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Neoadjuvant Pyrotinib-to-pertuzumab in HER2+ eBC

ConditionBreast Cancer Early Stage Breast Cancer (Stage 1-3)
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexFemale
Age18-70
SponsorShanghai Jiao Tong University School of Medicine

About this trial

This is a randomized, open-label, superiority, multicenter clinical trial for patients with early or locally advanced (T≥2cm, N0-3, M0) HER2-positive breast cancer. It aims to compare the efficacy of neoadjuvant treatment with 2 cycles of Pyrotinib + Trastuzumab + Docetaxel followed by 2 cycles of Pertuzumab + Trastuzumab + Docetaxel versus 4 cycles of Pertuzumab + Trastuzumab + Docetaxel. Exploratory analyses of ctDNA clearance rate and MRI response will also be conducted.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Signed informed consent.

Age: Female patients aged 18-70 years.

Histologically confirmed invasive breast cancer, with primary tumor diameter ≥ 2.0 cm, Stage II-III as assessed by local standard methods.

HER2-positive breast cancer, defined as Immunohistochemistry (IHC) score 3+ or In Situ Hybridization (ISH) showing HER2 gene amplification.

Disqualifiers

Bilateral breast cancer or metastatic (Stage IV) breast cancer.

History of myocardial infarction, acute coronary syndrome, or coronary angioplasty/stenting/bypass within the past 6 months.

New York Heart Association (NYHA) Class II-IV congestive heart failure (CHF) or history of NYHA Class III or IV CHF.

High-risk uncontrolled arrhythmias, such as atrial tachycardia, resting heart rate > 100 bpm, significant ventricular arrhythmias (e.g., ventricular tachycardia), or higher-grade atrioventricular (AV) block.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Docetaxel

    Drug

    docetaxel ivgtt q3w, 80-100mg/m2

  • Pyrotinib

    Drug

    pyrotinib 320mg p.o. qd

  • Trastuzumab (Herceptin)

    Drug

    trastuzumab ivgtt q3w, 8mg/kg for initiation, 6mg/kg for maintenance, or 600mg sc q3w

  • Pertuzumab

    Drug

    pertuzumab ivgtt q3w, 840mg for initiation, 420mg for maintenance

Treatment groups

220 Participants
are divided into 2 treatment groups
Group A: TPyPExperimental treatment 4 interventions
Group B: TPActive comparator 3 interventions

Trial outcomes

Primary outcomes

1

tpCR

After completion of neoadjuvant therapy and surgery, no residual invasive carcinoma in the evaluation of hematoxylin and eosin stained of breast and lymph node samples

Time frame
From enrollment to the end of treatment at 24 weeks

Secondary outcomes

1

bpCR

After completion of neoadjuvant therapy and surgery, no residual invasive carcinoma in the evaluation of hematoxylin and eosin stained breast samples

Time frame
From enrollment to the end of treatment at 24 weeks
2

EFS

The time interval from randomization to the first recording of the following events: disease progression (before surgery), as determined by investigator reference RECIST1.1, combined with clinical evaluation, final judgment; postoperative disease recurrence (local, regional, distal, or contralateral); second primary malignancy; Death from any cause

Time frame
through study completion, an average of 2 year
3

OS

Time interval from randomization to death from any cause.

Time frame
through study completion, an average of 5 year
4

Early ctDNA clearance

The rate of ctDNA clearance after first two cycles of neoadjuvant treatments

Time frame
From enrollment to the end of treatment at 24 weeks

Other outcomes

Sponsors and contacts

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

Shanghai Jiao Tong University School of Medicine

Lead sponsor

Source ClinicalTrials.gov
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