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

  • STATUS
    Recruiting
  • End date
    Dec 24, 2023
  • participants needed
    970
  • sponsor
    Shanghai Jiao Tong University School of Medicine
Updated on 24 January 2021
paclitaxel
cancer
cyclophosphamide
estrogen
carcinoma
breast cancer
progesterone
carboplatin
immunohistochemistry
HER2
carcinoma in situ
lobular carcinoma
docetaxel
adenocarcinoma
triple negative breast cancer
progesterone receptor
erbb2
estrogen receptor
breast adenocarcinoma
taxane
epirubicin
mastectomy
adjuvant chemotherapy
axillary lymph node dissection
immunostimulant
sentinel node
breast-conserving surgery
sentinel lymph node biopsy
renal function test

Summary

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.

Description

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.

Details
Condition Breast Cancer, breast neoplasm, breast tumors, tumor of the breast, breast tumor
Treatment Taxanes, Epirubicin plus Cyclophosphamide, Taxanes plus Carboplatin
Clinical Study IdentifierNCT02455141
SponsorShanghai Jiao Tong University School of Medicine
Last Modified on24 January 2021

Eligibility

Yes No Not Sure

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
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