Optimization of Dynamic Neoadjuvant Therapy Strategies for HER2-Positive Breast Cancer Based on H… (NCT07527806) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Optimization of Dynamic Neoadjuvant Therapy Strategies for HER2-Positive Breast Cancer Based on HER2-PET/CT Molecular Imaging
156 participantsStarted 2026-05-01
Plain-language summary
This study evaluates HER2-PET/CT-guided dynamic optimization of neoadjuvant therapy in patients with early-stage HER2-positive breast cancer. Based on metabolic response after two cycles, patients receive either intenstified treatment (Arm A) or de-escalation treatment (Arm B), alongside with a concurrent standard-treatment control group (Arm C). The study aims to establish a response-adaptive, imaging-guided treatment paradigm to optimize neoadjuvant therapy in HER2-positive breast cancer.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Voluntary participation with written informed consent obtained prior to any study-related procedures
* Age ≥ 18 years, male or female.
* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1
* Histologically confirmed HER2-positive (IHC 3+, or IHC 2+ with ISH amplification) stage I-III (cT1-3/cN0-2) breast cancer
* Tumor diameter ≥ 1.5 cm assessed by imaging, with at least one PET-evaluable lesion present
* Patient must have known estrogen receptor (ER) and progesterone receptor (PR) status. For Arm B, ER expression ≥ 10% and must be strongly positive.
* Adequate bone marrow, liver, and renal function: WBC \> 3.0 × 10⁹/L, ANC ≥ 1.5 × 10⁹/L, PLT ≥ 100 × 10⁹/L, Hb ≥ 10.0 g/dL; total bilirubin ≤ ULN (excluding Gilbert's syndrome), ALP ≤ 2.5 × ULN, AST/ALT ≤ 1.5 × ULN; creatinine ≤ 1.5 × ULN or creatinine clearance ≥ 50 mL/min.
* Patients who participate in the trial have good compliance and are willing to comply with the follow-up visit.
Exclusion Criteria:
* Prior treatment with any chemotherapy, anti-HER2 therapy, radiotherapy, or endocrine therapy, etc
* Locally advanced (cT4/cN3) or bilateral breast cancer
* Patients with known allergies to any active ingredients or excipients of investigational medicinal product
* Other malignancy diagnosed within 5 years prior to enrollment, excluding cervical carcinoma in situ and cured melanoma skin cancer
* Left ventricular ejection fraction (LVEF) \< 55%
* Uncontrolled hypertension (systolic \> 15…
What they're measuring
1
rate of pathologic complete response (pCR)
Timeframe: Up to 6 months after treatment start
Trial details
NCT IDNCT07527806
SponsorPeking University Cancer Hospital & Institute