Cohort Study to Evaluate the Efficacy and Safety of Postoperative Adjuvant Therapy in HER2 Positive Elderly Breast Cancer Patients with Muti-gene assay

Cohort Study to Evaluate the Efficacy and Safety of Postoperative Adjuvant Therapy in HER2 Positive Elderly Breast Cancer Patients with Muti-gene assay - N-SAS BC07 biomarker study (Trans-RESPECT)

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000051581

Enrollment

266

Registered

2023-08-01

Start date

2023-06-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HER2 Positive Elderly Breast Cancer Patients

Interventions

None listed

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 1) FAS of the N-SAS BC 07 RCT for the period October 2009 to November 2014 2) Consent to participate in the study has been obtained from the patients themselves via a consent form

Exclusion criteria

Exclusion criteria: Patient's physician determines that the patient is inappropriate to participate in this clinical trial

Design outcomes

Primary

Measure	Time frame
Recurrence-free survival in the trastuzumab monotherapy group	—

Secondary

Measure	Time frame
Overall Survival, Disease-Free Survival, Breast cancer-specific survival, RFS for trastuzumab alone and in combination with chemotherapy	—

Countries

Japan

Contacts

Public ContactKazuki Nozawa

Aichi Cancer Center Hospital Department of Breast Oncology

k.nozawa@aichi-cc.jp0527626111

Outcome results