Breast CancerPhase 2HIFUNCT05491694
To Evaluate the Efficacy of Toripalimab Combined With Chemotherapy After HIFU Induction in the Treatment of Early Triple-negative Breast Cancer
A Phase 2 study testing Toripalimab, Epirubicin and High Intensity Focused Ultrasoun in people with Breast Cancer and TNBC - Triple-Negative Breast Cancer, run by The First Affiliated Hospital with Nanjing Medical University.
Trial summary
To investigate the efficacy and safety of terbinumab combined with chemotherapy (epirubicin + cyclophosphamide → nab-paclitaxel + carboplatin) in neoadjuvant therapy of triple-negative breast cancer after HIFU. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer, TNBC - Triple-Negative Breast Cancer
- What is being tested?
- Toripalimab, Epirubicin and High Intensity Focused Ultrasoun
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2022to 30 Dec 2024
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female patients aged ≥ 18 years who require a negative pregnancy test for premenopausal and perimenopausal patients and promise to take reliable contraceptive measures during treatment;
- Histopathologically confirmed breast cancer patients who are negative for estrogen receptor (ER), progesterone receptor (PR), and HER-2 by immunohistochemistry; positive PD-L1 expression in tumor cells (≥ 1%);
- triple-negative breast cancer patients without distant metastasis;
- According to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, they have at least one evaluable target lesion;
- ECOG PS score: 0 - 1;
- New York Heart Association (NYHA) functional class I;
Show all 11Show fewer
- Electrocardiogram without myocardial ischemia, echocardiography LVEF > 55%, cardiac markers: cardiac troponin I (cTnI) and brain natriuretic peptide (BNP) test values within the normal range;
- Normal major organ function, Meet the following criteria:
- WBC ≥ 4.0 × 10 9/L,Neutrophil count (ANC) ≥ 1.5 × 10 9/L; platelet ≥ 100 × 10 9/L; hemoglobin ≥ 10 g/dL; serum creatinine ≤ 1.5 × upper limit of normal (ULN); aspartate aminotransferase (AST) ≤ 2.5 × ULN; alanine aminotransferase (ALT) ≤ 2.5 × ULN; total bilirubin ≤ 1.5 × ULN; serum creatinine ≤ 1.5 × ULN;
- 9) The subject is able to understand the study procedures, voluntarily join the study, sign the informed consent form, have good compliance, and cooperate with the follow-up.
- -
Who cannot join
- Patients during pregnancy and lactation, women of childbearing age who refuse to take effective contraceptive measures during the study period; Patients with peripheral nervous system disorders caused by diseases or those with a history of significant mental disorders and central nervous system disorders;
- Serious or uncontrolled infections that may affect the evaluation of study treatment or study results, including but not limited to: active hepatitis virus infection, human immunodeficiency virus (HIV) antibody positive, lung infection, etc.;
- Known allergy to the active ingredients or other components of the study drug or surgical contraindications;
- In addition to cured basal cell carcinoma of the skin and cured cervical carcinoma in situ, other cancers are disease-free for less than 5 years;
- Severe liver disease (such as cirrhosis, etc.), kidney disease, respiratory disease or uncontrolled diabetes, active gastrointestinal ulcers and other need treatment;
- Need to receive other anti-tumor therapy (except ovarian function inhibitors) during neoadjuvant therapy as judged by the investigator;
Show all 9Show fewer
- Patients who are participating in other clinical trials within one month;
- Patients with severe heart disease or discomfort, Expected intolerance to chemotherapy,Including, but not limited to: a. fatal arrhythmia or higher grade atrioventricular block (second-degree type 2 [Mobitz 2] atrioventricular block or third-degree atrioventricular block); b. unstable angina pectoris; c. clinically significant valvular heart disease; d. transmural myocardial infarction on electrocardiogram; e. uncontrolled hypertension;
- any other condition that in the opinion of the investigator would make the patient inappropriate for participation in this study.
About this study
Official title: To Evaluate the Efficacy and Safety of Toripalimab Combined With Chemotherapy (Epirubicin + Cyclophosphamide → Nab-paclitaxel + Carboplatin) in the Neoadjuvant Treatment of Triple-negative Breast Cancer After High-intensity Focused Ultrasound (HIFU) Induction
To investigate the efficacy and safety of terbinumab combined with chemotherapy (epirubicin + cyclophosphamide → nab-paclitaxel + carboplatin) in neoadjuvant therapy of triple-negative breast cancer after HIFU.
- Being tested
- Toripalimab, Epirubicin, High Intensity Focused Ultrasoun, Cyclophosphamide, Carboplatin
- Medical subject headings
- Breast Neoplasms, Triple Negative Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ToripalimabDrug
Toripalimab 240mg
EpirubicinDrug
90mg/m2，IVD，q3w
High Intensity Focused UltrasounProcedure or surgery
HIFU treatment at lesion site
CyclophosphamideDrug
600mg/m2，IVD，q3w
CarboplatinDrug
AUC 5，IVD，q3w
Nab-paclitaxelDrug
260mg/m2，IVD，q3w
| Study group | Role | What they receive |
|---|---|---|
| HIFU+Toripalimab+Chemotherapy | Experimental | High Intensity Focused Ultrasoun， followed by Toripalimab 240 mg + epirubicin 90 mg/m2 + cyclophosphamide 600 mg/m2 × 4 cycles → Toripalimab240 mg + carboplatin AUC 5 + nab-paclitaxel 260 mg/m2 IVD × 4 cycles every 3 weeks for 8 doses. Receives: Drug: Toripalimab; Drug: Epirubicin; Procedure: High Intensity Focused Ultrasoun; Drug: Cyclophosphamide; Drug: Carboplatin; Drug: Nab-paclitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
pCR
Pathologic complete response rate
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2022
- Study start1 Sep 2022 (estimated)
- Primary completion30 Dec 2023 (estimated)
- Study completion30 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital with Nanjing Medical UniversityThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shui Wang, The First Affiliated Hospital with Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05491694
- Sponsor's protocol ID
- HIFU202207
- Acronym
- HIFU
- Status last verified
- Aug 2022
- First submitted
- 5 Aug 2022
- Last updated
- 8 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 8 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Evaluate the Efficacy and Safety of Toripalimab Combined With Chemotherapy (Epirubicin + Cyclophosphamide → Nab-paclitaxel + Carboplatin) in the Neoadjuvant Treatment of Triple-negative Breast Cancer After High-intensity Focused Ultrasound (HIFU) Induction
- ClinicalTrials.gov ID
- NCT05491694
- Acronym / sponsor ID
- HIFU / HIFU202207
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 1 Sep 2022 (estimated)
- Primary completion
- 30 Dec 2023 (estimated)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 8 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.
To investigate the efficacy and safety of terbinumab combined with chemotherapy (epirubicin + cyclophosphamide → nab-paclitaxel + carboplatin) in neoadjuvant therapy of triple-negative breast cancer after HIFU.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HIFU+Toripalimab+Chemotherapy | Experimental | Drug: Toripalimab, Drug: Epirubicin, Procedure: High Intensity Focused Ultrasoun, Drug: Cyclophosphamide, Drug: Carboplatin, Drug: Nab-paclitaxelHigh Intensity Focused Ultrasoun， followed by Toripalimab 240 mg + epirubicin 90 mg/m2 + cyclophosphamide 600 mg/m2 × 4 cycles → Toripalimab240 mg + carboplatin AUC 5 + nab-paclitaxel 260 mg/m2 IVD × 4 cycles every 3 weeks for 8 doses. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Female patients aged ≥ 18 years who require a negative pregnancy test for premenopausal and perimenopausal patients and promise to take reliable contraceptive measures during treatment;
- Histopathologically confirmed breast cancer patients who are negative for estrogen receptor (ER), progesterone receptor (PR), and HER-2 by immunohistochemistry; positive PD-L1 expression in tumor cells (≥ 1%);
- triple-negative breast cancer patients without distant metastasis;
- According to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, they have at least one evaluable target lesion;
- ECOG PS score: 0 - 1;
Key exclusion criteria (9 listed)
- Patients during pregnancy and lactation, women of childbearing age who refuse to take effective contraceptive measures during the study period; Patients with peripheral nervous system disorders caused by diseases or those with a history of significant mental disorders and central nervous system disorders;
- Serious or uncontrolled infections that may affect the evaluation of study treatment or study results, including but not limited to: active hepatitis virus infection, human immunodeficiency virus (HIV) antibody positive, lung infection, etc.;
- Known allergy to the active ingredients or other components of the study drug or surgical contraindications;
- In addition to cured basal cell carcinoma of the skin and cured cervical carcinoma in situ, other cancers are disease-free for less than 5 years;
- Severe liver disease (such as cirrhosis, etc.), kidney disease, respiratory disease or uncontrolled diabetes, active gastrointestinal ulcers and other need treatment;
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 |
|---|---|---|
| ToripalimabToripalimab 240mg | Drug | HIFU+Toripalimab+Chemotherapy |
| Epirubicin90mg/m2，IVD，q3w | Drug | HIFU+Toripalimab+Chemotherapy |
| High Intensity Focused UltrasounHIFU treatment at lesion site | Procedure or surgery | HIFU+Toripalimab+Chemotherapy |
| Cyclophosphamide600mg/m2，IVD，q3w | Drug | HIFU+Toripalimab+Chemotherapy |
| CarboplatinAUC 5，IVD，q3w | Drug | HIFU+Toripalimab+Chemotherapy |
| Nab-paclitaxel260mg/m2，IVD，q3w | Drug | HIFU+Toripalimab+Chemotherapy |
Primary outcome
pCR
Time frame: 6 months
Pathologic complete response rate
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2022.
Related trials for Breast Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Toripalimab, Epirubicin and High Intensity Focused Ultrasoun in people with Breast Cancer and TNBC - Triple-Negative Breast Cancer, run by The First Affiliated Hospital with Nanjing Medical University.
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 11 inclusion and 9 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 8 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pCR (time frame: 6 months). 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 8 Aug 2022.