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NCT Number: NCT07335081

ctDNA in HER2+ EBC Neoadjuvant Treatment

This study is a randomized, open-label, multicenter clinical study for patients with early or locally advanced (T≥2cm, N0-3, M0) HER2-positive breast cancer, aiming to compare the peripheral blood ctDNA clearance of neoadjuvant pyrotinib + trastuzumab + docetaxel and pertuzumab + trastuzumab + docetaxel for one course and to evaluate the therapeutic effectiveness of four courses of neoadjuvant therapy

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • histologically diagnosed with Stage II-III HER2+ breast cancer (primary diameter >2cm)
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
  • Intact renal, hepatic, bone marrow and cardiac functions including baseline left ventricular ejection fraction (LVEF) ≥ 55% measured by echocardiography
  • No prior treatment

Exclusion criteria

  • Bilateral or metastatic breast cancer
  • History of other malignancies
  • Severe cardiovascular disease
  • Allergic to any of the regimens

Treatment and study plan

Pyrotinib

Drug

pyrotinib 320mg p.o. qd

Pertuzumab

Drug

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

Trastuzumab

Drug

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

docetaxel

Drug

docetaxel ivgtt q3w, 80-100mg/m2

Primary outcomes

  1. ctDNA clearance after one cycle neoadjuvant treatment

    Time frame: 3 months after neoadjuvant treatment initation

    The rate of ctDNA clearance after first cycle of neoadjuvant treatment

Secondary outcomes

  1. ctDNA clearance after two cycle neoadjuvant treatment

    Time frame: 3 months after neoadjuvant treatment initation

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

  2. pCR rate

    Time frame: 6 months after neoadjuvant treatment initation

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

  3. bpCR rate

    Time frame: 6 months after neoadjuvant treatment initation

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

  4. ORR

    Time frame: 6 months after neoadjuvant treatment initation

    The proportion of patients whose tumor volume shrinks to a prespecified value and is able to maintain the minimum time limit, defined as the sum of the proportion of complete response (CR) and partial response (PR, with a reduction in tumor length and diameter greater than 30%).

  5. EFS

    Time frame: 2 years after surgery

    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

  6. DFS

    Time frame: 2 years after surgery

    The time interval from the first date of disease-free (i.e., the date of surgery) to the first recording of the following events; Postoperative disease recurrence (local, regional, distal, or contralateral); second primary malignancy; Death from any cause.

  7. OS

    Time frame: 5 years after surgery

    Time interval from randomization to death from any cause.

Study contacts

Contact information is provided by the study sponsor or research team.

Haoyu Wang

CONTACT

[email protected]

86 18817865256

Sponsors and collaborators

Lead sponsor

Shanghai Jiao Tong University School of Medicine

Other

Registry information

Official study title

A Randomized, Multicenter, Open-label Clinical Study Using Peripheral Blood Circulating Tumor DNA to Evaluate the Efficacy of Preoperative Treatment With Pyrotinib + Trastuzumab + Docetaxel Versus Pertuzumab + Trastuzumab + Docetaxel in Early or Locally Advanced HER2-positive Breast Cancer

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Jan 12, 2026
Registry last updated
Mar 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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