Clinical trial · Interventional
Optimization of Dynamic Neoadjuvant Therapy Strategies for HER2-Positive Breast Cancer Based on HER2-PET/CT Molecular Imaging
A Prospective, Double-Arm Study on the Optimization of Dynamic Neoadjuvant Therapy Strategies for HER2-Positive Breast Cancer Based on HER2-PET/CT Molecular Imaging
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (8)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ADC | Drug | — | UNRESOLVED |
| Aromatase Inhibitor (AI) | Drug | Aromatase Inhibitor | ALIAS |
| carboplatin | Drug | Carboplatin | ALIAS |
| CDK4/6 inhibitor | Drug | — | UNRESOLVED |
| Combination product: Trastuzumab + Pertuzumab | Drug | — | UNRESOLVED |
| Docetaxel or Nab-paclitaxel | Drug | — | UNRESOLVED |
| Pertuzumab | Drug | Pertuzumab | ALIAS |
| Trastuzumab (Herceptin) | Drug | Trastuzumab | ALIAS |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Cohort A
- description
- The initial treatment regimen is the TCbHP (Trastuzumab + Pertuzumab + Docetaxel/Nab-paclitaxel + Carboplatin). After two cycles, patients assessed as metabolic responders by HER2 PET continue the TCbHP regimen for a total of six cycles, followed by surgery. Metabolic non-responders are switched to either SHR-A1811 (4.8 mg intravenously every 21 days) or Trastuzumab Deruxtecan (T-DXd, 5.4 mg/kg intravenously every 21 days) for four cycles of intensified therapy.
- interventionNames
- Drug: Trastuzumab (Herceptin)
- Drug: Pertuzumab
- Drug: Combination product: Trastuzumab + Pertuzumab
- Drug: Docetaxel or Nab-paclitaxel
- Drug: carboplatin
- Drug: ADC
- type
- EXPERIMENTAL
- label
- Cohort B
- description
- The initial treatment regimen consists of trastuzumab + pertuzumab + CDK4/6 inhibitor + aromatase inhibitor (AI) ± GnRHa. After two cycles, patients assessed as metabolic responders by HER2 PET continue the original regimen for a total of six cycles of dual HER2-antibody (HP), followed by surgery. Non-responders are switched to the TCbHP regimen for another six cycles, followed by surgery.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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 \> 150 mm Hg and/or diastolic \> 100 mm Hg) * Severely cardiovascular disease * Current known infection with HIV, hepatitis B virus, or hepatitis C virus * Patients with pulmonary disease requiring continuous oxygen therapy, previous history of bleeding diathesis or patient is currently receiving anti-coagulant therapy, or immunosuppressive agent * Major surgical procedure or significant traumatic injury * Patient has other concurrent severe and/or uncontrolled medical conditions. * Concurrent participation in other interventional clinical trial * History of receiving any investigational treatment within 28 days prior to randomization * Pregnant or breast-feeding women or patients not willing to apply highly effective contraception as defined in the protocol * Inability to lie flat or presence of psychiatric disorders such as claustrophobia
References
Publications (0)
Data not yet available