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

Primary Purpose

Breast Cancer, Estrogen Receptor Positive Tumor, HER2-positive Breast Cancer

Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Trastuzumab Pyrotinib Exemestane Dalpiciclib
Sponsored by
First Affiliated Hospital of Zhejiang University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • The First Affiliated Hospital, Zhejiang University School of MedicineRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Dalpiciclib in combination with exemestane and trastuzumab plus pyrotinib

Arm Description

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.

Outcomes

Primary Outcome Measures

pathological complete response (pCR)
Assess the rate of pathological complete response (pCR) defined as ypT0-ypTis ypN0 at surgery

Secondary Outcome Measures

Serial measures of Ki67
Changes in Ki67 scores from baseline before therapy, 2 weeks after and then at surgery
Objective response
Defined as the number of patients with partial or complete response according to RECIST 1.1

Full Information

First Posted
July 27, 2021
Last Updated
February 16, 2023
Sponsor
First Affiliated Hospital of Zhejiang University
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1. Study Identification

Unique Protocol Identification Number
NCT04997798
Brief Title
Dalpiciclib in Combination With Exemestane and Trastuzumab Plus Pyrotinib in Early Triple Positive Breast Cancer
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2022 (Actual)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
First Affiliated Hospital of Zhejiang University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Estrogen Receptor Positive Tumor, HER2-positive Breast Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Dalpiciclib in combination with exemestane and trastuzumab plus pyrotinib
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Trastuzumab Pyrotinib Exemestane Dalpiciclib
Other Intervention Name(s)
Herceptin Pyrotinib Aromasin Dalpiciclib
Intervention Description
Early triple positive breast cancer patients receive combination regimen of Dalpiciclib in Combination With Exemestane and Trastuzumab plus pyrotinib
Primary Outcome Measure Information:
Title
pathological complete response (pCR)
Description
Assess the rate of pathological complete response (pCR) defined as ypT0-ypTis ypN0 at surgery
Time Frame
at surgery
Secondary Outcome Measure Information:
Title
Serial measures of Ki67
Description
Changes in Ki67 scores from baseline before therapy, 2 weeks after and then at surgery
Time Frame
baseline before therapy, 2 weeks after and at surgery
Title
Objective response
Description
Defined as the number of patients with partial or complete response according to RECIST 1.1
Time Frame
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

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Luyan Chen, Doctor
Phone
13616522657
Email
yan.luo.yl5@hengrui.com
First Name & Middle Initial & Last Name or Official Title & Degree
Luyan Chen, Doctor
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peifen Fu, Doctor
Organizational Affiliation
Zhejiang University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The First Affiliated Hospital, Zhejiang University School of Medicine
City
Hangzhou
State/Province
Zhejiang
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jiaqi Jiang
Phone
15056602195

12. IPD Sharing Statement

Learn more about this trial

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

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