PERS Genetic Model Assistant Decision-making System of Neoadjuvant Chemotherapy for Breast Cancer (PERS)

January 13, 2017 updated by: Shi Yanxia

Using PERS(PErsonalized Regimen Selection) Genetic Model Assistant Decision-making System of Neoadjuvant Chemotherapy for Breast Cancer Multicentric, Prospective, Randomized Controlled Phase III Clinical Study

This study aims to explore new PERS prediction model can improve the pathological complete response rate of neoadjuvant chemotherapy of breast cancer and disease-free survival.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This is a multi-center, prospective, randomized phase III clinical trial. Planning 320 cases.

This study will be divided into two stages. Phase one, 120 cases of local advanced breast cancer (LABC)who need neoadjuvant chemotherapy. Gene prediction model test(PERS) is performed before treatment(ddEC-T+/-H), verify the prediction efficacy of PERS.

Phase two, 200 cases of LABC primary resistant of antharcycline and taxans. Patients were randomized to Arm ddEC-T+/-H and Arm PERS (regimens according to PERS,eg NVB+DDP,capacitabine,gemcitabine and so on) pCR rate and DFS is observed.

Study Type

Interventional

Enrollment (Anticipated)

320

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

Study Contact Backup

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510060
        • Recruiting
        • Sun Yat-sen University
        • 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

Yes

Genders Eligible for Study

Female

Description

Inclusion criteria: all of the patients in the trial need to meet

  • age: at least 18 years old;
  • ECOG(Eastern Cooperative Oncology Group) scoring ≤1;
  • confirmed by histology or cytology breast infiltrating ductal carcinoma
  • agreed to breast cancer tissue biopsy
  • here is a new adjuvant chemotherapy against patients with stage II/III
  • According to RECIST criteria, target lesion in patients with at least one, at least one single diameter measurable lesions .Is defined as a measurable lesions with the following method can accurately measure at least one of the diameter of the lesion: lesions or greater diameter 20 mm or measured in conventional methods spiral CT measurement lesions 10 mm diameter or greater. Positron emission tomography (CT) and ultrasound can not be used as measurement method lesions.
  • The normal numerical laboratory： The patient's level of organ function must meet the following requirements: enough reserves: bone marrow neutrophils (cent leaves and ribbon neutrophils) absolute count (ANC) ≥1.5*109 / L, or platelets≥ 100*109 / L, or acuity ≥ 9 g/dL and hemoglobin.Liver: bilirubin < 1.5 times the upper limit of normal, alkaline phosphatase (AP), aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 3.0 times the upper limit of normal (If allowed to AP with liver metastasis, AST, ALT < 5 times the upper limit of normal).Kidney： creatinine clearance or 45 mL/min.
  • Signed informed consent;
  • is expected to survival in patients with 3 or more months.
  • patient adherence and geographic location of residence meet the needs of the follow-up.
  • in the research into the group of 7 days before the serum or urine pregnancy test must be negative, and must be for the nursing of patients.Or sterilization surgery, patients after menopause, or agreed to in the research during the treatment and research within 6 months after the end of the treatment period using an approved by the medical contraception (such as intrauterine device (IUD), pill or condoms)

Exclusion Criteria:

  • ECOG(Eastern Cooperative Oncology Group) scoring ≥2 ;
  • At the same time to accept any other anti-tumor treatment.
  • In the past 12 months have congestive heart failure, drug treatment can't control history of arrhythmia, myocardial infarction, etc;
  • The serious, which has not been controlled intercurrent infection, organ dysfunction, or serious metabolic disorder of patients;
  • Active infection (decided by the researchers.
  • According to the researcher's judgment, there is serious to endanger the safety of patients, or patients completed the research associated with disease.
  • Pregnancy or breast-feeding women.
  • Always have a clear history of neurological or psychiatric disorders, including epilepsy, or dementia.
  • A history of other tumors or combined with other tumor patients.
  • Before study enrollment for any reason within 30 days of use had not been approved by the local drug ；
  • Unwilling or unable to continue to comply with the experimental program, or can not cope with patients follow-up;
  • Researchers think that is unfavorable to the participants.

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: PERS:NVB,DDP,GEM,CAP,H etc.
vinorelbine 25mg/m2 d1,d8 iv,q3w cisplatin 70mg/m2 d1，q3w gemcitabine 1000mg/m2 d1,d8,q3w capecitabine 1000mg/m2,bid,d1-14,q3w Trastuzumab
Drug: DDP
Other Names:
  • cisplatin
Drug: NVB
Other Names:
  • vinorelbine
Drug: CAP
Other Names:
  • capecitabine
Drug: GEM
Other Names:
  • gemcitabine
Drug: H
Other Names:
  • Trastuzumab
ACTIVE_COMPARATOR: EPI+CTX-T+/-H
Epirubicin 90mg/m2 d1+ CTX 600mg/m2 d1 q2w, Docetaxel 75mg/m2 +/-herceptin d1,q3w
Drug: H
Other Names:
  • Trastuzumab
Drug: EPI
Other Names:
  • epirubicin
Drug: CTX
Other Names:
  • cyclophosphamidem
Drug: T
Other Names:
  • docetaxel

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Surgical specimens of breast primary tumors and axillary lymph nodes as measured by Pathological examination.
Time Frame: up to 96 months
pCR(pathologic complete response)
up to 96 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time as a measure from randomization to disease recurrence or patients died due to disease progression.
Time Frame: up to 96 months
DFS(Disease-free survival)
up to 96 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with treatment-related adverse events as assessed by NCI(National Cancer Institude) CTC (Clinical Trials Center)v3.0
Time Frame: up to 96 months
Safety evaluation
up to 96 months

Collaborators and Investigators

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

Sponsor

Shi Yanxia

Investigators

  • Principal Investigator: YanXia Shi, doctor, Sun Yat-sen university of cancer center Recruiting

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

April 1, 2016

Primary Completion (ANTICIPATED)

March 1, 2018

Study Completion (ANTICIPATED)

March 1, 2023

Study Registration Dates

First Submitted

April 28, 2016

First Submitted That Met QC Criteria

December 28, 2016

First Posted (ESTIMATE)

December 30, 2016

Study Record Updates

Last Update Posted (ESTIMATE)

January 16, 2017

Last Update Submitted That Met QC Criteria

January 13, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2014-FXY-077-内科

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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