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

NCT03006614 | Unknown Phase 3

• 1 other identifier: 2014-FXY-077-内科
• Study Type: interventional
• Target: 320
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer Model; Effects of Chemotherapy; Breast Cancer

Keywords

Breast Cancer Model; Effects of Chemotherapy; breast cancer

Outcome Measures

Primary Outcomes (1)

• Surgical specimens of breast primary tumors and axillary lymph nodes as measured by Pathological examination.

  pCR(pathologic complete response)

  up to 96 months

Secondary Outcomes (1)

• Time as a measure from randomization to disease recurrence or patients died due to disease progression.

  up to 96 months

Other Outcomes (1)

• Number of participants with treatment-related adverse events as assessed by NCI(National Cancer Institude) CTC (Clinical Trials Center)v3.0

  up to 96 months

Study Arms (2)

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

EXPERIMENTAL

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: NVB; Drug: DDP; Drug: CAP; Drug: GEM; Drug: H

EPI+CTX-T+/-H

ACTIVE COMPARATOR

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

Drug: EPI; Drug: H; Drug: CTX; Drug: T

Interventions

NVB DRUG

Also known as: vinorelbine

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

EPI DRUG

Also known as: epirubicin

EPI+CTX-T+/-H

DDP DRUG

Also known as: cisplatin

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

CAP DRUG

Also known as: capecitabine

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

GEM DRUG

Also known as: gemcitabine

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

H DRUG

Also known as: Trastuzumab

EPI+CTX-T+/-H; PERS:NVB,DDP,GEM,CAP,H etc.

CTX DRUG

Also known as: cyclophosphamidem

EPI+CTX-T+/-H

T DRUG

Also known as: docetaxel

EPI+CTX-T+/-H

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shi Yanxia: lead

Study Sites (1)

Sun Yat-sen University

Guangzhou, Guangdong, 510060, China

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Vinorelbine; Epirubicin; Cisplatin; Capecitabine; Gemcitabine; Protons; Trastuzumab; Docetaxel

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines; Doxorubicin; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Cations, Monovalent; Cations; Ions; Electrolytes; Hydrogen; Elements; Gases; Nucleons; Elementary Particles; Physical Phenomena; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Diterpenes; Terpenes

Study Officials

• YanXia Shi, doctor

  Sun Yat-sen university of cancer center Recruiting

  PRINCIPAL INVESTIGATOR

Central Study Contacts

YanXia Shi, doctor

CONTACT

02087343488; shiyanxia@sysucc.org.cn

Cong Xue, doctor

CONTACT

02087343488; xuecong@sysucc.org.cn

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator, Clinical Professor

Study Record Dates

• First Submitted: April 28, 2016
• First Posted: December 30, 2016
• Study Start: April 1, 2016
• Primary Completion: March 1, 2018
• Study Completion: March 1, 2023
• Last Updated: January 16, 2017

Record last verified: 2017-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)