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

NCT03703427 | Unknown Phase 2

• 1 other identifier: ShandongCHI-07
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pathologic Residual Cancer Cells

Outcome Measures

Primary Outcomes (1)

• disease free survival(DFS)

  To determine the percentage of disease-free survival (DFS) for the capecitabine monotherapy arm or vinorelbine monotherapy arm.

  5 years

Secondary Outcomes (2)

• overall survival(OS)

  5 years

• medicine safety

  5 years

Study Arms (2)

Capecitabine

EXPERIMENTAL

Drug: Capecitabine, Oral, 500 Mg

Vinorelbine

EXPERIMENTAL

Drug: Vinorelbine Tartrate Oral

Interventions

Capecitabine, Oral, 500 Mg DRUG

1250mg/m2，d1-d14，q3w

Capecitabine

Vinorelbine Tartrate Oral DRUG

60mg/m2，d1；d8；q3w

Vinorelbine

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. 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.

You may not qualify if:

• \. 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.

Sponsors & Collaborators

• Zhiyong Yu: lead

Study Sites (1)

Zhiyong Yu

Jinan, Shandong, China

Location

MeSH Terms

Interventions

Capecitabine; Vinorelbine

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director of the Breast Surgery Ⅰ

Study Record Dates

• First Submitted: October 9, 2018
• First Posted: October 12, 2018
• Study Start: November 1, 2018
• Primary Completion: November 1, 2023
• Study Completion: November 1, 2025
• Last Updated: October 12, 2018

Record last verified: 2018-10

Locations

CN (1)