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

Primary Purpose

Breast Cancer Model, Effects of Chemotherapy, Breast Cancer

Status
Unknown status
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
NVB
EPI
DDP
CAP
GEM
H
CTX
T
Sponsored by
Shi Yanxia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer Model focused on measuring Breast Cancer Model, Effects of Chemotherapy, breast cancer

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

  • Sun Yat-sen UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

PERS:NVB,DDP,GEM,CAP,H etc.

EPI+CTX-T+/-H

Arm Description

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

Epirubicin 90mg/m2 d1+ CTX 600mg/m2 d1 q2w, Docetaxel 75mg/m2 +/-herceptin d1,q3w

Outcomes

Primary Outcome Measures

Surgical specimens of breast primary tumors and axillary lymph nodes as measured by Pathological examination.
pCR(pathologic complete response)

Secondary Outcome Measures

Time as a measure from randomization to disease recurrence or patients died due to disease progression.
DFS(Disease-free survival)

Full Information

First Posted
April 28, 2016
Last Updated
January 13, 2017
Sponsor
Shi Yanxia
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1. Study Identification

Unique Protocol Identification Number
NCT03006614
Brief Title
PERS Genetic Model Assistant Decision-making System of Neoadjuvant Chemotherapy for Breast Cancer
Acronym
PERS
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Unknown status
Study Start Date
April 2016 (undefined)
Primary Completion Date
March 2018 (Anticipated)
Study Completion Date
March 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Shi Yanxia

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer Model, Effects of Chemotherapy, Breast Cancer
Keywords
Breast Cancer Model, Effects of Chemotherapy, breast cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
320 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
PERS:NVB,DDP,GEM,CAP,H etc.
Arm Type
Experimental
Arm Description
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
Arm Title
EPI+CTX-T+/-H
Arm Type
Active Comparator
Arm Description
Epirubicin 90mg/m2 d1+ CTX 600mg/m2 d1 q2w, Docetaxel 75mg/m2 +/-herceptin d1,q3w
Intervention Type
Drug
Intervention Name(s)
NVB
Other Intervention Name(s)
vinorelbine
Intervention Type
Drug
Intervention Name(s)
EPI
Other Intervention Name(s)
epirubicin
Intervention Type
Drug
Intervention Name(s)
DDP
Other Intervention Name(s)
cisplatin
Intervention Type
Drug
Intervention Name(s)
CAP
Other Intervention Name(s)
capecitabine
Intervention Type
Drug
Intervention Name(s)
GEM
Other Intervention Name(s)
gemcitabine
Intervention Type
Drug
Intervention Name(s)
H
Other Intervention Name(s)
Trastuzumab
Intervention Type
Drug
Intervention Name(s)
CTX
Other Intervention Name(s)
cyclophosphamidem
Intervention Type
Drug
Intervention Name(s)
T
Other Intervention Name(s)
docetaxel
Primary Outcome Measure Information:
Title
Surgical specimens of breast primary tumors and axillary lymph nodes as measured by Pathological examination.
Description
pCR(pathologic complete response)
Time Frame
up to 96 months
Secondary Outcome Measure Information:
Title
Time as a measure from randomization to disease recurrence or patients died due to disease progression.
Description
DFS(Disease-free survival)
Time Frame
up to 96 months
Other Pre-specified Outcome Measures:
Title
Number of participants with treatment-related adverse events as assessed by NCI(National Cancer Institude) CTC (Clinical Trials Center)v3.0
Description
Safety evaluation
Time Frame
up to 96 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
YanXia Shi, doctor
Phone
02087343488
Email
shiyanxia@sysucc.org.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Cong Xue, doctor
Phone
02087343488
Email
xuecong@sysucc.org.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
YanXia Shi, doctor
Organizational Affiliation
Sun Yat-sen university of cancer center Recruiting
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sun Yat-sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510060
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yanxia Shi, doctor
Phone
13609058827
Email
shiyx@sysucc.org.cn

12. IPD Sharing Statement

Plan to Share IPD
No

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

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