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TA(E)C-GP Versus A(E)C-T for the High Risk TNBC Patients and Validation of the mRNA-lncRNA Signature

Primary Purpose

Triple Negative Breast Cancer, Breast Cancer

Status

Recruiting

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

docetaxel

doxorubicin or epirubicin

cyclophosphamide

gemcitabine

cisplatin

About this trial

This is an interventional treatment trial for Triple Negative Breast Cancer focused on measuring triple negative breast cancer, mRNA-lncRNA signature, chemotherapy, high risk

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

Age: 18-65 years old
Expected survival > 12 months
Baseline Eastern Cooperative Oncology Group Performance Status rating 0-1
Naïve to chemotherapy or hormonal treatments
Pathology confirmed invasive ductal carcinoma of breast
Triple negative breast cancer confirmed by pathology
No concurrent malignancy (except controlled cervical carcinoma in situ or basal cell carcinoma of skin)
No advanced metastasis or metastasis involving brain or liver
Adequate bone marrow function, blood routine examination shows neutrophil count ≥ 1.5x109/L, hemoglobin level ≥ 100 g/L, Platelets ≥ 100 x 109/L
Adequate liver and kidney function, serum aminotransferase (AST) ≤ 60 Unit/L, serum total bilirubin ≤ 2.5 times Upper Limit of Normal, serum creatinine ≤110μmol/L, urea nitrogen ≤7.1mmol/L
No coagulation abnormality
Normal heart function, with normal ECG and left ventricular ejection fraction ≥ 55%
Women of childbearing age agree to take reliable contraceptive measures during clinical trials, and negative serum or urine pregnancy test within 7 days prior to administration
No coagulation abnormality
Sign the informed consent statement and voluntarily receive follow-ups, treatments, laboratory tests and other research procedures according to protocol.

Exclusion Criteria:

Previous regional or systemic treatment for breast cancer (include but not limited to chemotherapy, radiotherapy, targeted therapy, other clinical trials)
Inflammatory breast cancer, bilateral breast cancer or breast cancer already with distant metastasis
Complicated with uncontrolled lung disease, severe infection, active peptic ulcer, blood clotting disorders, severe uncontrolled diabetes, connective tissue disorders or bone marrow suppression, and intolerance to neoadjuvant therapy or related treatment
Peripheral neuropathy >1 degree caused by any reason
History of congestive heart failure, uncontrolled or symptomatic angina, arrhythmias or history of myocardial infarction, refractory hypertension (systolic blood pressure > 180 mmHg or diastolic blood pressure > 100 mmHg);
Breast cancer during lactation or pregnancy
Mental illness or incompliance to treatment caused by other reasons
Known history of severe hypersusceptibility to any agents used in the treatment protocol
Patients received major surgery or suffered from severe trauma within 2 months of first administration
Currently enroll or recently used (30 days within enrollment) other agent under research or involved in other trial
Known to be infected with human immunodeficiency virus (HIV)
Other circumstances considered to be inappropriate to be enrolled by researchers

Sites / Locations

Fudan University Shanghai Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Other

Arm Label

High risk group A

High risk group B

Low risk group C

Arm Description

TA(E)C x 4 cycles to GP x 4 cycles (docetaxel + doxorubicin (epirubicin) + cyclophosphamide to gemcitabine + cisplatin), docetaxel: 75 mg/m2 IV on day 1; doxorubicin: 50 mg/m2 IV on day 1 or epirubicin 75 mg/m2 IV on day 1; cyclophosphamide: 500 mg/m2 IV on day 1; gemcitabine: 1250 mg/m2 IV on day 1 and 8; cisplatin: 75 mg/m2 IV on day 1, dosing interval is 21 days.

A(E)C x 4 cycles to T x 4 cycles (doxorubicin (epirubicin) + cyclophosphamide to docetaxel), doxorubicin: 60 mg/m2 IV on day 1 or epirubicin 90 mg/m2 IV on day 1; cyclophosphamide: 600 mg/m2 IV on day 1; docetaxel: 100 mg/m2 IV on day 1, dosing interval is 21 days.

Outcomes

Primary Outcome Measures

Disease free survival

Secondary Outcome Measures

Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

Recurrence free survival

Overall survival

Full Information

NCT ID

NCT02641847

First Posted

December 22, 2015

Last Updated

September 21, 2023

Sponsor

Fudan University

1. Study Identification

Unique Protocol Identification Number

NCT02641847

Brief Title

TA(E)C-GP Versus A(E)C-T for the High Risk TNBC Patients and Validation of the mRNA-lncRNA Signature

Official Title

Efficacy and Safety Study of TA(E)C-GP Versus A(E)C-T for the High Risk Triple-negative Breast Cancer Patients Predicted by the Messenger RNA (mRNA)-Long Non-coding RNA (lncRNA) Signature and Validation of the Signature's Efficacy

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Recruiting

Study Start Date

July 2015 (undefined)

Primary Completion Date

December 2023 (Anticipated)

Study Completion Date

December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Fudan University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The purpose of this study is to compare the efficacy and safety between docetaxel combined with doxorubicin (epirubicin) and cyclophosphamide followed by gemcitabine combined with cisplatin and doxorubicin (epirubicin) combined with cyclophosphamide followed by docetaxel for high risk triple negative breast cancer predicted by the mRNA-lncRNA integrated signature and validation the efficacy of the signature.

Detailed Description

Triple-negative breast cancer (TNBC) is one of the most aggressive subtypes of breast cancer. Chemotherapy is the current mainstay of treatment. The treatment of patients with TNBC has been challenging due to the heterogeneity of the disease and the absence of well-defined molecular targets. The investigators' previous study has successfully identified and independently validated prognostic and predictive RNA signatures for TNBC, which could be used to classify TNBC patients into high- or low-risk of recurrence. This study is intended to further validate the efficacy of the mRNA-lncRNA signature and also explore better chemotherapy for the predicted high risk TNBC patients. The current study is designed to validation the efficacy of the mRNA-lncRNA signature and evaluate the efficacy and safety between docetaxel combined with doxorubicin (epirubicin) and cyclophosphamide followed by gemcitabine combined with cisplatin and doxorubicin (epirubicin) combined with cyclophosphamide followed by docetaxel for high risk triple negative breast cancer predicted by the integrated signature. Primary endpoint for the study: recurrence free survival; second endpoint for the study: safety, disease free survival and overall survival; This open multi-center prospective randomized control study includes TNBC patients with invasive ductal carcinoma. All eligible patients' tumor samples were tested using real-time polymerase chain reaction (PCR) and recurrence risks were predicted using the mRNA-lncRNA signature. Patients with high recurrence risk were randomized to Group A or Group B to receive respective chemotherapy. Among which Group A: TA(E)C x 4 cycles to GP x 4 cycles (docetaxel + doxorubicin (epirubicin) + cyclophosphamide to gemcitabine + cisplatin), docetaxel: 75 mg/m2 IV on day 1; doxorubicin: 50 mg/m2 IV on day 1 or epirubicin 75 mg/m2 IV on day 1; cyclophosphamide: 500 mg/m2 IV on day 1; gemcitabine: 1250 mg/m2 IV on day 1 and 8; cisplatin: 75 mg/m2 IV on day 1, dosing interval is 21 days. Group B: A(E)C x 4 cycles to T x 4 cycles (doxorubicin (epirubicin) + cyclophosphamide to docetaxel), doxorubicin: 60 mg/m2 IV on day 1 or epirubicin 90 mg/m2 IV on day 1; cyclophosphamide: 600 mg/m2 IV on day 1; docetaxel: 100 mg/m2 IV on day 1, dosing interval is 21 days. Patients with low recurrence risk received chemotherapy in Group C: A(E)C x 4 cycles to T x 4 cycles (doxorubicin (epirubicin) + cyclophosphamide to docetaxel), doxorubicin: 60 mg/m2 IV on day 1 or epirubicin 90 mg/m2 IV on day 1; cyclophosphamide: 600 mg/m2 IV on day 1; docetaxel: 100 mg/m2 IV on day 1, dosing interval is 21 days.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Triple Negative Breast Cancer, Breast Cancer

Keywords

triple negative breast cancer, mRNA-lncRNA signature, chemotherapy, high risk

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

503 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

High risk group A

Arm Type

Experimental

Arm Description

Arm Title

High risk group B

Arm Type

Active Comparator

Arm Description

Arm Title

Low risk group C

Arm Type

Other

Arm Description

Intervention Type

Drug

Intervention Name(s)

docetaxel

Intervention Type

Drug

Intervention Name(s)

doxorubicin or epirubicin

Intervention Type

Drug

Intervention Name(s)

cyclophosphamide

Intervention Type

Drug

Intervention Name(s)

gemcitabine

Intervention Type

Drug

Intervention Name(s)

cisplatin

Primary Outcome Measure Information:

Title

Disease free survival

Time Frame

three years

Secondary Outcome Measure Information:

Title

Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

Time Frame

three years

Title

Recurrence free survival

Time Frame

three years

Title

Overall survival

Time Frame

three years

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Age: 18-65 years old Expected survival > 12 months Baseline Eastern Cooperative Oncology Group Performance Status rating 0-1 Naïve to chemotherapy or hormonal treatments Pathology confirmed invasive ductal carcinoma of breast Triple negative breast cancer confirmed by pathology No concurrent malignancy (except controlled cervical carcinoma in situ or basal cell carcinoma of skin) No advanced metastasis or metastasis involving brain or liver Adequate bone marrow function, blood routine examination shows neutrophil count ≥ 1.5x109/L, hemoglobin level ≥ 100 g/L, Platelets ≥ 100 x 109/L Adequate liver and kidney function, serum aminotransferase (AST) ≤ 60 Unit/L, serum total bilirubin ≤ 2.5 times Upper Limit of Normal, serum creatinine ≤110μmol/L, urea nitrogen ≤7.1mmol/L No coagulation abnormality Normal heart function, with normal ECG and left ventricular ejection fraction ≥ 55% Women of childbearing age agree to take reliable contraceptive measures during clinical trials, and negative serum or urine pregnancy test within 7 days prior to administration No coagulation abnormality Sign the informed consent statement and voluntarily receive follow-ups, treatments, laboratory tests and other research procedures according to protocol. Exclusion Criteria: Previous regional or systemic treatment for breast cancer (include but not limited to chemotherapy, radiotherapy, targeted therapy, other clinical trials) Inflammatory breast cancer, bilateral breast cancer or breast cancer already with distant metastasis Complicated with uncontrolled lung disease, severe infection, active peptic ulcer, blood clotting disorders, severe uncontrolled diabetes, connective tissue disorders or bone marrow suppression, and intolerance to neoadjuvant therapy or related treatment Peripheral neuropathy >1 degree caused by any reason History of congestive heart failure, uncontrolled or symptomatic angina, arrhythmias or history of myocardial infarction, refractory hypertension (systolic blood pressure > 180 mmHg or diastolic blood pressure > 100 mmHg); Breast cancer during lactation or pregnancy Mental illness or incompliance to treatment caused by other reasons Known history of severe hypersusceptibility to any agents used in the treatment protocol Patients received major surgery or suffered from severe trauma within 2 months of first administration Currently enroll or recently used (30 days within enrollment) other agent under research or involved in other trial Known to be infected with human immunodeficiency virus (HIV) Other circumstances considered to be inappropriate to be enrolled by researchers

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Zhi-min Shao, MD.PHD.

Phone

86-18017312288

zhimingshao@yahoo.com

First Name & Middle Initial & Last Name or Official Title & Degree

Yi-Zhou Jiang, MD.PHD.

Phone

86-15921910483

yizhoujiang@fudan.edu.cn

Facility Information:

Facility Name

Fudan University Shanghai Cancer Center

City

Shanghai

State/Province

Shanghai

ZIP/Postal Code

200032

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Zhi-Min Shao, MD.PhD.

Phone

86-18017312288

zhimingshao@yahoo.com

12. IPD Sharing Statement

Learn more about this trial

TA(E)C-GP Versus A(E)C-T for the High Risk TNBC Patients and Validation of the mRNA-lncRNA Signature

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