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Trial Title:
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
NCT ID:
NCT06389006
Condition:
Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Cyclophosphamide
Epirubicin
Disitamab vedotin
Conditions: Keywords:
Breast Cancer
HR-positive
HER2 low-expressing
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Disitamab Vedotin for Injection
Description:
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
Arm group label:
Disitamab Vedotin combined with Toripalimab sequential chemotherapy（Epirubicin +CTX）
Other name:
RC48
Intervention type:
Drug
Intervention name:
Toripalimab
Description:
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.
Arm group label:
Disitamab Vedotin combined with Toripalimab sequential chemotherapy（Epirubicin +CTX）
Other name:
JS001
Intervention type:
Drug
Intervention name:
Epirubicin
Description:
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.
Arm group label:
Disitamab Vedotin combined with Toripalimab sequential chemotherapy（Epirubicin +CTX）
Intervention type:
Drug
Intervention name:
Cyclophosphamide
Description:
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
Arm group label:
Disitamab Vedotin combined with Toripalimab sequential chemotherapy（Epirubicin +CTX）
Other name:
CTX
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
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
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Voluntarily agree to participate in the study and sign the informed consent;
2. Age ≥18 years old (including the threshold value);
3. Histologically confirmed invasive breast cancer with clinical stage
T1c-T2(≥2cm)cN1-2M0 or T3cN0-2M0;
4. 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;
5. 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;
6. 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%;
7. Histological grade (Nottingham grading system) G3 or G2 with ER expression
8. ECOG physical status 0 or 1;
9. At least one measurable lesion according to RECIST v1.1 standard;
10. Heart function:
1. New York Heart Association (NYHA) Grade < 3;
2. left ventricular ejection fraction ≥50%;
11. 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;
12. Fertile female subjects who meet the following conditions
1. 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.
2. Must agree to contraception for the duration of the study and for at least 6
months after the last dose of investigational drug.
3. 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.
4. 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.
13. Fertile male subjects who meet the following conditions
1. 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.
2. 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.
3. 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.
14. Able to understand trial requirements, willing and able to follow trial and
follow-up procedures.
Exclusion Criteria:
1. Bilateral invasive breast cancer;
2. Previous history of invasive breast cancer;
3. Previously had carcinoma in situ of the breast and received adjuvant endocrine
therapy within 5 years of surgery;
4. Use of the investigational drug or major surgery within 4 weeks prior to study
dosing;
5. Have received or plan to receive live or attenuated vaccine within 4 weeks before
the start of study dose;
6. Previous history of receiving allogeneic hematopoietic stem cell transplantation or
organ transplantation;
7. Previous treatment with PD-(L)1, PD-L2, CTLA4 inhibitors and other Antibody-Drug
Conjugates;
8. Uncontrolled or significant cardiovascular and cerebrovascular diseases
9. Presence of other treatable or serious lung diseases, including but not limited to
active tuberculosis, interstitial lung disease, etc.;
10. Suffering from an active infection that requires systematic treatment;
11. Have active autoimmune diseases requiring systemic treatment within the past 2
years, allowing for relevant replacement therapy;
12. Have a clear past or present history of neurological or psychiatric disorders,
including epilepsy or dementia;
13. Persistent ≥ grade 2 sensory or motor neuropathy;
14. 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;
15. Positive HIV test result; Patients with active hepatitis B or C; Persistent
coronavirus (COVID-19) infection;
16. 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;
17. Suffering from another malignancy within 5 years prior to signing the informed
consent
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Jiong Wu
Address:
City:
Shanghai
Zip:
200032
Country:
China
Status:
Recruiting
Contact:
Last name:
Jiong Wu, Ph.D
Start date:
April 29, 2024
Completion date:
December 31, 2026
Lead sponsor:
Agency:
RemeGen Co., Ltd.
Agency class:
Industry
Source:
RemeGen Co., Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06389006
