Actively Recruiting

Phase 2
Age: 18Years - 75Years
FEMALE
NCT07014410

Pyrotinib Combined With Dalpiciclib Combined With Letrozole in ER-positive and HER2-positive Advanced Breast Cancer

Led by Zhejiang Cancer Hospital · Updated on 2025-06-11

63

Participants Needed

1

Research Sites

360 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This is a a multicenter Phase II clinical study investigating efficacy of pyrotinib combined with dalpiciclib combined with letrozole in ER-positive and HER2-positive advanced breast cancer patients. The sample size is 63.

CONDITIONS

Official Title

Pyrotinib Combined With Dalpiciclib Combined With Letrozole in ER-positive and HER2-positive Advanced Breast Cancer

Who Can Participate

Age: 18Years - 75Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Voluntarily joined the study, signed informed consent, and have good compliance
  • Female participants who are postmenopausal or premenopausal/perimenopausal aged 18 to 75 years
  • Recurrent or metastatic breast cancer confirmed by histopathology with positive ER and HER2 expression
  • At least one extracranial measurable lesion meeting RECIST 1.1 criteria
  • At most one previous trastuzumab-containing systemic therapy for recurrent metastatic breast cancer
Not Eligible

You will not qualify if you...

  • Untreated central nervous system metastasis
  • Bilateral breast cancer, inflammatory breast cancer, or latent breast cancer
  • Previous treatment with any CDK4/6 inhibitors
  • Inability to swallow, intestinal obstruction, or other factors affecting drug absorption
  • Other malignancies within 5 years or at the same time except cured basal cell carcinoma of the skin and carcinoma in situ of the cervix

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China

Actively Recruiting

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Research Team

Z

Zhiqiang Xiao, Master

CONTACT

Z

Zhiqiang Xiao

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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Pyrotinib Combined With Dalpiciclib Combined With Letrozole in ER-positive and HER2-positive Advanced Breast Cancer | DecenTrialz