Breast CancerPhase 2NCT07014410
Pyrotinib Combined With Dalpiciclib Combined With Letrozole in ER-positive and HER2-positive Advanced Breast Cancer
A Phase 2 study testing pyrotinib dalpiciclib letrozole in people with Breast Cancer, run by Zhejiang Cancer Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- pyrotinib dalpiciclib letrozole
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2023to 31 Dec 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Subjects had 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 use and absorption
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Zhejiang Cancer Hospital
Hangzhou, Zhejiang
Zhanhong Chen
About this study
Official title: 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
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.
Read the detailed description
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. Patients receive pyrotinib 320mg/d, dalpiciclib 125mg/d, d1-21, q28d. One cycle is 28d.
- Conditions
- Breast Cancer
- Being tested
- pyrotinib dalpiciclib letrozole
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pyrotinib dalpiciclib letrozoleDrug
Also called Femar
ER positive HER2 positive advanced breast cancer patients are given pyrotinib+dalpiciclib+letrozole
| Study group | Role | What they receive |
|---|---|---|
| pyrotinib dalpiciclib letrozole | Experimental | Patients receive pyrotinib 320mg/d, dalpiciclib 125mg/d and letrozole 2.5mg/d until disease progression, intolerated toxicity. Receives: Drug: pyrotinib dalpiciclib letrozole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate
the proportion of patients achieving complete response or partial response
Measured: through study completion, an average of 2 year
Secondary outcomes (1)
Progression Free Survival
Time to progression or death, which comes first
Measured: through study completion, an average of 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2025
- Study start1 Feb 2023
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Zhejiang Cancer HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 63 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhejiang Cancer Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chen Zhanhong, Zhejiang Cancer Hospital
- Investigators
- Zhanhong Chen, Master, Principal investigator, Zhejiang Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07014410
- Sponsor's protocol ID
- DAPYLET
- Status last verified
- Jun 2025
- First submitted
- 5 May 2023
- Last updated
- 11 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07014410
- Acronym / sponsor ID
- DAPYLET
- Conditions
- Breast Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 63 participants (estimated)
- Lead sponsor
- Zhejiang Cancer HospitalUniversity, hospital or other
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 11 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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. Patients receive pyrotinib 320mg/d, dalpiciclib 125mg/d, d1-21, q28d. One cycle is 28d.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| pyrotinib dalpiciclib letrozole | Experimental | Drug: pyrotinib dalpiciclib letrozolePatients receive pyrotinib 320mg/d, dalpiciclib 125mg/d and letrozole 2.5mg/d until disease progression, intolerated toxicity. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- Subjects had 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 use and absorption
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| pyrotinib dalpiciclib letrozoleAlso: FemarER positive HER2 positive advanced breast cancer patients are given pyrotinib+dalpiciclib+letrozole | Drug | pyrotinib dalpiciclib letrozole |
Primary outcome
Objective response rate
Time frame: through study completion, an average of 2 year
the proportion of patients achieving complete response or partial response
1 secondary outcome
Progression Free Survival
Time frame: through study completion, an average of 2 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Zhanhong Chen, Master principal investigator
Zhejiang Cancer Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing pyrotinib dalpiciclib letrozole in people with Breast Cancer, run by Zhejiang Cancer Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zhiqiang Xiao, Master (17757194561, zhiqiang.xiao@hengrui.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate (time frame: through study completion, an average of 2 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2025.