Exploratory prospective clinical study on predictors of efficacy of immune checkpoint inhibitors and immune-related adverse events in early-stage breast cancer

Exploratory prospective clinical study on predictors of efficacy of immune checkpoint inhibitors and immune-related adverse events in early-stage breast cancer - Exploratory prospective clinical study on predictors of efficacy of immune checkpoint inhibitors and immune-related adverse events in early-stage breast cancer

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000050985

Enrollment

Registered

2023-05-10

Start date

2023-04-25

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

Breast cancer

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1)Patients who are pathologically diagnosed with invasive breast cancer and are scheduled for Neoadjubant chemotherapy. 2) ER-negative, PgR-negative, and HER2-negative by histopathological examination. 3)Patients who gave written informed consent to participate in this study.

Exclusion criteria

Exclusion criteria: 2) Patients who have not given consent to this study 3) Patients who also have other malignant tumors 4) Bilateral breast cancer 5) history of malignant tumor

Design outcomes

Primary

Measure	Time frame
To verify whether it is possible to predict the pCR and irAE of ICI combination therapy from microbiome in early-stage TNBC.	—

Secondary

Measure	Time frame
Presence or absence of changes in intestinal flora due to ICI administration Relationship between microbiome and IOscore	—

Countries

Japan

Contacts

Public ContactSayuka Nakayama

showa university Department of Surgery, Division of Breast surgical oncology

osau0310@gmail.com03-3784-8000

Outcome results