Pyrotinib Combined With Trastuzumab Subcutaneously Compared Intravenous Administration in the Treatment of HER2-positive Early Breast Cancer

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18-75
SponsorJiangsu Famous Medical Technology Co., Ltd.

About this trial

This study evaluated the clinical benefits of intravenous administration of pyrotinib combined with trastuzumab subcutaneous preparation by comparing the efficacy and quality of life of intravenous administration in the treatment of HER2-positive early breast cancer

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Women aged ≥18 years and ≤75 years who are newly treated for breast cancer;

Pathological examination confirmed HER2 positive (immunohistochemical staining ICH+++ or ICH++ and FISH positive);

Patients with invasive breast cancer diagnosed histologically plus imaging as early (T1c-3, N0-1, M0) or locally advanced (T2-3, N2, or N3, M0);

ECOG score 0-1;

Disqualifiers

Known allergic history of the drug components of this protocol;

Previously received antitumor therapy or radiation therapy for any malignant tumor (except for cured cervical carcinoma in situ and basal cell carcinoma);

Has undergone major non-breast cancer related surgery within 4 weeks, or has not fully recovered from such surgery;

Stage IV (metastatic) breast cancer patients;

Trial population

HER2-positive early stage breast cancer patients

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Trastuzumab intravenous drip/Trastuzumab Subcutaneous Injection

    Drug

    Group A is Trastuzumab intravenous drip,Group B is Trastuzumab Subcutaneous Injection

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: Group A1 intervention
Group B: Group B1 intervention

Trial outcomes

Primary outcomes

1

EORTC QLQ-C30 scale score

PRO scale scores between two groups collected at different time points

Time frame
through study completion, an average of 1 year

Secondary outcomes

1

tpCR

total pathological complete response

Time frame
1-2 weeks after surgery

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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