Breast CancerPhase 2NCT06389006
To Evaluate the Efficacy and Safety of Disitamab Vedotin Combined With Toripalimab Sequential Chemotherapy as Neoadjuvant Treatment in Patients With HR-positive, HER2-low Breast Cancer
A Phase 2 study testing Disitamab Vedotin for Injection, Toripalimab and Epirubicin in people with Breast Cancer, run by RemeGen Co., Ltd. at 1 site in China.
Trial summary
The purpose of this study is to evaluate the efficacy and safety of Disitamab Vedotin combined with Toripalimab sequential chemotherapy as in patients with HR-positive, HER2-low breast cancer Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Disitamab Vedotin for Injection, Toripalimab and Epirubicin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 79 participants
- Where
- 1 siteChina
- Study dates
- 29 Apr 2024to 31 Dec 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Voluntarily agree to participate in the study and sign the informed consent;
- Age ≥18 years old (including the threshold value);
- Histologically confirmed invasive breast cancer with clinical stage T1c-T2(≥2cm)cN1-2M0 or T3cN0-2M0;
- As assessed by the research Center, the subjects can tolerate and plan to undergo radical surgery for breast cancer and have not previously received any anti-tumor systemic therapy for breast cancer;
- Invasive breast tumor tissue with low HER2 expression confirmed by the central laboratory is defined as IHC 1+ or IHC 2+ expression of HER2 protein detected by immunohistochemistry (IHC), and no amplification detected by in situ hybridization (ISH) (according to the Breast Cancer HER2 Detection Guidelines 2019); Primary tumor specimens (wax pieces, slices or fresh tissues) can be provided for HER2 detection;
- According to the American Society of Clinical Oncology/College of American Pathologists (ASCO/CAP) 2020 guidelines, tumor tissue estrogen receptor (ER) and progesterone receptor (PgR) expression ≥ 1%;
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- Histological grade (Nottingham grading system) G3 or G2 with ER expression
- ECOG physical status 0 or 1;
- At least one measurable lesion according to RECIST v1.1 standard;
- Heart function:
- New York Heart Association (NYHA) Grade < 3;
- left ventricular ejection fraction ≥50%;
- Bone marrow or organ function should meet the following criteria within 7 days before the study dose:
- Hemoglobin ≥ 90g/L; Absolute neutrophil count (ANC) ≥1.5×109/L; Platelet ≥ 100 ×109/L; Serum total bilirubin ≤ 1.5 times the upper limit of normal value (ULN); Aspartate aminotransferase (AST) and glutamic pyruvic transaminase (ALT) ≤ 2.5 times the upper limit of normal value; International normalized ratio (INR) and activated partial thrombin time ≤ 1.5×ULN; Serum creatinine ≤ 1.5×ULN or creatinine clearance (CrCl) ≥ 50 mL/min according to Cockcroft-Gault formula method;
- Fertile female subjects who meet the following conditions
- A serum pregnancy test (minimum sensitivity 25 mIU/mL or equivalent units of β-human chorionic gonadotropin [β-hCG]) must be negative within 72 hours before the first dosing of the study intervention. Subjects with false positive results who are confirmed not to be pregnant are eligible for study.
- Must agree to contraception for the duration of the study and for at least 6 months after the last dose of investigational drug.
- Must agree not to breastfeed or donate eggs from the time of signing the informed consent until 6 months after the last dose of investigational drug.
- If sexually active and likely to result in pregnancy, continuous use of at least 2 acceptable forms of contraception, at least 1 of which must be highly effective from the time of the informed consent and continue until at least 6 months after the last dosing of the investigational drug.
- Fertile male subjects who meet the following conditions
- Must agree not to donate sperm from the time of signing the informed consent until at least 4 months after the last dose of investigational drug.
- If sexual activity with a fertile person is likely to result in pregnancy, continuous use of at least 2 acceptable forms of contraception, at least 1 of which must be highly effective from the time of the informed consent and continue until at least 4 months after the last dosing of the investigational drug.
- If sexually active with a pregnant or breastfeeding patient, condom use must continue from informed consent until at least 4 months after the last dosing of the investigational drug.
- Able to understand trial requirements, willing and able to follow trial and follow-up procedures.
Who cannot join
- Bilateral invasive breast cancer;
- Previous history of invasive breast cancer;
- Previously had carcinoma in situ of the breast and received adjuvant endocrine therapy within 5 years of surgery;
- Use of the investigational drug or major surgery within 4 weeks prior to study dosing;
- Have received or plan to receive live or attenuated vaccine within 4 weeks before the start of study dose;
- Previous history of receiving allogeneic hematopoietic stem cell transplantation or organ transplantation;
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- Previous treatment with PD-(L)1, PD-L2, CTLA4 inhibitors and other Antibody-Drug Conjugates;
- Uncontrolled or significant cardiovascular and cerebrovascular diseases
- Presence of other treatable or serious lung diseases, including but not limited to active tuberculosis, interstitial lung disease, etc.;
- Suffering from an active infection that requires systematic treatment;
- Have active autoimmune diseases requiring systemic treatment within the past 2 years, allowing for relevant replacement therapy;
- Have a clear past or present history of neurological or psychiatric disorders, including epilepsy or dementia;
- Persistent ≥ grade 2 sensory or motor neuropathy;
- In the judgment of the investigator, there is a serious concomitant disease that endangers the safety of the subject or interferes with the completion of the clinical study;
- Positive HIV test result; Patients with active hepatitis B or C; Persistent coronavirus (COVID-19) infection;
- Known hypersensitivity or delayed anaphylaxis to certain components of Disitamab Vedotin, and Toripalimab or Certain components of chemotherapy drugs or similar drugs used in the study;
- Suffering from another malignancy within 5 years prior to signing the informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Jiong Wu
Shanghai, Fudan University Shanghai Cancer Center, 200032
Jiong Wu, Ph.D
About this study
Official title: A Single-arm, Open-label, Multicenter Phase II Clinical Trial to Evaluate the Efficacy and Safety of Disitamab Vedotin Combined With Toripalimab Sequential Chemotherapy as Neoadjuvant Treatment in Patients With HR-positive, HER2-low Breast Cancer
The purpose of this study is to evaluate the efficacy and safety of Disitamab Vedotin combined with Toripalimab sequential chemotherapy as in patients with HR-positive, HER2-low breast cancer
Read the detailed description
This is a single-arm, open-label, multicenter phase II clinical trial to evaluate the efficacy and safety of Disitamab Vedotin combined with Toripalimab sequential chemotherapy as neoadjuvant treatment in patients with HR-positive, HER2-low breast cancer
- Conditions
- Breast Cancer
- Being tested
- Disitamab Vedotin for Injection, Toripalimab, Epirubicin, Cyclophosphamide
- Keywords
- Breast Cancer, HR-positive, HER2 low-expressing
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Disitamab Vedotin for InjectionDrug
Also called RC48
2.0mg/kg, intravenous infusion，D1, every 2 weeks, Every 6 weeks is a treatment cycle. A total of 2 cycles (12 weeks) of treatment are performed
ToripalimabDrug
Also called JS001
3.0 mg/kg, intravenous infusion, D1, every 2 weeks, every 6 weeks is a treatment cycle. A total of 2 cycles (12 weeks) of treatment are performed. Sequential therapy 3.0 mg/kg, intravenous infusion, D1, every 2 weeks,every 6 weeks is a treatment cycle. A total of 2 cycles (12 weeks) of treatment are performed.
EpirubicinDrug
According to body surface area, 90mg/m2, intravenous infusion, D1, every 3 weeks, Every 6 weeks is a treatment cycle. A total of 12 weeks of treatment are performed.
CyclophosphamideDrug
Also called CTX
According to body surface area,600mg/m2, intravenous infusion, D1, every 3 weeks , Every 6 weeks is a treatment cycle. A total of 12 weeks of treatment are performed
| Study group | Role | What they receive |
|---|---|---|
| Disitamab Vedotin combined with Toripalimab sequential chemotherapy（Epirubicin +CTX） | Experimental | Disitamab Vedotin combined with Toripalimab sequential chemotherapy arm Receives: Drug: Disitamab Vedotin for Injection; Drug: Toripalimab; Drug: Epirubicin; Drug: Cyclophosphamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total pathological complete response (tpCR) rate
Defined as the proportion of participants with a pathological assessment of pCR (ypT0/Tis, ypN0) in the analyzed population
Measured: 1month after surgery
Secondary outcomes (10)
Breast pathological complete response（bpCR）
Defined as the proportion of participants with a pathological assessment of bpCR in the analyzed population
Measured: 1 month after surgery
Event free survival (EFS)
The time from random assignment to disease progression, including local progression before surgery; disease recurrence-local, regional, distant, ipsilateral noninvasive, or contralateral (invasive or noninvasive)-or death from any cause
Measured: Up to approximately 3 or 5 years
Disease-free survival (DFS)
From the date of surgery to the first local, regional, contralateral or distant recurrence, and death from any cause including 3- and 5-year event-free survival
Measured: Up to approximately 3 or 5 years
Objective Response Rate (ORR)
Objective response rate.ORR assessed according to the evaluation criteria for the efficacy of solid tumors (RECIST 1.1)
Measured: Baseline to surgery
Adverse events (AEs)
To evaluate safety including adverse event rate and adverse event grade
Measured: Up to approximately 2 months after surgery
Change in cluster of differentiation 8 (CD8)
CD8 in tumor samples by biopsy at baseline and by surgery immediately after surgery would be evaluated by HE or immune staining.
Measured: At baseline to surgery
Health-related quality of life - EORTC-QLQ-C30
Change from baseline in the physical functioning subscale of the European Organisation for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) scores. Scale scores range from 0-100. For functioning and global health status/ QoL scales, higher scores indicate better functioning or global health status/QoL. For symptom scales, higher scores indicate greater symptom burden
Measured: Up to approximately 2 years
Residual cancer burden score
According to the extent of the residual cancer in the primary breast cancer site (mm*mm), the residual cancer (mm*mm), cell density of residual cancer (%), proportion of carcinoma in situ (%), number of positive lymph nodes and maximum diameter of lymph node metastasis (mm), the RCB index and corresponding RCB classification can be obtained. The RCB index and the corresponding RCB grade can be obtained based on the maximum diameter of the cancer (mm).
Measured: 1 month after surgery
Change in tumor-infiltrating lymphocytes (TILs)
Defined as infiltrating lymphocytes isolated from tumor tissue.TILs in tumor samples by biopsy right before the first neoadjuvant therapy (baseline) and by surgery immediately after surgery would be evaluated by HE or immune staining.
Measured: At baseline to surgery
Change in programmed cell death protein L1 (PD-L1)
PD1 in tumor samples by biopsy at baseline and by surgery immediately after surgery would be evaluated by HE or immune staining.
Measured: At baseline to surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2024
- Study start29 Apr 2024
- Primary completion1 Jun 2025 (estimated)
- Study completion31 Dec 2026 (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 RemeGen Co., Ltd.The 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
- 79 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RemeGen Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Leng Kang, Study director, RemeGen Co., Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06389006
- Sponsor's protocol ID
- RC48-C025
- Status last verified
- Apr 2024
- First submitted
- 24 Apr 2024
- Last updated
- 23 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-arm, Open-label, Multicenter Phase II Clinical Trial to Evaluate the Efficacy and Safety of Disitamab Vedotin Combined With Toripalimab Sequential Chemotherapy as Neoadjuvant Treatment in Patients With HR-positive, HER2-low Breast Cancer
- ClinicalTrials.gov ID
- NCT06389006
- Acronym / sponsor ID
- RC48-C025
- Conditions
- Breast Cancer
- Keywords
- Breast Cancer, HR-positive, HER2 low-expressing
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 79 participants (estimated)
- Lead sponsor
- RemeGen Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 29 Apr 2024 (actual)
- Primary completion
- 1 Jun 2025 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 29 Apr 2024 (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.
The purpose of this study is to evaluate the efficacy and safety of Disitamab Vedotin combined with Toripalimab sequential chemotherapy as in patients with HR-positive, HER2-low breast cancer
Detailed description
This is a single-arm, open-label, multicenter phase II clinical trial to evaluate the efficacy and safety of Disitamab Vedotin combined with Toripalimab sequential chemotherapy as neoadjuvant treatment in patients with HR-positive, HER2-low breast cancer
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Disitamab Vedotin combined with Toripalimab sequential chemotherapy（Epirubicin +CTX） | Experimental | Drug: Disitamab Vedotin for Injection, Drug: Toripalimab, Drug: Epirubicin, Drug: CyclophosphamideDisitamab Vedotin combined with Toripalimab sequential chemotherapy arm |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (24 listed)
- Voluntarily agree to participate in the study and sign the informed consent;
- Age ≥18 years old (including the threshold value);
- Histologically confirmed invasive breast cancer with clinical stage T1c-T2(≥2cm)cN1-2M0 or T3cN0-2M0;
- As assessed by the research Center, the subjects can tolerate and plan to undergo radical surgery for breast cancer and have not previously received any anti-tumor systemic therapy for breast cancer;
- Invasive breast tumor tissue with low HER2 expression confirmed by the central laboratory is defined as IHC 1+ or IHC 2+ expression of HER2 protein detected by immunohistochemistry (IHC), and no amplification detected by in situ hybridization (ISH) (according to the Breast Cancer HER2 Detection Guidelines 2019); Primary tumor specimens (wax pieces, slices or fresh tissues) can be provided for HER2 detection;
Key exclusion criteria (17 listed)
- Bilateral invasive breast cancer;
- Previous history of invasive breast cancer;
- Previously had carcinoma in situ of the breast and received adjuvant endocrine therapy within 5 years of surgery;
- Use of the investigational drug or major surgery within 4 weeks prior to study dosing;
- Have received or plan to receive live or attenuated vaccine within 4 weeks before the start of study dose;
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 |
|---|---|---|
| Disitamab Vedotin for InjectionAlso: RC482.0mg/kg, intravenous infusion，D1, every 2 weeks, Every 6 weeks is a treatment cycle. A total of 2 cycles (12 weeks) of treatment are performed | Drug | Disitamab Vedotin combined with Toripalimab sequential chemotherapy（Epirubicin +CTX） |
| ToripalimabAlso: JS0013.0 mg/kg, intravenous infusion, D1, every 2 weeks, every 6 weeks is a treatment cycle. A total of 2 cycles (12 weeks) of treatment are performed. Sequential therapy 3.0 mg/kg, intravenous infusion, D1, every 2 weeks,every 6 weeks is a treatment cycle. A total of 2 cycles (12 weeks) of treatment are performed. | Drug | Disitamab Vedotin combined with Toripalimab sequential chemotherapy（Epirubicin +CTX） |
| EpirubicinAccording to body surface area, 90mg/m2, intravenous infusion, D1, every 3 weeks, Every 6 weeks is a treatment cycle. A total of 12 weeks of treatment are performed. | Drug | Disitamab Vedotin combined with Toripalimab sequential chemotherapy（Epirubicin +CTX） |
| CyclophosphamideAlso: CTXAccording to body surface area,600mg/m2, intravenous infusion, D1, every 3 weeks , Every 6 weeks is a treatment cycle. A total of 12 weeks of treatment are performed | Drug | Disitamab Vedotin combined with Toripalimab sequential chemotherapy（Epirubicin +CTX） |
Primary outcome
Total pathological complete response (tpCR) rate
Time frame: 1month after surgery
Defined as the proportion of participants with a pathological assessment of pCR (ypT0/Tis, ypN0) in the analyzed population
10 secondary outcomes
Breast pathological complete response（bpCR）
Time frame: 1 month after surgery
Event free survival (EFS)
Time frame: Up to approximately 3 or 5 years
Disease-free survival (DFS)
Time frame: Up to approximately 3 or 5 years
Objective Response Rate (ORR)
Time frame: Baseline to surgery
Adverse events (AEs)
Time frame: Up to approximately 2 months after surgery
Change in cluster of differentiation 8 (CD8)
Time frame: At baseline to surgery
Health-related quality of life - EORTC-QLQ-C30
Time frame: Up to approximately 2 years
Residual cancer burden score
Time frame: 1 month after surgery
Change in tumor-infiltrating lymphocytes (TILs)
Time frame: At baseline to surgery
Change in programmed cell death protein L1 (PD-L1)
Time frame: At baseline to surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2024.
- Individual participant dataSharing planned: No
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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.
Leng Kang study director
RemeGen Co., Ltd.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Disitamab Vedotin for Injection, Toripalimab and Epirubicin in people with Breast Cancer, run by RemeGen Co., Ltd. at 1 site 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 24 inclusion and 17 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: looking for participants now, as of the sponsor's last update on 23 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Leng Kang (+8610-58075763, kang.leng@remegen.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total pathological complete response (tpCR) rate (time frame: 1month 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 23 May 2024.