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

Breast Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00352378
• Other study ID #: NCCCTS-02-034
• Status: Completed
• Phase: Phase 3
• First received: July 13, 2006
• Last updated: June 23, 2011
• Start date: June 2002
• Est. completion date: January 2006

Study information

• Verified date: September 2007
• Source: National Cancer Center, Korea
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 209
• Est. completion date: January 2006
• Est. primary completion date: October 2005
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• Anthracycline, Cyclophosphamide, Docetaxel, Capecitabine
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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Center, Korea

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pathologic complete remission		5 years	Yes