+H
On Day 1 of each 21-day cycle for a total of 4 cycles, patients will receive, in this order: docetaxel (Taxotere) 75 mg/m2 IV (over 1 hour), plus cyclophosphamide (Cytoxan) 600 mg/m2 IV (over 15-30 minutes), plus weekly trastuzumab (Herceptin) 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.
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.
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.
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.
Interventions
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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.
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.
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 Intervention Names
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Eligibility Criteria
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Inclusion 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
* 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
18 Years
70 Years
FEMALE
No
Sponsors
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Sanofi
INDUSTRY
US Oncology Research
INDUSTRY
Responsible Party
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Principal Investigators
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Stephen E Jones, MD
Role: PRINCIPAL_INVESTIGATOR
US Oncology Research
Locations
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Birmingham Hematology and Oncology
Birmingham, Alabama, United States
Hematology Oncology Associates
Phoenix, Arizona, United States
Northern AZ Hematology & Oncology Associates
Sedona, Arizona, United States
Arizona Oncology Associates DBA HOPE
Tucson, Arizona, United States
Rocky Mountain Cancer Center-Rose
Denver, Colorado, United States
Connecticut Oncology & Hematology, LLP
Torrington, Connecticut, United States
Florida Cancer Institute
New Port Richey, Florida, United States
Ocala Oncology Center
Ocala, Florida, United States
Cancer Centers of Florida, P.A.
Ocoee, Florida, United States
Hematology Oncology Associates of IL
Chicago, Illinois, United States
Cancer Care & Hematology Specialists of Chicagoland
Niles, Illinois, United States
Central Indiana Cancer Centers
Indianapolis, Indiana, United States
Hope Center
Terre Haute, Indiana, United States
Kansas City Cancer Centers-Southwest
Overland Park, Kansas, United States
Maryland Oncology Hematology, P.A.
Columbia, Maryland, United States
Alliance Hematology Oncology P.A.
Westminster, Maryland, United States
Minnesota Oncology Hematology, P.A.
Minneapolis, Minnesota, United States
Missouri Cancer Associates
Columbia, Missouri, United States
Arch Medical Services, Inc.
St Louis, Missouri, United States
Comprehensive Cancer Centers of Nevada
Henderson, Nevada, United States
Hematology-Oncology Associates of NNJ, P.A.
Morristown, New Jersey, United States
New Mexico Cancer Care Associates
Santa Fe, New Mexico, United States
New York Oncology Hematology, P.C.
Albany, New York, United States
Ruth Oratz MD
New York, New York, United States
Interlakes Oncology Hematology, PC
Rochester, New York, United States
Cancer Centers of North Carolina
Raleigh, North Carolina, United States
Greater Dayton Cancer Center
Kettering, Ohio, United States
Willamette Valley Cancer Center
Eugene, Oregon, United States
Medical Oncology Associates
Kingston, Pennsylvania, United States
Cancer Centers of the Carolinas
Greenville, South Carolina, United States
Texas Cancer Center-Abilene (South)
Abilene, Texas, United States
Texas Oncology, P.A.-Amarillo
Amarillo, Texas, United States
Texas Cancer Center
Arlington, Texas, United States
Texas Oncology Cancer Center
Austin, Texas, United States
Mamie McFaddin Ward Cancer Center
Beaumont, Texas, United States
Texas Oncology, P.A.-Bedford
Bedford, Texas, United States
Texas Cancer Center at Medical City
Dallas, Texas, United States
Texas Oncology, P.A.
Dallas, Texas, United States
Methodist Charlton Cancer Ctr.
Dallas, Texas, United States
Texas Oncology, P.A.
Dallas, Texas, United States
Texas Cancer Center
Denton, Texas, United States
El Paso Cancer Treatment Ctr
El Paso, Texas, United States
Texas Oncology, P.A.
Fort Worth, Texas, United States
Texas Oncology, P.A.
Garland, Texas, United States
Texas Oncology, P.A.
Houston, Texas, United States
Lake Vista Cancer Center
Lewisville, Texas, United States
Longview Cancer Center
Longview, Texas, United States
South Texas Cancer Center-McAllen
McAllen, Texas, United States
Texas Cancer Center of Mesquite
Mesquite, Texas, United States
Allison Cancer Center
Midland, Texas, United States
Texas Oncology-Odessa
Odessa, Texas, United States
Paris Regional Cancer Center
Paris, Texas, United States
San Antonio Tumor and Blood Clinic
San Antonio, Texas, United States
HOAST-Medical Dr.
San Antonio, Texas, United States
Texas Cancer Center-Sherman
Sherman, Texas, United States
Texas Oncology Cancer Center-Sugar Land
Sugar Land, Texas, United States
Tyler Cancer Center
Tyler, Texas, United States
Texas Oncology Cancer Care and Research
Waco, Texas, United States
Texas Oncology PA
Webster, Texas, United States
Texoma Cancer Center
Wichita Falls, Texas, United States
Fairfax Northern VA Hem-Onc PC
Fairfax, Virginia, United States
Virginia Oncology Associates
Norfolk, Virginia, United States
Onc and Hem Associates of SW VA, Inc.
Salem, Virginia, United States
Highline Medical Oncology
Burien, Washington, United States
Puget Sound Cancer Center-Edmonds
Edmonds, Washington, United States
Puget Sound Cancer Center-Seattle
Seattle, Washington, United States
Cancer Care Northwest-South
Spokane, Washington, United States
Northwest Cancer Specialists-Vancouver
Vancouver, Washington, United States
Yakima Valley Mem Hosp/North Star Lodge
Yakima, Washington, United States
Countries
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References
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Jones SE, Collea R, Paul D, Sedlacek S, Favret AM, Gore I Jr, Lindquist DL, Holmes FA, Allison MAK, Brooks BD, Portillo RM, Vukelja SJ, Steinberg MS, Stokoe C, Crockett MW, Wang Y, Asmar L, Robert NJ, O'Shaughnessy J. Adjuvant docetaxel and cyclophosphamide plus trastuzumab in patients with HER2-amplified early stage breast cancer: a single-group, open-label, phase 2 study. Lancet Oncol. 2013 Oct;14(11):1121-1128. doi: 10.1016/S1470-2045(13)70384-X. Epub 2013 Sep 3.
Other Identifiers
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11270
Identifier Type: OTHER
Identifier Source: secondary_id
06-038
Identifier Type: -
Identifier Source: org_study_id