A Phase 2 interventional study of Culmerciclib and Letrozole in Breast Cancer and HR Positive, HER2 Positive Breast Cancer, sponsored by Shengjing Hospital. Not yet recruiting at 1 site in China. Open to female participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-08-31.
Sponsored by Shengjing Hospital · Phase 2, Interventional, and Treatment
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.
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:
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.
14,825 studies on the registry are indexed under Breast Neoplasms; 3,319 are open to participants now.
This study's planned enrollment of 33 is below the median of 72 across 10,896 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Shengjing Hospital is the lead sponsor of 127 studies on the registry; 59 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
HER2 is a protein, made from the ERBB2 gene, that drives the growth of some cancers. A study may look for a level of the protein, extra copies of the gene, or a particular change in it.
In breast cancer, protein tests are read as HER2-positive, HER2-low or HER2-negative; other cancers use their own rules. Check which test result the study requires.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HER2
HER2 is a protein, made from the ERBB2 gene, that drives the growth of some cancers. A study may look for a level of the protein, extra copies of the gene, or a particular change in it.
In breast cancer, protein tests are read as HER2-positive, HER2-low or HER2-negative; other cancers use their own rules. Check which test result the study requires.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients receive Culmerciclib plus letrozole, trastuzumab (TQB211) and pertuzumab (TQB2440) as neoadjuvant therapy for 5 cycles, followed by definitive breast cancer surgery.
Drug: Culmerciclib · Drug: Letrozole · Drug: Trastuzumab (TQB211) · Drug: Pertuzumab (TQB2440)
180 mg orally once daily, in 28-day cycles, for a total of 5 cycles.
2.5 mg orally once daily, in 28-day cycles, for a total of 5 cycles.
8 mg/kg intravenous loading dose, followed by 6 mg/kg intravenously every 3 weeks, for a total of 6 doses.
840 mg intravenous loading dose, followed by 420 mg intravenously every 3 weeks, for a total of 6 doses
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.
Time frame: At time of surgery, after completion of 5 cycles of neoadjuvant therapy (approximately 5 months from treatment start)
Objective Response Rate (ORR)
Proportion of patients achieving complete response (CR) or partial response (PR) assessed by imaging according to RECIST 1.1.
Time frame: 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.
Time frame: 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.
Time frame: From baseline to surgery (approximately 5 months)
Patient-Reported Outcomes (PRO)
Patient-reported quality of life and symptom measures collected during treatment.
Time frame: 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.
Time frame: From first dose through 30 days after surgery (approximately 6 months)
Plan to share: Undecided
No publications or documents are linked to this record.
Start is estimated for Sep 2026; primary completion for Mar 2028, 18 months later.
Of 1,070 non-industry phase 2 interventional studies under Breast Neoplasms, half reached primary completion within 56 months of starting (the median), counting those still running; a quarter within 34 and three quarters within 87. This study's planned 18 months is below that.
Counting every sponsor, half of 1,302 studies reached it within 51 months; a quarter within 30 and three quarters within 82.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Culmerciclib