Informations générales (source: ClinicalTrials.gov)
A Phase 3 Open-label, Randomised Study of Datopotamab Deruxtecan (DatoDXd) With or Without Durvalumab Versus Investigator's Choice of Therapy in Patients With Stage I-III Triple-negative Breast Cancer Who Have Residual Invasive Disease in the Breast and/or Axillary Lymph Nodes at Surgical Resection Following Neoadjuvant Systemic Therapy (TROPION-Breast03)
Interventional
Phase 3
AstraZeneca (Voir sur ClinicalTrials)
novembre 2022
mars 2030
28 septembre 2024
This is a Phase III, randomized, open-label, 3-arm, multicenter, international study
assessing the efficacy and safety of Dato-DXd with or without durvalumab compared with
ICT in participants with stage I to III TNBC with residual invasive disease in the breast
and/or axillary lymph nodes at surgical resection following neoadjuvant systemic therapy
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT CURIE | 04/09/2024 13:49:40 | Contact (sur clinicalTrials) | |||
| CLCC INSTITUT GUSTAVE ROUSSY | Barbara PISTILLI | 19/06/2024 12:27:24 | Contacter | ||
| CLCC RENE HUGUENIN INSTITUT CURIE | 04/09/2024 13:49:27 | Contact (sur clinicalTrials) | |||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Research Site - 21000 - Dijon - France | Contact (sur clinicalTrials) | ||||
| Research Site - 30029 - Nimes - France | Contact (sur clinicalTrials) | ||||
| Research Site - 33076 - Bordeaux - France | Contact (sur clinicalTrials) | ||||
| Research Site - 34070 - Montpellier - France | Contact (sur clinicalTrials) | ||||
| Research Site - 35000 - Rennes - France | Contact (sur clinicalTrials) | ||||
| Research Site - 44805 - Saint Herblain Cedex - France | Contact (sur clinicalTrials) | ||||
| Research Site - 49055 - Angers Cedex 02 - France | Contact (sur clinicalTrials) | ||||
| Research Site - 54000 - Vandoeuvre Les Nancy - France | Contact (sur clinicalTrials) | ||||
| Research Site - 69008 - Lyon - France | Contact (sur clinicalTrials) | ||||
| Research Site - 74370 - Epagny Metz-Tessy - France | Contact (sur clinicalTrials) | ||||
| Research Site - 75248 - Paris Cedex 05 - France | Contact (sur clinicalTrials) | ||||
| Research Site - 86021 - Poitiers - France | Contact (sur clinicalTrials) | ||||
| Research Site - 94805 - Villejuif Cedex - France | Contact (sur clinicalTrials) | ||||
Critères
Tous
Inclusion Criteria:
1. Participant must be ≥ 18 years at the time of screening.
2. Histologically confirmed invasive TNBC, as defined by the ASCO/CAP guidelines.
3. Residual invasive disease in the breast and/or axillary lymph node(s) at surgical
resection following neoadjuvant therapy.
4. Completed at least 6 cycles of neoadjuvant therapy containing an anthracycline
and/or a taxane with or without platinum chemotherapy, with or without
pembrolizumab.
5. No evidence of locoregional or distant relapse.
6. Surgical removal of all clinically evident disease in the breast and lymph nodes.
7. ECOG performance status of 0 or 1 with no deterioration over the previous 2 weeks
prior to randomisation.
8. All participants must provide an FFPE tumour sample from residual invasive disease
at surgery for tissue-based analysis.
9. No adjuvant systemic therapy.
10. Radiotherapy (if indicated) delivered before the start of study intervention.
11. If post-operative radiation therapy is given, an interval of no more than 6 weeks
between the completion of radiation therapy and the date of randomisation (radiation
therapy can be completed during screening period). If no post-operative radiation
therapy is given, an interval of no more than 16 weeks between the date of breast
surgery and the date of randomisation.
12. Has LVEF ≥ 50% by either an ECHO or MUGA scan within 28 days before randomisation.
13. Eligible for one of the therapy options listed as investigator's choice per
investigator assessment.
14. No known germline BRCA1 or BRCA2 pathogenic mutation.
15. Adequate bone marrow reserve and organ function within 7 days before randomisation.
1. Participant must be ≥ 18 years at the time of screening.
2. Histologically confirmed invasive TNBC, as defined by the ASCO/CAP guidelines.
3. Residual invasive disease in the breast and/or axillary lymph node(s) at surgical
resection following neoadjuvant therapy.
4. Completed at least 6 cycles of neoadjuvant therapy containing an anthracycline
and/or a taxane with or without platinum chemotherapy, with or without
pembrolizumab.
5. No evidence of locoregional or distant relapse.
6. Surgical removal of all clinically evident disease in the breast and lymph nodes.
7. ECOG performance status of 0 or 1 with no deterioration over the previous 2 weeks
prior to randomisation.
8. All participants must provide an FFPE tumour sample from residual invasive disease
at surgery for tissue-based analysis.
9. No adjuvant systemic therapy.
10. Radiotherapy (if indicated) delivered before the start of study intervention.
11. If post-operative radiation therapy is given, an interval of no more than 6 weeks
between the completion of radiation therapy and the date of randomisation (radiation
therapy can be completed during screening period). If no post-operative radiation
therapy is given, an interval of no more than 16 weeks between the date of breast
surgery and the date of randomisation.
12. Has LVEF ≥ 50% by either an ECHO or MUGA scan within 28 days before randomisation.
13. Eligible for one of the therapy options listed as investigator's choice per
investigator assessment.
14. No known germline BRCA1 or BRCA2 pathogenic mutation.
15. Adequate bone marrow reserve and organ function within 7 days before randomisation.
1. Stage IV (metastatic) TNBC.
2. History of prior invasive breast cancer, or evidence of recurrent disease following
preoperative therapy and surgery.
3. Severe or uncontrolled medical conditions including systemic diseases, history of
allogeneic organ transplant and active bleeding diseases, ongoing or active
infection, serious chronic gastrointestinal conditions associated with diarrhea
chronic diverticulitis or previous complicated diverticulitis.
4. History of another primary malignancy except for adequately resected basal cell
carcinoma of the skin or squamous cell carcinoma of the skin, in situ disease
(including ductal carcinoma in situ) that has undergone potentially curative
therapy, or other solid malignancy treated with curative intent with no known active
disease within 5 years before randomisation and of low potential risk for
recurrence.
5. Persistent toxicities caused by previous anticancer therapy, excluding alopecia, not
yet improved to Grade ≤ 1 or baseline. Participants with irreversible toxicity that
is not reasonably expected to be exacerbated by study intervention may be included
(eg, hearing loss).
6. Active or prior documented autoimmune or inflammatory disorders.
7. Clinically significant corneal disease.
8. Active or uncontrolled hepatitis B or C virus infection.
9. Known HIV infection that is not well controlled
10. Active tuberculosis infection.
11. Mean resting corrected QTcF > 470 ms regardless of gender, obtained from triplicate
12-lead ECGs performed at screening.
12. Uncontrolled or significant cardiac disease.
13. History of non-infectious ILD/pneumonitis including radiation, pneumonitis that
required steroids, has current ILD/pneumonitis, or has suspected ILD/pneumonitis
that cannot be ruled out by imaging at screening.
14. Has severe pulmonary function compromise.
15. Any known active liver disease.
16. Grade ≥ 2 peripheral neuropathy of any aetiology.
17. Prior exposure to a PD-1/PD-L1 inhibitor other than pembrolizumab.
18. Current or prior use of immunosuppressive medication within 14 days prior to
randomisation.
19. 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.
20. Participants with a known severe hypersensitivity to PD-1/PD-L1 inhibitors.
21. Participation in another clinical study with a study intervention or investigational
medicinal device administered in the last 4 weeks prior to randomisation,
randomisation into a prior Dato-DXd, T-DXd, or durvalumab study regardless of
treatment assignment.
22. Currently pregnant (confirmed with positive pregnancy test), breastfeeding or
planning to become pregnant.