Datopotamab Deruxtecan for Triple Negative Breast Cancer

(PREDICT-RD Trial)

Overseen By Taylor Pierce

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: UNC Lineberger Comprehensive Cancer Center

Disqualifiers: Pregnant, Breastfeeding

Stay on Your Current Meds You can continue your current medications while participating

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 6

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment, Datopotamab Deruxtecan (an experimental drug), for individuals with triple negative breast cancer, a type that lacks three common receptors. The study aims to determine the treatment's effectiveness for patients with residual cancer after chemotherapy and surgery. It will monitor cancer recurrence using a blood test that detects tiny amounts of cancer DNA. Suitable candidates have stage II or III triple negative breast cancer with remaining cancer after initial treatment and surgery. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of participants.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

A previous study found Datopotamab deruxtecan (Dato-DXd) to be generally safe. Most participants experienced mild side effects, while serious side effects were less common. Research shows that although many participants had some side effects, only a few experienced severe ones. This suggests the treatment was generally well-tolerated. The safety profile is considered manageable, offering reassurance to those considering joining a trial with this treatment. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Datopotamab deruxtecan is unique because it targets triple negative breast cancer (TNBC) in a novel way. Unlike standard treatments, which may include chemotherapy, this drug is an antibody-drug conjugate. It combines an antibody that specifically seeks out cancer cells with a powerful chemotherapy agent, delivering the treatment directly to the cancer cells and sparing more healthy cells. Researchers are excited about its potential to reduce recurrence risk in patients with high residual cancer burden after initial treatments.

What evidence suggests that Datopotamab deruxtecan might be an effective treatment for triple negative breast cancer?

Studies have shown that datopotamab deruxtecan (Dato-DXd) can significantly benefit patients with triple-negative breast cancer (TNBC). Specifically, research found that Dato-DXd improved overall survival by five months compared to standard chemotherapy in patients with advanced TNBC. It also reduced the risk of disease progression by 43% for those unable to receive immunotherapy. These findings suggest that Dato-DXd could be a promising option for improving outcomes in TNBC patients, particularly those with limited treatment options. The treatment has demonstrated a manageable safety profile, making it a viable choice for many patients. Participants in this trial will receive Dato-DXd, focusing on those with higher residual cancer burden post-neoadjuvant therapy. ^{1 3 5 6 7}

Who Is on the Research Team?

Yara Abdou, MD

Principal Investigator

UNC Lineberger Comprehensive Cancer Center

Are You a Good Fit for This Trial?

This trial is for stage II/III triple negative breast cancer patients who still have some cancer after chemo-immunotherapy and surgery. Participants must have a certain level of residual disease (RCB II/III) to join.

Inclusion Criteria

My breast cancer is triple-negative based on specific test results.

The participant must have archival diagnostic tissue and/or surgical resection tissue available

I am 18 years old or older.

Exclusion Criteria

Participants are pregnant or breastfeeding

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Post-surgery Surveillance

Participants undergo ctDNA-based MRD status evaluation to detect MRD-only recurrence

Up to 3 years

Regular ctDNA measurements every 6 weeks during therapy and every 12 weeks thereafter

Treatment with Dato-DXd

Participants receive Dato-DXd to evaluate safety, efficacy, and ctDNA clearance

Variable, up to 3 years

Follow-up

Participants are monitored for recurrence-free survival and overall survival

Up to 3 years

What Are the Treatments Tested in This Trial?

Interventions

• Datopotamab deruxtecan

Trial Overview The study tests if ctDNA testing can detect cancer recurrence without visible tumors, and evaluates the safety and effectiveness of Datopotamab deruxtecan (Dato-DXd), an experimental drug, in these cases.

How Is the Trial Designed?

Group I: Patients with higher residual cancer burden Experimental Treatment 2 Interventions

Participants with stage II/III triple negative breast cancer (TNBC) and residual disease post-neoadjuvant therapy, particularly patients with higher residual cancer burden (RCB II/III), remain at high risk for developing recurrence.

Who Is Running the Clinical Trial?

UNC Lineberger Comprehensive Cancer Center

Lead Sponsor

Trials

377

Recruited

95,900+

AstraZeneca

Industry Sponsor

Trials

4,491

Recruited

290,540,000+

Sir Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Dr. Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology

Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Medical Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology

Translational Breast Cancer Research Consortium

Collaborator

Trials

27

Recruited

3,100+

Citations

1. astrazeneca-us.com astrazeneca-us.com/media/press-releases/2025/DATROWAY-datopotamab-deruxtecan-dlnk-demonstrated-an-unprecedented-median-overall-survival-improvement-of-five-months-vs-chemotherapy-as-1st-line-treatment-for-patients-with-metastatic-triple-negative-breast-cancer-for-whom-immunotherapy-was-not-an-option-in-TROPION-Breast02.html

DATROWAY® (datopotamab deruxtecan-dlnk) ... DATROWAY® (datopotamab deruxtecan-dlnk) demonstrated an unprecedented median overall survival improvement of five months vs. chemotherapy as 1st ...

2. onclive.com onclive.com/view/tropion-breast02-data-support-dato-dxd-as-new-first-line-soc-in-triple-negative-breast-cancer

TROPION-Breast02 Data Support Dato-DXd as New First ... Dato-DXd significantly improved OS and PFS in TNBC patients not eligible for immunotherapy, reducing disease progression risk by 43% and death ...

3. targetedonc.com targetedonc.com/view/dato-dxd-delivers-significant-tnbc-survival-benefits-in-phase-3-trial

Dato-DXd Delivers Significant TNBC Survival Benefits in ... Dato-DXd significantly improves overall and progression-free survival in first-line treatment of metastatic TNBC without immunotherapy options.

4. sciencedirect.com sciencedirect.com/science/article/pii/S2468294223000977

Safety evaluation of Datopotamab deruxtecan for triple ... The pooled results suggests that Dato-DXd is associated with a favorable safety profile: while any grade treatment-related toxicities were common, grade 3-4 ...

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39917260/

TROPION-Breast04: a randomized phase III study of ... This study will evaluate the potential use of neoadjuvant Dato-DXd plus durvalumab followed by adjuvant durvalumab with or without chemotherapy versus standard ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37956525/

Safety evaluation of Datopotamab deruxtecan for triple- ... We performed a meta-analysis aimed to evaluate any grade adverse events, grade 3-4 adverse events, dose reduction, and serious adverse events in TNBC patients ...

7. ascopubs.org ascopubs.org/doi/10.1200/JCO.23.01909

Datopotamab Deruxtecan in Advanced or Metastatic HR+/ ... The median progression-free survival in patients with HR+/HER2– BC and TNBC was 8.3 and 4.4 months, respectively. All-cause treatment-emergent ...