The efficacy and safety of 21-gene assay (Oncotype DX) in neoadjuvant endocrine therapy for postmenopausal breast cancer, single-arm phase II study.

Status

Recruiting

Phases

Phase 2

Study type

Observational

Source

JPRN

Registry ID

JPRN-jRCT1032230536

Enrollment

Registered

2023-12-25

Start date

2023-12-25

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 Hormone receptor positive breast cancer, Neoadjuvant endocrine therapy, Oncotype DX

Interventions

None listed

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 1. Women with untreated invasive and hormone receptor positive and HER2 negative breast cancer 2. Postmenopausal state 3. Can be written informed consent

Exclusion criteria

Exclusion criteria: 1. BRCA1/2 variant 2. Allergy of hormone therapy or contrast agent

Design outcomes

Primary

Measure	Time frame
The response rate of RECIST The side effect rate of CTCAE	—

Secondary

Measure	Time frame
The rate of pathological complete response (ypT0 and Tis) The rate of breast conserving surgery PEPI score	—

Contacts

Public ContactHiroyuki Takei

Nippon Medical School Hospital

takei-hiroyuki@nms.ac.jp+81-3-3822-2131

Outcome results