NCT07014410 Pyrotinib Combined With Dalpiciclib Combined With Letrozole in ER-positive and HER2-positive Advanced Breast Cancer
| NCT ID | NCT07014410 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Zhejiang Cancer Hospital |
| Condition | Breast Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 63 participants |
| Start Date | 2023-02-01 |
| Primary Completion | 2027-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 63 participants in total. It began in 2023-02-01 with a primary completion date of 2027-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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
Contact & Investigator
Zhanhong Chen, Master
PRINCIPAL INVESTIGATOR
Zhejiang Cancer Hospital
Frequently Asked Questions
Who can join the NCT07014410 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 75 Years, studying Breast Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07014410 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07014410 currently recruiting?
Yes, NCT07014410 is actively recruiting participants. Contact the research team at zhiqiang.xiao@hengrui.com for enrollment information.
Where is the NCT07014410 trial being conducted?
This trial is being conducted at Hangzhou, China.
Who is sponsoring the NCT07014410 clinical trial?
NCT07014410 is sponsored by Zhejiang Cancer Hospital. The principal investigator is Zhanhong Chen, Master at Zhejiang Cancer Hospital. The trial plans to enroll 63 participants.
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