A retrospective chart review study of trastuzumab deruxtecan treatment for HER2-positive breast cancer with brain metastases

Conditions

HER2-positive breast cancer with brain metastases

Takashi Yamanaka, Naoki Niikura, Takahiro Nakayama, M. Yamamoto, Kazuo Matsuura et al. (20 authors)

Cancer Research2024-05-021 citations

Treatment with trastuzumab deruxtecan in patients with HER2-positive breast cancer and brain metastases and/or leptomeningeal disease (ROSET-BM)

Naoki Niikura, Takashi Yamanaka, Hironori Nomura, Kazuhiro Shiraishi, Hiroki Kusama et al. (20 authors)

npj Breast Cancer2023-10-1159 citations

10.1038/s41523-023-00584-5

Abstract PD7-01: Trastuzumab deruxtecan for the treatment of patients with HER2-positive breast cancer with brain and/or leptomeningeal metastases: A multicenter retrospective study (ROSET-BM study)

Takashi Yamanaka, Naoki Niikura, Hironori Nomura, Hiroki Kusama, M. Yamamoto et al. (20 authors)

Cancer Research2023-03-019 citations

10.1158/1538-7445.sabcs22-pd7-01

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Patients who were 20 or older at the beginning of T-DXd treatment 2) Patients diagnosed pathologically with HER2 positive breast cancer 3) Patients with brain metastases (including stable brain metastases after local treatment, brain metastases before local treatment,and symptomatic brain metastases) 4) Patients who received T-DXd between 25-May-2020 and 30-April-2021 for HER2 positive breast cancer

Exclusion criteria

Exclusion criteria: 1) Patients who expressed not to participate in the study prior to data fixation 2) Patients who have received T-DXd supplied in clinical trials

Design outcomes

Primary

Measure	Time frame
Analysis for the whole population 1) TTF 2) PFS 3) ORR based on investigator assessment 4) OS 5) Time to Deterioration of CNS metastasis-related symptoms Analysis for the population with imaging data of brain lesions 1) IC-ORR 2) IC-PFS 3) Time to CNS progression 4) IC-DOR 5) IC-CBR Evaluated according to RECIST1.1. Evaluated by central review (brain). Items for survival evaluation at follow-up period Analysis for the whole population 1) TTF 2) PFS 3) OS 4) Time to Deterioration of CNS metastasis-related symptoms	—

Measure

Time frame

Analysis for the whole population 1) TTF 2) PFS 3) ORR based on investigator assessment 4) OS 5) Time to Deterioration of CNS metastasis-related symptoms Analysis for the population with imaging data of brain lesions 1) IC-ORR 2) IC-PFS 3) Time to CNS progression 4) IC-DOR 5) IC-CBR Evaluated according to RECIST1.1. Evaluated by central review (brain). Items for survival evaluation at follow-up period Analysis for the whole population 1) TTF 2) PFS 3) OS 4) Time to Deterioration of CNS metastasis-related symptoms

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Countries

Japan

Contacts

Public ContactKosaku Fujiwara

Daiichi Sankyo Co., Ltd Oncology Medical Science Department

izutani.tadahiro.sa@daiichisankyo.co.jp03-6225-1186

Outcome results