Trial comparing treatments for Breast Cancer
Official title A Phase III Study of Dato-DXd With or Without Durvalumab Compared With Investigator's Choice of Chemotherapy in Combination With Pembrolizumab in Patients With PD-L1 Positive Locally Recurrent Inoperable or Metastatic Triple-negative Breast Cancer (TROPION-Breast05)
ClinicalTrials.gov ID: NCT06103864
What this study is testing
What is Dato-DXd?
This is an investigational medicine being studied as a potential treatment for breast cancer. It is designed to attach to specific targets on cancer cells and deliver a chemotherapy drug directly into them.
Also referred to as Datopotamab deruxtecan.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study wants to see if the new drug combination works better and is safe compared to the usual chemotherapy plus a drug called pembrolizumab.
- Who it's for
- It is looking for adults with locally recurrent or metastatic triple‑negative breast cancer that tests positive for PD‑L1.
- What's involved
- Participants may receive the new drug (Dato‑DXd) with or without another drug (durvalumab) or the standard chemotherapy plus pembrolizumab, and will have regular visits and tests to monitor safety and effectiveness.
- Time commitment
- The study lasts several months, with multiple clinic visits and tests scheduled throughout the treatment period.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Key Histologically or cytologically documented locally recurrent inoperable, which cannot be treated with curative intent, or metastatic TNBC, as...
- ECOG PS 0 or 1.
- Participants are expected to provide an FFPE tumour sample collected from a locally recurrent inoperable or metastatic tumour.
- PD-L1 positive TNBC based on results from an appropriately validated investigational PD-L1 (22C3) assay (CPS ≥ 10) from a sponsor designated central...
- No prior chemotherapy or other systemic anti-cancer therapy for metastatic or locally recurrent inoperable breast cancer.
You likely can't join if
- As judged by investigator, any evidence of diseases (such as severe or uncontrolled medical conditions including systemic diseases, uncontrolled...
- History of another primary malignancy except for malignancy treated with curative intent with no known active disease within 2 years before Cycle 1...
- Participants with a history of previously treated neoplastic spinal cord compression or treated, clinically inactive brain metastases that are no...
- Uncontrolled infection requiring IV antibiotics, antivirals or antifungals.
- Active or uncontrolled hepatitis B or C virus infection.
- Known HIV infection that is not well controlled.
See the full eligibility criteria
- Key Histologically or cytologically documented locally recurrent inoperable, which cannot be treated with curative intent, or metastatic TNBC, as defined by the ASCO-CAP guidelines.
- ECOG PS 0 or 1.
- Participants are expected to provide an FFPE tumour sample collected from a locally recurrent inoperable or metastatic tumour. Alternatively, an archival FFPE tumour sample can be submitted
- PD-L1 positive TNBC based on results from an appropriately validated investigational PD-L1 (22C3) assay (CPS ≥ 10) from a sponsor designated central laboratory.
- No prior chemotherapy or other systemic anti-cancer therapy for metastatic or locally recurrent inoperable breast cancer.
- Eligible for one of the chemotherapy options listed as ICC (paclitaxel, nab-paclitaxel, or gemcitabine + carboplatin).
- Measurable disease as per RECIST 1.1.
- Adequate bone marrow reserve and organ function.
- Male and female participants of childbearing potential must agree to use protocol-specified method(s) of contraception. Key
- As judged by investigator, any evidence of diseases (such as severe or uncontrolled medical conditions including systemic diseases, uncontrolled hypertension, serious gastrointestinal conditions associated with...
- History of another primary malignancy except for malignancy treated with curative intent with no known active disease within 2 years before Cycle 1 Day 1 and of low potential risk for recurrence.
- Participants with a history of previously treated neoplastic spinal cord compression or treated, clinically inactive brain metastases that are no longer symptomatic, who require no treatment with corticosteroids or...
- Uncontrolled infection requiring IV antibiotics, antivirals or antifungals.
- Active or uncontrolled hepatitis B or C virus infection.
- Known HIV infection that is not well controlled.
- Uncontrolled or significant cardiac disease.
- History of non-infectious ILD/pneumonitis (including radiation pneumonitis) that required steroids, current ILD/pneumonitis, or suspected ILD/pneumonitis that cannot be ruled out by imaging at screening.
- Clinically severe pulmonary function compromise.
- Clinically significant corneal disease.
- Active or prior documented autoimmune or inflammatory disorders.
- Prior exposure to any treatment including ADC containing a chemotherapeutic agent targeting topoisomerase I and TROP2-targeted therapy.
- Any concurrent anti-cancer treatment.
- Participants with a known severe hypersensitivity to PD-1/PD-L1 inhibitors or Dato-DXd.
- Currently pregnant (confirmed with positive pregnancy test), breastfeeding or planning to become pregnant.
The study team makes the final eligibility decision.
Where it is enrolling
- Daphne, Alabama, United States
- Springdale, Arkansas, United States
- Glendale, California, United States
- Sacramento, California, United States
- Aurora, Colorado, United States
- New Haven, Connecticut, United States
- Miami, Florida, United States
- Plantation, Florida, United States
- Chicago, Illinois, United States
- Des Moines, Iowa, United States
- Baton Rouge, Louisiana, United States
- Columbia, Maryland, United States
- Detroit, Michigan, United States
- Saint Paul, Minnesota, United States
- St Louis, Missouri, United States
- Albuquerque, New Mexico, United States
- New York, New York, United States
- Stony Brook, New York, United States
- Cincinnati, Ohio, United States
- Cleveland, Ohio, United States
+ 183 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Daphne, Alabama, United States; Springdale, Arkansas, United States; Glendale, California, United States; Sacramento, California, United States; Aurora, Colorado, United States; New Haven, Connecticut, United States and 197 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.