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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04997798
• Other study ID #: ZYYY-BC-001
• Status: Recruiting
• Phase: Phase 2
• Start date: September 1, 2022
• Est. completion date: December 2024

Study information

• Verified date: February 2023
• Source: First Affiliated Hospital of Zhejiang University
• Contact: Luyan Chen, Doctor
• Phone: 13616522657
• Email: yan.luo.yl5[@]hengrui.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Estrogen Receptor Positive Tumor
• HER2-positive Breast Cancer

Intervention

Drug:
• Trastuzumab Pyrotinib Exemestane Dalpiciclib
Early triple positive breast cancer patients receive combination regimen of Dalpiciclib in Combination With Exemestane and Trastuzumab plus pyrotinib

Locations

Country	Name	City	State
China	The First Affiliated Hospital, Zhejiang University School of Medicine	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
First Affiliated Hospital of Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pathological complete response (pCR)	Assess the rate of pathological complete response (pCR) defined as ypT0-ypTis ypN0 at surgery	at surgery
Secondary	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
Secondary	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