BREAST CANCER PHASE 3
CLINICAL TRIALS
Breast Cancer Phase 3 Trials Recruiting for Triple Negative. Quick reference guide to trials that are likely to be currently recruiting in the the US.
Trial Name
Trial Type
What is being tested?
Why is this trial significant?
Who might qualify
Who is likely to be excluded?
TroFuse-012
New Approach
Whether the addition of sacituzumab tirumotecan (a newer antibody-drug conjugate, ADC) to pembrolizumab (typical immunotherapy) is more effective than standard therapy – pembrolizumab alone or with capecitabine.
This explores new approaches in a situation with relatively few treatment options currently..
- Triple negative
- Received pembrolizumab + chemotherapy before surgery (neoadjuvant)
- Cancer was present at the time of surgery
- Prior ADC (antibody-drug conjugate) therapy targeted at TROP2
ASCENT-
05 /OptimICE-RD
New Approach
Whether the addition of sacituzumab govitecan (Trodelvy, an ADC) to pembrolizumab is more effective than standard treatment.
Results of this trial with Trofuse-012 will increase understanding of the bigger picture in terms of the role of ADCs.
- Triple negative
- Received pembrolizumab + chemotherapy before surgery (neoadjuvant)
- Cancer was present at the time of surgery
- Prior ADC therapy targeted at TROP2
TROPION- Breast05
New Drug
Datopotamab deruxtecan (Dato-DXd, an ADC) with durvalumab versus pembrolizumab with chemotherapy.
This explores the potential to replace chemotherapy with more a more targeted approach with an ADC
- Triple negative
- Locally recurrent and inoperable or metastatic cancer
- PD-L1 positive, defined as a CPS ≥10 using the 22C3 assay
- 6 months after surgery with curative intent
- Previous systemic treatment
OptimICE-PCR
New Approach
After surgery, no treatment versus ~27 weeks of pembrolizumab
This is a de-escalation trial assessing whether immunotherapy can be stopped sooner if there is a good response to (pre-)surgical treatment.
- Triple negative
- Stage II – III • Complete response to neoadjuvant (before surgery) chemotherapy and pembrolizumab plus surgery
- Other treatment regimen received before surgery