NCT07014410RecruitingPhase 2
Pyrotinib Combined With Dalpiciclib Combined With Letrozole in ER-positive and 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
Source: ClinicalTrials.gov · Last updated 11 Jun 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 63 (estimated)
- First submitted
- 5 May 2023
- Start date
- 1 Feb 2023
- Primary completion date
- 31 Dec 2027
- Lead sponsor
- Zhejiang Cancer Hospital
- Diseases
- Metastatic breast cancer
- NCT number
- NCT07014410
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 63
- From 1 Feb 2023 to the primary completion date, 31 Dec 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous treatment with any CDK4/6 inhibitors
- Inability to swallow, intestinal obstruction, or other factors affecting drug use and absorption
Other illness
- Bilateral breast cancer, inflammatory breast cancer, or latent breast cancer
- 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
Other
- Subjects had untreated central nervous system metastasis
Who the study is looking for
- The subjects voluntarily joined the study, signed the informed consent, and had good compliance
- Postmenopausal or premenopausal/perimenopausal women aged ≥18 years and ≤75 years
- Patients with recurrent/metastatic breast cancer confirmed by histopathology with positive ER expression and positive HER2 expression
- Have at least one extracranial measurable lesion that meets RECIST 1.1 criteria
- At most one previous trastuzumab containing systemic therapy for recurrent metastatic breast cancer
Age in the registry: 18 years to 75 years · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Zhejiang Cancer Hospital Coordinator of this site? Confirm its status | Hangzhou | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.