Overview

Dalpiciclib Combined With Letrozole in Neoadjuvant Treatment of Stage Ⅱ-Ⅲ HR-positive/HER2-negative Breast Cancer

Status:
Not yet recruiting

Trial end date:
2024-08-10

Target enrollment:
0

Participant gender:
Female

Summary

This is a single-arm, open-label, exploratory clinical study

Phase:

Phase 2

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Hebei Medical University Fourth Hospital

Treatments:

Letrozole

Criteria

Inclusion Criteria:

- 1. Postmenopausal women aged ≥18 years, the definition of postmenopausal:

1. the patients with the history of bilateral oophorectomy, or age ≥ 60 years; or

2. Age <60, natural postmenopausal state (defined as the spontaneous cessation of
regular menstruation for at least 12 consecutive months, without other
pathological or physiological causes), E2 and FSH at the postmenopausal levels 2.
All patients were estrogen receptor (ER) positive (>10%), HER2 -negative invasive
breast cancer regardless of PR expression level. Immunohistochemistry (IHC) score
of 0+, or 2+ confirmed by pathology laboratory and negative in situ hybridization
(ISH) test (HER-2/CEP17 ratio <2.0); 3. Treatment-naive patients with stage Ⅱ-Ⅲ
tumors whose tumor staging meets the criteria of the 8th edition of the American
Joint Committee on Cancer (AJCC) Staging;

Exclusion Criteria:

- 1. Received any form of anti-tumor therapy (chemotherapy, radiotherapy, molecular
targeted therapy, endocrine therapy, etc.) 2. Concurrently receiving any other
anti-tumor therapy that those specified in the protocol; 3. Bilateral breast cancer,
inflammatory breast cancer, or occult breast cancer; 4. Stage Ⅳ breast cancer;