A Phase III Randomised Study to Evaluate Dato-DXd and Durvalumab for Neoadjuvant/Adjuvant Treatment of Triple-Negative or Hormone Receptor-low/HER2-negative Breast Cancer

Studien-Informationen

Ein-/Ausschlusskriterien

Studien-Rationale

Studien-Arme

• Experimental: Dato-DXd plus durvalumab
  Participants receive durvalumab every 3 weeks (Q3W) + Dato-DXd Q3W as neoadjuvant therapy prior to surgery; followed by 9 cycles of durvaluamb Q3W as adjuvant therapy post-surgery. Adjuvant chemotherapy may be given in combination with durvalumab only if participants have residual disease. Olaparib may be given for participants with gBRCA-positive tumours and residual disease Adjuvant chemotherapy may be one of these: 1. Doxorubicin (Q3W) or epirubicin (Q3W) + cyclophosphamide (Q3W) for 4 cycles (12 weeks) followed by paclitaxel (weekly) and carboplatin (weekly or Q3W) for 4 cycles (12 weeks); 2. Doxorubicin (Q3W) or epirubicin (Q3W) + cyclophosphamide (Q3W) for 4 cycles (12 weeks) followed by paclitaxel (weekly) for 4 cycles (12 weeks); 3. Carboplatin (weekly or Q3W) + paclitaxel (weekly) for 4 cycles (12 weeks); 4. Capecitabine (Q3W) for 8 cycles.
• Active Comparator: Pembrolizumab plus chemotherapy
  Participants receive pembrolizumab every 3 weeks (Q3W) + paclitaxel weekly + carboplatin (weekly or Q3W) x 4 cycles, followed by pembrolizumab Q3W + (doxorubicin OR epirubicin) + cyclophosphamide Q3W x 4 cycles as neoadjuvant therapy prior to surgery; followed by 9 cycles of pembrolizumab Q3W as adjuvant therapy post-surgery. Adjuvant capecitabine (Q3W) for 8 cycles may be given in combination with pembrolizumab only if participants have residual disease. Olaparib may be given for participants with gBRCA-positive tumours and residual disease.

Geprüfte Regime

• Dato-DXd (Datopotamab deruxtecan (Dato-DXd, DS-1062a)):
  Experimental drug IV infusion
• Durvalumab (MEDI4736):
  Experimental drug IV Infusion
• Pembrolizumab (KEYTRUDA®):
  IV Infusion Active comparator
• Doxorubicin:
  IV infusion Experimental/Active Comparator
• Epirubicin:
  IV Infusion Experimental/Active Comparator
• Cyclophosphamide:
  IV infusion Experimental/Active Comparator
• Paclitaxel:
  IV infusion Experimental/Active Comparator
• Carboplatin:
  IV infusion Experimental/Active Comparator
• Capecitabine (XELODA®, Capecitabine Cell Pharm, Capecitabine EG, Capecitabine Accord):
  Tablet Oral route of administration Experimental/Active Comparator
• Olaparib (LYNPARZA®):
  Tablet Oral route of administration Experimental/Active Comparator

Quelle: ClinicalTrials.gov