Pyrotinib + Dalpiciclib + Letrozole for ER-positive, HER2-positive advanced breast cancer
A Multicenter Phase II Clinical Study of Pyrotinib Combined With Dalpiciclib Combined With Letrozole in the Treatment of ER-positive and HER2-positive Advanced Breast Cancer
PHASE2 · Zhejiang Cancer Hospital · NCT07014410
This trial tests whether combining pyrotinib, dalpiciclib, and letrozole can help people with ER-positive, HER2-positive advanced breast cancer.
Quick facts
| Phase | PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 63 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | Female |
| Sponsor | Zhejiang Cancer Hospital (other) |
| Drugs / interventions | trastuzumab, pyrotinib |
| Locations | 1 site (Hangzhou, Zhejiang) |
| Trial ID | NCT07014410 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Women aged 18–75 who are postmenopausal or premenopausal/perimenopausal with recurrent or metastatic ER-positive, HER2-positive breast cancer, at least one extracranial measurable lesion, and no more than one prior trastuzumab-containing metastatic regimen are the intended participants.
Not a fit: Patients with untreated central nervous system metastases, prior CDK4/6 inhibitor treatment, recent other malignancies, or conditions preventing oral drug absorption are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, the combination could offer a more effective oral treatment option to help control disease in this subtype of advanced breast cancer.
How similar studies have performed: Related combinations of HER2-targeted TKIs, CDK4/6 inhibitors, and endocrine therapy have shown promising activity in small studies, but strong confirmatory data are still limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Hangzhou, Zhejiang
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Breast Cancer