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

JRCT ID: jRCT1032230536

Registered date:25/12/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Breast Cancer
• Date of first enrollment: 25/12/2023
• Target sample size: 26
• Study type: Observational

Outcome(s)

Primary Outcome

The response rate of RECIST
The side effect rate of CTCAE

Secondary Outcome

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

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Female

Include criteria

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

Exclude criteria

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

Related Information

• Primary Sponsor: Takei Hiroyuki