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Sac-TMT Combined With Toripalimab for First-line Treatment of PD-L1 Positive a/mTNBC

ConditionsTNBC - Triple-Negative Breast CancerPD-L1 Positive
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18+
SponsorTianjin Medical University Cancer Institute and Hospital

About this trial

This study is aimed to evaluate the efficacy and safety of Sacituzumab Tirumotecan combined with Toripalimab for first-line treatment of PD-L1 positive unresectable Locally Advanced/metastatic triple negative breast cancer (a/mTNBC).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Female patients with breast cancer aged >= 18 years.

Based on the pathological report of the latest biopsy or other pathological specimens, the histology and/or cytology are confirmed as invasive breast cancer, and the following conditions are met: a) Pathological classification: ER <= 10%, PR <= 10%; HER2 negative (IHC 0, 1+, 2+and FISH negative); Note: Subjects with initial histopathological diagnosis of HR>10% or HER2+breast cancer and recent pathological findings of metastatic lesions meeting the above conditions are allowed to be included in the study. b) Tumor staging: locally advanced, recurrent, or metastatic tumors that cannot be surgically removed; Note: Patients who have received perioperative treatment in the past are required to have a disease-free survival period of >= 6 months;

ECOG overall state is 0-1.

Have not received systematic treatment for advanced diseases.

Disqualifiers

Patients with central nervous system metastases.

Received radiotherapy, endocrine therapy, chemotherapy, surgical treatment (excluding local puncture or biopsy) or molecular targeted therapy during the recurrence/metastasis stage.

Participated in clinical trials of other drugs within 4 weeks prior to enrollment.

Previously treated with anti-PD-1, anti-PD-L1, anti-PD-L-2, or anti-CTLA-4 antibodies, or any other antibodies or drugs that specifically target T cell co stimulatory or checkpoint pathways.

Trial design

Design model

Single group

Treatments tested in this trial

  • Sacituzumab tirumotecan

    Drug

    5mg/kg, Q2W

  • Toripalimab

    Drug

    240mg，Q3W

Treatment groups

41 Participants
are divided into 1 treatment group
Group A: Sacituzumab Tirumotecan + ToripalimabExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Objective response rate (ORR)

Time frame
Up to approximately 15 months

Secondary outcomes

1

Progression-Free-Survival

Time frame
Up to approximately 15 moths
2

Duration of Response

Time frame
Up to approximately 15 months
3

Overall Survival

Time frame
Up to approximately 4 years
4

adverse events

Time frame
Up to approximately 15 months

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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

Tianjin Medical University Cancer Institute and Hospital

Lead sponsor

Southwest Hospital, China

Collaborator

Source ClinicalTrials.gov

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