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

This study has been completed.
Sponsor:
Information provided by:
National Cancer Center, Korea
ClinicalTrials.gov Identifier:
NCT00352378
First received: July 13, 2006
Last updated: June 23, 2011
Last verified: September 2007
History of Changes
  Purpose

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.


Condition Intervention Phase
Breast Cancer
 Drug: Anthracycline, Cyclophosphamide, Docetaxel, Capecitabine
 Phase 3

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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by National Cancer Center, Korea:

Primary Outcome Measures:
  • pathologic complete remission [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]

Enrollment: 209
Study Start Date: June 2002
Study Completion Date: January 2006
Primary Completion Date: October 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Adriamycin plus Cyclophosphamide
Intravenous infusion of Adriamycin 60mg/m2 , over 30 min, onD1 and Intravenous infusion of cyclophosphamide 600 mg/m2 over 30 min on D1.
 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

Other Names:
  • Taxotere
  • Xeloda
  • Cytoxan
  • doxorubicin
Experimental: Taxotere plus Xeloda
Intravenous infusion of Taxotere 75 mg/m2 over 1 hr, on D1, and Xeloda 1000mg/m2.p.o. BID x 14days on D1-D14
 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

Other Names:
  • Taxotere
  • Xeloda
  • Cytoxan
  • doxorubicin

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00352378

Sponsors and Collaborators
National Cancer Center, Korea
Investigators
Principal Investigator: Jungsil Ro, MD,PhD National Cancer Center, Korea
  More Information

No publications provided

Responsible Party: Jungsil Ro / Center for Breast Cancer, National Cancer Center
ClinicalTrials.gov Identifier: NCT00352378     History of Changes
Other Study ID Numbers: NCCCTS-02-034
Study First Received: July 13, 2006
Last Updated: June 23, 2011
Health Authority: South Korea: Institutional Review Board

Keywords provided by National Cancer Center, Korea:
Primary

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Cyclophosphamide
Docetaxel
Capecitabine
Doxorubicin
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
 Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antibiotics, Antineoplastic
Antimetabolites, Antineoplastic
Antimetabolites

ClinicalTrials.gov processed this record on May 16, 2013