Primary Chemotherapy With Adriamycin/Cyclophosphamide(AC) vs Taxotere/Xeloda(TX) for Stage II and III Breast Cancer

Phase 3

Completed

• Conditions: Breast Cancer
• Interventions: Drug: Anthracycline, Cyclophosphamide, Docetaxel, Capecitabine

• Registration Number: NCT00352378
• Lead Sponsor: National Cancer Center, Korea

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

Study Timeline

• Study Start: 2002-06
• Primary Completion: 2005-10
• Study Completion: 2006-01
• Study First Submitted: 2006-07-13
• Study First Submitted QC: 2006-07-13
• Study First Posted: 2006-07-14
• Status Verified: 2007-09
• Last Update Submitted: 2011-06-23
• Last Update Posted: 2011-06-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 209

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Adriamycin plus Cyclophosphamide	Anthracycline, Cyclophosphamide, Docetaxel, Capecitabine	Intravenous infusion of Adriamycin 60mg/m2 , over 30 min, onD1 and Intravenous infusion of cyclophosphamide 600 mg/m2 over 30 min on D1.
Taxotere plus Xeloda	Anthracycline, Cyclophosphamide, Docetaxel, Capecitabine	Intravenous infusion of Taxotere 75 mg/m2 over 1 hr, on D1, and Xeloda 1000mg/m2.p.o. BID x 14days on D1-D14

Primary Outcome Measures

Name	Time	Method
pathologic complete remission	5 years