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The goal of this clinical trial is to evaluate the efficacy and safety of SHR-A1811 plus pertuzumab in combination with or without albumin-paclitaxel neoadjuvant therapy for early or locally advanced HER2-positive breast cancer. The main questions it aims to answer are:
Subjects will be randomly assigned 1:1:1 to:
There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic and may require frequent medical assessments, blood tests, questionnaires, and scans.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1:SHR-A1811+Pertuzumab | Experimental | Participants will receive SHR-A1811+Pertuzumab for 6 cycles. |
|
| Cohort 2:SHR-A1811+Pertuzumab+Albumin-Paclitaxel | Experimental | Participants will receive SHR-A1811+Pertuzumab+Albumin-Paclitaxel for 6 cycles. |
|
| Cohort 3:TCbHP | Active Comparator | Participants will receive Docetaxel +Carboplatin +Trastuzumab +Pertuzumab for 6 cycles. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHR-A1811 | Drug | an anti-HER2 antibody-drug conjugate (ADC) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pathological complete response rate (pCR rate) | After neoadjuvant chemotherapy and surgery, the resected specimen (breast + axilla) was free of any invasive cancer (ie, ypT0/is, ypN0) | After surgery(within 1 month) |
| Measure | Description | Time Frame |
|---|---|---|
| Invasive Disease Free Survival of 5 years | 5-year Invasive Disease-Free Survival was defined as patients who did not experience regional, contralateral or distant recurrence, or dies during a follow-up period of at least 5 years from the date of surgery. | 5-year |
| Event-Free Survival of 5 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhenzhen Liu | Contact | 86+13603862755 | liuzhenzhen73@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Zhenzhen Liu | Henan Cancer Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Henan Cancer Hospital | Recruiting | Zhengzhou | Henan | China |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D000095384 | Pathologic Complete Response |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| C485206 | pertuzumab |
| D000077143 | Docetaxel |
| D016190 | Carboplatin |
| D000068878 | Trastuzumab |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
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Patients who meet the inclusion criteria were randomly divided into SHR-A1811+pertuzumab and SHR-A1811+pertuzumab+albumin-paclitaxel and TCbHP group in a 1:1:1 ratio.
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| Pertuzumab | Drug | Pertuzumab |
|
| Albumin-Paclitaxel | Drug | Nab paclitaxel |
|
| Docetaxel | Drug | Docetaxel |
|
| Carboplatin | Drug | Carboplatin |
|
| Trastuzumab | Drug | Trastuzumab |
|
5-year Event-Free Survival was defined as patients who did not experience disease progression during neoadjuvant therapy, local or distant recurrence, second primary malignancy (breast or other cancer), or dies during a follow-up period of at least 5 years after treatment. |
| 5-year |
| Objective Response Rate (ORR) | ORR is the proportion of patients whose tumors have shrunk significantly over the course of treatment. Specifically, ORR includes both partial response (PR) and complete response (CR). Partial response (PR) : The maximum diameter or volume of the tumor is reduced by at least 30%, but it does not completely disappear. Complete response (CR) : The tumor disappears completely and no visible signs of cancer are confirmed by imaging tests, such as CT scans, MRI, or ultrasound. | During neoadjuvant therapy before surgery(within 6 months) |
| Adverse Events rate | Evaluate the nature, incidence and severity of chemotherapy adverse events according to CTCAE 5.0 | 2-year |
| D017437 |
| Skin and Connective Tissue Diseases |
| D018450 | Disease Progression |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D056831 | Coordination Complexes |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |