Pyrotinib + Dalpiciclib + Letrozole for ER-positive, HER2-positive advanced breast cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a multicenter Phase II trial planning to enroll 63 patients with recurrent or metastatic ER-positive, HER2-positive breast cancer. Participants receive oral pyrotinib 320 mg daily and oral dalpiciclib 125 mg daily on days 1–21 of each 28-day cycle, together with letrozole. Eligible patients must have at least one extracranial measurable lesion and may have had at most one prior trastuzumab-containing systemic therapy for metastatic disease. The study will monitor tumor response and safety on the combination regimen.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. The subjects voluntarily joined the study, signed the informed consent, and had good compliance
2. Postmenopausal or premenopausal/perimenopausal women aged ≥18 years and ≤75 years
3. Patients with recurrent/metastatic breast cancer confirmed by histopathology with positive ER expression and positive HER2 expression
4. Have at least one extracranial measurable lesion that meets RECIST 1.1 criteria
5. At most one previous trastuzumab containing systemic therapy for recurrent metastatic breast cancer

Exclusion Criteria:

1. Subjects had untreated central nervous system metastasis
2. Bilateral breast cancer, inflammatory breast cancer, or latent breast cancer
3. Previous treatment with any CDK4/6 inhibitors
4. Inability to swallow, intestinal obstruction, or other factors affecting drug use and absorption
5. Subject has had other malignancies (except cured basal cell carcinoma of the skin and carcinoma in situ of the cervix) within 5 years or at the same time

Where it's running

• Zhejiang Cancer Hospital
  Hangzhou, Zhejiang, China Recruiting

Study contacts

• Principal investigator: Zhanhong Chen, Master — Zhejiang Cancer Hospital
• Study coordinator: Zhiqiang Xiao, Master
• Email: zhiqiang.xiao@hengrui.com
• Phone: 17757194561

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Entinostat with Pyrotinib and Endocrine Therapy in HER2-positive, HR-positive Advanced Breast Cancer after Trastuzumab Failure

  This study tests whether adding entinostat to pyrotinib and hormone therapy is safe and helps patients with advanced HR+/HER2+ breast cancer who progressed after trastuzumab.

  Recruiting Phase 1/2 Tianjin Medical University Cancer Institute and Hospital · Tianjin, Tianjin Municipality · NCT07708194

• Pyrotinib and Trastuzumab with Dalpiciclib vs with Docetaxel in advanced HER2-positive breast cancer

  This study tests whether an oral regimen of pyrotinib + subcutaneous trastuzumab + dalpiciclib works as well as the standard IV regimen with docetaxel in people with advanced HER2-positive breast cancer who have limited prior treatment.

  Recruiting Phase 3 Fudan University · Shanghai, Shanghai Municipality · NCT07615751

• Using blood ctDNA to compare two pre-surgery HER2-positive breast cancer regimens

  We will test whether two different pre-surgery drug combinations clear tumor DNA from the blood better in people with HER2-positive early breast cancer.

  Recruiting Phase 2 Shanghai Jiao Tong University School of Medicine · Shanghai · NCT07335081

• Gut bacteria and diarrhea in breast cancer patients on pyrotinib

  This study will see if gut bacteria differ between breast cancer patients on pyrotinib who develop diarrhea and those who don’t, to understand why this side effect happens.

  Recruiting Hubei Cancer Hospital · Wuhan, Hubei · NCT07264985

• Evaluating Pyrotinib for HER2-positive Advanced Breast Cancer

  This study is testing if a new drug called Pyrotinib, given with standard chemotherapy, can help people with advanced HER2-positive breast cancer feel better and improve their treatment outcomes.

  Recruiting Phase 1 The First Affiliated Hospital with Nanjing Medical University · Nanjing, Jiangsu · NCT06770296

• Evaluating Pyrotinib dosing for advanced HER2-positive breast cancer

  This study is testing if a lower dose of Pyrotinib is safer and just as effective as the standard dose for people with advanced HER2-positive breast cancer.

  Recruiting Phase 2 The First Affiliated Hospital with Nanjing Medical University · Nanjing, Jiangsu · NCT06254690

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.