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Trial Title:
A Study of Immunotherapy Combined With Neoadjuvant Therapy Versus Neoadjuvant Therapy for Breast Cancer
NCT ID:
NCT05483439
Condition:
Stage II-III Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Cyclophosphamide
Carboplatin
Docetaxel
Trastuzumab
Epirubicin
Pertuzumab
Antibodies
Antibodies, Monoclonal
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Unknown status
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
cytotoxic chemotherapy (docetaxel or epirubicin or cyclophosphamide or carboplatin)
Description:
Drug: cytotoxic chemotherapy (docetaxel or epirubicin or cyclophosphamide or carboplatin)
Arm group label:
Immunotherapy and neoadjuvant therapy
Arm group label:
neoadjuvant therapy
Intervention type:
Drug
Intervention name:
anti-Her2 monoclonal antibody (Trastuzumab, Pertuzumab)
Description:
anti-Her2 monoclonal antibody (Trastuzumab, Pertuzumab)
Arm group label:
Immunotherapy and neoadjuvant therapy
Arm group label:
neoadjuvant therapy
Intervention type:
Drug
Intervention name:
traditional herbal medicine
Description:
traditional herbal medicine
Arm group label:
Immunotherapy and neoadjuvant therapy
Summary:
This is a randomized, open label Phase II neoadjuvant study comparing the efficacy and
safety of the combination of traditional herbal medicine for cancer immunotherapy and
neoadjuvant therapy versus neoadjuvant therapy in patients with breast cancer.
Detailed description:
This is a randomized, open label Phase II neoadjuvant study comparing the efficacy and
safety of the combination of traditional herbal medicine for cancer immunotherapy and
neoadjuvant therapy versus neoadjuvant therapy in patients with breast cancer. Patients
will be randomized (1:1) to one of the two treatment arms: arm 1, combination of
traditional herbal medicine for cancer immunotherapy and neoadjuvant therapy for 6 or 8
cycles; arm 2, neoadjuvant therapy 6 or 8 cycles. Patients will undergo surgery after
neoadjuvant therapy. Efficacy will be assessed every 2 cycles.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Female patients aged ≥ 18 but ≤ 75 years;
2. Diagnosis of breast cancer meets the following criteria: Stage II-III patients who
meet the 8th edition of AJCC Cancer Staging Manual and meet the indications of
neoadjuvant therapy;
3. Diagnosis of breast cancer meets the following criteria: Histologically confirmed
invasive breast cancer
4. KPS score≥70
5. The functional level of major organs must conform to the following requirements:
Neutrophils (ANC) ≥ 1.5×10^9/L (with no use of growth factors within 14 days);
Platelet count (PLT) ≥ 100×10^9/L (with no correct treatment within 7 days );
Hemoglobin (Hb) ≥ 90 g/L (with no correct treatment within 7 days ); Total bilirubin
(TBIL) ≤ 1.5×upper limit of normal (ULN); Alanine aminotransferase (ALT) and
aspartate aminotransferase (AST) ≤ 3×ULN; Urea nitrogen and creatinine ≤ 1.5×ULN and
creatinine clearance ≥ 50 mL/min (Cockcroft-Gault formula); Cardiac color Doppler
ultrasound: left ventricular ejection fraction (LVEF) ≥ 50%; 12-lead
electrocardiogram: QT interval ≤ 480 ms;
6. Patients who participate in the trial voluntarily, sign an informed consent, have
good compliance and are willing to comply with the follow-up visit.
Exclusion Criteria:
1. Previously received any anti-tumor therapy (chemotherapy, radiotherapy, molecular
targeted therapy, endocrine therapy, etc.);
2. Patients who are concurrently receiving other anti-tumor therapy;
3. Bilateral breast cancer, inflammatory breast cancer, or occult breast cancer;
4. Stage IV breast cancer;
5. Intolerant to herbs or poor compliance;
6. With a history of any malignancies other than breast cancer in the past 5 years,
excluding cured cervical carcinoma in situ and melanoma skin cancer;
7. Severe heart, liver, kidney and other important organ dysfunction;
8. Inability to swallow, chronic diarrhea and intestinal obstruction, and having many
factors that affect drug administration and absorption;
9. Participated in clinical trials of other drugs within 4 weeks before enrollment;
10. Known history of allergy to the drug components of this regimen; History of
immunodeficiency, including HIV positive, HCV, live active hepatitis B or other
acquired or congenital immune deficiency diseases, or a history of organ
transplantation;
11. Have used drugs that affect immune function within 1 year;
12. Once suffered from any heart disease, including: (1) arrhythmia with clinical
significance, (2) myocardial infarction; (3) heart failure; (4) investigator's
judgment as not suitable for participating in this trial;
13. Pregnant, lactating women, fertile women with positive baseline pregnancy test or in
the entire women of reproductive age who were unwilling to use effective
contraception during the trial;
14. According to the investigator's judgment, there are comorbidities (including but)
that seriously endanger the patient's safety or affect the patient's ability to
complete the study not limited to severe hypertension, severe diabetes, active
infection, etc., which cannot be controlled by drugs);
15. A clear past history of neurological or psychiatric disorders, including epilepsy or
dementia. The investigator considered the patient unsuitable for the study in any
other case.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
ShengJing ospital of China Medical University
Address:
City:
Shenyang
Zip:
110022
Country:
China
Status:
Recruiting
Contact:
Last name:
Liu Caigang
Phone:
+8618940254967
Email:
liucg@sj-hospital.org
Contact backup:
Last name:
Niu Nan
Phone:
+8618940256668
Email:
niunannancy@163.com
Investigator:
Last name:
Liu Caigang
Email:
Principal Investigator
Facility:
Name:
Shengjing Hospital Affiliated to China Medical University
Address:
City:
Shenyang
Country:
China
Status:
Recruiting
Contact:
Last name:
CaoShuo Cao, doctor
Phone:
18940254228
Start date:
October 20, 2021
Completion date:
July 1, 2023
Lead sponsor:
Agency:
Shengjing Hospital
Agency class:
Other
Source:
Shengjing Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05483439