HER2-negative or HER2-low unresectable or recurrent breast cancer
Conditions
Interventions
None listed
Sponsors
Eisai Co.,Ltd.
Japan Breast Cancer Research Group (JBCRG)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients who are confirmed to be HER2 positive or HER2 low by a primary physician in accordance with the American Society of Clinical Oncology/College of American Pathologists guidelines. 2) Patients who have given their consent to participate in this study. However, if it is difficult to explain and give consent, they have not declined the use of their clinical information in the public announcement of the study contents. 3) Patients aged 18 years or older at the time of tumor tissue collection (metastatic/recurrent stage) 4) Patients have a history of T-DXd treatment as second to fourth line chemotherapy for unresectable or recurrent breast cancer. 5) T-DXd treatment meets the criteria for either early progression or efficacy. < the criteria of early progression or effective cases (T-DXd treatment period and response)> 1. HER2 positive/early progression; 2nd line therapy: less than 9M, 3rd line therapy: less than 6M, 4th line therapy: less than 6M 2. HER2 positive/effective; 2nd line therapy: more than 20M or complete response (CR), 3rd line therapy: more than 11M or CR, 4th line therapy: more than 11M or CR 3. HER2 low expression/early progression; 2nd line therapy: less than 4M, 3rd line therapy: less than 4M, 4th line therapy: less than 4M 4. HER2 low expression /effective; 2nd line therapy: more than 10M or complete response (CR), 3rd line therapy: more than 10M or CR, 4th line therapy: more than 10M or CR 6) Patients must have archived tumor tissue samples from the metastatic/recurrent stage (at the time of diagnosis of unresectable or metastatic breast cancer or later) and before T-DXd treatment. However, for early progression cases, patients who only have samples from after progression of T-DXd treatment are also eligible. At the National Cancer Center Hospital, samples from which comprehensive consent has been obtained will be used.
Exclusion criteria
Exclusion criteria: 1) Patients in which treatment was discontinued within the early progression criteria due to adverse events during T-DXd treatment 2) Patients who were treated T-DXd for reasons other than disease progression in effective groups 3) Patients who could not consent to the secondary use of information obtained in this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1) HER2 expression status 2) Exploration of factors related to T-DXd efficacy | — |
Countries
Japan
Contacts
Public ContactTatsunori Shimoi
National Cancer Center Hospital Department of Medical Oncology
Outcome results
None listed