NCT04997798

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for phase_2 breast-cancer

Timeline
Completed

Started Sep 2022

Shorter than P25 for phase_2 breast-cancer

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 27, 2021

Completed
14 days until next milestone

First Posted

Study publicly available on registry

August 10, 2021

Completed
1.1 years until next milestone

Study Start

First participant enrolled

September 1, 2022

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

February 21, 2023

Status Verified

February 1, 2023

Enrollment Period

2.3 years

First QC Date

July 27, 2021

Last Update Submit

February 16, 2023

Conditions

Breast CancerEstrogen Receptor Positive TumorHER2-positive Breast Cancer

Outcome Measures

Primary Outcomes (1)

  • pathological complete response (pCR)

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

    at surgery

Secondary Outcomes (2)

  • Serial measures of Ki67

    baseline before therapy, 2 weeks after and at surgery

  • Objective response

    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

Study Arms (1)

Dalpiciclib in combination with exemestane and trastuzumab plus pyrotinib

EXPERIMENTAL

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

Interventions

Trastuzumab Pyrotinib Exemestane DalpiciclibDRUG

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

Also known as: Herceptin Pyrotinib Aromasin Dalpiciclib
Dalpiciclib in combination with exemestane and trastuzumab plus pyrotinib

Eligibility Criteria

Age18 Years - 75 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The First Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Peifen Fu, Doctor

    Zhejiang University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Luyan Chen, Doctor

CONTACT

13616522657yan.luo.yl5@hengrui.com

Luyan Chen, Doctor

CONTACT

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 27, 2021

First Posted

August 10, 2021

Study Start

September 1, 2022

Primary Completion

December 1, 2024

Study Completion

December 1, 2024

Last Updated

February 21, 2023

Record last verified: 2023-02

Locations

CN(1)