Dato-DXd for Breast Cancer

(TB06 Trial)

Recruiting at 31 trial locations

Overseen By AstraZeneca Clinical Study Information Center

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: AstraZeneca

Must not be taking: Chloroquine, Hydroxychloroquine, Corticosteroids, others

Disqualifiers: Severe diseases, Brain metastases, ILD, others

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

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

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

Compensation: Varies

Number of Visits: 31

Duration: Up to 24 months

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called Dato-DXd for individuals with a specific type of advanced breast cancer. The goal is to evaluate the drug's effectiveness and safety for patients with breast cancer that has spread, is hormone receptor-positive, and lacks the HER2 protein. Participants should have previously tried hormone therapies without benefit and should not have undergone chemotherapy in the metastatic setting. The trial targets those whose daily lives are impacted by breast cancer, offering a new treatment option before considering chemotherapy. As a Phase 3 trial, this study serves as the final step before FDA approval, providing participants access to a potentially groundbreaking treatment.

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, certain medications like chloroquine/hydroxychloroquine require a washout period (time without taking the medication) of more than 14 days before starting the study. It's best to discuss your specific medications with the trial team.

Is there any evidence suggesting that Dato-DXd is likely to be safe for humans?

Research shows that Dato-DXd is generally well-tolerated by patients. Studies have found it safe for people with certain types of breast cancer. While side effects are common, they are usually mild, and serious side effects occur less frequently. Most patients handle the treatment without major problems. Prospective trial participants may find this information reassuring regarding its safety. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard breast cancer treatments, which often include hormone therapies, chemotherapy, and targeted therapies like Herceptin (trastuzumab), Dato-DXd is unique because it combines a monoclonal antibody with a chemotherapy agent, creating an antibody-drug conjugate. This innovative approach allows Dato-DXd to specifically target cancer cells, delivering the chemotherapy directly to them, which may reduce damage to healthy cells. Researchers are excited about Dato-DXd because this targeted delivery could lead to fewer side effects and improved outcomes for patients, making it a promising option in the fight against breast cancer.

What evidence suggests that Dato-DXd might be an effective treatment for breast cancer?

Research has shown that Dato-DXd yields promising results for certain types of breast cancer. In one study, Dato-DXd helped patients live 37% longer without their cancer worsening, a measure known as progression-free survival. Another study found it reduced the chance of the disease worsening by 43% and lowered the risk of death in patients with triple-negative breast cancer. For patients with HR-positive, HER2-negative breast cancer, Dato-DXd also significantly improved progression-free survival. These findings suggest that Dato-DXd might effectively treat breast cancer by slowing its growth and potentially extending patients' lives. All participants in this trial will receive Dato-DXd to further evaluate its effectiveness and safety. ^{2 3 5 6 7}

Are You a Good Fit for This Trial?

This trial is for individuals with inoperable or metastatic hormone receptor-positive, HER2 IHC 0 breast cancer. Specific eligibility criteria are not provided, but typically participants would need to meet certain health standards and have not received chemotherapy for this condition.

Inclusion Criteria

I can care for myself and have not gotten worse in the past 2 weeks.

I have provided a tumor sample for the study before starting treatment.

My blood tests and organ functions are within normal ranges.

Exclusion Criteria

I have fluid build-up that can't be regularly drained.

I have a serious eye condition affecting my cornea.

I have been treated with specific cancer drugs before.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Dato-DXd 6 mg/kg as an intravenous infusion every 3 weeks until disease progression or unacceptable toxicity

Up to 24 months

Infusion every 3 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Safety follow-up 28 days after last dose

Long-term Follow-up

Participants are monitored for overall survival and progression-free survival

Up to 24-30 months

What Are the Treatments Tested in This Trial?

Interventions

• Dato-DXd

Trial Overview The study is testing the effectiveness and safety of a drug called Dato-DXd in patients before they receive any chemotherapy treatment. The goal is to see how well it works against specific types of advanced breast cancer.

How Is the Trial Designed?

Group I: single arm group Experimental Treatment 1 Intervention

All participants will receive Dato-DXd (6 mg/kg IV on Day 1, Q3W; up to a maximum of 540 mg Q3W for participants ≥ 90 kg) until investigator-defined disease progression according to RECIST 1.1 or until unacceptable toxicity, withdrawal of consent, or another criterion for discontinuation is met.

Who Is Running the Clinical Trial?

AstraZeneca

Lead 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

Daiichi Sankyo

Industry Sponsor

Trials

443

Recruited

493,000+

Hiroyuki Okuzawa

Daiichi Sankyo

Chief Executive Officer

Degree in Social Sciences from Hitotsubashi University

Yuki Abe

Daiichi Sankyo

Chief Medical Officer since 2023

MD

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. astrazeneca.com astrazeneca.com/content/astraz/media-centre/press-releases/2024/datopotamab-deruxtecan-final-overall-survival-results-reported-in-patients-with-metastatic-hr-positive-her2-low-or-negative-breast-cancer-in-tropion-breast01-phase-iii-trial.html

Datopotamab deruxtecan final overall survival results ... Datopotamab deruxtecan has previously shown a statistically significant progression-free survival benefit in TROPION-Breast01, a result supported by multiple ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12393668/

Datopotamab deruxtecan-dlnk for treatment of patients with ... In a head-to-head trial, Dato-DXd was associated with a statistically significant improvement in PFS and an OS HR~1, with no clear trend toward ...

4. ascopubs.org ascopubs.org/doi/10.1200/JCO.24.00920

Primary Results From TROPION-Breast01 In this primary analysis, TROPION-Breast01 met its dual primary PFS end point; Dato-DXd reduced the risk of disease progression or death by 37% ...

5. 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 ...

6. 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 ...

7. daiichisankyo.us daiichisankyo.us/press-releases/-/article/datopotamab-deruxtecan-final-overall-survival-results-reported-in-patients-with-metastatic-hr-positive-her2-low-or-negative-breast-cancer-in-tropion-b

Datopotamab Deruxtecan Final Overall Survival Results ... Datopotamab deruxtecan has previously shown a statistically significant progression-free survival benefit in TROPION-Breast01, a result supported by multiple ...