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Pyrotinib after trastuzumab-based adjuvant therapy in HER2- positive breast cancer: a single-arm, open, exploratory research

Pyrotinib after trastuzumab-based adjuvant therapy in HER2- positive breast cancer: a single-arm, open, exploratory research

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000035114
Enrollment
Unknown
Registered
2020-08-01
Start date
2020-08-01
Completion date
Unknown
Last updated
2020-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast cancer

Interventions

singal-arm:pyrotinib

Sponsors

The Affiliated Hospital of Hebei Engineering University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Aged >= 18 and 5cm; not receiving neoadjuvant treatment, postoperative pathological examination shows that there was lymph node metastasis. receiving neoadjuvant treatment, postoperative pathological examination shows there exists invasive cancer in breast and axillary lymph node. 5. Who have been accepted trastuzumab or combined with pertuzumab therapy. 6. Known about hormone receptor status ER/PR; 7. ECOG performence status 0-2 score.

Exclusion criteria

Exclusion criteria: 1. Subject who comfirmed local/regional recurrent/metastasis at the time of enrollment; 2. Subject who have previously received other TKI and T-DM1 treatment; 3. History of gastrointestinal disease,with diarrhea as the main symptom; 4. Subjects with a history of mental illness or psychotropic substance abuse, unable to cooperate; 5. Women who are pregnant or breastfeeding; 6. The investigators think its not suitable.

Design outcomes

Primary

MeasureTime frame
Invasive disease-free survival;

Secondary

MeasureTime frame
Overall survival;Disease-free survival;Distance disease-free survival;Safety;

Countries

China

Contacts

Public ContactHanJianJun

The Affiliated Hospital of Hebei Engineering University

18031028138@189.cn+86 18031028138

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026