A Study of Immunotherapy Combined With Neoadjuvant Therapy Versus Neoadjuvant Therapy for 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

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-20

Study Completion Date

2023-07-01

Brief Summary

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

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.

Related Clinical Trials

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

Trastuzumab Plus Taxane Neoadjuvant Therapy for HER2-Positive Breast Ductal Carcinoma In Situ (DCIS) : A Phase II Study

NCT06843681

Breast Carcinoma in Situ

ENROLLING_BY_INVITATION PHASE2

Neoadjuvant Chemotherapy + PD-1 Inhibitor+Different Radiotherapy Fractionations for HR+/HER2- Breast Cancer

NCT06639672

HR+HER2- Breast Cancer

NOT_YET_RECRUITING PHASE2

Study of Preoperative Chemotherapy for Early Triple Negative or HER2-positive Operable Breast Cancer

NCT02934828

Breast Cancer

UNKNOWN PHASE2

Pre-operative Immunotherapy Combination Strategies in Breast Cancer

NCT03395899

Breast Cancer Estrogen Receptor-positive Breast Cancer

COMPLETED PHASE2

Eliminating Breast Surgery for Breast Cancer Patients With Clinical Complete Response to Neoadjuvant Systemic Therapy

NCT06498154

Breast Cancer

RECRUITING PHASE2

Detailed Description

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

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.

Conditions

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

Stage II-III Breast Cancer

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.

Immunotherapy and neoadjuvant therapy

Traditional herbal medicine twice daily combined with neoadjuvant therapy recommended by the guidelines every 3 weeks, for 6 or 8 cycles.

Group Type EXPERIMENTAL

cytotoxic chemotherapy (docetaxel or epirubicin or cyclophosphamide or carboplatin)

Intervention Type DRUG

Drug: cytotoxic chemotherapy (docetaxel or epirubicin or cyclophosphamide or carboplatin)

anti-Her2 monoclonal antibody (Trastuzumab, Pertuzumab)

Intervention Type DRUG

anti-Her2 monoclonal antibody (Trastuzumab, Pertuzumab)

traditional herbal medicine

Intervention Type DRUG

traditional herbal medicine

neoadjuvant therapy

Only received neoadjuvant therapy recommended by the guidelines every 3 weeks, for 6 or 8 cycles.

Group Type OTHER

cytotoxic chemotherapy (docetaxel or epirubicin or cyclophosphamide or carboplatin)

Intervention Type DRUG

Drug: cytotoxic chemotherapy (docetaxel or epirubicin or cyclophosphamide or carboplatin)

anti-Her2 monoclonal antibody (Trastuzumab, Pertuzumab)

Intervention Type DRUG

anti-Her2 monoclonal antibody (Trastuzumab, Pertuzumab)

Interventions

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

cytotoxic chemotherapy (docetaxel or epirubicin or cyclophosphamide or carboplatin)

Drug: cytotoxic chemotherapy (docetaxel or epirubicin or cyclophosphamide or carboplatin)

Intervention Type DRUG

anti-Her2 monoclonal antibody (Trastuzumab, Pertuzumab)

Intervention Type DRUG

traditional herbal medicine

Intervention Type DRUG

Eligibility Criteria

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

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No