Clinical trial NCT00352378: Primary Chemotherapy With Adriamycin/Cyclophosphamide(AC) vs Taxotere/Xeloda(TX) for Stage II and III Breast Cancer
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Breast Cancer
Keywords: Primary
Lead sponsor: National Cancer Center, Korea
Sponsor class: OTHER_GOV
First posted: 2006-07-14
Enrollment: 209
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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.

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 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

Primary outcomes:
measure: pathologic complete remission
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: National Cancer Center, Korea
name: Jungsil Ro, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References: