Sequential Neo-adjuvant Chemotherapy Followed by Capecitabine Vs. Conventional Adjuvant Chemotherapy in Breast Cancer (NACVCAC)

January 8, 2017 updated by: The First Hospital of Jilin University

A Prospective Randomized Controlled Trail to Evaluate Efficacy and Safety of Sequential Neo-adjuvant Chemotherapy Plus Surgery Followed by Capecitabine Versus Conventional Postoperative Adjuvant Chemotherapy

This study evaluates whether sequential neo-adjuvant chemotherapy plus surgery followed by Capecitabine could achieve additional benefits over traditional postoperative chemotherapy. In the study group, patients that do not achieve pathological complete response(pCR) will receive sequential neo-adjuvant chemotherapy followed by Capecitabine. In the control group, patients will be treated with postoperative adjuvant chemotherapy.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Neo-adjuvant chemotherapy(NAC) is a standard treatment for locally advanced breast cancer(LABC). By down-staging LABC, NAC is able to make inoperable cases operable as well as to make breast conserving surgery an option again for some patients.Neo-adjuvant chemotherapy is more and more widely used in operable breast cancer since it provides critical information on chemotherapy response. However, only 15% to 20% of the patients can benefit from Neo-adjuvant chemotherapy and achieve pCR. Although we obtained the information chemotherapy response for the rest of the patients who received Neo-adjuvant chemotherapy, there are still controversies on how the information will be used for further treatment. Therefore, it is a problem that needs resolving how these patients can benefit from the information Neo-adjuvant chemotherapy provides and whether Neo-adjuvant chemotherapy can replace conventional adjuvant chemotherapy at all. Our study aims to make Neo-adjuvant chemotherapy benefit more patients.

Registered patients in stage Ⅰ- Ⅲ A breast cancer is randomly split into two groups(study group and control group).In the study group, patients achieving pCR will be followed up for 5 years while patients that do not achieve pCR after neo-adjuvant chemotherapy will be treated with Capecitabine for 8 cycles after surgery. On the other hand, patients in the control group will accept surgeries and conventional adjuvant chemotherapies. Follow-up study will last 5 years. DFS and OS will be compared between the two groups.

This study provides an important basis and methods for the further treatment of patients after neo-adjuvant chemotherapy. It discusses whether neo-adjuvant chemotherapy could replace conventional adjuvant chemotherapy and become a new standard for breast cancer treatment.

Study Type

Interventional

Enrollment (Anticipated)

1588

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Fan Zhimin, Professor
  • Phone Number: +8613756661286
  • Email: fanzhimn@163.com

Study Contact Backup

Study Locations

  • China
    • Jilin
      • Changchun, Jilin, China, 130000
        • Recruiting
        • The First Hospital of Jilin University
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  1. Pathologically confirmed unilateral invasive carcinoma (all pathological types);
  2. No gross or microscopic residual tumor after resection;
  3. Clinical stage Ⅰ-stage Ⅲ A, no absolute surgical contraindications;
  4. Eastern Cooperative Oncology Group(ECOG) score ≤1;
  5. Accepting adjuvant chemotherapy within 15 days after surgery;
  6. No peripheral neuropathy;

  7. Normal bone marrow and organ functions:

    1. Bone marrow function: ANC≥1500/mm3，PLT≥100000/mm3，HGB≥8g/dl
    2. Renal function: serum creatinine≤1.5 times the upper limit of normal(ULN), Liver function: total bilirubin ≤1.5 times the upper limit of normal，AST≤2.5 times the upper limit of normal，alanine aminotransferase(ALT)≤2.5 times the upper limit of normal
    3. Cardiac function:LVEF≥50%
  8. Signed informed consent form.

Exclusion Criteria:

  1. Patients with the history of oral fluorouracil chemotherapy or Chinese medicine treatment;

  2. Patients with organ dysfunction:

    1. Renal function: serum creatinine>1.5 times the upper limit of normal
    2. Liver function: total bilirubin>1.5 times the upper limit of normal，AST>1.5 times the upper limit of normal, alanine aminotransferase(ALT)>1.5 times the upper limit of normal or alkaline phosphatase (ALP) >2.5 times the upper limit of normal
    3. Cardiac function：LVEF<50%;
  3. Human epidermal growth factor receptor-2(HER-2) positive patients who cannot receive Herceptin treatment with a left ventricular ejection fraction(LVEF) less than 55%;
  4. Patients allergic to docetaxel, capecitabine, epirubicin and cyclophosphamide;
  5. Patients with severe systemic disease and/or uncontrollable infections;
  6. Patients with previous malignancies, including contralateral breast cancer;
  7. Patients with severe cardiovascular and cerebrovascular disease(i.e. Unstable angina, chronic cardiac failure, uncontrollable high blood pressure of >150/90 mmhg, myocardial infarction and cerebrovascular accident) history within 6 months before randomization;
  8. Pregnant or lactating women.
  9. Patients who have cognitive or psychological impairment as well as cannot understand the test program or stand side effects, which will result in a suspension of the trial program and follow-up;
  10. Patients without personal freedom or independent civil capacity.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: NAC not achieving pCR

Patients in the study group will accept neo-adjuvant chemotherapy. Among these patients, those who do not achieve pCR after neo-adjuvant chemotherapy will be treated with Capecitabine after surgery. And then they will be followed up for 5 years.

Capecitabine 1000mg/m2 tablets twice a day for 8 cycles.
Procedure: Neo-adjuvant Chemotherapy
A preoperative chemotherapy based on anthracyclines and taxanes.
Other Names:
  • Preoperative Chemotherapy
  • Primary Chemotherapy
  • Induction Chemotherapy
Drug: Capecitabine
Capecitabine 1000mg/m2 tablets twice a day for 8 cycles.
Other Names:
  • Xeloda
EXPERIMENTAL: NAC achieving pCR
Patients in the study group will accept neo-adjuvant chemotherapy. In these patients, those who reach to pCR after neo-adjuvant chemotherapy will be followed up for 5 years after surgery.
Procedure: Neo-adjuvant Chemotherapy
A preoperative chemotherapy based on anthracyclines and taxanes.
Other Names:
  • Preoperative Chemotherapy
  • Primary Chemotherapy
  • Induction Chemotherapy
NO_INTERVENTION: Adjuvant Chemotherapy
Patients in the control group will accept surgeries and corresponding adjuvant chemotherapy.They will be followed up for 5 years after adjuvant chemotherapy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Disease-free survival(DFS)
Time Frame: 5 years
5 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Overall survival(OS)
Time Frame: 5 years
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The First Hospital of Jilin University

Collaborators

First Affiliated Hospital Xi'an Jiaotong University
Qingdao University
First Hospital of China Medical University
The Second Affiliated Hospital of Harbin Medical University
Baotou Cancer Hospital

Investigators

  • Study Chair: Fan Zhimin, Professor, The First Hospital of Jilin University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2016

Primary Completion (ANTICIPATED)

December 1, 2024

Study Completion (ANTICIPATED)

February 1, 2025

Study Registration Dates

First Submitted

January 3, 2017

First Submitted That Met QC Criteria

January 4, 2017

First Posted (ESTIMATE)

January 5, 2017

Study Record Updates

Last Update Posted (ESTIMATE)

January 10, 2017

Last Update Submitted That Met QC Criteria

January 8, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JLUDBSCRH 001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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