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Sacituzumab Tirumotecan in Neoadjuvant Treatment of Early-Stage TNBC

ConditionTriple -Negative Breast Cancer
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18-70
SponsorXijing Hospital

About this trial

To explore the application of Sacituzumab Tirumotecan in neoadjuvant treatment of early-stage TNBC, a multicenter, Phase II clinical study of Sacituzumab Tirumotecan in neoadjuvant treatment of early-stage TNBC is proposed. The study aims to evaluate the efficacy and safety of Sacituzumab Tirumotecan and to provide a new treatment option for neoadjuvant treatment of early-stage TNBC.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age: Female subjects aged ≥18 years and ≤70 years at the time of signing the informed consent form.

ECOG Performance Status: 0-1.

Life Expectancy: Estimated survival of not less than 3 months.

Measurable Disease: Presence of at least one measurable lesion according to RECIST 1.1 criteria.

Disqualifiers

Patients with metastatic breast cancer (Stage IV).

Baseline left ventricular ejection fraction (LVEF) <50% as assessed by echocardiogram (ECHO) or multigated acquisition (MUGA) scan at screening, or other significant cardiovascular diseases, or a history of Class III or IV cardiomyopathy described by the New York Heart Association on the same side as the invasive breast cancer.

Chemotherapy, endocrine therapy (ET), targeted therapy, and/or radiotherapy for the currently diagnosed breast cancer before enrollment.

Previous treatment targeting TROP2 or treatment with a topoisomerase I inhibitor.

Trial design

Design model

Single group

Treatments tested in this trial

  • Sacituzumab Tirumotecan

    Drug

    Sacituzumab Tirumotecan monotherapy before surgery at a dose of 5mg/kg, with a dosing schedule of once every 2 weeks for a total of 12 weeks

Treatment groups

35 Participants
are divided into 1 treatment group
Group A: Neadjuvant Sacituzumab TirumotecanExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Pathological complete response rate (pCR)

Time frame
At the end of Cycle 1 (each cycle is 14 days)

Secondary outcomes

1

adverse effects

Serious adverse effect occur within neoadjuvant chemotherapy

Time frame
through each neoadjuvant chemotherapy Cycle (each cycle is 14 days)]
2

Objective Reaponse Rate(ORR)

Time frame
At the end of every cycle (each cycle is 14 days)
3

Event-free survival (EFS)

Defined as the time from treatment initiation to the first occurrence of any of the following events: disease progression precluding surgical treatment, local or distant recurrence, or death from any cause.

Time frame
Up to 2 years

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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

Xijing Hospital

Lead sponsor

Source ClinicalTrials.gov

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