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Compares treatment options 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?
Dato-DXd is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for breast cancer.
Also referred to as Datopotamab deruxtecan (Dato-DXd, DS-1062a).
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
- This is a Phase III, randomised, open-label, 3-arm, multicentre, international study assessing the efficacy and safety of Dato-DXd with or without durvalumab compared with investigator's choice chemotherapy in combination with pembrolizumab in participants with PD-L1 positive locally recurrent inoperable or metastatic TNBC.
- 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. Alternatively, an...
- 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. \- Patients with recurrent...
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; it must have been collected...
- 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. \- Patients with recurrent disease will be eligible if they have completed treatment for Stage...
- 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's taking place
- Daphne, Alabama, United States
- Springdale, Arkansas, United States
- Duarte, California, United States
- Fountain Valley, California, United States
- Glendale, California, United States
- Sacramento, California, United States
- Santa Rosa, California, United States
- Aurora, Colorado, United States
- Denver, Colorado, United States
- New Haven, Connecticut, United States
- Altamonte Springs, Florida, United States
- Jacksonville, Florida, United States
- Miami, Florida, United States
- Palm Bay, Florida, United States
- Plantation, Florida, United States
- Atlanta, Georgia, United States
- Honolulu, Hawaii, United States
- Chicago, Illinois, United States
- Decatur, Illinois, United States
- Elmhurst, Illinois, United States
+ 245 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 - 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?
Study sites include Daphne, Alabama, United States; Springdale, Arkansas, United States; Duarte, California, United States; Fountain Valley, California, United States; Glendale, California, United States; Sacramento, California, United States and 259 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.