NCT07335081

Brief Summary

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P50-P75 for phase_2 breast-cancer

Timeline
6mo left

Started Feb 2024

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress81%
Feb 2024Dec 2026

Study Start

First participant enrolled

February 1, 2024

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

December 21, 2025

Completed
10 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 12, 2026

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Expected
Last Updated

March 24, 2026

Status Verified

March 1, 2026

Enrollment Period

1.9 years

First QC Date

December 21, 2025

Last Update Submit

March 20, 2026

Conditions

Breast Cancer

Keywords

Breast cancerNeoadjuvant therapyHER2 positivectDNA

Outcome Measures

Primary Outcomes (1)

  • ctDNA clearance after one cycle neoadjuvant treatment

    The rate of ctDNA clearance after first cycle of neoadjuvant treatment

    3 months after neoadjuvant treatment initation

Secondary Outcomes (7)

  • ctDNA clearance after two cycle neoadjuvant treatment

    3 months after neoadjuvant treatment initation

  • pCR rate

    6 months after neoadjuvant treatment initation

  • bpCR rate

    6 months after neoadjuvant treatment initation

  • ORR

    6 months after neoadjuvant treatment initation

  • EFS

    2 years after surgery

  • +2 more secondary outcomes

Study Arms (2)

Pyrotinib-initiated arm

EXPERIMENTAL

two cycles of docetaxel + trastuzumab + pyrotinib followed by two cycles of docetaxel + trastuzumab + pertuzumab

Drug: pyrotinibDrug: pertuzumabDrug: trastuzumabDrug: docetaxel

Pertuzumab-initiated arm

ACTIVE COMPARATOR

four cycles of docetaxel + trastuzumab + pertuzumab

Drug: pertuzumabDrug: trastuzumabDrug: docetaxel

Interventions

pyrotinibDRUG

pyrotinib 320mg p.o. qd

Pyrotinib-initiated arm
pertuzumabDRUG

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

Pertuzumab-initiated armPyrotinib-initiated arm
docetaxelDRUG

docetaxel ivgtt q3w, 80-100mg/m2

Pertuzumab-initiated armPyrotinib-initiated arm
trastuzumabDRUG

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

Pertuzumab-initiated armPyrotinib-initiated arm

Eligibility Criteria

Age18 Years - 70 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ruijin Hospital

Shanghai, 200025, China

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Interventions

pyrotinibpertuzumabTrastuzumabDocetaxel

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulinsTaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenes

Central Study Contacts

Haoyu Wang

CONTACT

86 18817865256meredithwhy@163.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

December 21, 2025

First Posted

January 12, 2026

Study Start

February 1, 2024

Primary Completion

December 31, 2025

Study Completion (Estimated)

December 31, 2026

Last Updated

March 24, 2026

Record last verified: 2026-03

Locations

CN(1)