Clinical trial NCT05483439: A Study of Immunotherapy Combined With Neoadjuvant Therapy Versus Neoadjuvant Therapy for Breast Cancer
Official title: Clinical Study Comparing the Efficacy and Safety of Traditional Herbal Medicine for Cancer Immunotherapy Combined With Neoadjuvant Therapy Versus Neoadjuvant Therapy in Patients With Stage II-III Breast Cancer.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Stage II-III Breast Cancer
Lead sponsor: Shengjing Hospital
Sponsor class: OTHER
First posted: 2022-08-02
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Primary outcomes:
measure: Total pathological complete response rate (tpCR)
timeFrame: One month after surgery
Secondary outcomes:
measure: Global health status and functioning subscales
timeFrame: One month after surgery
measure: Cancer-related fatigue scores
timeFrame: One month after surgery
measure: Adverse events (AE) and serious adverse events (SAE)
timeFrame: Period of neoadjuvant therapy (treatment 1-6 months)
measure: Disease free survival (DFS)
timeFrame: 5 years
measure: Five-year overall survival (OS)
timeFrame: 5 years
measure: Expression of immune cells
timeFrame: One month after surgery
measure: Expression of cytokines (IL, INF-r, TNF-a)
timeFrame: One month after surgery
Other outcomes:
Locations:
city: Shenyang
country: China
facility: ShengJing ospital of China Medical University
state: Liaoning
city: Shenyang
country: China
facility: Shengjing Hospital Affiliated to China Medical University
state: Liaoning
Study officials:
affiliation: Shengjing Hospital
name: Caigang Liu, doctor
role: PRINCIPAL_INVESTIGATOR
References: