Clinical Trials /

Adjuvant Treatment of EC Followed by Taxane +/- Carboplatin in Triple-Negative Breast Cancer

NCT02455141

Description:

To compare disease-free survival (DFS) rate of adjuvant chemotherapy epirubicin-cyclophosphamide followed by weekly paclitaxel or docetaxel (EC-T), or weekly paclitaxel or docetaxel-carboplatin (EC-TCb) in triple-negative breast cancer.

Related Conditions:
  • Breast Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 3

Trial Eligibility

Document

Title

  • Brief Title: Adjuvant Treatment of EC Followed by Taxane +/- Carboplatin in Triple-Negative Breast Cancer
  • Official Title: Epirubicin-Cyclophosphamide Followed by Taxanes or Taxanes Plus Carboplatin in Triple-Negative Breast Cancer:A Prospective, Randomized, Phase III Trial

Clinical Trial IDs

  • ORG STUDY ID: RJBC1501
  • NCT ID: NCT02455141

Conditions

  • Breast Neoplasm

Interventions

DrugSynonymsArms
Epirubicin plus CyclophosphamideECTaxanes
TaxanesTaxanes
Taxanes plus CarboplatinTaxanes plus carboplatin

Purpose

To compare disease-free survival (DFS) rate of adjuvant chemotherapy epirubicin-cyclophosphamide followed by weekly paclitaxel or docetaxel (EC-T), or weekly paclitaxel or docetaxel-carboplatin (EC-TCb) in triple-negative breast cancer.

Detailed Description

      This study plans to enroll triple-negative breast cancer patients who have complete tumor
      removal. Patients are randomized to receive either EC-wP/T or EC-wP/TCb adjuvant
      chemotherapy. For triple-negative breast cancer, a subgroup of triple-negative breast cancer
      has DNA repairement deficiency and adding carboplatin to paclitaxel may improve DFS on the
      basis of weekly paclitaxel adjuvant chemotherapy.
    

Trial Arms

NameTypeDescriptionInterventions
TaxanesActive ComparatorEpirubicin plus Cyclophosphamide followed by Paclitaxel or Docetaxel
  • Epirubicin plus Cyclophosphamide
  • Taxanes
Taxanes plus carboplatinExperimentalEpirubicin plus Cyclophosphamide followed by Paclitaxel or Docetaxel + Carboplatin
  • Epirubicin plus Cyclophosphamide
  • Taxanes plus Carboplatin

Eligibility Criteria

        Inclusion Criteria

          -  Histologically confirmed adenocarcinoma of the breast, completely tumor removal by
             either modified radical mastectomy or local excision plus axillary lymph node
             dissection (i.e., breast conservation therapy) or sentinel node biopsy. (Tumor-free
             margins at least 1 mm for both invasive and noninvasive carcinoma except for lobular
             carcinoma in situ (less than 1 mm allowed);

          -  Tumor specimens are available for estrogen receptor (ER), progesterone receptor (PgR)
             and Her2 (human epidermal-growth-factor receptor 2) detection, patients should be with
             triple negative breast cancer. Triple-negative disease is defined as ER <1%
             positivity, PgR <1% positivity, and negativity for Her2 (IHC (immunohistochemistry)
             0-1+ or FISH (fluorescence in situ hybridization) negative);

          -  Adequate bone marrow function

          -  Adequate liver and renal function

          -  Eastern Cooperative Oncology Group (ECOG) Performance Score 0-1;

          -  Women with potential child-bearing must have a negative pregnancy test (urine or
             serum) within 7 days of drug administration and agree to use an acceptable method of
             birth control to avoid pregnancy for the duration of the study;

          -  Written informed consent according to the local ethics committee requirements.

        Exclusion Criteria:

          -  Prior systemic of breast cancer, including chemotherapy;

          -  Metastatic breast cancer;

          -  With a history of malignant tumor except uterine cervix cancer in situ or skin basal
             cell carcinoma;

          -  Patients with medical conditions that indicate intolerant to adjuvant therapy and
             related treatment, including uncontrolled pulmonary disease, diabetes mellitus, severe
             infection, active peptic ulcer, coagulation disorder, connective tissue disease or
             myelo-suppressive disease;

          -  Has active hepatitis B or hepatitis C with abnormal liver function tests (LFTs) or is
             known to be HIV positive;

          -  Contraindication for using dexamethasone;

          -  History of congestive heart failure, uncontrolled or symptomatic angina pectoris,
             arrhythmia or myocardial infarction; poorly controlled hypertension (systolic BP>180
             mmHg or diastolic BP>100 mmHg);

          -  Has peripheral neuropathy no less than grade 1;

          -  Patient is pregnant or breast feeding;

          -  Patients with psychiatric disorder or other diseases leading to incompliance to the
             therapy;

          -  Known severe hypersensitivity to any drugs in this study;

          -  Treatment with any investigational drugs within 30 days before the beginning of study
             treatment.
      
Maximum Eligible Age:70 Years
Minimum Eligible Age:18 Years
Eligible Gender:Female
Healthy Volunteers:No

Primary Outcome Measures

Measure:Disease-free survival
Time Frame:3 years
Safety Issue:
Description:to compare the disease-free survival among two treatment arms

Secondary Outcome Measures

Measure:Overall Survival
Time Frame:3 years
Safety Issue:
Description:to compare the overall survival among two treatment arms
Measure:Incidence of neutropenia fever
Time Frame:up to 7 months
Safety Issue:
Description:to compare the neutropenia fever among two treatment arms
Measure:Incidence of grade 3-4 side effects
Time Frame:up to 7 months
Safety Issue:
Description:to compare the grade 3-4 side effects among two treatment arms

Details

Phase:Phase 3
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Shanghai Jiao Tong University School of Medicine

Trial Keywords

  • chemptherapy
  • triple negative
  • taxanes
  • carboplatin

Last Updated

September 20, 2017