Health Trials

Culmerciclib Combined With Letrozole and Dual HER2 Blockade as Neoadjuvant Therapy for HR+/HER2+ Breast Cancer

ConditionsBreast CancerHR Positive, HER2 Positive Breast Cancer
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18-70
SponsorShengjing Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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;

Trial design

Design model

Single group

Treatments tested in this trial

  • Culmerciclib

    Drug

    180 mg orally once daily, in 28-day cycles, for a total of 5 cycles.

  • Letrozole

    Drug

    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

Treatment groups

33 Participants
are divided into 1 treatment group
Group A: Culmerciclib + Letrozole + TQB211 + TQB2440Experimental treatment 4 interventions

Trial outcomes

Primary outcomes

1

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)

Secondary outcomes

1

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)
2

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)
3

Ki67 Change Rate

Change in Ki67 proliferation index from baseline (pre-treatment biopsy) to surgery.

Time frame
From baseline to surgery (approximately 5 months)
4

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)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Shengjing Hospital

Lead sponsor

Liaoning Cancer Hospital & Institute

Sponsor institution

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: