Adjuvant Treatment of EC Followed by Taxane +/- Carboplatin in Triple-Negative Breast Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE3

Total Enrollment

786 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-03-31

Study Completion Date

2030-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

To compare disease-free survival (DFS) rate of adjuvant chemotherapy epirubicin-cyclophosphamide followed by weekly paclitaxel or docetaxel (EC-T), or weekly paclitaxel or docetaxel-carboplatin (EC-TCb) in triple-negative breast cancer.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Docetaxel+Carboplatin vs Epirubicin+Cyclophosphamide Followed by Docetaxel as Adjuvant Treatment in Triple-negative Breast Cancer

NCT01150513

Breast Cancer

COMPLETED PHASE2/PHASE3

The Trial Comparing Dose-dense AC-T With PC as Adjuvant Therapy for TNBC

NCT01378533

Breast Cancer

UNKNOWN PHASE3

The Trial Comparing Dose-dense AC-T With TP as Adjuvant Therapy for TNBC With Homologous Recombination Repair Deficiency

NCT03876886

Triple Negative Breast Cancer

UNKNOWN PHASE3

Adjuvant Chemotherapy for Triple Negative Breast Cancer Patients With Residual Disease After Neoadjuvant Chemotherapy

NCT04437160

Triple Negative Breast Cancer

RECRUITING PHASE2

Comparison Study of Neoadjuvant Paclitaxel Plus Carboplatin/Epirubicin Treatment in Triple-negative Breast Cancer

NCT01276769

Triple Negative Breast Cancer

UNKNOWN PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

This study plans to enroll triple-negative breast cancer patients who have complete tumor removal. Patients are randomized to receive either EC-wP/T or EC-wP/TCb adjuvant chemotherapy. For triple-negative breast cancer, a subgroup of triple-negative breast cancer has DNA repairement deficiency and adding carboplatin to paclitaxel may improve DFS on the basis of weekly paclitaxel adjuvant chemotherapy.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Breast Neoplasm

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Taxanes

Epirubicin plus Cyclophosphamide followed by Paclitaxel or Docetaxel

Group Type ACTIVE_COMPARATOR

Epirubicin plus Cyclophosphamide

Intervention Type DRUG

Epirubicin 90mg/m2, d1, q3w\*4 Cyclophosphamide: 600mg/m2, d1, q3w\*4

Taxanes

Intervention Type DRUG

Paclitaxel: 80mg/m2, d1, qw\*12 or Docetaxel: 80-100mg/m2,d1,q3w\*4

Taxanes plus carboplatin

Epirubicin plus Cyclophosphamide followed by Paclitaxel or Docetaxel + Carboplatin

Group Type EXPERIMENTAL

Epirubicin plus Cyclophosphamide

Intervention Type DRUG

Epirubicin 90mg/m2, d1, q3w\*4 Cyclophosphamide: 600mg/m2, d1, q3w\*4

Taxanes plus Carboplatin

Intervention Type DRUG

Paclitaxel: 80mg/m2, d1,d8,d15, q4w\*4 Carboplatin AUC=2, d1,d8,d15, q4w\*4 or Docetaxel: 75mg/m2,d1,q3w\*4 plus Carboplatin AUC=5-6, d1, q3w\*4

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Epirubicin plus Cyclophosphamide

Epirubicin 90mg/m2, d1, q3w\*4 Cyclophosphamide: 600mg/m2, d1, q3w\*4

Intervention Type DRUG

Taxanes

Paclitaxel: 80mg/m2, d1, qw\*12 or Docetaxel: 80-100mg/m2,d1,q3w\*4

Intervention Type DRUG

Taxanes plus Carboplatin

Paclitaxel: 80mg/m2, d1,d8,d15, q4w\*4 Carboplatin AUC=2, d1,d8,d15, q4w\*4 or Docetaxel: 75mg/m2,d1,q3w\*4 plus Carboplatin AUC=5-6, d1, q3w\*4

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

EC

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Histologically confirmed adenocarcinoma of the breast, completely tumor removal by either modified radical mastectomy or local excision plus axillary lymph node dissection (i.e., breast conservation therapy) or sentinel node biopsy. (Tumor-free margins at least 1 mm for both invasive and noninvasive carcinoma except for lobular carcinoma in situ (less than 1 mm allowed);
* Tumor specimens are available for estrogen receptor (ER), progesterone receptor (PgR) and Her2 (human epidermal-growth-factor receptor 2) detection, patients should be with triple negative breast cancer. Triple-negative disease is defined as ER \<10% positivity, PgR \<10% positivity, and negativity for Her2 (IHC (immunohistochemistry) 0-1+ or FISH (fluorescence in situ hybridization) negative);
* Adequate bone marrow function
* Adequate liver and renal function
* Eastern Cooperative Oncology Group (ECOG) Performance Score 0-1;
* Women with potential child-bearing must have a negative pregnancy test (urine or serum) within 7 days of drug administration and agree to use an acceptable method of birth control to avoid pregnancy for the duration of the study;
* Written informed consent according to the local ethics committee requirements.

Exclusion Criteria

* Prior systemic of breast cancer, including chemotherapy;
* Metastatic breast cancer;
* With a history of malignant tumor except uterine cervix cancer in situ or skin basal cell carcinoma;
* Patients with medical conditions that indicate intolerant to adjuvant therapy and related treatment, including uncontrolled pulmonary disease, diabetes mellitus, severe infection, active peptic ulcer, coagulation disorder, connective tissue disease or myelo-suppressive disease;
* Has active hepatitis B or hepatitis C with abnormal liver function tests (LFTs) or is known to be HIV positive;
* Contraindication for using dexamethasone;
* History of congestive heart failure, uncontrolled or symptomatic angina pectoris, arrhythmia or myocardial infarction; poorly controlled hypertension (systolic BP\>180 mmHg or diastolic BP\>100 mmHg);
* Has peripheral neuropathy no less than grade 1;
* Patient is pregnant or breast feeding;
* Patients with psychiatric disorder or other diseases leading to incompliance to the therapy;
* Known severe hypersensitivity to any drugs in this study;
* Treatment with any investigational drugs within 30 days before the beginning of study treatment.

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Kunwei Shen

professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Kunwei Shen, professor

Role: PRINCIPAL_INVESTIGATOR

Affiliated Ruijin Hospital of Shanghai JiaoTong University School of Medicine

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Fuding Hospital

Fuding, Fujian, China

Site Status

The First Affiliated Hospital of Fujian Medical University

Fuzhou, Fujian, China

Site Status

Quanzhou First Hospital

Quanzhou, Fujian, China

Site Status

Foshan No.1 People's Hospital

Foshan, Guangdong, China

Site Status

Guangdong Maternal and Child Health Care Hospital

Guangzhou, Guangdong, China

Site Status

Cancer Hospital Affiliated to Harbin Medical University

Harbin, Heilongjiang, China

Site Status

Jiangsu Jiangyin People's Hospital

Jiangyin, Jiangsu, China

Site Status

The First People's Hospital of Wujiang District

Suzhou, Jiangsu, China

Site Status