A Study of Dato-DXd With or Without Durvalumab Versus Investigator's Choice of Therapy in Patients With Stage I-III Triple-negative Breast Cancer Without Pathological Complete Response Following Neoadjuvant Therapy (TROPION-Breast03)

Conditions

• Breast Cancer

Eligibility Criteria

Sex

ALL

Age

18 Years - 130 Years

Healthy Volunteers

Not accepted

Interventions

• Dato-DXd — DRUG
  Experimental drug. Provided in 100mg vials. IV infusion
• Durvalumab — DRUG
  Experimental drug. Provided in 50mg vials. IV infusion
• Capecitabine — DRUG
  Active Comparator. Tablet. Oral route of administration
• Pembrolizumab — DRUG
  Active Comparator. Provided in 100mg vials. IV infusion

Study Details

This is a Phase III, randomized, open-label, 3-arm, multicenter, international study assessing the efficacy and safety of Dato-DXd with or without durvalumab compared with ICT in participants with stage I to III TNBC with residual invasive disease in the breast and/or axillary lymph nodes at surgical resection following neoadjuvant systemic therapy.

Key Dates

Start date

Nov 28, 2022

Status verified

Mar 2026

Primary completion

Sep 20, 2027

Completion

Jan 30, 2030

Study Design

Enrollment

1,174 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Dato-DXd in combination with Durvalumab
  Arm 1: Dato-DXd 6 mg/kg IV Q3W x 8 cycles + Durvalumab 1120 mg IV Q3W x 9 cycles
• Experimental: Dato-DXd
  Arm 2: Dato-DXd 6 mg/kg IV Q3W x 8 cycles
• Active Comparator: Investigators Choice Therapy
  Arm 3: Capecitabine (1000 or 1250 mg/m2 oral BID on Days 1 to 14, Q3W) for 8 cycles Pembrolizumab\* (200 mg IV on Day 1, Q3W) for 9 cycles Capecitabine (1000 or 1250 mg/m2 oral BID on Days 1 to 14, Q3W) for 8 cycles + pembrolizumab\* (200 mg IV on Day 1, Q3W) for 9 cycles \* Only participants who have received prior pembrolizumab in the neoadjuvant setting should receive pembrolizumab as part of their adjuvant therapy on Arm 3.

Primary Outcome Measure

Invasive disease-free survival (iDFS) for Dato-DXd + durvalumab vs. ICT [ Time Frame: From randomisation to date of the event, up to 57 months from first subject in ]

Locations (88)

Find similar trials in Gilbert, AZ

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