Testing sacituzumab tirumotecan with pembrolizumab before surgery for early breast cancer

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with new, untreated, high-risk, early-stage breast cancer that is triple-negative or hormone receptor-low positive and HER2-negative.

Age

18 years or older

Sex

All sexes can join

Disease stage

High-risk, early-stage breast cancer that has not spread (M0), with tumor and lymph node stage cT1c N1-N2, cT2 N0-N2, cT3 N0-N2 or cT4a-d N0-N2.

Earlier treatment

No earlier treatment for this breast cancer, including radiation, drug treatment or definitive surgery. No earlier anti-PD-1, anti-PD-L1 or anti-PD-L2 therapy.

Biomarker or test result

Triple-negative breast cancer, or HR-low positive/HER2-negative breast cancer (estrogen receptor expression in 1% to 10% of cells), confirmed by a central laboratory.

Main reasons for not taking part

• Metastatic (Stage IV) breast cancer or clinical node stage 3 (cN3)
• Earlier treatment for this breast cancer, including radiation, drug treatment or definitive surgery
• Earlier excisional biopsy of the tumor, axillary lymph node dissection or sentinel lymph node biopsy
• Earlier treatment with a TROP2-targeted antibody-drug conjugate or a topoisomerase I inhibitor-containing antibody-drug conjugate
• History of or current pneumonitis or interstitial lung disease that needed steroids

The registry criteria, word for word

What the trial wants to find out

Researchers are looking for new ways to treat types of breast cancer that are both:

The 2 groups in the trial

• sac-TMTTreatment being tested

  Participants receive sacituzumab tirumotecan intravenously (IV) at a dose of 4 mg/kg every 2 weeks (Q2W) + IV pembrolizumab 200 mg every 3 weeks (Q3W), for 12 weeks; then receive IV pembrolizumab 200 mg Q3W and IV carboplatin area under the curve (AUC) 1.5 + IV paclitaxel 80 mg/m\^2 once weekly, for 12 weeks. 3-6 weeks later, participants undergo surgery and optional radiation therapy, and receive IV pembrolizumab 400 mg once every 6 weeks or 200 mg Q3W for up to approximately 28 weeks. Additional adjuvant treatment of physician's choice (TPC) may be administered to participants with residual disease. TPC options are olaparib 300 mg oral twice daily (BID) for 1 year (participants with germline breast cancer susceptibility gene mutation (gBRCAm) only); capecitabine 1000-1250 mg/m\^2 oral twice daily on days 1-14 and 22-35 each cycle for 4 six-week cycles; or doxorubicin 60mg/m\^2 (or epirubicin 90 mg/m\^2) IV infusion Q3W/Q2W + cyclophosphamide 600 mg/m\^2 IV infusion Q3W/Q2W for 4 doses.

  Treatment: Sacituzumab tirumotecan, Pembrolizumab, Rescue Medication, Carboplatin, Paclitaxel, Doxorubicin, Epirubicin, Cyclophosphamide, Capecitabine, and Olaparib

• ChemotherapyExisting treatment, for comparison

  Participants receive IV carboplatin AUC 1.5 and paclitaxel 80 mg/m\^2 once weekly, alongside pembrolizumab 200 mg Q3W, for 6 weeks; then receive IV pembrolizumab 200 mg Q3W alongside IV cyclophosphamide 600 mg/m\^2 Q3W and either doxorubicin 60 mg/m\^2 Q3W or epirubicin 90 mg/m\^2 Q3W, for up to 12 weeks. 3-6 weeks later, participants undergo surgery and optional radiation therapy, and receive IV pembrolizumab 400 mg once every 6 weeks or 200 mg Q3W for up to approximately 28 weeks. Additional adjuvant TPC may be administered to participants with residual disease. TPC options are olaparib 300 mg oral BID for 1 year (participants with germline breast cancer susceptibility gene mutation (gBRCAm) only); or capecitabine 1000-1250 mg/m\^2 oral BID on days 1-14 and 22-35 each cycle for 4 six-week cycles.

  Treatment: Pembrolizumab, Rescue Medication, Carboplatin, Paclitaxel, Doxorubicin, Epirubicin, Cyclophosphamide, Capecitabine, and Olaparib