Clinical Trials /

Alternative Non-cross-resistant Adjuvant Chemotherapy for Operable Breast Cancer Non-response to Primary Chemotherapy

NCT01019616

Description:

The purpose of this phase Ⅲ, multi-center, prospective, open-label, randomized,controlled study is to determine whether alternative non-cross-resistant adjuvant chemotherapy can increase distant disease free survival(DDFS) in operable patients non-response to primary chemotherapy.

Related Conditions:
  • Breast Carcinoma
Recruiting Status:

Active, not recruiting

Phase:

Phase 3

Trial Eligibility

Document

Title

  • Brief Title: Alternative Non-cross-resistant Adjuvant Chemotherapy for Operable Breast Cancer Non-response to Primary Chemotherapy
  • Official Title: A Phase Ⅲ Study of Alternative Non-cross-resistant Adjuvant Chemotherapy for Operable Breast Cancer Non-response to Primary Chemotherapy

Clinical Trial IDs

  • ORG STUDY ID: D09050703570904
  • NCT ID: NCT01019616

Conditions

  • Primary Breast Cancer

Interventions

DrugSynonymsArms
paclitaxel/anthracyclineAlternative Non-cross-resistant Adjuvant ChemotherapyChemotherapy

Purpose

The purpose of this phase Ⅲ, multi-center, prospective, open-label, randomized,controlled study is to determine whether alternative non-cross-resistant adjuvant chemotherapy can increase distant disease free survival(DDFS) in operable patients non-response to primary chemotherapy.

Trial Arms

NameTypeDescriptionInterventions
ChemotherapyExperimental
  • paclitaxel/anthracycline
ControlNo Intervention

    Eligibility Criteria

            Inclusion Criteria:
    
              -  Female patients, age ≦65 years
    
              -  Biopsy proven lymph node positive, estrogen receptor- positive primary breast cancer
    
              -  Must have completed a 4-cycle neo-adjuvant chemotherapy with a standard
                 regimen(containing anthracycline or paclitaxel)
    
              -  Must have undergone surgery to remove the primary tumor by either a mastectomy or
                 enlarged local excision
    
              -  Postoperative residual positive lymph nodes or G1/G2/G3 of Miller & Payne Grading
                 System
    
              -  Adequate recovery from recent surgery
    
              -  No history of other malignancies
    
              -  No currently uncontrolled diseased or active infection
    
              -  Not pregnant or breast feeding, and on appropriate birth control if of child-bearing
                 potential
    
              -  Adequate cardiovascular function reserve with a myocardial infarction within the past
                 six month
    
              -  Adequate hematologic function with:
    
                   1. Absolute neutrophil count (ANC) ≥1500/mm3
    
                   2. Platelets ≥100,000/ mm3
    
                   3. Hemoglobin ≥10 g/dL
    
              -  Adequate hepatic and renal function with:
    
                   1. Serum bilirubin ≤1.5×UNL
    
                   2. Alkaline phosphatase and alanine aminotransferase (ALT) ≤2.5 x ULN. (≤5 x ULN is
                      acceptable in the setting of hepatic metastasis)
    
                   3. BUN between 1.7 and 8.3 mmol/L
    
                   4. Cr between 40 and 110 umol/L
    
              -  Knowledge of the investigational nature of the study and Ability to give informed
                 consent
    
              -  Ability and willingness to comply with study procedures.
    
            Exclusion Criteria:
    
              -  Known or suspected distant metastases
    
              -  Concurrent malignancy or history of other malignancy
    
              -  Uncontrolled diseases(e.g., heart failure, myocardial infarction within 6 months,
                 arrhythmia, unstable diabetes, hypercalcemia) or active infection
    
              -  Geographical, social, or psychological problems that would compromise study compliance
    
              -  Known or suspected hypersensitivity to anthracycline or paclitaxel
          
    Maximum Eligible Age:65 Years
    Minimum Eligible Age:18 Years
    Eligible Gender:Female
    Healthy Volunteers:No

    Primary Outcome Measures

    Measure:distant disease-free survival (DDFS)
    Time Frame:3 years after surgery
    Safety Issue:
    Description:

    Details

    Phase:Phase 3
    Primary Purpose:Interventional
    Overall Status:Recruiting
    Lead Sponsor:Tao OUYANG

    Last Updated

    December 17, 2017