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SHR-A1811 for HER2-positive Breast Cancer With Suboptimal Neoadjuvant Response

ConditionsEarly Breast CancerHER2 + Breast CancerStage II Breast CancerStage III Breast Cancer
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18-70
SponsorChuan Wang

About this trial

This is an open-label, single-arm, multicenter clinical study to evaluate the efficacy and safety of SHR-A1811 in early or locally advanced HER2-positive breast cancer patients with suboptimal response to neoadjuvant regimen. Patients who were determined by the researchers to have poor therapeutic effect will switch to SHR-A1811.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

1.Female patients with newly diagnosed breast cancer aged 18 to 70 years old;

2.Early or locally advanced HER2-positive invasive breast cancer;

3.Known hormone receptor status;

4.ECOG score of 0-1;

Disqualifiers

1. Patients with metastatic or bilateral breast cancer, or inflammatory breast cancer

2. Patients with grade 3 or higher thrombocytopenia during previous treatment, or grade 3 or higher nausea and vomiting despite primary prevention

3. History of other malignant tumors (except cured carcinoma in situ of the cervix, basal cell carcinoma, etc.) and related treatment history

4. Patients who received major non-breast cancer surgery within 4 weeks before enrollment and have not recovered (except biopsy and PICC)

Trial design

Design model

Single group

Treatments tested in this trial

  • SHR-A1811

    Drug

    Drug: SHR-A1811 4.8mg/kg

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: SHR-A1811Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

tpCR

It is defined as the absence of residual invasive carcinoma in the resected breast cancer specimens stained with hematoxylin and eosin, and no cancer metastasis in all ipsilateral lymph node samples, after completion of neoadjuvant therapy and surgery.

Time frame
immediately after surgery

Secondary outcomes

1

Breast Pathological Complete Response

It is defined as the absence of residual invasive carcinoma in the primary breast lesion after neoadjuvant therapy, with the permission of residual ductal carcinoma in situ within the primary breast lesion.

Time frame
immediately after surgery
2

event free survival

Time frame
until the end of the study
3

residual cancer burden

Time frame
immediately after surgery

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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

Chuan Wang

Lead sponsor

Fujian Medical University Union Hospital

Sponsor institution

Source ClinicalTrials.gov

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