Primary Chemotherapy With Adriamycin/Cyclophosphamide(AC) vs Taxotere/Xeloda(TX) for Stage II and III Breast Cancer
Information source: National Cancer Center, Korea
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Breast Cancer
Intervention: Anthracycline, Cyclophosphamide, Docetaxel, Capecitabine (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: National Cancer Center, Korea Official(s) and/or principal investigator(s): Jungsil Ro, MD,PhD, Principal Investigator, Affiliation: National Cancer Center, Korea
Summary
This is an open labeled phase III randomized trial. The patients with clinical stage II and
III will undergo mammotome biopsy of breast tumor for histologic diagnosis,
immunohistochemical studies for estrogen receptor(ER), progesterone receptor(PR), HER-2/neu
and others. PET results will determine the positivity of lymph node metastasis.
Clinical Details
Official title: A Phase III Randomized Study of Primary Chemotherapy With Adriamycin/Cyclophosphamide(AC) vs Taxotere/Xeloda(TX) for Stage II and III Breast Cancer
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: pathologic complete remission
Detailed description:
- Patients will be randomized to receive regimen A (AC) and regimen B(TX),
preoperatively,as follows: Regimen A (AC): Intravenous infusion of Adriamycin 60mg/m2 , over
30 min, onD1 and Intravenous infusion of cyclophosphamide 600 mg/m2 over 30 min on D1.
Regimen B(TX): Intravenous infusion of Taxotere 75 mg/m2 over 1 hr, on D1, and Xeloda
1000mg/m2. p.o. BID x 14days on D1-D14 The cycle repeats every 3 weeks for 4 times.
Premedication for regimen A includes antiemetics, for regimen B, dexamethasone as routinely
given.
Patients who do not respond to the initial two cycles of preoperative chemotherapy will
undergo operation.
The response rate will be determined by the number of patients with complete and partial
responses according to RECIST guidelines. Pathologic complete response is defined as no
pathologic evidence of residual disease. Safety will be evaluated by the frequency,
severity, and relationship of adverse events graded by NCI Common Toxicity Criteria(CTC)
that occur during the treatment and follow-up periods. Time to disease progression will be
calculated from the date of study entry to the first objective documentation of progressive
disease. Response duration will be measured from the date a patient first fulfills the CR or
PR criteria to the first date of objective documentation of disease progression. Survival
time will be calculated from the date of study entry to the date of death
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Female.
Criteria:
Inclusion Criteria:
- All patients must have histologically confirmed and newly diagnosed breast cancer:
stage II and III breast cancer.
- PET results will determine node positivity.
- No prior hormonal , chemotherapy or radiotherapy is allowed.
- No breast operation other than biopsy to make diagnosis is allowed.
- Age: 18-years and older, not pregnant pre-, and postmenopausal women with good
performance status (ECOG 0-1)
- Adequate hematopoietic function:
1. Absolute granulocyte count >=1500/mm3,
2. platelet >=100,000/mm3, Hemoglobin >=10 g/mm3
- Adequate renal function: Serum creatinine <=1. 5 mg/dl
- Adequate hepatic function:
1. total bilirubin: <=1. 5 mg/dl
2. AST/ALT: <=three times normal
3. Alkaline phosphatase: <=three times normal
- Adequate cardiac function: normal or nonspecific EKG taken within 1 mo of enrollment
Exclusion Criteria:
- Patients who received hormonal , chemotherapy or radiotherapy for breast cancer
- Patients who underwent surgery for breast cancer
- Patients who have history of cancer other than in situ uterine cervix cancer or
nonmelanotic skin cancer
Locations and Contacts
Additional Information
Starting date: June 2002
Last updated: June 23, 2011
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