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Optimization of Dynamic Neoadjuvant Therapy Strategies for HER2-Positive Breast Cancer Based on HER2-PET/CT Molecular Imaging

ConditionBreast Cancer
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorPeking University Cancer Hospital & Institute

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Crossover

Treatments tested in this trial

  • Trastuzumab (Herceptin)

    Drug

    8 mg/kg first dose, followed 6 mg/kg given into the vein (IV; intravenously) every 21 days

  • Pertuzumab

    Drug

    840 mg first dose, followed 420 mg given by IV every 21 days

  • Combination product: Trastuzumab + Pertuzumab

    Drug

    600 mg Pertuzumab, 600 mg Trastuzumab, and 20,000 units hyaluronidase will be given by subcutaneous injection every 21 days

  • Docetaxel or Nab-paclitaxel

    Drug

    Docetaxe 75mg/m²/ Nab-paclitaxel：260mg/m²

  • carboplatin

    Drug

    AUC6

  • CDK4/6 inhibitor

    Drug

    Ribociclib 600mg once daily every 21days/ Dalpiciclib 150mg once daily every 21days/ Palbociclib 125mg once daily every 21days

  • Aromatase Inhibitor (AI)

    Drug

    Letrozole 2.5mg once daily/ Anastrozole 1mg once daily/ Exemestane25mg once daily

  • ADC

    Drug

    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

Treatment groups

156 Participants
are divided into 3 treatment groups
Group A: Cohort AExperimental treatment 6 interventions
Group B: Cohort BExperimental treatment 7 interventions
Group C: Cohort CActive comparator 5 interventions

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

1

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

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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

Peking University Cancer Hospital & Institute

Lead sponsor

Source ClinicalTrials.gov

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