Breast CancerPhase 2NCT07492394
Dalpiciclib With or Without Entinostat and Letrozole in HR+/HER2- Early Breast Cancer
A Phase 2 study testing entinostat, Dalpiciclib and Letrozole in people with Breast Cancer, run by Hebei Medical University Fourth Hospital at 1 site in China.
Trial summary
Brief Summary This is an open-label, randomized, phase II clinical study designed to evaluate neoadjuvant treatment regimens in patients with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) early breast cancer. 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?
- entinostat, Dalpiciclib and Letrozole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 12 Sep 2025to 31 Dec 2031
- 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
- Inclusion Criteria
- Female patients aged ≥18 and <75 years, including postmenopausal, premenopausal, or perimenopausal. Postmenopause is defined as:Prior bilateral oophorectomy, or age ≥60 years; orAge <60 years, natural postmenopause (spontaneous cessation of menses for ≥12 months without other pathological or physiological cause) with estradiol (E2) and FSH in postmenopausal range; orPremenopausal or perimenopausal women willing to receive LHRH agonist (OFS) therapy during the study.
- Histologically confirmed estrogen receptor (ER)-positive (>10%) invasive breast cancer, regardless of PR expression, and HER2-negative according to the 2018 ASCO/CAP HER2 testing guidelines (IHC 0+ or IHC 2+ with ISH-negative, amplification ratio <2.0).
- At least one measurable lesion according to RECIST 1.1; clinical stage T1c-T2, cN1-2, or T3-T4, cN0-2.
- No prior anticancer therapy for breast cancer, including chemotherapy,endocrine therapy, or targeted therapy.
- Ability to swallow oral medications.
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- Baseline left ventricular ejection fraction (LVEF) ≥50%.
- Adequate organ function:Hematology (within 1 week):Absolute neutrophil count (ANC) ≥1.5 × 10⁹/L;White blood cell count (WBC) ≥3.0 × 10⁹/L;Platelet count ≥90 × 10⁹/L;Hemoglobin ≥90 g/L Liver and kidney function (within 1 week):Total bilirubin (TBIL) ≤ upper limit of normal (ULN);ALT and AST ≤1.5 × ULNBUN and creatinine ≤1.5 × ULN, with creatinine clearance ≥60 mL/min (Cockcroft-Gault formula)
- ECG: Corrected QT interval ≤470 ms (12-lead ECG)
- Willingness and ability to undergo all required biopsy procedures.
- Women of childbearing potential must have a negative pregnancy test before study entry and agree to use medically acceptable contraception during the study; postmenopausal women are exempt.
- Voluntary participation with signed informed consent, good compliance, and willingness to adhere to follow-up requirements.
Who cannot join
- Exclusion Criteria
- Pregnant or breastfeeding women, or women with a positive pregnancy test at baseline; women of childbearing potential unwilling to use effective contraception during the study.
- Bilateral breast cancer or inflammatory breast cancer.
- Stage IV (metastatic) breast cancer at initial diagnosis.
- History of congestive heart failure, unstable angina, significant arrhythmia, or myocardial infarction.
- Active pulmonary disease, including interstitial lung disease, pneumonia, pulmonary fibrosis, or other acute lung conditions.
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- Significant liver disease, such as acute or fulminant hepatitis, impaired coagulation factor synthesis, or other severe hepatic dysfunction.
- For patients positive for HBsAg or HBV core antibody, peripheral blood HBV DNA must be <1×10³ IU/mL to be eligible.
- Any concurrent disease or condition that may interfere with study participation or affect patient safety (e.g., active or uncontrolled infection).
- Other invasive malignancies (including second primary breast cancer) that may interfere with study outcomes or compliance.
- Prior chemotherapy, endocrine therapy, or biologic therapy for breast cancer (except diagnostic biopsy for primary breast cancer).
- Major surgery within 4 weeks prior to study entry or unresolved significant medical conditions.
- Tumors that are non-measurable during the study treatment.
- Any other condition that, in the investigator's judgment, makes the subject unsuitable for participation.
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
The Fourth Hospital of Hebei Medical University
Shijiazhuang, Hebei, 050000
Zhenchuan Song, 185 31117857, songzhch@hotmail.com
About this study
Official title: An Open-Label, Randomized, Phase II Study of Dalpiciclib in Combination With Entinostat and Letrozole Versus Dalpiciclib Plus Letrozole as Neoadjuvant Therapy in Patients With HR-positive, HER2-negative Early Breast Cancer
Brief Summary This is an open-label, randomized, phase II clinical study designed to evaluate neoadjuvant treatment regimens in patients with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) early breast cancer.
A total of 60 premenopausal, perimenopausal, and postmenopausal patients with HR+/HER2- breast cancer who meet the inclusion criteria will be enrolled. During the study, clinical information will be collected according to standard practice, including demographic data, tumor imaging, and pathological results (e.g., Ki-67). Investigator-assessed outcomes will be used as the final results.
Read more
After 14 days of treatment, patients who provide consent will undergo a second biopsy to evaluate the rate of complete cell-cycle arrest. Safety assessments and imaging evaluations will be performed at treatment completion or upon study withdrawal. Informed consent must be obtained at each study center before participation.
Treatment arms:
Arm A (30 patients):
Dalpiciclib 125 mg orally once daily on Days 1-21 of each 28-day cycle (3 weeks on, 1 week off), for 6 cycles Letrozole 2.5 mg orally once daily continuously for 6 cycles Entinostat 3 mg orally once weekly (Days 1-28 of each 28-day cycle), for 6 cycles
Arm B (30 patients):
Dalpiciclib 150 mg orally once daily on Days 1-21 of each 28-day cycle, for 6 cycles Letrozole 2.5 mg orally once daily continuously for 6 cycles Premenopausal and perimenopausal women will also receive ovarian function suppression (OFS), such as with a GnRHa agent.
After signing informed consent, patients will begin neoadjuvant therapy with dalpiciclib plus entinostat and letrozole ± OFS. Ultrasound assessments will be conducted every two treatment cycles and before surgery under the same imaging conditions as baseline. Bone scans will be performed at the end of neoadjuvant treatment. MRI of the breast will be performed at baseline, after two cycles, and before surgery to assess treatment efficacy. Treatment discontinuation will occur if toxicity is intolerable, consent is withdrawn, or the investigator determines it is necessary.
Adjuvant therapy:
After surgery, patients will receive physician's choice of therapy (TPC).
Safety follow-up:
Patients will be followed until they start another anticancer therapy, all adverse events have resolved to Grade 0-1 or baseline level, or death-whichever occurs first.
Read the detailed description
For patients with HR-positive, HER2-negative early or locally advanced breast cancer, achieving a clinical complete response with traditional neoadjuvant chemotherapy is challenging, and treatment tolerance is often suboptimal. Endocrine therapy plays an important role in both early-stage and advanced HR+/HER2- breast cancer; however, its efficacy in the neoadjuvant setting remains to be further clarified. Existing studies have shown that, compared with neoadjuvant chemotherapy, neoadjuvant endocrine therapy in HR+/HER2- breast cancer yields comparable clinical complete response and breast-conserving surgery rates, with substantially lower toxicity. Therefore, strategies to further improve response to neoadjuvant endocrine therapy may be more meaningful than intensifying chemotherapy in this population.
With the clinical availability of CDK4/6 inhibitors, the efficacy of neoadjuvant endocrine therapy has been further improved. Results from DAWNA-1, DAWNA-2, and DAWNA-A have strengthened the evidence base supporting the use of the domestically developed CDK4/6 inhibitor dalpiciclib in the adjuvant treatment of breast cancer.
However, some studies have found that increased histone deacetylase (HDAC) activity in the estrogen receptor (ER) promoter region can suppress ER expression and lead to endocrine therapy resistance. Entinostat is an oral HDAC inhibitor that selectively inhibits class I (primarily HDAC1 and HDAC3) and class IV HDACs. In the phase III study EOC103A3101 conducted in China, entinostat significantly improved median progression-free survival (PFS) compared with placebo (6.32 vs. 3.72 months), reducing the risk of disease progression or death by 24% (HR 0.76). Median overall survival (OS) was also prolonged in the entinostat group (38.39 months), with a 17% reduction in mortality risk (HR 0.83), demonstrating clinically meaningful survival benefits.
Based on these findings, the present study aims to further evaluate whether the combination of dalpiciclib, entinostat, and letrozole as neoadjuvant therapy for patients with HR-positive, HER2-negative early breast cancer may provide an improved clinical strategy compared with current standards.
- Conditions
- Breast Cancer
- Being tested
- entinostat, 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.
entinostatDrug
Also called HDAC inhibitor
Entinostat is added in the experimental arm, while the control arm does not receive Entinostat.
DalpiciclibDrug
Dalpiciclib is both added in the experimental arm and control arm.
LetrozoleDrug
Letrozole is both added in the experimental arm and control arm.
| Study group | Role | What they receive |
|---|---|---|
| Dalpiciclib Plus Letrozole and Entinostat Arm | Experimental | Dalpiciclib: 125 mg orally once daily on Days 1-21 of each 28-day cycle (3 weeks on, 1 week off), for a total of 6 cycles.
Letrozole: 2.5 mg orally once daily continuously, for a total of 6 cycles. Entinostat: 3 mg orally once weekly on Days 1-28 of each 28-day cycle, for a total of 6 cycles. Receives: Drug: Dalpiciclib; Drug: Letrozole |
| Dalpiciclib Plus Letrozole Arm | Placebo comparator | Dalpiciclib: 150 mg orally once daily on Days 1-21 of each 28-day cycle (3 weeks on, 1 week off), for a total of 6 cycles.
Letrozole: 2.5 mg orally once daily continuously, for a total of 6 cycles. Receives: Drug: entinostat; Drug: Dalpiciclib; Drug: Letrozole |
What is being measured
The primary outcome is the main question the study is designed to answer.
ORR
Objective Response Rate (ORR) is defined as the proportion of participants who achieve a complete response (CR) or partial response (PR) as assessed according to RECIST v1.1 criteria. Tumor response must be confirmed by repeat imaging at least 4 weeks after the initial documentation of response.
Measured: From baseline to end of neoadjuvant therapy (approximately 6 cycles, ~24 weeks
Secondary outcomes (3)
tpCR
Total pathological complete response (tpCR) is defined as the absence of residual invasive cancer in both the breast and axillary lymph nodes following neoadjuvant therapy, corresponding to ypT0/Tis, ypN0.
Measured: At the time of definitive surgery (approximately 18-24 weeks after initiation of neoadjuvant therapy)
Breast-conserving surgery (BCS) rate
Breast-conserving surgery rate is defined as the proportion of participants who undergo breast-conserving surgery (lumpectomy) among all participants who proceed to definitive breast surgery after completion of neoadjuvant therapy. The classification of breast-conserving surgery is based on the operative report and pathology assessment.
Measured: At the time of definitive surgery
Proportion of participants achieving PEPI 0
PEPI 0 (Preoperative Endocrine Prognostic Index score of 0) is defined as meeting all of the following criteria at surgery after completion of neoadjuvant endocrine-based therapy:
Pathologic tumor size: ypT1 or smaller (≤2 cm)
Nodal status: ypN0 (no metastatic involvement in regional lymph nodes)
Ki-67 proliferation index: ≤2.7% in the surgical specimen
Estrogen receptor (ER): Allred score of 3-8 (ER-positive)
Participants meeting all components are classified as achieving PEPI score = 0, indicating an extremely low risk of relapse.
Measured: At the time of definitive surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2026
- Study start12 Sep 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2031 (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 Hebei Medical University Fourth 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
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hebei Medical University Fourth Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Jiangsu Hengrui Pharmaceutical Co., Ltd.
- Responsible party
- Sponsor
- Investigators
- Zhenchuan Song, Study chair, he Fourth Hospital of Hebei Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07492394
- Sponsor's protocol ID
- OBU-BC-II-278
- Status last verified
- Mar 2026
- First submitted
- 4 Dec 2025
- Last updated
- 2 Apr 2026
- 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 2 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Randomized, Phase II Study of Dalpiciclib in Combination With Entinostat and Letrozole Versus Dalpiciclib Plus Letrozole as Neoadjuvant Therapy in Patients With HR-positive, HER2-negative Early Breast Cancer
- ClinicalTrials.gov ID
- NCT07492394
- Acronym / sponsor ID
- OBU-BC-II-278
- Conditions
- Breast Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Hebei Medical University Fourth HospitalUniversity, hospital or other
- Collaborators
- Jiangsu Hengrui Pharmaceutical Co., Ltd.
- Study start
- 12 Sep 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2031 (estimated)
- First posted
- 25 Mar 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.
Brief Summary This is an open-label, randomized, phase II clinical study designed to evaluate neoadjuvant treatment regimens in patients with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) early breast cancer.
A total of 60 premenopausal, perimenopausal, and postmenopausal patients with HR+/HER2- breast cancer who meet the inclusion criteria will be enrolled. During the study, clinical information will be collected according to standard practice, including demographic data, tumor imaging, and pathological results (e.g., Ki-67). Investigator-assessed outcomes will be used as the final results.
After 14 days of treatment, patients who provide consent will undergo a second biopsy to evaluate the rate of complete cell-cycle arrest. Safety assessments and imaging evaluations will be performed at treatment completion or upon study withdrawal. Informed consent must be obtained at each study center before participation.
Treatment arms:
Arm A (30 patients):
Dalpiciclib 125 mg orally once daily on Days 1-21 of each 28-day cycle (3 weeks on, 1 week off), for 6 cycles Letrozole 2.5 mg orally once daily continuously for 6 cycles Entinostat 3 mg orally once weekly (Days 1-28 of each 28-day cycle), for 6 cycles
Arm B (30 patients):
Dalpiciclib 150 mg orally once daily on Days 1-21 of each 28-day cycle, for 6 cycles Letrozole 2.5 mg orally once daily continuously for 6 cycles Premenopausal and perimenopausal women will also receive ovarian function suppression (OFS), such as with a GnRHa agent.
After signing informed consent, patients will begin neoadjuvant therapy with dalpiciclib plus entinostat and letrozole ± OFS. Ultrasound assessments will be conducted every two treatment cycles and before surgery under the same imaging conditions as baseline. Bone scans will be performed at the end of neoadjuvant treatment. MRI of the breast will be performed at baseline, after two cycles, and before surgery to assess treatment efficacy. Treatment discontinuation will occur if toxicity is intolerable, consent is withdrawn, or the investigator determines it is necessary.
Adjuvant therapy:
After surgery, patients will receive physician's choice of therapy (TPC).
Safety follow-up:
Patients will be followed until they start another anticancer therapy, all adverse events have resolved to Grade 0-1 or baseline level, or death-whichever occurs first.
Detailed description
For patients with HR-positive, HER2-negative early or locally advanced breast cancer, achieving a clinical complete response with traditional neoadjuvant chemotherapy is challenging, and treatment tolerance is often suboptimal. Endocrine therapy plays an important role in both early-stage and advanced HR+/HER2- breast cancer; however, its efficacy in the neoadjuvant setting remains to be further clarified. Existing studies have shown that, compared with neoadjuvant chemotherapy, neoadjuvant endocrine therapy in HR+/HER2- breast cancer yields comparable clinical complete response and breast-conserving surgery rates, with substantially lower toxicity. Therefore, strategies to further improve response to neoadjuvant endocrine therapy may be more meaningful than intensifying chemotherapy in this population.
With the clinical availability of CDK4/6 inhibitors, the efficacy of neoadjuvant endocrine therapy has been further improved. Results from DAWNA-1, DAWNA-2, and DAWNA-A have strengthened the evidence base supporting the use of the domestically developed CDK4/6 inhibitor dalpiciclib in the adjuvant treatment of breast cancer.
However, some studies have found that increased histone deacetylase (HDAC) activity in the estrogen receptor (ER) promoter region can suppress ER expression and lead to endocrine therapy resistance. Entinostat is an oral HDAC inhibitor that selectively inhibits class I (primarily HDAC1 and HDAC3) and class IV HDACs. In the phase III study EOC103A3101 conducted in China, entinostat significantly improved median progression-free survival (PFS) compared with placebo (6.32 vs. 3.72 months), reducing the risk of disease progression or death by 24% (HR 0.76). Median overall survival (OS) was also prolonged in the entinostat group (38.39 months), with a 17% reduction in mortality risk (HR 0.83), demonstrating clinically meaningful survival benefits.
Based on these findings, the present study aims to further evaluate whether the combination of dalpiciclib, entinostat, and letrozole as neoadjuvant therapy for patients with HR-positive, HER2-negative early breast cancer may provide an improved clinical strategy compared with current standards.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dalpiciclib Plus Letrozole and Entinostat Arm | Experimental | Drug: Dalpiciclib, Drug: LetrozoleDalpiciclib: 125 mg orally once daily on Days 1-21 of each 28-day cycle (3 weeks on, 1 week off), for a total of 6 cycles. Letrozole: 2.5 mg orally once daily continuously, for a total of 6 cycles. Entinostat: 3 mg orally once weekly on Days 1-28 of each 28-day cycle, for a total of 6 cycles. |
| Dalpiciclib Plus Letrozole Arm | Placebo comparator | Drug: entinostat, Drug: Dalpiciclib, Drug: LetrozoleDalpiciclib: 150 mg orally once daily on Days 1-21 of each 28-day cycle (3 weeks on, 1 week off), for a total of 6 cycles. Letrozole: 2.5 mg orally once daily continuously, for a total of 6 cycles. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Inclusion Criteria
- Female patients aged ≥18 and <75 years, including postmenopausal, premenopausal, or perimenopausal. Postmenopause is defined as:Prior bilateral oophorectomy, or age ≥60 years; orAge <60 years, natural postmenopause (spontaneous cessation of menses for ≥12 months without other pathological or physiological cause) with estradiol (E2) and FSH in postmenopausal range; orPremenopausal or perimenopausal women willing to receive LHRH agonist (OFS) therapy during the study.
- Histologically confirmed estrogen receptor (ER)-positive (>10%) invasive breast cancer, regardless of PR expression, and HER2-negative according to the 2018 ASCO/CAP HER2 testing guidelines (IHC 0+ or IHC 2+ with ISH-negative, amplification ratio <2.0).
- At least one measurable lesion according to RECIST 1.1; clinical stage T1c-T2, cN1-2, or T3-T4, cN0-2.
- No prior anticancer therapy for breast cancer, including chemotherapy,endocrine therapy, or targeted therapy.
Key exclusion criteria (14 listed)
- Exclusion Criteria
- Pregnant or breastfeeding women, or women with a positive pregnancy test at baseline; women of childbearing potential unwilling to use effective contraception during the study.
- Bilateral breast cancer or inflammatory breast cancer.
- Stage IV (metastatic) breast cancer at initial diagnosis.
- History of congestive heart failure, unstable angina, significant arrhythmia, or myocardial infarction.
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 |
|---|---|---|
| entinostatAlso: HDAC inhibitorEntinostat is added in the experimental arm, while the control arm does not receive Entinostat. | Drug | Dalpiciclib Plus Letrozole Arm |
| DalpiciclibDalpiciclib is both added in the experimental arm and control arm. | Drug | Dalpiciclib Plus Letrozole Arm, Dalpiciclib Plus Letrozole and Entinostat Arm |
| LetrozoleLetrozole is both added in the experimental arm and control arm. | Drug | Dalpiciclib Plus Letrozole Arm, Dalpiciclib Plus Letrozole and Entinostat Arm |
Primary outcome
ORR
Time frame: From baseline to end of neoadjuvant therapy (approximately 6 cycles, ~24 weeks
Objective Response Rate (ORR) is defined as the proportion of participants who achieve a complete response (CR) or partial response (PR) as assessed according to RECIST v1.1 criteria. Tumor response must be confirmed by repeat imaging at least 4 weeks after the initial documentation of response.
3 secondary outcomes
tpCR
Time frame: At the time of definitive surgery (approximately 18-24 weeks after initiation of neoadjuvant therapy)
Breast-conserving surgery (BCS) rate
Time frame: At the time of definitive surgery
Proportion of participants achieving PEPI 0
Time frame: At the time of definitive surgery
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 2 Apr 2026.
- 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.
Zhenchuan Song study chair
he Fourth Hospital of Hebei Medical University
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 entinostat, Dalpiciclib and Letrozole in people with Breast Cancer, run by Hebei Medical University Fourth 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 12 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: looking for participants now, as of the sponsor's last update on 2 Apr 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. Some participants in this study may receive a placebo. 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 Zhenchuan Song (18531117857, songzhch@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ORR (time frame: From baseline to end of neoadjuvant therapy (approximately 6 cycles, ~24 weeks). 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 2 Apr 2026.