Clinical Trials /

Capecitabine Versus Vinorelbine in High Risk Breast Cancer With Pathologic Residual Tumors After Preoperative Chemotherapy

NCT03703427

Description:

This study is designed to investigate the efficacy and safety of capecitabine versus vinorelbine as a postoperative adjuvant chemotherapy, for high risk breast cancer patients who have pathologic residual cancer cells after the preoperative chemotherapy.

Related Conditions:
  • Breast Carcinoma
Recruiting Status:

Not yet recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Capecitabine Versus Vinorelbine in High Risk Breast Cancer With Pathologic Residual Tumors After Preoperative Chemotherapy
  • Official Title: Randomised, Multicenter Phase II Study in Patients With High Risk Breast Cancer With Capecitabine Versus Vinorelbine With Pathologic Residual Tumors After Preoperative Chemotherapy Secondary ID

Clinical Trial IDs

  • ORG STUDY ID: ShandongCHI-07
  • NCT ID: NCT03703427

Conditions

  • Pathologic Residual Cancer Cells

Interventions

DrugSynonymsArms
Capecitabine, Oral, 500 MgCapecitabine
Vinorelbine Tartrate OralVinorelbine

Purpose

This study is designed to investigate the efficacy and safety of capecitabine versus vinorelbine as a postoperative adjuvant chemotherapy, for high risk breast cancer patients who have pathologic residual cancer cells after the preoperative chemotherapy.

Trial Arms

NameTypeDescriptionInterventions
CapecitabineExperimental
  • Capecitabine, Oral, 500 Mg
VinorelbineExperimental
  • Vinorelbine Tartrate Oral

Eligibility Criteria

        Inclusion Criteria:

          -  1. Female patient with primary, infiltrative breast cancer who has been diagnosed on a
             histological basis. 2. Stage I-IIIB at the first diagnosis and underwent curative
             resection. 3. The patient was non-pCR after preoperative chemotherapy including
             anthracycline agents and paclitaxel or docetaxel; that is, she had undergone primary
             tumor resection and pathologically confirmed to have residual cancer cells.The
             previously adminstered preoperative chemotherapy must have involved 8 cycles of EC-T
             or 6 cycles of TEC.If HER-2 is positive, trastuzumab is applied with T chemotherapy 4.
             The patient has high risk: young;triple negtive breast caner; positive axillary
             lymphnode;HER-2 positive;ect 5. The patient's general performance status is 0 to 1. 6.
             The patient must have no carry-over of efficacy from any previous treatment. 7. The
             patient has maintained sufficient organ function to permit valid evaluation. 8. The
             patient must have no adverse drug reactions of grade 2 or higher carried over from
             previous treatment. 9. The patient's creatinine clearance is higher than 50 ml/min 10.
             The patient has personally given written, informed consent to participate in this
             study.

        Exclusion Criteria:

          -  1. The patient is considered to require postoperative chemotherapy other than
             capecitabine and vinorelbine. 2. The patient has previously been treated with oral
             5-FU agents (however, previous treatment with iv 5-FU is acceptable). 3. The patient
             has either simultaneous or non-simultaneous bilateral breast cancer. 4. The patient
             has a history of other malignancies or synchronic multiple cancers. However, lesions
             corresponding to carcinoma in situ or intramucosal carcinoma healed by topical therapy
             are eligible. 5. The patient is pregnant, has the potential and/or wishes to become
             pregnant, or is breastfeeding. 6. The patient has previously had an organ transplant.
             7. The patient shows hypersensitivity to fluoropyrimidine agents; has previously
             suffered severe adverse drug reactions with fluoropyrimidine agents; or has a history
             of serious hypersensitivity to LHRH analogs, tamoxifen, letrozole, anastrozole, and/or
             exemestane. 8. The patient is currently suffering from serious complications or
             associated disorders, such as malignant hypertension, congestive heart failure,
             coronary failure, arrhythmias requiring treatment, infectious diseases, and/or
             hemorrhagic tendency, and/or has suffered a myocardial infarction within the previous
             6 months. 9. The patient has a fever, and there is the possibility that she has an
             infection. 10. The patient has been shown to have metastasis to other organs. 11. The
             patient requires treatment for epilepsy and/or central nervous system disorders. 12.
             The patient is currently being treated for, or has a history of, psychiatric disease.
             13. It would be difficult to orally administer drugs to the patient, and/or she
             suffers from functional insufficiency of the upper gastrointestinal tract and/or
             malabsorption syndrome. 14. For any other reason, the investigator or sub-investigator
             has judged the patient to be ineligible for participation.
      
Maximum Eligible Age:75 Years
Minimum Eligible Age:20 Years
Eligible Gender:Female
Healthy Volunteers:No

Primary Outcome Measures

Measure:disease free survival(DFS)
Time Frame:5 years
Safety Issue:
Description:To determine the percentage of disease-free survival (DFS) for the capecitabine monotherapy arm or vinorelbine monotherapy arm.

Secondary Outcome Measures

Measure:overall survival(OS)
Time Frame:5 years
Safety Issue:
Description:To determine the percentage of disease-free survival (DFS) for the capecitabine monotherapy arm or vinorelbine monotherapy arm.
Measure:medicine safety
Time Frame:5 years
Safety Issue:
Description:To determine the percentage of disease-free survival (DFS) for the capecitabine monotherapy arm or vinorelbine monotherapy arm.

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Not yet recruiting
Lead Sponsor:Zhiyong Yu

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