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

An Exploratory Clinical Study of CDK4/6 Inhibitor Dalpiciclib Combined With Letrozole in Neoadjuvant Treatment of Stage Ⅱ-Ⅲ HR-positive/HER2-negative Breast Cancer

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

Study Overview

• Status: Not yet recruiting
• Conditions: Solid Tumor
• Intervention / Treatment: Drug: Dalpiciclib

Detailed Description

This is a single-arm, open-label, exploratory clinical study initiated by the investigator to evaluate the objective response rate (ORR), efficacy, and safety of Dalpiciclib combined with letrozole in the neoadjuvant treatment of stage Ⅱ-Ⅲ HR+/HER2- breast cancer.

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dalpiciclib+ letrozole; Dalpiciclib combined with Letrozole,28 days as one cycle.; Dalpiciclib: 150 mg (p.o.) was given once daily for 3 weeks, followed by 1 week off in each 4-week cycle.; Letrozole: 2.5mg, p.o., once a day, continuous administration.	Drug: Dalpiciclib; An exploratory study of a single-arm, open design All subjects enrolled will receive the following treatment: Dalpiciclib combined with Letrozole, 28 days as one cycle.; Other Names: Letrozole

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ORR	Objective response rate	24 month

Collaborators and Investigators

• Sponsor: Hebei Medical University Fourth Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): September 10, 2022
• Primary Completion (Anticipated): August 10, 2023
• Study Completion (Anticipated): August 10, 2024

Study Registration Dates

• First Submitted: August 22, 2022
• First Submitted That Met QC Criteria: August 22, 2022
• First Posted (Actual): August 23, 2022

Study Record Updates

• Last Update Posted (Actual): August 23, 2022
• Last Update Submitted That Met QC Criteria: August 22, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Hormones, Hormone Substitutes, and Hormone Antagonists; Hormone Antagonists; Aromatase Inhibitors; Steroid Synthesis Inhibitors; Estrogen Antagonists; Letrozole
• Other Study ID Numbers: 2022037

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No