Locally Advanced Breast Cancer (LABC)Phase 1/2NCT07189884
Pyrotinib Maleate Tablets in Combination With Dalpiciclib Isethionate Tablets and Standard Endocrine Therapy
A Phase 1/2 study testing Pyrotinib Maleate Tablets + Dalpiciclib Isethionate Tablets + Standard Endocrine in people with Locally Advanced Breast Cancer (LABC), run by The First Affiliated Hospital of Xiamen University.
Trial summary
This study is a prospective, exploratory clinical study design, and plans to enroll 33 patients with HR+HER2 low expression breast cancer who received pyrotinib combined with darcili and standard endocrine neoadjuvant therapy to evaluate the efficacy of this regimen in HR+HER2 low expression breast cancer. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Locally Advanced Breast Cancer (LABC)
- What is being tested?
- Pyrotinib Maleate Tablets + Dalpiciclib Isethionate Tablets + Standard Endocrine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- No sites listed yet
- Study dates
- 23 Sep 2025to 31 Dec 2028
- Phase
- Phase 1/2
- 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
- Female patients aged ≥18 years and ≤75 years old, who have just been treated for breast cancer;
- Pathological examination confirmed that HR was positive (ER≥10%) and HER2 was low (immunohistochemical staining ICH++ and FISH negative);
- Patients with invasive breast cancer confirmed by pathological examination (T≥3 or N≥1) who are eligible for neoadjuvant therapy;
- ECOG score 0~1 points;
- Planned to undergo definitive surgical resection of breast cancer, i.e., breast-conserving surgery or total mastectomy, sentinel lymph node (SN) biopsy, or axillary lymph node dissection (ALND);
- Normal function of major organs, i.e. meeting the following criteria:
- Blood routine examination standards must meet: ANC ≥1.5×109/L; PLT ≥90×109/L； Hb ≥90g/L； (2) Biochemical examination must meet the following criteria: TBIL ≤upper limit of normal (ULN); ALT and AST ≤ 1.5 times the upper limit of normal (ULN), alkaline phosphatase ≤ 2.5 times the upper limit of normal (ULN), BUN and Cr ≤ 1.5× ULN and creatinine clearance ≥ 50 mL/min (CockcroftGault formula); (3) Cardiac color ultrasound and echocardiography: left ventricular ejection fraction (LVEF≥55%); (4) 18-lead ECG corrected by Fridericia's QT interval (QTcF) in women< 470 ms; 7. For female patients who are not menopausal or surgically sterilized: agree to abstain from sexual activity or use an effective contraceptive method during the treatment period and for at least 7 months after the last dose of study treatment; 8. Volunteer to join this study and sign the informed consent form.
Who cannot join
- Those who have a known history of allergy to the drug components of this regimen;
- Previous anti-tumor therapy or radiotherapy for any malignant tumor (except for cured cervical carcinoma in situ and basal cell carcinoma);
- Underwent major surgical procedures unrelated to breast cancer within 4 weeks, or patients have not fully recovered from such surgical procedures;
- Patients with stage IV (metastatic) breast cancer;
- Inability to swallow, intestinal obstruction, or other factors affecting drug intake and absorption;
- Severe heart disease or discomfort that cannot be treated;
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- Suffering from mental illness or psychotropic substance abuse and unable to cooperate;
- Pregnant or lactating female patients;
- Patients with severe liver and kidney function diseases and hematological diseases;
- Those who are not suitable for enrollment in the investigator's opinion: such as a history of drug abuse, blood products, anticoagulant drugs and immunological drugs in the past year; Those with poor compliance and refusal to cooperate with treatment; Doctors with severe hypertension and diabetes are not suitable for the study.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Single-arm, Exploratory Clinical Study of Pyrotinib in Combination With Darcilib and Standard Endocrine Neoadjuvant Therapy for the Treatment of HR+HER2 Low-expression Breast Cancer
This study is a prospective, exploratory clinical study design, and plans to enroll 33 patients with HR+HER2 low expression breast cancer who received pyrotinib combined with darcili and standard endocrine neoadjuvant therapy to evaluate the efficacy of this regimen in HR+HER2 low expression breast cancer. Imaging evaluation was performed according to RECIST 1.1 criteria, and tumor imaging evaluation was performed by the participating center. The pathological evaluation after surgery of neoadjuvant patients was the pCR assessed by the pathologist of the participating center.
- Conditions
- Locally Advanced Breast Cancer (LABC)
- Being tested
- Pyrotinib Maleate Tablets + Dalpiciclib Isethionate Tablets + Standard Endocrine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pyrotinib Maleate Tablets + Dalpiciclib Isethionate Tablets + Standard EndocrineDrug
Pyrotinib Maleate Tablets: 320 mg/day administered continuously from the first day of the first course of treatment, orally within 30 minutes after breakfast, missed doses without refill, every 21 days as a cycle.
Dalpiciclib Isethionate Tablets: 125 mg orally every 28 days as a treatment cycle, with continuous medication for the first 3 weeks (Day 1 to Day 21), and rest (no medication) for the next 1 week (Day 22 to Day 28).
Endocrine therapy: The endocrine therapy drug is selected by the investigator.
| Study group | Role | What they receive |
|---|---|---|
| Pyrotinib Maleate Tablets + Dalpiciclib Isethionate Tablets + Standard Endocrine | Experimental | Pyrotinib Maleate Tablets: 320 mg/day administered continuously from the first day of the first course of treatment, orally within 30 minutes after breakfast, missed doses without refill, every 21 days as a cycle.
Dalpiciclib Isethionate Tablets: 125 mg orally every 28 days as a treatment cycle, with continuous medication for the first 3 weeks (Day 1 to Day 21), and rest (no medication) for the next 1 week (Day 22 to Day 28).
Endocrine therapy: The endocrine therapy drug is selected by the investigator. Receives: Drug: Pyrotinib Maleate Tablets + Dalpiciclib Isethionate Tablets + Standard Endocrine |
What is being measured
The primary outcome is the main question the study is designed to answer.
ORR
Objective remission rate
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2025
- Study start23 Sep 2025 (estimated)
- Primary completion30 Jun 2026 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Locally Advanced Breast Cancer (LABC)Studies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital of Xiamen 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 33 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07189884
- Sponsor's protocol ID
- OBU-BC-Ⅱ-246
- Status last verified
- Aug 2025
- First submitted
- 17 Sep 2025
- Last updated
- 24 Sep 2025
- Results posted
- 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 24 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-arm, Exploratory Clinical Study of Pyrotinib in Combination With Darcilib and Standard Endocrine Neoadjuvant Therapy for the Treatment of HR+HER2 Low-expression Breast Cancer
- ClinicalTrials.gov ID
- NCT07189884
- Acronym / sponsor ID
- OBU-BC-Ⅱ-246
- Conditions
- Locally Advanced Breast Cancer (LABC)
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 33 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Xiamen UniversityUniversity, hospital or other
- Study start
- 23 Sep 2025 (estimated)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 24 Sep 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 study is a prospective, exploratory clinical study design, and plans to enroll 33 patients with HR+HER2 low expression breast cancer who received pyrotinib combined with darcili and standard endocrine neoadjuvant therapy to evaluate the efficacy of this regimen in HR+HER2 low expression breast cancer. Imaging evaluation was performed according to RECIST 1.1 criteria, and tumor imaging evaluation was performed by the participating center. The pathological evaluation after surgery of neoadjuvant patients was the pCR assessed by the pathologist of the participating center.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pyrotinib Maleate Tablets + Dalpiciclib Isethionate Tablets + Standard Endocrine | Experimental | Drug: Pyrotinib Maleate Tablets + Dalpiciclib Isethionate Tablets + Standard EndocrinePyrotinib Maleate Tablets: 320 mg/day administered continuously from the first day of the first course of treatment, orally within 30 minutes after breakfast, missed doses without refill, every 21 days as a cycle. Dalpiciclib Isethionate Tablets: 125 mg orally every 28 days as a treatment cycle, with continuous medication for the first 3 weeks (Day 1 to Day 21), and rest (no medication) for the next 1 week (Day 22 to Day 28). Endocrine therapy: The endocrine therapy drug is selected by the investigator. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Female patients aged ≥18 years and ≤75 years old, who have just been treated for breast cancer;
- Pathological examination confirmed that HR was positive (ER≥10%) and HER2 was low (immunohistochemical staining ICH++ and FISH negative);
- Patients with invasive breast cancer confirmed by pathological examination (T≥3 or N≥1) who are eligible for neoadjuvant therapy;
- ECOG score 0~1 points;
- Planned to undergo definitive surgical resection of breast cancer, i.e., breast-conserving surgery or total mastectomy, sentinel lymph node (SN) biopsy, or axillary lymph node dissection (ALND);
Key exclusion criteria (10 listed)
- Those who have a known history of allergy to the drug components of this regimen;
- Previous anti-tumor therapy or radiotherapy for any malignant tumor (except for cured cervical carcinoma in situ and basal cell carcinoma);
- Underwent major surgical procedures unrelated to breast cancer within 4 weeks, or patients have not fully recovered from such surgical procedures;
- Patients with stage IV (metastatic) breast cancer;
- Inability to swallow, intestinal obstruction, or other factors affecting drug intake and absorption;
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 Maleate Tablets + Dalpiciclib Isethionate Tablets + Standard EndocrinePyrotinib Maleate Tablets: 320 mg/day administered continuously from the first day of the first course of treatment, orally within 30 minutes after breakfast, missed doses without refill, every 21 days as a cycle. Dalpiciclib Isethionate Tablets: 125 mg orally every 28 days as a treatment cycle, with continuous medication for the first 3 weeks (Day 1 to Day 21), and rest (no medication) for the next 1 week (Day 22 to Day 28). Endocrine therapy: The endocrine therapy drug is selected by the investigator. | Drug | Pyrotinib Maleate Tablets + Dalpiciclib Isethionate Tablets + Standard Endocrine |
Primary outcome
ORR
Time frame: 6 month
Objective remission rate
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 24 Sep 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.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Pyrotinib Maleate Tablets + Dalpiciclib Isethionate Tablets + Standard Endocrine in people with Locally Advanced Breast Cancer (LABC), run by The First Affiliated Hospital of Xiamen University.
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 7 inclusion and 10 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: opening soon, as of the sponsor's last update on 24 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 Shuanglong Chen (15618959221850, 1868012@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ORR (time frame: 6 month). 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 24 Sep 2025.