Breast CancerPhase 2NCT07795424
Culmerciclib Combined With Letrozole and Dual HER2 Blockade as Neoadjuvant Therapy for HR+/HER2+ Breast Cancer
A Phase 2 study testing Culmerciclib, Letrozole and Trastuzumab (TQB211) in people with Breast Cancer and HR Positive, HER2 Positive Breast Cancer, run by Shengjing Hospital at 1 site in China.
Trial summary
This is a single-arm, prospective, multicenter, phase II clinical study evaluating the efficacy and safety of a chemotherapy-free neoadjuvant regimen in patients with HR-positive/HER2-positive (HR+/HER2+) early or locally advanced breast cancer. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Breast Cancer, HR Positive, HER2 Positive Breast Cancer
- What is being tested?
- Culmerciclib, Letrozole and Trastuzumab (TQB211)
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2026to 30 Jun 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 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed HR-positive (ER >=50%, PR >=10%) and HER2-positive (IHC 3+ or ISH+) breast cancer;
- Clinical stage II-III (AJCC 8th edition);
- Treatment-naive: no prior systemic anti-tumor therapy for breast cancer;
- ECOG performance status 0-1;
- Adequate organ function;
- Signed informed consent.
Who cannot join
- Distant metastasis (stage IV disease);
- Prior chemotherapy, endocrine therapy, or anti-HER2 therapy for the current breast cancer;
- Severe cardiac dysfunction or left ventricular ejection fraction (LVEF) below the institutional lower limit of normal;
- Pregnancy or lactation;
- Any other condition that, in the investigator's opinion, makes the patient unsuitable for the study.
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
Liaoning Cancer Hospital & Institute
Shenyang, Liaoning, 110042
Jianyi Li, MD, PhD, +86-13390127607, sjbreast@yeah.net
About this study
Official title: A Single-Arm, Prospective, Multicenter Phase II Study of Culmerciclib Plus Letrozole and Trastuzumab (TQB211)/Pertuzumab (TQB2440) as Neoadjuvant Therapy in Patients With HR-Positive/HER2-Positive Early or Locally Advanced Breast Cancer
This is a single-arm, prospective, multicenter, phase II clinical study evaluating the efficacy and safety of a chemotherapy-free neoadjuvant regimen in patients with HR-positive/HER2-positive (HR+/HER2+) early or locally advanced breast cancer.
Approximately 33 treatment-naive patients with stage II-III (AJCC 8th edition) HR+/HER2+ breast cancer will receive 5 cycles of neoadjuvant treatment with culmerciclib (a CDK4/6 inhibitor) plus letrozole, trastuzumab (TQB211) and pertuzumab (TQB2440), followed by definitive breast surgery.
The primary endpoint is breast pathological complete response rate (bpCR, ypT0/is ypN0). Secondary endpoints include objective response rate (ORR), residual cancer burden (RCB), Ki67 change rate, patient-reported outcomes, and safety assessed per CTCAE v5.0.
Read the detailed description
HR-positive/HER2-positive breast cancer accounts for approximately 10% of all breast cancers and shows lower pathological complete response rates to neoadjuvant therapy compared with the HR-negative/HER2-positive subtype. Crosstalk between HER2 and ER signaling pathways contributes to resistance to endocrine and anti-HER2 therapy. Preclinical evidence suggests that CDK4/6 inhibitors synergize with anti-HER2 therapy and may restore tumor sensitivity to HER2 blockade.
Eligible patients receive:
- culmerciclib 180 mg orally once daily, in 28-day cycles, for 5 cycles;
- Letrozole 2.5 mg orally once daily, in 28-day cycles, for 5 cycles;
- Trastuzumab (TQB211) 8 mg/kg loading dose followed by 6 mg/kg intravenously every 3 weeks, for 6 doses;
- Pertuzumab (TQB2440) 840 mg loading dose followed by 420 mg intravenously every 3 weeks, for 6 doses.
Tumor response is assessed by imaging (ultrasound, mammography, and MRI) according to RECIST 1.1. After completion of 5 cycles of neoadjuvant treatment, patients undergo definitive breast cancer surgery, and postoperative pathology is evaluated for bpCR and RCB. Adverse events are assessed per CTCAE v5.0. Exploratory analyses will investigate correlations between biomarkers and treatment response.
- Being tested
- Culmerciclib, Letrozole, Trastuzumab (TQB211), Pertuzumab (TQB2440)
- Keywords
- Neoadjuvant Therapy CDK4/6 Inhibitor Culmerciclib Letrozole Trastuzumab Pertuzumab Chemotherapy-free
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CulmerciclibDrug
180 mg orally once daily, in 28-day cycles, for a total of 5 cycles.
LetrozoleDrug
2.5 mg orally once daily, in 28-day cycles, for a total of 5 cycles.
Trastuzumab (TQB211)Drug
8 mg/kg intravenous loading dose, followed by 6 mg/kg intravenously every 3 weeks, for a total of 6 doses.
Pertuzumab (TQB2440)Drug
840 mg intravenous loading dose, followed by 420 mg intravenously every 3 weeks, for a total of 6 doses
| Study group | Role | What they receive |
|---|---|---|
| Culmerciclib + Letrozole + TQB211 + TQB2440 | Experimental | Patients receive Culmerciclib plus letrozole, trastuzumab (TQB211) and pertuzumab (TQB2440) as neoadjuvant therapy for 5 cycles, followed by definitive breast cancer surgery. Receives: Drug: Culmerciclib; Drug: Letrozole; Drug: Trastuzumab (TQB211); Drug: Pertuzumab (TQB2440) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Breast Pathological Complete Response Rate (bpCR)
Proportion of patients achieving ypT0/is ypN0 (no invasive cancer in the breast and no involved axillary lymph nodes), assessed by postoperative pathology.
Measured: At time of surgery, after completion of 5 cycles of neoadjuvant therapy (approximately 5 months from treatment start)
Secondary outcomes (5)
Objective Response Rate (ORR)
Proportion of patients achieving complete response (CR) or partial response (PR) assessed by imaging according to RECIST 1.1.
Measured: At end of neoadjuvant treatment (approximately 5 months from treatment start)
Residual Cancer Burden (RCB)
Residual cancer burden index and class (RCB-0, I, II, III) assessed by postoperative pathology.
Measured: At time of surgery (approximately 5 months from treatment start)
Ki67 Change Rate
Change in Ki67 proliferation index from baseline (pre-treatment biopsy) to surgery.
Measured: From baseline to surgery (approximately 5 months)
Patient-Reported Outcomes (PRO)
Patient-reported quality of life and symptom measures collected during treatment.
Measured: From baseline through end of treatment (approximately 5 months)
Incidence and Severity of Adverse Events
Number and severity of adverse events graded according to CTCAE v5.0.
Measured: From first dose through 30 days after surgery (approximately 6 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2026
- Study start1 Sep 2026 (estimated)
- Primary completion30 Mar 2028 (estimated)
- Study completion30 Jun 2028 (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.
- 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
- 33 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shengjing Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jianyi Li, Liaoning Cancer Hospital & Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07795424
- Sponsor's protocol ID
- IIT2026052
- Status last verified
- Aug 2026
- First submitted
- 26 Aug 2026
- Last updated
- 31 Aug 2026
- Results posted
- No
- 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 31 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Arm, Prospective, Multicenter Phase II Study of Culmerciclib Plus Letrozole and Trastuzumab (TQB211)/Pertuzumab (TQB2440) as Neoadjuvant Therapy in Patients With HR-Positive/HER2-Positive Early or Locally Advanced Breast Cancer
- ClinicalTrials.gov ID
- NCT07795424
- Acronym / sponsor ID
- IIT2026052
- Keywords
- Neoadjuvant Therapy CDK4/6 Inhibitor Culmerciclib Letrozole Trastuzumab Pertuzumab Chemotherapy-free
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 33 participants (estimated)
- Lead sponsor
- Shengjing HospitalUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 30 Mar 2028 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 31 Aug 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.
This is a single-arm, prospective, multicenter, phase II clinical study evaluating the efficacy and safety of a chemotherapy-free neoadjuvant regimen in patients with HR-positive/HER2-positive (HR+/HER2+) early or locally advanced breast cancer.
Approximately 33 treatment-naive patients with stage II-III (AJCC 8th edition) HR+/HER2+ breast cancer will receive 5 cycles of neoadjuvant treatment with culmerciclib (a CDK4/6 inhibitor) plus letrozole, trastuzumab (TQB211) and pertuzumab (TQB2440), followed by definitive breast surgery.
The primary endpoint is breast pathological complete response rate (bpCR, ypT0/is ypN0). Secondary endpoints include objective response rate (ORR), residual cancer burden (RCB), Ki67 change rate, patient-reported outcomes, and safety assessed per CTCAE v5.0.
Detailed description
HR-positive/HER2-positive breast cancer accounts for approximately 10% of all breast cancers and shows lower pathological complete response rates to neoadjuvant therapy compared with the HR-negative/HER2-positive subtype. Crosstalk between HER2 and ER signaling pathways contributes to resistance to endocrine and anti-HER2 therapy. Preclinical evidence suggests that CDK4/6 inhibitors synergize with anti-HER2 therapy and may restore tumor sensitivity to HER2 blockade.
Eligible patients receive:
- culmerciclib 180 mg orally once daily, in 28-day cycles, for 5 cycles;
- Letrozole 2.5 mg orally once daily, in 28-day cycles, for 5 cycles;
- Trastuzumab (TQB211) 8 mg/kg loading dose followed by 6 mg/kg intravenously every 3 weeks, for 6 doses;
- Pertuzumab (TQB2440) 840 mg loading dose followed by 420 mg intravenously every 3 weeks, for 6 doses.
Tumor response is assessed by imaging (ultrasound, mammography, and MRI) according to RECIST 1.1. After completion of 5 cycles of neoadjuvant treatment, patients undergo definitive breast cancer surgery, and postoperative pathology is evaluated for bpCR and RCB. Adverse events are assessed per CTCAE v5.0. Exploratory analyses will investigate correlations between biomarkers and treatment response.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Culmerciclib + Letrozole + TQB211 + TQB2440 | Experimental | Drug: Culmerciclib, Drug: Letrozole, Drug: Trastuzumab (TQB211), Drug: Pertuzumab (TQB2440)Patients receive Culmerciclib plus letrozole, trastuzumab (TQB211) and pertuzumab (TQB2440) as neoadjuvant therapy for 5 cycles, followed by definitive breast cancer surgery. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Histologically confirmed HR-positive (ER >=50%, PR >=10%) and HER2-positive (IHC 3+ or ISH+) breast cancer;
- Clinical stage II-III (AJCC 8th edition);
- Treatment-naive: no prior systemic anti-tumor therapy for breast cancer;
- ECOG performance status 0-1;
- Adequate organ function;
Key exclusion criteria (5 listed)
- Distant metastasis (stage IV disease);
- Prior chemotherapy, endocrine therapy, or anti-HER2 therapy for the current breast cancer;
- Severe cardiac dysfunction or left ventricular ejection fraction (LVEF) below the institutional lower limit of normal;
- Pregnancy or lactation;
- Any other condition that, in the investigator's opinion, makes the patient unsuitable for the study.
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 |
|---|---|---|
| Culmerciclib180 mg orally once daily, in 28-day cycles, for a total of 5 cycles. | Drug | Culmerciclib + Letrozole + TQB211 + TQB2440 |
| Letrozole2.5 mg orally once daily, in 28-day cycles, for a total of 5 cycles. | Drug | Culmerciclib + Letrozole + TQB211 + TQB2440 |
| Trastuzumab (TQB211)8 mg/kg intravenous loading dose, followed by 6 mg/kg intravenously every 3 weeks, for a total of 6 doses. | Drug | Culmerciclib + Letrozole + TQB211 + TQB2440 |
| Pertuzumab (TQB2440)840 mg intravenous loading dose, followed by 420 mg intravenously every 3 weeks, for a total of 6 doses | Drug | Culmerciclib + Letrozole + TQB211 + TQB2440 |
Primary outcome
Breast Pathological Complete Response Rate (bpCR)
Time frame: At time of surgery, after completion of 5 cycles of neoadjuvant therapy (approximately 5 months from treatment start)
Proportion of patients achieving ypT0/is ypN0 (no invasive cancer in the breast and no involved axillary lymph nodes), assessed by postoperative pathology.
5 secondary outcomes
Objective Response Rate (ORR)
Time frame: At end of neoadjuvant treatment (approximately 5 months from treatment start)
Residual Cancer Burden (RCB)
Time frame: At time of surgery (approximately 5 months from treatment start)
Ki67 Change Rate
Time frame: From baseline to surgery (approximately 5 months)
Patient-Reported Outcomes (PRO)
Time frame: From baseline through end of treatment (approximately 5 months)
Incidence and Severity of Adverse Events
Time frame: From first dose through 30 days after surgery (approximately 6 months)
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 31 Aug 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 Culmerciclib, Letrozole and Trastuzumab (TQB211) in people with Breast Cancer and HR Positive, HER2 Positive Breast Cancer, run by Shengjing 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 6 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: opening soon, as of the sponsor's last update on 31 Aug 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 Mingda Zhao (+86-18509866694, zhaomingda2021@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Breast Pathological Complete Response Rate (bpCR) (time frame: At time of surgery, after completion of 5 cycles of neoadjuvant therapy (approximately 5 months from treatment start)). 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 31 Aug 2026.