1174 Participants Needed

Dato-DXd +/− Durvalumab for Breast Cancer

Recruiting at 238 trial locations
AC
AB
Overseen ByAstraZeneca Breast Cancer Study Locator Service
Stay on Your Current MedsYou can continue your current medications while participating
No Placebo GroupAll 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 DataThis treatment has passed at least one previous human trial

Trial Summary

What is the purpose of this trial?

This trial is testing a new treatment for patients with a specific type of breast cancer who still have cancer after surgery and initial treatments. The treatment uses a drug called Dato-DXd, which targets and kills cancer cells, and may also include durvalumab, which helps the immune system fight cancer. The goal is to see if this new treatment works better than current options.

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

The trial protocol does not specify if you must stop taking your current medications. However, you cannot use immunosuppressive medication within 14 days before randomization.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, it mentions that you should not have used immunosuppressive medication within 14 days before joining the trial.

What data supports the idea that Dato-DXd +/− Durvalumab for Breast Cancer is an effective treatment?

The available research shows that Dato-DXd is being tested in a phase 3 study called TROPION-Breast01, which compares its effectiveness to standard chemotherapy in patients with a specific type of breast cancer that is hard to treat. This study focuses on patients whose cancer has not responded to other treatments. Although the results are not detailed here, the fact that Dato-DXd is being compared to standard treatments in a large study suggests it has potential as an effective option. Additionally, another study, TROPION-Breast02, is testing Dato-DXd in a different type of breast cancer, further indicating its potential effectiveness.12345

What data supports the effectiveness of the drug Dato-DXd for breast cancer?

Research shows that Dato-DXd, an antibody-drug conjugate, is being tested in clinical trials for its effectiveness in treating different types of breast cancer, including HR+/HER2- and triple-negative breast cancer. These trials aim to compare Dato-DXd with standard chemotherapy, suggesting it could be a promising option for patients with limited treatment choices.12345

What safety data is available for Dato-DXd and Durvalumab in breast cancer treatment?

The TROPION-Breast01 study is evaluating the safety of Datopotamab deruxtecan (Dato-DXd) compared to standard chemotherapy in patients with HR+/HER2- breast cancer. While specific safety data for Dato-DXd in combination with Durvalumab is not detailed in the provided research, Dato-DXd is an antibody-drug conjugate with a TROP2-directed monoclonal antibody linked to a topoisomerase I inhibitor. Safety profiles of similar drugs, like trastuzumab deruxtecan, indicate manageable adverse events such as low-grade hematologic and gastrointestinal issues, with interstitial lung disease/pneumonitis being a severe but observed risk. Further specific safety data for the combination with Durvalumab would likely be available from ongoing or future clinical trials.45678

What is known about the safety of Dato-DXd and Durvalumab for breast cancer treatment?

Dato-DXd, an antibody-drug conjugate, is being studied for safety in breast cancer treatment, with common side effects including low-grade blood and stomach issues. Durvalumab, an immune therapy, has been used in various cancer treatments and is generally considered safe, but specific safety data for its combination with Dato-DXd in breast cancer is still being evaluated.45678

Is the drug Dato-DXd a promising treatment for breast cancer?

The information provided does not directly address Dato-DXd, so we cannot determine if it is a promising treatment for breast cancer based on this data.910111213

What makes the drug Dato-DXd unique for breast cancer treatment?

Dato-DXd is unique because it is an antibody-drug conjugate, which means it combines an antibody that targets cancer cells with a chemotherapy drug, allowing for more precise delivery of the treatment directly to the cancer cells, potentially reducing side effects compared to traditional chemotherapy.910111213

Research Team

AB

Aditya Bardia, MD, MPH

Principal Investigator

Massachusetts General Hospital

Eligibility Criteria

Adults over 18 with stage I-III triple-negative breast cancer who didn't have a complete response after neoadjuvant therapy. They must have finished at least 6 cycles of specific chemotherapy, had surgery to remove the disease, and can't be in relapse. Participants need good heart function and overall health but can't join if they've had certain severe diseases, other cancers within 5 years, or known genetic mutations related to breast cancer.

Inclusion Criteria

I have not received any additional treatment after my primary cancer treatment.
I am 18 years old or older.
I can provide a tissue sample from my surgery for analysis.
See 27 more

Exclusion Criteria

Participants with a known severe hypersensitivity to Dato-DXd or any of the excipients of these products including but not limited to polysorbate 80 or other monoclonal antibodies.
I do not have an active tuberculosis infection.
I have or had lung inflammation treated with steroids, or it's suspected but not confirmed by scans.
See 19 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Dato-DXd with or without durvalumab or Investigator's Choice Therapy for 8-9 cycles

24-27 weeks
Every 3 weeks for 8-9 cycles

Follow-up

Participants are monitored for safety and effectiveness after treatment

57 months

Long-term follow-up

Participants are monitored for overall survival and disease-free survival

Up to 87 months

Treatment Details

Interventions

  • Capecitabine
  • Dato-DXd
  • Durvalumab
  • Pembrolizumab
Trial OverviewThe study is testing Dato-DXd alone or combined with Durvalumab against standard treatments chosen by the investigator for patients with triple-negative breast cancer post-surgery. It's an open-label trial where everyone knows which treatment they're getting, and it involves multiple international centers.
Participant Groups
3Treatment groups
Experimental Treatment
Active Control
Group I: Dato-DXd in combination with DurvalumabExperimental Treatment2 Interventions
Arm 1: Dato-DXd 6 mg/kg IV Q3W x 8 cycles + Durvalumab 1120 mg IV Q3W x 9 cycles
Group II: Dato-DXdExperimental Treatment1 Intervention
Arm 2: Dato-DXd 6 mg/kg IV Q3W x 8 cycles
Group III: Investigators Choice TherapyActive Control2 Interventions
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.

Find a Clinic Near You

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

SWOG Clinical Trials Partnership

Collaborator

Trials
1
Recruited
1,200+

Daiichi Sankyo

Industry Sponsor

Trials
443
Recruited
493,000+
Hiroyuki Okuzawa profile image

Hiroyuki Okuzawa

Daiichi Sankyo

Chief Executive Officer

Degree in Social Sciences from Hitotsubashi University

Yuki Abe profile image

Yuki Abe

Daiichi Sankyo

Chief Medical Officer since 2023

MD

Daiichi Sankyo, Inc.

Industry Sponsor

Trials
390
Recruited
442,000+
Yuki Abe profile image

Yuki Abe

Daiichi Sankyo, Inc.

Chief Medical Officer since 2022

MD

Hiroyuki Okuzawa profile image

Hiroyuki Okuzawa

Daiichi Sankyo, Inc.

Chief Executive Officer

Degree in Social Sciences from Hitotsubashi University

SWOG Clinical Trials Partnerships

Collaborator

Trials
1
Recruited
1,200+

Findings from Research

Trastuzumab deruxtecan (T-DXd) has shown superior efficacy compared to capecitabine-based chemotherapy and T-DM1 in patients with metastatic HER2-positive breast cancer, based on the latest phase III data from the DESTINY-Breast02 and DESTINY-Breast03 trials.
T-DXd may also be effective as a neoadjuvant treatment for HER2-low breast cancer, suggesting its potential for broader applications in HER2-targeted therapies.
T-DXd Keeps Shining in Breast Cancer.[2023]
The phase III TROPION-Breast02 trial is investigating the efficacy and safety of the antibody-drug conjugate datopotamab deruxtecan (Dato-DXd) in approximately 600 patients with locally recurrent inoperable or metastatic triple-negative breast cancer (TNBC) who have not received prior treatment.
Dato-DXd is designed to target TROP2 and deliver a topoisomerase I inhibitor directly to cancer cells, and the trial will compare its effectiveness against standard chemotherapy options, focusing on progression-free survival and overall survival as primary outcomes.
TROPION-Breast02: Datopotamab deruxtecan for locally recurrent inoperable or metastatic triple-negative breast cancer.Dent, RA., Cescon, DW., Bachelot, T., et al.[2023]
Trastuzumab deruxtecan (T-DXd) is effective for breast cancer patients with low ERBB2 positivity (IHC scores of 1+ or 2+), but current standard assays show poor accuracy in distinguishing between low scores (0 and 1+), which could misassign patients for treatment.
In a study involving 18 pathologists assessing 170 breast cancer biopsies, there was only 26% concordance in scoring between 0 and 1+, indicating significant variability in ERBB2 IHC scoring that may impact patient eligibility for T-DXd.
Examination of Low ERBB2 Protein Expression in Breast Cancer Tissue.Fernandez, AI., Liu, M., Bellizzi, A., et al.[2023]

References

T-DXd Keeps Shining in Breast Cancer. [2023]
TROPION-Breast02: Datopotamab deruxtecan for locally recurrent inoperable or metastatic triple-negative breast cancer. [2023]
Examination of Low ERBB2 Protein Expression in Breast Cancer Tissue. [2023]
TROPION-Breast01: Datopotamab deruxtecan vs chemotherapy in pre-treated inoperable or metastatic HR+/HER2- breast cancer. [2023]
Real-World Outcomes of Trastuzumab Deruxtecan in Patients With HER2+ Metastatic Breast Cancer: The DE-REAL Study. [2023]
Safety of trastuzumab deruxtecan: A meta-analysis and pharmacovigilance study. [2023]
Optimizing treatment management of trastuzumab deruxtecan in clinical practice of breast cancer. [2022]
Trastuzumab deruxtecan for the treatment of HER2-positive gastric cancer. [2022]
Letrozole in the neoadjuvant setting: the P024 trial. [2021]
10.United Arab Emiratespubmed.ncbi.nlm.nih.gov
Estrogen receptors as therapeutic targets in breast cancer. [2018]
A meta-analysis of clinical benefit rates for fulvestrant 500 mg vs. alternative endocrine therapies for hormone receptor-positive advanced breast cancer. [2020]
Phase III randomized trial of droloxifene and tamoxifen as first-line endocrine treatment of ER/PgR-positive advanced breast cancer. [2019]
Fulvestrant in heavily pre-treated patients with advanced breast cancer: results from a single compassionate use programme centre. [2018]