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

January 24, 2024 updated by: Zhimin Shao, Fudan University

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
503

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • 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

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200032
        • Fudan University Shanghai Cancer Center

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 61 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Age: 18-70 years old
  2. Expected survival > 12 months
  3. Baseline Eastern Cooperative Oncology Group Performance Status rating 0-1
  4. Naïve to chemotherapy or hormonal treatments
  5. Pathology confirmed invasive ductal carcinoma of breast
  6. Triple negative breast cancer confirmed by pathology
  7. No concurrent malignancy (except controlled cervical carcinoma in situ or basal cell carcinoma of skin)
  8. No advanced metastasis or metastasis involving brain or liver
  9. Adequate bone marrow function, blood routine examination shows neutrophil count ≥ 1.5x109/L, hemoglobin level ≥ 100 g/L, Platelets ≥ 100 x 109/L
  10. 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
  11. No coagulation abnormality
  12. Normal heart function, with normal ECG and left ventricular ejection fraction ≥ 55%
  13. 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
  14. No coagulation abnormality
  15. Sign the informed consent statement and voluntarily receive follow-ups, treatments, laboratory tests and other research procedures according to protocol.

Exclusion Criteria:

  1. Previous regional or systemic treatment for breast cancer (include but not limited to chemotherapy, radiotherapy, targeted therapy, other clinical trials)
  2. Inflammatory breast cancer, bilateral breast cancer or breast cancer already with distant metastasis
  3. 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
  4. Peripheral neuropathy >1 degree caused by any reason
  5. 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);
  6. Breast cancer during lactation or pregnancy
  7. Mental illness or incompliance to treatment caused by other reasons
  8. Known history of severe hypersusceptibility to any agents used in the treatment protocol
  9. Patients received major surgery or suffered from severe trauma within 2 months of first administration
  10. Currently enroll or recently used (30 days within enrollment) other agent under research or involved in other trial
  11. Known to be infected with human immunodeficiency virus (HIV)
  12. Other circumstances considered to be inappropriate to be enrolled by researchers

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 Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: High risk 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.
Drug: cyclophosphamide
Drug: docetaxel
Drug: cisplatin
Drug: gemcitabine
Drug: doxorubicin or epirubicin
Active Comparator: High risk 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.
Drug: cyclophosphamide
Drug: docetaxel
Drug: doxorubicin or epirubicin
Other: Low risk 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.
Drug: cyclophosphamide
Drug: docetaxel
Drug: doxorubicin or epirubicin

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Disease free survival
Time Frame: three years
three years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Recurrence free survival
Time Frame: three years
three years
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time Frame: three years
three years
Overall survival
Time Frame: three years
three years

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Fudan University

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 (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2023

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 22, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 24, 2015

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 30, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 25, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 24, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 1506147-4

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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings