A multicenter observational study to explore risk factors for early recurrence in patients with hormone receptor-positive HER2-negative early breast cancer(WJOG15721B)

A multicenter observational study to explore risk factors for early recurrence in patients with hormone receptor-positive HER2-negative early breast cancer(WJOG15721B) - RealisE

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000047049

Enrollment

3000

Registered

2022-03-01

Start date

2022-06-24

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

Hormone receptor positive and HER2 negative early breast cancer

Interventions

None listed

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 1) Female>=20 years of age at the time of diagnosis of breast cancer. 2) The patient is histologically diagnosed with invasive breast cancer 3) The patient has confirmed ER positive or PgR positive breast cancer. 4) The patient has confirmed HER2 negative breast cancer. 5) The patient must have undergone surgery as initial treatment for clinical Stage II-III, hormone receptor positive (HR) positive, HER2 negative breast cancer. It does not matter whether the patient has received neoadjuvant chemotherapy or adjuvant chemotherapy. 6) The patient has started postoperative endocrine therapy between January 1, 2012, and January 1, 2017. Any duration of postoperative endocrine therapy administration is acceptable.

Exclusion criteria

Exclusion criteria: 1)Patients judged to be inappropriate for inclusion by the physician.

Design outcomes

Primary

Measure	Time frame
3-year invasive disease-free survival (IDFS) rate	—

Secondary

Measure	Time frame
IDFS, overall survival, 3-year distant recurrence free survival (DRFS) rate, DRFS	—

Countries

Japan

Contacts

Public ContactNakamura Shinichiro

West Japan Oncology Group WJOG datacenter

datacenter@wjog.jp06-6633-7400

Outcome results