Dalpiciclib in Combination With Exemestane and Trastuzumab Plus Pyrotinib in Early Triple Positive Breast Cancer

Phase II Open-label, Multicentre, Exploratory Trial of Neoadjuvant Dalpiciclib in Combination With Exemestane and Trastuzumab Plus Pyrotinib in Early Triple Positive Breast Cancer

This is a phase II open-label, multicenter trial assessing the efficacy of combination regimen"Dalpiciclib plus Exemestane plus trastuzumab plus pyrotinib"in early triple positive breast cancer patients.

Study Overview

• Status: Recruiting
• Conditions: Breast Cancer; HER2-positive Breast Cancer; Estrogen Receptor Positive Tumor
• Intervention / Treatment: Drug: Trastuzumab Pyrotinib Exemestane Dalpiciclib

Detailed Description

This is a phase II open-label, multicenter trial. The study assesses the treatment of patients with ER-positive /HER2 positive early breast cancer with neoadjuvant Dalpiciclib in Combination With Exemestane and Trastuzumab plus Pyrotinib. Patients were treated with intravenous trastuzumab (8 mg/kg loading dose followed by 6 mg/kg, Q3W) for six cycles plus oral Dalpiciclib (125 mg QD x 21，Q4W) and Exemestane (25 mg po QD ）and oral pyrotinib (320 mg po QD) for 20 weeks. The primary endpoints was pathological complete response.

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

Contacts and Locations

• Study Contact: Name: Luyan Chen, Doctor; Phone Number: 13616522657; Email: yan.luo.yl5@hengrui.com
• Study Contact Backup: Name: Luyan Chen, Doctor

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China
      • Recruiting
      • The First Affiliated Hospital, Zhejiang University School of Medicine
      • Contact: Jiaqi Jiang; Phone Number: 15056602195

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:

• 18 Years to 75 Years
• Newly diagnosed clinical stage II or III ER+/HER2+ breast cancer, staging criteria is to be based on AJCC 7.
• Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
• Primary tumor must have positive estrogen receptor (ER) ≥10%
• Primary tumor must be HER2-positive (IHC 3+ or FISH/CISH amplification)
• Baseline LVEF ≥50% measured by Echocardiography (preferred) or MUGA scan
• Normal organ and marrow function
• Written Informed Consent (IC) must be signed and dated by the patient and the Investigator prior to randomization.
• Baseline corrected QT interval (QTcF) < 480 ms
• All patients must be female.

Exclusion Criteria:

• Inflammatory breast cancer
• Evidence of bilateral invasive breast cancer or metastatic disease
• Received any prior treatment for primary invasive breast cancer
• Pregnant or lactating women
• Abnormal baseline hematological values:
• Abnormal baseline liver function, bilirubin, creatinine and/or INR (international normalized ratio)
• Subjects with known infection with HIV, HBV, HCV
• Other investigational drugs while on study
• Severe or uncontrolled hypertension, history of congestive heart failure or severe coronary arterial disease.
• Subjects assessed by the investigator to be unable or unwilling to comply with the requirements of the protocol

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 in combination with exemestane and trastuzumab plus pyrotinib; Patients are treated with intravenous trastuzumab (8 mg/kg loading dose followed by 6 mg/kg, Q3W) for six cycles plus oral Dalpiciclib (125 mg QD x 21，Q4W) and Exemestane (25 mg po QD ）and oral pyrotinib (320 mg po QD) for 20 weeks.	Drug: Trastuzumab Pyrotinib Exemestane Dalpiciclib; Early triple positive breast cancer patients receive combination regimen of Dalpiciclib in Combination With Exemestane and Trastuzumab plus pyrotinib; Other Names: Herceptin Pyrotinib Aromasin Dalpiciclib

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
pathological complete response (pCR)	Assess the rate of pathological complete response (pCR) defined as ypT0-ypTis ypN0 at surgery	at surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Serial measures of Ki67	Changes in Ki67 scores from baseline before therapy, 2 weeks after and then at surgery	baseline before therapy, 2 weeks after and at surgery
Objective response	Defined as the number of patients with partial or complete response according to RECIST 1.1	Tumour assessments will be performed by ultrasound and mammography at screening (prior to start of treatment), and before surgery, an expected average of 24 weeks

Collaborators and Investigators

• Sponsor: First Affiliated Hospital of Zhejiang University
• Investigators: Principal Investigator: Peifen Fu, Doctor, Zhejiang University

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2022
• Primary Completion (Anticipated): December 1, 2024
• Study Completion (Anticipated): December 1, 2024

Study Registration Dates

• First Submitted: July 27, 2021
• First Submitted That Met QC Criteria: August 1, 2021
• First Posted (Actual): August 10, 2021

Study Record Updates

• Last Update Posted (Estimate): February 20, 2023
• Last Update Submitted That Met QC Criteria: February 16, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Immunological; Hormone Antagonists; Aromatase Inhibitors; Steroid Synthesis Inhibitors; Estrogen Antagonists; Trastuzumab; Exemestane
• Other Study ID Numbers: ZYYY-BC-001

Drug and device information, study documents

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