A multicenter cohort study to build better breast cancer care and consensus based on the real world evidence (KBCSG-TR 1316)

A multicenter cohort study to build better breast cancer care and consensus based on the real world evidence (KBCSG-TR 1316) - Building RWE in Breast Cancer Practice (KBCSG-TR1316)

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000049957

Enrollment

3000

Registered

2023-01-03

Start date

2021-02-01

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

Breast cancer

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1) Patients must be treated at a facility certified by the Japanese Breast Cancer Society where a Japanese Breast Cancer Society-certified specialist physician works. (2) Patients whose initial treatment started on or after January 1, 2000 (3) Patients must have a histopathological diagnosis of primary breast cancer. (4) 20 years of age or older (5) No disagreement with the use of data in this observational study. Participating facilities will post a summary of the study on their websites and in outpatient consultation rooms to inform eligible patients (opt-out). All cases from participating facilities that meet the above eligibility criteria will be compiled into a database without arbitrary exclusion (consecutive cases). From the database, more detailed subjects will be selected according to each theme, which will be defined in the analysis plan.

Exclusion criteria

Exclusion criteria: None stipulated

Design outcomes

Primary

Measure	Time frame
Within the scope of clinical, pathological, and imaging data that can be examined based on the clinical data, pathological data, and imaging data that can be collected from medical record information, themes requiring resolution in breast cancer treatment will be established, and primary and secondary endpoints will be established for each theme. (1) Significance of pCR in preoperative chemotherapy (2) Axillary lymph node management (3) Prediction of late recurrence in luminal subtype (4) Treatment of breast cancer in young patients and significance of LH-RH agonist in premenopausal breast cancer (5) Treatment algorithm in advanced recurrent breast cancer (6) Rare disease database construction (7) Investigation of the optimal timing of PMRT in breast reconstruction (8) Prediction of appropriate surgical procedures in patients undergoing preoperative chemotherapy (9) Significance of tumor markers (10) Exploring the relationship between breast cancer pharmacotherapy and the cancer immune microenvironment	—

Measure

Time frame

Within the scope of clinical, pathological, and imaging data that can be examined based on the clinical data, pathological data, and imaging data that can be collected from medical record information, themes requiring resolution in breast cancer treatment will be established, and primary and secondary endpoints will be established for each theme. (1) Significance of pCR in preoperative chemotherapy (2) Axillary lymph node management (3) Prediction of late recurrence in luminal subtype (4) Treatment of breast cancer in young patients and significance of LH-RH agonist in premenopausal breast cancer (5) Treatment algorithm in advanced recurrent breast cancer (6) Rare disease database construction (7) Investigation of the optimal timing of PMRT in breast reconstruction (8) Prediction of appropriate surgical procedures in patients undergoing preoperative chemotherapy (9) Significance of tumor markers (10) Exploring the relationship between breast cancer pharmacotherapy and the cancer immune microenvironment

—

Countries

Japan

Contacts

Public ContactTakahiro Nakayama

KBCSG-TR Representative

taqnakayama@hotmail.com06-6972-1181

Outcome results