Stage II-III Breast CancerPhase 2NCT05483439
A Study of Immunotherapy Combined With Neoadjuvant Therapy Versus Neoadjuvant Therapy for Breast Cancer
A Phase 2 study testing cytotoxic chemotherapy (docetaxel or epirubicin or cyclophosphamide or carboplatin), anti-Her2 monoclonal antibody (Trastuzumab, Pertuzumab) and traditional herbal medicine in people with Stage II-III Breast Cancer, run by Shengjing Hospital at 2 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Stage II-III Breast Cancer
- What is being tested?
- cytotoxic chemotherapy (docetaxel or epirubicin or cyclophosphamide or carboplatin), anti-Her2 monoclonal antibody (Trastuzumab, Pertuzumab) and traditional herbal medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesChina
- Study dates
- 20 Oct 2021to 1 Jul 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female patients aged ≥ 18 but ≤ 75 years;
- 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;
- Diagnosis of breast cancer meets the following criteria: Histologically confirmed invasive breast cancer
- KPS score≥70
- 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;
- Patients who participate in the trial voluntarily, sign an informed consent, have good compliance and are willing to comply with the follow-up visit.
Who cannot join
- Previously received any anti-tumor therapy (chemotherapy, radiotherapy, molecular targeted therapy, endocrine therapy, etc.);
- Patients who are concurrently receiving other anti-tumor therapy;
- Bilateral breast cancer, inflammatory breast cancer, or occult breast cancer;
- Stage IV breast cancer;
- Intolerant to herbs or poor compliance;
- 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;
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- Severe heart, liver, kidney and other important organ dysfunction;
- Inability to swallow, chronic diarrhea and intestinal obstruction, and having many factors that affect drug administration and absorption;
- Participated in clinical trials of other drugs within 4 weeks before enrollment;
- 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;
- Have used drugs that affect immune function within 1 year;
- 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;
- 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;
- 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);
- 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.
Trial locations and contacts
2 sites in 1 country.
China2 sites, 2 recruiting
- Recruiting
ShengJing ospital of China Medical University
Shenyang, Liaoning, 110022
Liu Caigang, +8618940254967, liucg@sj-hospital.org
Niu Nan, +8618940256668, niunannancy@163.com
- Recruiting
Shengjing Hospital Affiliated to China Medical University
Shenyang, Liaoning
CaoShuo Cao, doctor, 18940254228
About this study
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.
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.
Read the 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.
- Conditions
- Stage II-III Breast Cancer
- Being tested
- cytotoxic chemotherapy (docetaxel or epirubicin or cyclophosphamide or carboplatin), anti-Her2 monoclonal antibody (Trastuzumab, Pertuzumab), traditional herbal medicine
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cytotoxic chemotherapy (docetaxel or epirubicin or cyclophosphamide or carboplatin)Drug
Drug: cytotoxic chemotherapy (docetaxel or epirubicin or cyclophosphamide or carboplatin)
anti-Her2 monoclonal antibody (Trastuzumab, Pertuzumab)Drug
anti-Her2 monoclonal antibody (Trastuzumab, Pertuzumab)
traditional herbal medicineDrug
traditional herbal medicine
| Study group | Role | What they receive |
|---|---|---|
| Immunotherapy and neoadjuvant therapy | Experimental | Traditional herbal medicine twice daily combined with neoadjuvant therapy recommended by the guidelines every 3 weeks, for 6 or 8 cycles. Receives: Drug: cytotoxic chemotherapy (docetaxel or epirubicin or cyclophosphamide or carboplatin); Drug: anti-Her2 monoclonal antibody (Trastuzumab, Pertuzumab); Drug: traditional herbal medicine |
| neoadjuvant therapy | Other | Only received neoadjuvant therapy recommended by the guidelines every 3 weeks, for 6 or 8 cycles. Receives: Drug: cytotoxic chemotherapy (docetaxel or epirubicin or cyclophosphamide or carboplatin); Drug: anti-Her2 monoclonal antibody (Trastuzumab, Pertuzumab) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total pathological complete response rate (tpCR)
The disappearance of all invasive tumours in the breast and axillary lymph nodes
Measured: One month after surgery
Secondary outcomes (7)
Global health status and functioning subscales
Health-related quality of life (HRQoL) was measured using the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core-30 (QLQ-C30; version 3).
Measured: One month after surgery
Cancer-related fatigue scores
Piper Fatigue Scale will be used to measure cancer-related fatigue. The scale scores were measured：at baseline, at the end of cycles 2 and 4, and before surgery. Each score represents the degree of fatigue: a score of 0 means none, 1-3 means mild, 4-6 means moderate, 7-10 means severe.
Measured: One month after surgery
Adverse events (AE) and serious adverse events (SAE)
For adverse events (AE) and serious adverse events (SAE), refer to NCI-CTC AE 5.0 standard.
Measured: Period of neoadjuvant therapy (treatment 1-6 months)
Disease free survival (DFS)
Disease-free survival (DFS) is the time from the day of enrollment to the first occurrence of recurrent disease, including second primary malignancies in the non-breast area and breast ductal carcinoma in situ.
Measured: 5 years
Five-year overall survival (OS)
Five-year overall survival (OS) is the time from the random date to death due to any cause.
Measured: 5 years
Expression of immune cells
Expression of immune cells (T cell, B cell, NK cell )
Measured: One month after surgery
Expression of cytokines (IL, INF-r, TNF-a)
Expression of cytokines (IL, INF-r, TNF-a)
Measured: One month after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2022
- Study start20 Oct 2021
- Primary completion1 Jul 2023 (estimated)
- Study completion1 Jul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stage II-III Breast CancerStudies of the same condition, open and under way.
- More trials run by Shengjing HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shengjing Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Caigang Liu, Shengjing Hospital
- Investigators
- Caigang Liu, doctor, Principal investigator, Shengjing Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05483439
- Sponsor's protocol ID
- Shengjing-LCG012
- Status last verified
- Aug 2022
- First submitted
- 21 Jul 2022
- Last updated
- 5 Aug 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT05483439
- Acronym / sponsor ID
- Shengjing-LCG012
- Conditions
- Stage II-III Breast Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Shengjing HospitalUniversity, hospital or other
- Study start
- 20 Oct 2021 (actual)
- Primary completion
- 1 Jul 2023 (estimated)
- Study completion
- 1 Jul 2023 (estimated)
- First posted
- 2 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Immunotherapy and neoadjuvant therapy | Experimental | Drug: cytotoxic chemotherapy (docetaxel or epirubicin or cyclophosphamide or carboplatin), Drug: anti-Her2 monoclonal antibody (Trastuzumab, Pertuzumab), Drug: traditional herbal medicineTraditional herbal medicine twice daily combined with neoadjuvant therapy recommended by the guidelines every 3 weeks, for 6 or 8 cycles. |
| neoadjuvant therapy | Other | Drug: cytotoxic chemotherapy (docetaxel or epirubicin or cyclophosphamide or carboplatin), Drug: anti-Her2 monoclonal antibody (Trastuzumab, Pertuzumab)Only received neoadjuvant therapy recommended by the guidelines every 3 weeks, for 6 or 8 cycles. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Female patients aged ≥ 18 but ≤ 75 years;
- 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;
- Diagnosis of breast cancer meets the following criteria: Histologically confirmed invasive breast cancer
- KPS score≥70
- 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;
Key exclusion criteria (15 listed)
- Previously received any anti-tumor therapy (chemotherapy, radiotherapy, molecular targeted therapy, endocrine therapy, etc.);
- Patients who are concurrently receiving other anti-tumor therapy;
- Bilateral breast cancer, inflammatory breast cancer, or occult breast cancer;
- Stage IV breast cancer;
- Intolerant to herbs or poor compliance;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cytotoxic chemotherapy (docetaxel or epirubicin or cyclophosphamide or carboplatin)Drug: cytotoxic chemotherapy (docetaxel or epirubicin or cyclophosphamide or carboplatin) | Drug | Immunotherapy and neoadjuvant therapy, neoadjuvant therapy |
| anti-Her2 monoclonal antibody (Trastuzumab, Pertuzumab)anti-Her2 monoclonal antibody (Trastuzumab, Pertuzumab) | Drug | Immunotherapy and neoadjuvant therapy, neoadjuvant therapy |
| traditional herbal medicinetraditional herbal medicine | Drug | Immunotherapy and neoadjuvant therapy |
Primary outcome
Total pathological complete response rate (tpCR)
Time frame: One month after surgery
The disappearance of all invasive tumours in the breast and axillary lymph nodes
7 secondary outcomes
Global health status and functioning subscales
Time frame: One month after surgery
Cancer-related fatigue scores
Time frame: One month after surgery
Adverse events (AE) and serious adverse events (SAE)
Time frame: Period of neoadjuvant therapy (treatment 1-6 months)
Disease free survival (DFS)
Time frame: 5 years
Five-year overall survival (OS)
Time frame: 5 years
Expression of immune cells
Time frame: One month after surgery
Expression of cytokines (IL, INF-r, TNF-a)
Time frame: One month after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Caigang Liu, doctor principal investigator
Shengjing Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing cytotoxic chemotherapy (docetaxel or epirubicin or cyclophosphamide or carboplatin), anti-Her2 monoclonal antibody (Trastuzumab, Pertuzumab) and traditional herbal medicine in people with Stage II-III Breast Cancer, run by Shengjing Hospital at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Caigang Liu, doctor (18940254967, liucg@sj-hospital.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total pathological complete response rate (tpCR) (time frame: One month after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2022.