Trial Title:
TCb vs EC-T in High Risk ER+/HER2- Breast Cancer
NCT ID:
NCT05901428
Condition:
Hormone Receptor Positive HER-2 Negative Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Cyclophosphamide
Carboplatin
Docetaxel
Epirubicin
Conditions: Keywords:
LN≥4
TCb
EC-T
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Docetaxel
Description:
Docetaxel is a taxoid antineoplastic agent used in the treatment of breast cancer
Arm group label:
EC-T arm
Arm group label:
TCb arm
Intervention type:
Drug
Intervention name:
Carboplatin
Description:
Carboplatin is a deoxyribonucleic acid (DNA) synthesis inhibitor which binds to DNA,
inhibits replication and transcription and induces cell death.
Arm group label:
TCb arm
Intervention type:
Drug
Intervention name:
Epirubicin
Description:
Epirubicin is an antineoplastic agent derived from doxorubicin.Epirubicin, like
doxorubicin, exerts its antitumor effects by interference with the synthesis and function
of DNA and is most active during the S phase of the cell cycle.
Arm group label:
EC-T arm
Intervention type:
Drug
Intervention name:
Cyclophosphamide
Description:
Cyclophosphamide is a nitrogen mustard that exerts its anti-neoplastic effects through
alkylation.
Arm group label:
EC-T arm
Summary:
This study will evaluate the efficacy and safety of docetaxel plus carboplatin (TCb)
regimen compared with conventional chemotherapy regimen (epirubicin plus cyclophosphamide
followed by docetaxel, EC-T) regimen as adjuvant chemotherapy in patients with
early-stage high-risk estrogen receptor (ER) positive and human epidermal growth factor
receptor 2 (HER2) negative (ER+/HER2-) breast cancer.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Women aged 18-70
2. Unilateral invasive carcinoma confirmed by histology (regardless of pathological
type)
3. The initial diagnosis condition can be directly operated, without absolute surgical
contraindications
4. No gross or microscopic tumor remains after surgical resection
5. Adjuvant chemotherapy should be started within eight weeks after surgery
6. Patients with Hormone receptor-positive, HER2-negative (HR+HER2-), and positive
axillary lymph nodes ≥4
7. Definition of ER and Progesterone Receptor (PgR) positive: Positive ER for tumor
cells detected by immunohistochemistry is defined as ER positive , and positive PgR
for tumor cells detected as PgR positive .
8. There was no evidence of metastasis in clinical or imaging aspects during
preoperative examination
9. No peripheral neuropathy;
10. Eastern Oncology Collaborative Group (ECOG) physical status score: 0 or 1
11. Good postoperative recovery, at least 1 week interval between surgery
12. Adequate hematological and end-organ function as defined by the following laboratory
test results, which need to be completed within 28 days prior to the first study
treatment: absolute neutrophil count (ANC) ≥ 1500 cells/μL (no granulocyte colony
stimulating factor (G-CSF) support therapy within 2 weeks prior to day 1 of course
1); Lymphocyte count≥ 500 cells/μL; Platelet count≥ 100,000 cells/μL (no platelet
transfusion within 2 weeks before day 1 of course 1; hemoglobin≥ 9.0 g/dL; Aspartate
transferase (AST), Alanine aminotransferase (ALT), and alkaline phosphatase≤ 2.5 ×
upper limit of normal (ULN) serum total bilirubin ≤ 1.0 × ULN; Patients with known
Gilbert disease and serum bilirubin levels ≤ 3× ULN may be admitted; For patients
not receiving anticoagulant therapy: INR or activated partial thromboplastin time
(APTT) ≤ 1.5 × ULN within 28 days prior to initiation of study therapy; For patients
receiving anticoagulant therapy: a stable anticoagulant regimen within 28 days
before the start of study therapy and a stable International normalised ratio (INR);
creatinine clearance≥ 30 mL/min (calculated using the Cockcroft-Gault formula);
Serum albumin ≥ 2.5 g/dL
13. For women of childbearing age: agree to remain abstinent (avoid heterosexual
intercourse) or take an annual failure rate for at least 5 months during treatment
and at least 6 months after the last dose of docetaxel or epirubicin, or 12 months
after the last dose of cyclophosphamide, whichever occurs last < 1% of
contraception. A woman who is postmenopausal but has not yet reached postmenopausal
status (menopause lasts ≥for 12 consecutive months, for no reason other than
menopause) and has not undergone sterilization (ovarian and/or hysterectomy) is
considered fertile.
14. Cardiac function: left ventricular ejection fraction (LVEF) >50% by ultrasound
examination
15. Sign the Informed Consent Form (ICF)
Exclusion Criteria:
1. Have a history of invasive cancer
2. T4 clinical tumors as specified in the Union for International Cancer
Control/American Joint Committee on Cancer tumor (UICC/AJCC) Tumor-Lymph Node
Metastasis Classification (8th Edition), including inflammatory breast cancer
3. For currently diagnosed breast cancer, prior systemic anticancer therapy (eg,
neoadjuvant therapy or adjuvant therapy) includes, but is not limited to,
chemotherapy, anti-HER2 therapy (eg, trastuzumab emtansine, pertuzumab, lapatinib,
neratinib or other tyrosine kinase inhibitors), hormone therapy, or anti-cancer
radiotherapy (RT), except for treatments planned under this study condition
4. Previous treatment with anthracyclines or taxane for any malignant tumor
5. History of ductal carcinoma in situ (DCIS) and/or lobular carcinoma in situ (LCIS),
treatment of ipsilateral breast cancer with systemic therapy, hormone therapy, or
RT, followed by invasive cancer, patients treated with DCIS/LCIS only surgery and/or
RT for contralateral DCIS may be enrolled in the study.
6. Prior to randomization, cardiopulmonary dysfunction according to any of the
following: history of NCI CTCAE v4.0 ≥3 symptomatic congestive heart failure or New
York College of Cardiology (NYHA) standard classification≥ II, angina requiring
antianginal drugs, severe arrhythmias not treated with appropriate medical therapy,
severe conduction abnormalities, or clinically significant valvular disease,
high-risk, uncontrolled arrhythmias (i.e., atrial tachycardia with > resting rate).
100/min, significant ventricular arrhythmia [ventricular tachycardia], or high-grade
atrioventricular (AV) block [second-degree AV block type 2, or third-degree
atrioventricular block]), significant symptoms associated with left ventricular
dysfunction, arrhythmia, or myocardial ischemia (grade ≥2), myocardial infarction
within 12 hours prior to randomization; with uncontrolled hypertension (systolic
blood pressure> 180 mmHg and/or diastolic blood pressure > 100 mmHg; ECG findings
show transmural infarction; Oxygen therapy is required
7. Prior malignancy within 5 years prior to randomization, with negligible risk of
metastasis or death, except for malignancy that is expected to heal after treatment
(i.e., appropriately treated carcinoma in situ or basal or squamous cell skin
cancer).
8. Known allergic or hypersensitivity to any component of the docetaxel, carboplatin,
cyclophosphamide, or epirubicin preparations; Allergic or hypersensitivity reactions
are known to filgrastim, pegfilgrastim, or granulocyte-macrophage colony-stimulating
factor (GM-CSF) preparations
9. Patients with serious infections (including but not limited to hospitalization due
to infectious complications, bacteremia, or severe pneumonia) that occurred within 4
weeks prior to initiation of study treatment, who received therapeutic oral or
intravenous antibiotics within 2 weeks prior to initiation of study treatment, and
who received prophylactic antibiotic therapy (such as prophylaxis for urinary tract
infection or prevention of chronic obstructive pulmonary disease) may be enrolled.
10. Pregnant or lactating women, or women planning to become pregnant during the study
period.
11. Poorly controlled hypertension (defined as: systolic blood pressure > 150 mmHg
and/or diastolic blood pressure >100 mmHg)
12. Mental illness, cognitive impairment, inability to understand the trial protocol and
side effects, and inability to complete the trial protocol and follow-up workers
(systematic evaluation is required before trial enrollment)
13. Persons without personal freedom and independent capacity for civil conduct.
Gender:
Female
Minimum age:
18 Years
Maximum age:
70 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Breast cancer institute of Fudan University Cancer Hospital
Address:
City:
Shanghai
Zip:
200032
Country:
China
Status:
Recruiting
Contact:
Last name:
Zhi-Ming Shao, MD
Phone:
86-21-641755901105
Email:
zhimingshao@yahoo.com
Contact backup:
Last name:
Lei Fan, MD
Phone:
86-21-641755901105
Email:
cmchen@medmail.com.cn
Investigator:
Last name:
Zhi-Ming Shao, MD
Email:
Principal Investigator
Investigator:
Last name:
Min He, MD
Email:
Sub-Investigator
Investigator:
Last name:
Linxiaoxi Ma, MD
Email:
Sub-Investigator
Investigator:
Last name:
Ying Zhou
Email:
Sub-Investigator
Start date:
June 1, 2023
Completion date:
June 2028
Lead sponsor:
Agency:
Fudan University
Agency class:
Other
Source:
Fudan University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05901428
