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

Conditions

• Breast Cancer

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Dato-DXd — DRUG
  Experimental drug IV infusion
• Durvalumab — DRUG
  Experimental drug IV Infusion
• Pembrolizumab — DRUG
  IV Infusion Active comparator
• Doxorubicin — DRUG
  IV infusion Experimental/Active Comparator
• Epirubicin — DRUG
  IV Infusion Experimental/Active Comparator
• Cyclophosphamide — DRUG
  IV infusion Experimental/Active Comparator
• Paclitaxel — DRUG
  IV infusion Experimental/Active Comparator
• Carboplatin — DRUG
  IV infusion Experimental/Active Comparator
• Capecitabine — DRUG
  Tablet Oral route of administration Experimental/Active Comparator
• Olaparib — DRUG
  Tablet Oral route of administration Experimental/Active Comparator

Study Details

This is a Phase III, 2-arm, randomised, open-label, multicentre, global study assessing the efficacy and safety of neoadjuvant Dato-DXd plus durvalumab followed by adjuvant durvalumab with or without chemotherapy compared with neoadjuvant pembrolizumab plus chemotherapy followed by adjuvant pembrolizumab with or without chemotherapy in participants with previously untreated TNBC or hormone receptor-low/HER2-negative breast cancer.

Key Dates

Start date

Nov 14, 2023

Status verified

Mar 2026

Primary completion

Nov 20, 2028

Completion

Sep 23, 2032

Study Design

Enrollment

1,902 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• 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.

Primary Outcome Measure

Event-free survival (EFS) in the experimental vs control arms [ Time Frame: Date of randomization to date of the EFS event, up to 93 months after the first subject randomized ]

Locations (58)

Find similar trials in Daphne, AL

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