Advanced/Metastatic Breast CancerPhase 2NCT07610720
Dalpiciclib, Anti-HER2 Therapy, and Endocrine Therapy for Hormone-Receptor-Positive, HER2-Positive Metastatic Breast Cancer
A Phase 2 study testing Dalpiciclib, Trastuzumab (Herceptin) and Pertuzumab in people with Advanced/Metastatic Breast Cancer and HER2-Positive Metastatic Breast Cancer, run by Sun Yat-sen University at 1 site in China.
Trial summary
Efficacy and Safety of Dalpiciclib Combined with Anti-HER2 Targeted Therapy and Endocrine Therapy as First-line Maintenance Treatment for Patients with Recurrent or Metastatic Hormone-Receptor-Positive, HER2-positive Breast Cancer. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Advanced/Metastatic Breast Cancer, HER2-Positive Metastatic Breast Cancer
- What is being tested?
- Dalpiciclib, Trastuzumab (Herceptin) and Pertuzumab
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2026to 1 Nov 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
- Females aged 18 to 75 years with pathologically confirmed metastatic or locally advanced unresectable breast cancer.
- Hormone receptor (HR)-positive and HER2-positive.
- Patients with no evidence of disease progression (including CR, PR, or SD)after 4-8 cycles of first-line systemic anti-tumor therapy.
- ECOG Performance Status: 0-1.
Who cannot join
- Symptomatic active brain metastases or extensive leptomeningeal metastases.
- History of Grade 3 or 4 allergic reaction related to the study drugs.
- Currently receiving other anti-tumor therapies.
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
Sun yat-Sen University Cancer Center, Guangzhou, Yuexiu District
Guangdong, GUANGZHOU, 510060
About this study
Official title: Evaluating the Efficacy and Safety of Dalpiciclib Plus Anti-HER2 Therapy and Endocrine Therapy in Patients With Induction-Treated Hormone-Receptor-Positive, HER2-Positive Metastatic Breast Cancer
Efficacy and Safety of Dalpiciclib Combined with Anti-HER2 Targeted Therapy and Endocrine Therapy as First-line Maintenance Treatment for Patients with Recurrent or Metastatic Hormone-Receptor-Positive, HER2-positive Breast Cancer.
Read the detailed description
This is a multicenter, single-arm, open-label, phase II clinical trial evaluating the efficacy and safety of dalpiciclib (a novel oral CDK4/6 inhibitor) combined with anti-HER2 therapy and endocrine therapy as maintenance treatment in patients with hormone receptor-positive (HR+)/HER2-positive metastatic breast cancer who have completed induction systemic therapy without disease progression.
Triple-positive (HR+/HER2+) metastatic breast cancer represents a unique subtype requiring dual pathway inhibition. Current standard first-line induction therapy includes taxane-based chemotherapy combined with trastuzumab and pertuzumab (THP) or pyrotinib (THPy), followed by maintenance with anti-HER2 therapy plus endocrine therapy. However, approximately 50% of patients progress within 18 months during maintenance therapy.
This study explores the addition of dalpiciclib to standard anti-HER2 and endocrine maintenance therapy to prolong progression-free survival. Dalpiciclib, the first domestically developed CDK4/6 inhibitor in China, has demonstrated favorable efficacy and a manageable safety profile in HR+/HER2- advanced breast cancer, with a lower incidence of febrile neutropenia and no observed interstitial lung disease.
- Being tested
- Dalpiciclib, Trastuzumab (Herceptin), Pertuzumab, Pyrotinib, Endocrine Therapy 1
- Keywords
- Dalpiciclib, Dalpiciclib Plus Anti-HER2 Therapy and Endocrine Therapy
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DalpiciclibDrug
Oral CDK4/6 inhibitor (dose modification permitted for toxicity management)
Trastuzumab (Herceptin)Drug
Subcutaneous, 600mg Q3W; IV: 8mg/kg (loading) → 6mg/kg Q3W
PertuzumabDrug
IV: 840mg (loading) → 420mg Q3W
PyrotinibDrug
240mg qd Week 1 → 320mg qd from Week 2 (max dose); loperamide prophylaxis for diarrhea
Endocrine Therapy 1Drug
Letrozole 2.5mg, Anastrozole 1mg, Exemestane 25mg, or Fulvestrant 0.5g IM on Days 1, 28 (initial: Days 1, 15, 28)
| Study group | Role | What they receive |
|---|---|---|
| Dalpiciclib + Endocrine Therapy + Trastuzumab ± Pertuzumab or Pyrotinib | Experimental | Not described Receives: Drug: Dalpiciclib; Drug: Trastuzumab (Herceptin); Drug: Pertuzumab; Drug: Pyrotinib; Drug: Endocrine Therapy 1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-Free Survival (PFS)
Time from enrollment to radiographic disease progression (per RECIST 1.1) or death from any cause, whichever occurs first
Measured: From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years after the last participant completes treatment.
Secondary outcomes (5)
Objective Response Rate (ORR)
Proportion of patients achieving Complete Response (CR) or Partial Response (PR) per RECIST 1.1
Measured: From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years after the last participant completes treatment.
Overall Survival (OS)
Time from enrollment to death from any cause
Measured: From randomization until the end of the study (approximately 36 months)
Safety and Tolerability
Incidence, type, severity, and relationship of adverse events (AEs) graded by NCI CTCAE v5.0
Measured: From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years after the last participant completes treatment.
Disease-Specific Quality of Life Assessed by EORTC QLQ-BR45
Assessed by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Breast Cancer-Specific Module (EORTC QLQ-BR45). The EORTC QLQ-BR45 contains 45 items divided into functional and symptom scales evaluating breast cancer-specific issues and treatment side effects. All scales range in score from 0 to 100. A higher score for a functional scale represents a higher/healthy level of functioning, whereas a higher score for a symptom scale represents a higher level of breast cancer-related symptomatology or treatment-related problems.
Measured: From the date of enrollment until the date of first documented progression or the date of death from any cause, whichever came first, assessed up to 2 years after the last participant completes treatment.
Quality of Life Assessed by EORTC QLQ-C30
Assessed by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30). The EORTC QLQ-C30 consists of 30 items incorporating 5 functional scales, 3 symptom scales, a global health status scale, and 6 single items. All scales and single-item measures range in score from 0 to 100. A higher score for a functional scale or global health status represents a higher/healthy level of functioning, whereas a higher score for a symptom scale/item represents a higher level of symptomatology or problems.
Measured: From the date of enrollment until the date of first documented progression or the date of death from any cause, whichever came first, assessed up to 2 years after the last participant completes treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2026
- Study start1 Jun 2026 (estimated)
- Primary completion1 Nov 2028 (estimated)
- Study completion1 Nov 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced/Metastatic Breast CancerStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe 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
- 57 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jia-Jia Huang, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07610720
- Sponsor's protocol ID
- DALTINA
- Status last verified
- May 2026
- First submitted
- 6 May 2026
- Last updated
- 28 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Efficacy and Safety of Dalpiciclib Plus Anti-HER2 Therapy and Endocrine Therapy in Patients With Induction-Treated Hormone-Receptor-Positive, HER2-Positive Metastatic Breast Cancer
- ClinicalTrials.gov ID
- NCT07610720
- Acronym / sponsor ID
- DALTINA
- Keywords
- Dalpiciclib, Dalpiciclib Plus Anti-HER2 Therapy and Endocrine Therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 57 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 1 Jun 2026 (estimated)
- Primary completion
- 1 Nov 2028 (estimated)
- Study completion
- 1 Nov 2029 (estimated)
- First posted
- 28 May 2026 (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.
Efficacy and Safety of Dalpiciclib Combined with Anti-HER2 Targeted Therapy and Endocrine Therapy as First-line Maintenance Treatment for Patients with Recurrent or Metastatic Hormone-Receptor-Positive, HER2-positive Breast Cancer.
Detailed description
This is a multicenter, single-arm, open-label, phase II clinical trial evaluating the efficacy and safety of dalpiciclib (a novel oral CDK4/6 inhibitor) combined with anti-HER2 therapy and endocrine therapy as maintenance treatment in patients with hormone receptor-positive (HR+)/HER2-positive metastatic breast cancer who have completed induction systemic therapy without disease progression.
Triple-positive (HR+/HER2+) metastatic breast cancer represents a unique subtype requiring dual pathway inhibition. Current standard first-line induction therapy includes taxane-based chemotherapy combined with trastuzumab and pertuzumab (THP) or pyrotinib (THPy), followed by maintenance with anti-HER2 therapy plus endocrine therapy. However, approximately 50% of patients progress within 18 months during maintenance therapy.
This study explores the addition of dalpiciclib to standard anti-HER2 and endocrine maintenance therapy to prolong progression-free survival. Dalpiciclib, the first domestically developed CDK4/6 inhibitor in China, has demonstrated favorable efficacy and a manageable safety profile in HR+/HER2- advanced breast cancer, with a lower incidence of febrile neutropenia and no observed interstitial lung disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dalpiciclib + Endocrine Therapy + Trastuzumab ± Pertuzumab or Pyrotinib | Experimental | Drug: Dalpiciclib, Drug: Trastuzumab (Herceptin), Drug: Pertuzumab, Drug: Pyrotinib, Drug: Endocrine Therapy 1 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Females aged 18 to 75 years with pathologically confirmed metastatic or locally advanced unresectable breast cancer.
- Hormone receptor (HR)-positive and HER2-positive.
- Patients with no evidence of disease progression (including CR, PR, or SD)after 4-8 cycles of first-line systemic anti-tumor therapy.
- ECOG Performance Status: 0-1.
Key exclusion criteria (3 listed)
- Symptomatic active brain metastases or extensive leptomeningeal metastases.
- History of Grade 3 or 4 allergic reaction related to the study drugs.
- Currently receiving other anti-tumor therapies.
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 |
|---|---|---|
| DalpiciclibOral CDK4/6 inhibitor (dose modification permitted for toxicity management) | Drug | Dalpiciclib + Endocrine Therapy + Trastuzumab ± Pertuzumab or Pyrotinib |
| Trastuzumab (Herceptin)Subcutaneous, 600mg Q3W; IV: 8mg/kg (loading) → 6mg/kg Q3W | Drug | Dalpiciclib + Endocrine Therapy + Trastuzumab ± Pertuzumab or Pyrotinib |
| PertuzumabIV: 840mg (loading) → 420mg Q3W | Drug | Dalpiciclib + Endocrine Therapy + Trastuzumab ± Pertuzumab or Pyrotinib |
| Pyrotinib240mg qd Week 1 → 320mg qd from Week 2 (max dose); loperamide prophylaxis for diarrhea | Drug | Dalpiciclib + Endocrine Therapy + Trastuzumab ± Pertuzumab or Pyrotinib |
| Endocrine Therapy 1Letrozole 2.5mg, Anastrozole 1mg, Exemestane 25mg, or Fulvestrant 0.5g IM on Days 1, 28 (initial: Days 1, 15, 28) | Drug | Dalpiciclib + Endocrine Therapy + Trastuzumab ± Pertuzumab or Pyrotinib |
Primary outcome
Progression-Free Survival (PFS)
Time frame: From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years after the last participant completes treatment.
Time from enrollment to radiographic disease progression (per RECIST 1.1) or death from any cause, whichever occurs first
5 secondary outcomes
Objective Response Rate (ORR)
Time frame: From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years after the last participant completes treatment.
Overall Survival (OS)
Time frame: From randomization until the end of the study (approximately 36 months)
Safety and Tolerability
Time frame: From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years after the last participant completes treatment.
Disease-Specific Quality of Life Assessed by EORTC QLQ-BR45
Time frame: From the date of enrollment until the date of first documented progression or the date of death from any cause, whichever came first, assessed up to 2 years after the last participant completes treatment.
Quality of Life Assessed by EORTC QLQ-C30
Time frame: From the date of enrollment until the date of first documented progression or the date of death from any cause, whichever came first, assessed up to 2 years after the last participant completes treatment.
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 28 May 2026.
- Individual participant dataSharing planned: Undecided
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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.
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 Dalpiciclib, Trastuzumab (Herceptin) and Pertuzumab in people with Advanced/Metastatic Breast Cancer and HER2-Positive Metastatic Breast Cancer, run by Sun Yat-sen University 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 4 inclusion and 3 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 28 May 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?
Contact Chen Doctor Chen, PhD / Doctorate (02087341812, chenmt@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-Free Survival (PFS) (time frame: From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years after the last participant completes treatment.). 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 28 May 2026.