A Phase 2 interventional study of Trastuzumab (Herceptin) and Pertuzumab in Breast Cancer, sponsored by Peking University Cancer Hospital & Institute. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-17.
Sponsored by Peking University Cancer Hospital & Institute · Phase 2, Interventional, and Treatment
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.
This is a prospective, two-arm, interventional study. Eligible patients with early-stage HER2-positive breast cancer are enrolled into Arm A (TCbHP: trastuzumab, pertuzumab, docetaxel/nab-paclitaxel, and carboplatin) or Arm B (trastuzumab, pertuzumab, CDK4/6 inhibitor, and aromatase inhibitor), based on molecular subtype and patient preference. Patients in the control group (ArmC) will receive standard TCbHP therapy without intervention. All patients will undergo HER2-PET/CT imaging at baseline and after two cycles of treatment. Metabolic response, defined as a ≥40% reduction in SUVmax of target lesions, guides subsequent therapy: responders continue the initial regimen, while non-responders switch to an alternative strategy (ADC in Arm A or TCbHP in Arm B). The primary endpoint is the total pathological complete response (tpCR) rate in Arm A and ArmB.
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's planned enrollment of 156 is above the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.
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Exclusion Criteria:
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.
Drug: Trastuzumab (Herceptin) · Drug: Pertuzumab · Drug: Combination product: Trastuzumab + Pertuzumab · Drug: Docetaxel or Nab-paclitaxel · Drug: carboplatin · Drug: ADC
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.
Drug: Trastuzumab (Herceptin) · Drug: Pertuzumab · Drug: Combination product: Trastuzumab + Pertuzumab · Drug: Docetaxel or Nab-paclitaxel · Drug: carboplatin · Drug: CDK4/6 inhibitor · Drug: Aromatase Inhibitor (AI)
Patients who will receive surgery after completion of standard TCbHP regimen were be consecutively enrolled. Neither HER2-PET evaluation nor regimen adjustment based on the evaluation results was allowed.
Drug: Trastuzumab (Herceptin) · Drug: Pertuzumab · Drug: Combination product: Trastuzumab + Pertuzumab · Drug: Docetaxel or Nab-paclitaxel · Drug: carboplatin
8 mg/kg first dose, followed 6 mg/kg given into the vein (IV; intravenously) every 21 days
840 mg first dose, followed 420 mg given by IV every 21 days
600 mg Pertuzumab, 600 mg Trastuzumab, and 20,000 units hyaluronidase will be given by subcutaneous injection every 21 days
Docetaxe 75mg/m²/ Nab-paclitaxel：260mg/m²
AUC6
Ribociclib 600mg once daily every 21days/ Dalpiciclib 150mg once daily every 21days/ Palbociclib 125mg once daily every 21days
Letrozole 2.5mg once daily/ Anastrozole 1mg once daily/ Exemestane25mg once daily
T-Dxd: 5.4mg/kg given into the vein (IV; intravenously) every 21 days SHR-A1811: 4.8mg/kg given into the vein (IV; intravenously) every 21 days
rate of pathologic complete response (pCR)
Proportion of participants who have no evidence by H\&E staining of residual invasive disease
Time frame: Up to 6 months after treatment start
SUVmax change on HER2-PET
The change in SUVmax value of HER2-PET after 2 cycles of treatment compared to the baseline level
Time frame: Up to 6 months after treatment start
No study locations are listed for this record.
This study is not yet recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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Peking University Cancer Hospital & Institute