Informations générales (source: ClinicalTrials.gov)
A Phase III, Open-label, Randomised Study of Datopotamab Deruxtecan (Dato-DXd) With or Without Durvalumab Compared With Investigator's Choice of Chemotherapy (Paclitaxel, Nab-paclitaxel or Gemcitabine + Carboplatin) in Combination With Pembrolizumab in Patients With PD-L1 Positive Locally Recurrent Inoperable or Metastatic Triple-negative Breast Cancer (TROPION-Breast05)
Interventional
Phase 3
AstraZeneca (Voir sur ClinicalTrials)
novembre 2023
septembre 2030
02 mars 2026
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.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT GUSTAVE ROUSSY | Barbara PISTILLI | 04/06/2026 12:10:05 | Contacter | ||
Critères
Tous
Key Inclusion Criteria
- 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 ≤ 3 years prior to the
participant signing informed consent (screening start).
- 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 I-III breast cancer, if indicated, and ≥6 months have elapsed between
completion of treatment with curative intent and the first documented recurrence.
- 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 Exclusion Criteria
- 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 diarrhoea, chronic diverticulitis or
previous complicated diverticulitis, history of allogeneic organ transplant, and
active bleeding diseases, ongoing and active infection, significant cardiac
conditions, substance abuse, psychiatric illness/social situation or psychological
conditions) which, in the investigator's opinion, makes it undesirable for the
participant to participate in the study or that would jeopardize compliance with the
protocol.
- 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 anticonvulsants, may be included in the
study if they have recovered from acute toxic effects of radiotherapy.
- Participants with treated clinically inactive brain metastases that are no longer
symptomatic, who require no treatment with corticosteroids or anticonvulsants, may
be included in the study if they have recovered from acute toxic effects of
radiotherapy.
- 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.
- 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 ≤ 3 years prior to the
participant signing informed consent (screening start).
- 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 I-III breast cancer, if indicated, and ≥6 months have elapsed between
completion of treatment with curative intent and the first documented recurrence.
- 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 Exclusion Criteria
- 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 diarrhoea, chronic diverticulitis or
previous complicated diverticulitis, history of allogeneic organ transplant, and
active bleeding diseases, ongoing and active infection, significant cardiac
conditions, substance abuse, psychiatric illness/social situation or psychological
conditions) which, in the investigator's opinion, makes it undesirable for the
participant to participate in the study or that would jeopardize compliance with the
protocol.
- 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 anticonvulsants, may be included in the
study if they have recovered from acute toxic effects of radiotherapy.
- Participants with treated clinically inactive brain metastases that are no longer
symptomatic, who require no treatment with corticosteroids or anticonvulsants, may
be included in the study if they have recovered from acute toxic effects of
radiotherapy.
- 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.