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This study will evaluate the safety and efficacy of neoadjuvant trastuzumab, pertuzumab and chemotherapy chosen by the investigators and identify the molecular characterization and subtypes in human epidermal growth factor receptor 2 (HER2)-positive breast cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Trastuzumab+Pertuzumab+Chemotherapy | Experimental | Participants will be administered at least 4-6 cycles of neoadjuvant pertuzumab plus trastuzumab -containing regimens chosen by the investigators prior to surgery. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Trastuzumab | Drug | Trastuzumab (8 mg/kg loading dose, followed by 6 mg/kg every 3 weeks) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Total pathological complete response (tpCR) rate | The pathological complete response rate described as the absence of invasive tumor cells in the breast and ipsilateral axillary lymph nodes upon microscopic examination following | At surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) | ORR defined as the percentage of participants with a confirmed complete response (CR) or partial response (PR) based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. | Before surgery |
| Breast pathological complete response (bPCR) rate |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Linlin Wang, PhD, MD | Contact | +86 13793187739 | wanglinlinatjn@163.com | |
| Jinming Yu, PhD, MD | Contact | +86 13806406293 | jn7984729@public.jn.sd.cn |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D000068878 | Trastuzumab |
| D036881 | Long-Term Synaptic Depression |
| C485206 | pertuzumab |
| D004358 | Drug Therapy |
| D008408 | Mastectomy |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| Pertuzumab | Drug | Pertuzumab (loading dose 840 mg, followed by 420 mg every 3 weeks) |
|
|
| Chemotherapy | Drug | Chemotherapy chosen by the investigators. |
|
| Excision of tumor/mastectomy | Procedure | Definitive breast cancer surgery (excision or mastectomy) marks the end of protocol mandated therapy. |
|
It is defined as no invasive tumor cells in the breast examined by microscopy after primary tumor resection (ypT0/is). |
| At surgery |
| Number of participants with adverse events (AEs) | Assessment of the toxicity profile of regimen according to the National Cancer Institute Common Toxicity Criteria version 5.0 (NCI CTCAE v 5.0). | Assessed every 2 cycles of neoadjuvant therapy prior to surgery, up to approximately 30 days after the last neoadjuvant treatment. |
| Identification of HER2-Positive Breast Cancer Molecular Characterization and Subtypes. | Tumor tissue samples are analyzed by gene expression analysis and genome sequencing to classify novel subtypes and compare the molecular characteristics with patients' clinical data. | Up to approximately 2 years from study enrollment |
| D017437 |
| Skin and Connective Tissue Diseases |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D009473 | Neuronal Plasticity |
| D009424 | Nervous System Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
| D013812 | Therapeutics |
| D013514 | Surgical Procedures, Operative |