Validation study of the prognostic and predictive value of TP53 signature for breast cancer

Not Applicable

• Conditions: Breast Cancer

• Registration Number: JPRN-UMIN000037505
• Lead Sponsor: Japan Agency for Medical Research and Development

Brief Summary

A total of 800 specimens were collected from 23 sites in Japan, and TP53 signature data were obtained for a total of 753 cases, excluding insufficient specimen cases (wild-type (wt) 361 cases and mutant (mt) 392 cases).In a preoperative chemotherapy cohort, the pCR ratio in the mt group was significantly higher than that of wt group (the estimate of the common odds ratio of the mt group for the wt group: 5.599, 95% CI: 1.876-16.705, p=0.0008).

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-09-18
• Study Completion: 2021-03-31
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: Female
• Target Recruitment: 800

Inclusion Criteria

Not provided

Exclusion Criteria

1. Male 2. Cases judged by investigator to be unfit to be enrolled into the study

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pathological complete response rate