Breast NeoplasmsPhase 2NCT05328440
Treatment of Dalpiciclib Combined With Pyrotinib for Trastuzumab-sensitive HER2+ Advanced Breast Cancer(DAP-Her-02)
A Phase 2 study testing Pyrotinib Maleate, Dalpiciclib Isethionate Tablets and Inetetamab in people with Breast Neoplasms, run by Henan Cancer Hospital at 1 site in China.
Trial summary
Based on different HR status, we explored the efficacy and safety of Pyrotinib and Dalpiciclib Isethionate Tablets based combination regimen in the first-line treatment of HER2 + MBC. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Neoplasms
- What is being tested?
- Pyrotinib Maleate, Dalpiciclib Isethionate Tablets and Inetetamab
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 20 May 2022to 1 Jan 2028
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Premenopausal / perimenopausal / postmenopausal women who aged ≥ 18 years
- Suffering from non resectable locally advanced recurrent breast cancer or metastatic breast cancer
- group A: Women who have breast cancer histopathologically confirmed by positive estrogen receptor (ER; >10%), positive progesterone receptor (PR; >1%), and positive human epidermal growth factor receptor 2 (HER2) according to the 2018 American Society of Clinical Oncology/College of American Pathologists (ASCO/CAP) human epidermal growth factor receptor 2 (HER2) guideline. The pathological laboratory confirmed that the immunohistochemical (IHC) score was 3 +, or 2 +, and the in situ hybridization (ISH) test was positive (ISH amplification rate ≥ 2.0); (New) the end of trastuzumab treatment in the adjuvant treatment stage > 12 months, recurrence and metastasis, or no trastuzumab treatment in the early stage; No adjuvant endocrine therapy or postoperative adjuvant endocrine therapy > 24 months; Premenopausal or perimenopausal patients need to be combined with ofs (OFS includes bilateral ovariectomy or GnRHa drugs); group B: Women who have breast cancer histopathologically confirmed by negative estrogen receptor (ER), negative progesterone receptor (PR; <1%), and positive human epidermal growth factor receptor 2 (HER2) according to the 2018 American Society of Clinical Oncology/College of American Pathologists (ASCO/CAP) human epidermal growth factor receptor 2 (HER2) guideline. The pathological laboratory confirmed that the immunohistochemical (IHC) score was 3 +, or 2 +, and the in situ hybridization (ISH) test was positive (ISH amplification rate ≥ 2.0); (New) the end of trastuzumab treatment in the adjuvant treatment stage > 12 months, recurrence and metastasis, or no trastuzumab treatment in the early stage;
- No previous systematic treatment for advanced diseases
- at least one measurable lesion or only bone metastasis according to RECIST 1.1.
- Eastern Cooperative Oncology Group (ECOG) performance status 0～1.
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- The patient must be able to swallow oral drugs
- The functional level of organs must meet the following requirements:
- Bone marrow function i) Absolute neutrophil count（ANC）≥1.5×109/L (no use of growth factor within 14 days) ii) Platelet count（PLT）≥100×109/L (no corrective treatment within 7 days) iii) Hemoglobin level（Hb）≥100 g/L (no corrective treatment within 7 days) b) Liver and kidney function i) Total bilirubin（TBIL）≤1.5 upper limit of normal value (ULN) ii) Alanine transaminase (ALT) and aspartate transaminase (AST) ≤3×ULN iii) Blood urea nitrogen (BUN) and creatinine ≤1.5×ULN and creatinine clearance≥50 mL/min (Cockcroft-Gault formula); c) Color Doppler echocardiography: Left ventricular ejection fraction ≥50% d) 12-lead electrocardiography: QTc interval ≤480 ms
- Volunteers to participate in the study, provision of signed informed consent, good compliance and willingness to cooperate with follow-ups.
Who cannot join
- Patients with symptomatic brain metastasis;
- Unable to swallow, chronic diarrhea and intestinal obstruction, there are many factors affecting drug use and absorption;
- patient who received radiotherapy, chemotherapy, surgery (excluding local puncture) or molecular targeted therapy within 4 weeks before admission; those who received anti-tumor endocrine therapy after screening period;
- Participated in other drug clinical trials within 4 weeks before admission;
- Tyrosine kinase inhibitors targeting HER2 (Neratinib, Lapatinib, pyrotinib, etc.) have been used or are being used in the past;
- Patients previously treated with any CDK4 / 6 inhibitor;
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- Those who have other malignant tumors (with the exception of healed cervical carcinoma in situ) occurring in the past 5 years;
- Those who are known to have a history of allergy to the component of study drugs; those who have a history of immunodeficiency, including positive detection of human immunodeficiency virus, hepatitis C virus, active hepatitis B or other acquired, congenital immunodeficiency diseases, or organ transplantation;
- Those who had suffered from any heart disease, including arrhythmia which requires drug treatment or is of clinical significance; myocardial infarction; heart failure; and any other heart disease judged by the investigator as unsuitable for this trial;
- Pregnant and lactating women; fertile women who provide positive results of baseline pregnancy test; women of childbearing age who are unwilling to take effective contraceptive measures during the whole study period;
- If the accompanying diseases (including, but not limited to, severe hypertension, severe diabetes, and active infection, which cannot be controlled by drugs) that would be a potential hazard to participant's health, or affect the completion of the study as per investigator's judgement;
- Moderate infection occurs within 4 weeks before the first administration (e.g. intravenous drip of antibiotics, antifungal or antiviral drugs according to clinical criteria), fever（> 38.5 ℃） of unknown origin occurs during the screening period/before the first administration.
- A clear history of neurological or psychiatric disorders, including epilepsy or dementia.
- Researchers believe that patients are not suitable for any other situation in this study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Treatment of Dalpiciclib Combined With Pyrotinib for Trastuzumab-sensitive HER2+ Advanced Breast Cancer: a Single Arm, Dual Cohort, Prospective, Open Phase II Exploratory Study
Based on different HR status, we explored the efficacy and safety of Pyrotinib and Dalpiciclib Isethionate Tablets based combination regimen in the first-line treatment of HER2 + MBC.
Read the detailed description
Cyclin D-CDK4/6-RB-E2F signaling pathway regulates the transformation of breast cancer cells from stage G1 to S, and plays an important role in the proliferation of breast cancer cells. HER2 protein regulates proliferation of breast cancer cells through PI3K/AKT signaling pathway. HER2 positive breast cancer patients need anti HER2 therapy. Data indicate that HER2 positive breast cancer patients often express cyclin D1 and E1, suggesting that anti HER2 therapy can synergy with CDK4/6 inhibitors.
A preclinical study shows that the combination of CDK4/6 inhibitor Dulcie and anti HER2 drug pyrrolidone can effectively reduce the phosphorylation of AKT and HER3, thereby promoting the apoptosis of HER2 positive breast cancer cells and achieving the purpose of inhibiting tumor.
In the clinical study of na-phere 2, piperacillin combined with trastuzumab, patuzumab and fluvestrant can significantly inhibit the expression of Ki67. MonarcHER study shows that the treatment of patients with advanced HR+HER2+ breast cancer after the failure of anti HER2+ is better than conventional chemotherapy plus anti HER2 therapy. The successful challenge of traditional chemotherapy is the opening of a new chapter in the treatment of HR+/HER2+. In 2021, ESMO 276P reported the interim data of darcilil combined with pyrroltinib in the first-line / second-line treatment of MBC. HR -, HER2 + MBC ORR can reach 81.8%, and the safety is controllable.
Based on different HR status, we explored the efficacy and safety of Pyrotinib and Dalpiciclib Isethionate Tablets based combination regimen in the first-line treatment of HER2 + MBC.
- Conditions
- Breast Neoplasms
- Being tested
- Pyrotinib Maleate, Dalpiciclib Isethionate Tablets, Inetetamab, Fulvestrant
- Keywords
- HER2-positive MBC
- 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 MaleateDrug
Also called Pyrotinib
once a day, 125mg each time, taking for 3 weeks, stopping for 1 week, 4 weeks as a cycle. It is recommended to take medicine at about the same time every day, take it with warm water, and fast at least 1 hour before and after taking medicine
Dalpiciclib Isethionate TabletsDrug
Also called SHR6390
400mg once a day, oral administration within 30 minutes after breakfast, continuous administration for 28 days as a cycle
InetetamabDrug
the initial dose is 8mg / kg and the subsequent dose is 6mg / kg. It is administered intravenously for 21 days.
FulvestrantDrug
fluvestrant is administered intravenously on the 1/15 day of the first cycle, and then on the first day of each cycle, 500mg / time, intravenously
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Experimental | HR-positive/HER2-positive MBC Receives: Drug: Pyrotinib Maleate; Drug: Dalpiciclib Isethionate Tablets; Drug: Fulvestrant |
| Arm B | Experimental | HR-negative/HER2-positive MBC Receives: Drug: Pyrotinib Maleate; Drug: Dalpiciclib Isethionate Tablets; Drug: Inetetamab |
What is being measured
The primary outcome is the main question the study is designed to answer.
PFS (Progression-Free survival)
From the date into this study (signed ICF) to tumor progression or death.
Measured: up to 2 years
Secondary outcomes (2)
ORR (Objective control rate)
The rate of CR and PR, determined using RECIST v1.1 criteria
Measured: up to 2 years
Overall survival (OS)
It refers to the length of time from the start of treatment to the death of the patient
Measured: up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2022
- Study start20 May 2022
- Primary completion1 Jan 2028 (estimated)
- Study completion1 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast NeoplasmsStudies of the same condition, open and under way.
- More trials run by Henan 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Henan Cancer Hospital
- Sponsor type
- Other government
- Collaborators
- Jiangsu HengRui Medicine Co., Ltd.
- Responsible party
- Principal investigator, Min Yan, MD, Henan Cancer Hospital
- Investigators
- Min Yan, Principal investigator, Henan Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05328440
- Sponsor's protocol ID
- MA-BC-II-037
- Status last verified
- Oct 2026
- First submitted
- 14 Mar 2022
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in this article, after de-identificationare available following article publication.
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Dalpiciclib Combined With Pyrotinib for Trastuzumab-sensitive HER2+ Advanced Breast Cancer: a Single Arm, Dual Cohort, Prospective, Open Phase II Exploratory Study
- ClinicalTrials.gov ID
- NCT05328440
- Acronym / sponsor ID
- MA-BC-II-037
- Conditions
- Breast Neoplasms
- Keywords
- HER2-positive MBC
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Henan Cancer HospitalOther government
- Collaborators
- Jiangsu HengRui Medicine Co., Ltd.
- Study start
- 20 May 2022 (actual)
- Primary completion
- 1 Jan 2028 (estimated)
- Study completion
- 1 Jan 2028 (estimated)
- First posted
- 14 Apr 2022 (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.
Based on different HR status, we explored the efficacy and safety of Pyrotinib and Dalpiciclib Isethionate Tablets based combination regimen in the first-line treatment of HER2 + MBC.
Detailed description
Cyclin D-CDK4/6-RB-E2F signaling pathway regulates the transformation of breast cancer cells from stage G1 to S, and plays an important role in the proliferation of breast cancer cells. HER2 protein regulates proliferation of breast cancer cells through PI3K/AKT signaling pathway. HER2 positive breast cancer patients need anti HER2 therapy. Data indicate that HER2 positive breast cancer patients often express cyclin D1 and E1, suggesting that anti HER2 therapy can synergy with CDK4/6 inhibitors.
A preclinical study shows that the combination of CDK4/6 inhibitor Dulcie and anti HER2 drug pyrrolidone can effectively reduce the phosphorylation of AKT and HER3, thereby promoting the apoptosis of HER2 positive breast cancer cells and achieving the purpose of inhibiting tumor.
In the clinical study of na-phere 2, piperacillin combined with trastuzumab, patuzumab and fluvestrant can significantly inhibit the expression of Ki67. MonarcHER study shows that the treatment of patients with advanced HR+HER2+ breast cancer after the failure of anti HER2+ is better than conventional chemotherapy plus anti HER2 therapy. The successful challenge of traditional chemotherapy is the opening of a new chapter in the treatment of HR+/HER2+. In 2021, ESMO 276P reported the interim data of darcilil combined with pyrroltinib in the first-line / second-line treatment of MBC. HR -, HER2 + MBC ORR can reach 81.8%, and the safety is controllable.
Based on different HR status, we explored the efficacy and safety of Pyrotinib and Dalpiciclib Isethionate Tablets based combination regimen in the first-line treatment of HER2 + MBC.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A | Experimental | Drug: Pyrotinib Maleate, Drug: Dalpiciclib Isethionate Tablets, Drug: FulvestrantHR-positive/HER2-positive MBC |
| Arm B | Experimental | Drug: Pyrotinib Maleate, Drug: Dalpiciclib Isethionate Tablets, Drug: InetetamabHR-negative/HER2-positive MBC |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Premenopausal / perimenopausal / postmenopausal women who aged ≥ 18 years
- Suffering from non resectable locally advanced recurrent breast cancer or metastatic breast cancer
- group A: Women who have breast cancer histopathologically confirmed by positive estrogen receptor (ER; >10%), positive progesterone receptor (PR; >1%), and positive human epidermal growth factor receptor 2 (HER2) according to the 2018 American Society of Clinical Oncology/College of American Pathologists (ASCO/CAP) human epidermal growth factor receptor 2 (HER2) guideline. The pathological laboratory confirmed that the immunohistochemical (IHC) score was 3 +, or 2 +, and the in situ hybridization (ISH) test was positive (ISH amplification rate ≥ 2.0); (New) the end of trastuzumab treatment in the adjuvant treatment stage > 12 months, recurrence and metastasis, or no trastuzumab treatment in the early stage; No adjuvant endocrine therapy or postoperative adjuvant endocrine therapy > 24 months; Premenopausal or perimenopausal patients need to be combined with ofs (OFS includes bilateral ovariectomy or GnRHa drugs); group B: Women who have breast cancer histopathologically confirmed by negative estrogen receptor (ER), negative progesterone receptor (PR; <1%), and positive human epidermal growth factor receptor 2 (HER2) according to the 2018 American Society of Clinical Oncology/College of American Pathologists (ASCO/CAP) human epidermal growth factor receptor 2 (HER2) guideline. The pathological laboratory confirmed that the immunohistochemical (IHC) score was 3 +, or 2 +, and the in situ hybridization (ISH) test was positive (ISH amplification rate ≥ 2.0); (New) the end of trastuzumab treatment in the adjuvant treatment stage > 12 months, recurrence and metastasis, or no trastuzumab treatment in the early stage;
- No previous systematic treatment for advanced diseases
- at least one measurable lesion or only bone metastasis according to RECIST 1.1.
Key exclusion criteria (14 listed)
- Patients with symptomatic brain metastasis;
- Unable to swallow, chronic diarrhea and intestinal obstruction, there are many factors affecting drug use and absorption;
- patient who received radiotherapy, chemotherapy, surgery (excluding local puncture) or molecular targeted therapy within 4 weeks before admission; those who received anti-tumor endocrine therapy after screening period;
- Participated in other drug clinical trials within 4 weeks before admission;
- Tyrosine kinase inhibitors targeting HER2 (Neratinib, Lapatinib, pyrotinib, etc.) have been used or are being used in the past;
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 MaleateAlso: Pyrotinibonce a day, 125mg each time, taking for 3 weeks, stopping for 1 week, 4 weeks as a cycle. It is recommended to take medicine at about the same time every day, take it with warm water, and fast at least 1 hour before and after taking medicine | Drug | Arm A, Arm B |
| Dalpiciclib Isethionate TabletsAlso: SHR6390400mg once a day, oral administration within 30 minutes after breakfast, continuous administration for 28 days as a cycle | Drug | Arm A, Arm B |
| Inetetamabthe initial dose is 8mg / kg and the subsequent dose is 6mg / kg. It is administered intravenously for 21 days. | Drug | Arm B |
| Fulvestrantfluvestrant is administered intravenously on the 1/15 day of the first cycle, and then on the first day of each cycle, 500mg / time, intravenously | Drug | Arm A |
Primary outcome
PFS (Progression-Free survival)
Time frame: up to 2 years
From the date into this study (signed ICF) to tumor progression or death.
2 secondary outcomes
ORR (Objective control rate)
Time frame: up to 2 years
Overall survival (OS)
Time frame: up to 2 years
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 16 Oct 2026.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in this article, after de-identificationare available following article publication.
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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. This study is not recruiting at the moment.
Min Yan principal investigator
Henan 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 Maleate, Dalpiciclib Isethionate Tablets and Inetetamab in people with Breast Neoplasms, run by Henan 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 10 inclusion and 14 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: under way, not looking for participants, as of the sponsor's last update on 16 Oct 2026. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PFS (Progression-Free survival) (time frame: up to 2 years). 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 16 Oct 2026.