A Study of Dato-DXd Versus Investigator's Choice Chemotherapy in Patients With Locally Recurrent Inoperable or Metastatic Triple-negative Breast Cancer, Who Are Not Candidates for PD-1/PD-L1 Inhibitor Therapy (TROPION-Breast02)
Indikation (Clinical Trials):
Breast Neoplasms, Triple Negative Breast Neoplasms
Geschlecht:
Alle
Altersgruppe:
Erwachsene (18+)
Phase:
Phase 3
Sponsor:
AstraZeneca
Collaborator:
Daiichi Sankyo
Kontakt
AstraZeneca Clinical Study Information Center Kontakt: Phone: 1-877-240-9479 E-Mail: information.center@astrazeneca.com» Kontaktdaten anzeigen
Studienlocations (3 von 275)
Research Site 63739 Aschaffenburg (Bayern) GermanyRekrutierend» Google-MapsResearch Site 53111 Bonn (Nordrhein-Westfalen) GermanyRekrutierend» Google-MapsResearch Site 40479 Düsseldorf (Nordrhein-Westfalen) GermanyZurückgezogen» Google-Maps
Research Site 60431 Frankfurt am Main (Hessen) GermanyRekrutierend» Google-MapsResearch Site 49124 Georgsmarienhuette (Niedersachsen) GermanyRekrutierend» Google-MapsResearch Site 70839 Gerlingen (Baden-Württemberg) GermanyZurückgezogen» Google-MapsResearch Site 20357 Hamburg (Hamburg) GermanyZurückgezogen» Google-MapsResearch Site 30625 Hannover (Niedersachsen) GermanyRekrutierend» Google-MapsResearch Site 74078 Heilbronn (Baden-Württemberg) GermanyRekrutierend» Google-MapsResearch Site 56068 Koblenz Am Rhein (Rheinland-Pfalz) GermanyRekrutierend» Google-MapsResearch Site 63225 Langen (Hessen) GermanyRekrutierend» Google-MapsResearch Site 81377 München (Bayern) GermanyRekrutierend» Google-MapsResearch Site 48149 Münster (Nordrhein-Westfalen) GermanyRekrutierend» Google-MapsResearch Site 65199 Wiesbaden (Hessen) GermanyRekrutierend» Google-MapsResearch Site 91010 Duarte United StatesRekrutierend» Google-MapsResearch Site 90017 Los Angeles United StatesRekrutierend» Google-MapsResearch 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Google-MapsResearch Site 162-8655 Shinjuku-ku JapanRekrutierend» Google-MapsResearch Site 514-8507 Tsu-shi JapanRekrutierend» Google-MapsResearch Site 305-8577 Tsukuba JapanRekrutierend» Google-MapsResearch Site 241-8515 Yokohama-shi JapanRekrutierend» Google-MapsResearch Site 602-739 Busan-si Korea, Republic ofRekrutierend» Google-MapsResearch Site 41404 Daegu Korea, Republic ofRekrutierend» Google-MapsResearch Site 10408 Goyang-si Korea, Republic ofZurückgezogen» Google-MapsResearch Site 03080 Seoul Korea, Republic ofRekrutierend» Google-MapsResearch Site 03722 Seoul Korea, Republic ofRekrutierend» Google-MapsResearch Site 05505 Seoul Korea, Republic ofRekrutierend» Google-MapsResearch Site 06273 Seoul Korea, Republic ofRekrutierend» Google-MapsResearch Site 06351 Seoul Korea, Republic ofRekrutierend» Google-MapsResearch Site 04980 CD Mexico MexicoRekrutierend» Google-MapsResearch Site 44280 Guadalajara Jalisco MexicoRekrutierend» Google-MapsResearch Site 44670 Guadalajara 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1. Progression Free Survival (PFS) (Time Frame - From randomization until progression as assessed by BICR or death due to any cause (anticipated to be up to 26 months)): PFS is defined as time from randomisation until progression per RECIST 1.1 as assessed by BICR, or death due to any cause.
The analysis will include all randomised participants, as randomised, regardless of whether the participant withdraws from randomised therapy, receives another anti-cancer therapy or clinically progresses prior to RECIST 1.1 progression. However, if the participant progresses or dies immediately after 2 or more consecutive missed visits, the participant will be censored at the time of the latest evaluable assessment prior to the 2 missed visits.
The measure of interest is the hazard ratio [HR] of PFS.
2. Overall Survival (OS) (Time Frame - From randomisation until the date of death due to any cause (approximately 42 months)): OS is defined as the time from randomisation until the date of death due to any cause.
The analysis will include all randomised participants, by treatment group as randomised. The measure of interest is the hazard ratio [HR] of OS.
Secondary outcome:
1. Objective Response Rate (ORR) (Time Frame - From randomisation up until progression (anticipated to be up to 26 months)): ORR is defined as the proportion of participants who have a confirmed CR or PR, as determined by BICR/investigator assessment, per RECIST 1.1.
The analysis will include all randomised participants, by treatment group as randomised.
Data obtained from randomisation up until progression, or the last evaluable assessment in the absence of progression, will be included in the assessment of ORR, regardless of whether the participant withdraws from therapy. Participants who go off treatment without a response or progression, receive a subsequent anti-cancer therapy, and then respond will not be included as responders in the ORR.
The measure of interest is the odds ratio of the ORR.
2. Duration of Response (DoR) (Time Frame - From the date of first documented confirmed response until date of documented progression per RECIST 1.1, as assessed by BICR/investigator assessment or death due to any cause (anticipated to be up to 26 months)): DoR is defined as the time from the date of first documented confirmed response until date of documented progression per RECIST 1.1, as assessed by BICR/investigator assessment or death due to any cause.
The analysis will include all randomised participants as randomised who have a confirmed response, regardless of whether the participant withdraws from therapy, receives another anti-cancer therapy or clinically progresses prior to RECIST 1.1 progression.
The measure of interest is the median of DoR,
3. Progression-Free Survival (PFS) by Investigator assessment (Time Frame - From randomisation until progression per RECIST 1.1 as assessed by the investigator, or death due to any cause (anticipated to be up to 26 months)): PFS is defined as time from randomisation until progression per RECIST 1.1 as assessed by the investigator, or death due to any cause.
The analysis will include all randomised participants, as randomised, regardless of whether the participant withdraws from randomised therapy, receives another anti-cancer therapy or clinically progresses prior to RECIST 1.1 progression.
The measure of interest is the hazard ratio [HR] of PFS.
4. Disease Control Rate (DCR) (Time Frame - At least 11 weeks after randomization to 23 months): DCR at 12 weeks is defined as the percentage of participants who have a confirmed CR or PR or who have SD, per RECIST 1.1, as assessed by BICR/investigator assessment and derived from the raw tumour data for at least 11 weeks after randomisation.
The analysis will include all randomised participants by treatment group as randomised.
Data obtained from randomisation up until progression, or the last evaluable assessment in the absence of progression, will be included in the assessment of DCR, regardless of whether the participant withdraws from therapy. Participants who receive a subsequent anticancer therapy prior to Week 11 will not be considered to have disease control in the analysis.
The measure of interest is the odds ratio of the DCR.
5. Time to deterioration (TTD) in pain in participants treated with Dato DXd compared with ICC (Time Frame - From the date of randomisation to the date of deterioration (from randomization to 18 weeks post-progression)): TTD in pain as measured by the pain scale from EORTC IL146. TTD is defined as time from the date of randomisation to the date of deterioration. Deterioration is defined as change from baseline that reaches a clinically meaningful deterioration threshold. The analysis will include all randomised participants.
The measure of interest is the hazard ratio [HR] of TTD in pain.
6. Time to deterioration (TTD) in physical functioning in participants treated with Dato DXd compared with ICC (Time Frame - From the date of randomisation to the date of deterioration (from randomization to 18 weeks post-progression)): TTD in physical functioning as measured by the physical functioning scale from EORTC IL146.
TTD is defined as time from the date of randomisation to the date of deterioration. Deterioration is defined as change from baseline that reaches a clinically meaningful deterioration threshold. The analysis will include all randomised participants.
The measure of interest is the hazard ratio [HR] of TTD in physical functioning.
7. Time to deterioration (TTD) in breast and arm symptoms in participants treated with Dato DXd compared to ICC (Time Frame - From the date of randomisation to the date of deterioration (from randomization to 18 weeks post-progression)): TTD in breast symptoms as measured by the breast symptoms scale from EORTC IL116
TTD in arm symptoms as measured by the arm symptoms scale from EORTC IL116 TTD is defined as time from the date of randomisation to the date of deterioration. Deterioration is defined as change from baseline that reaches a clinically meaningful deterioration threshold. The analysis will include all randomised participants.
The measure of interest is the hazard ratio [HR] of TTD in breast symptoms/arm symptoms.
8. Time to deterioration (TTD) in GHS/QoL in participants treated with Dato DXd compared with ICC (Time Frame - From the date of randomisation to the date of deterioration (from randomization to 18 weeks post-progression)): TTD in GHS/QoL as measured by the GHS/QoL scale from EORTC IL146. TTD is defined as time from the date of randomisation to the date of deterioration. Deterioration is defined as change from baseline that reaches a clinically meaningful deterioration threshold. The analysis will include all randomised participants.
The measure of interest is the hazard ratio [HR] of TTD in GHS/QoL.
9. Time to First Subsequent Therapy (TFST) (Time Frame - From randomisation until the start date of the first subsequent anti-cancer therapy after discontinuation of randomised treatment, or death due to any cause (anticipated to be up to 26 months)): TFST is defined as the time from randomisation until the start date of the first subsequent anti-cancer therapy after discontinuation of randomised treatment, or death due to any cause.
The analysis will include all randomised participants as randomised, regardless of progression status.
The measure of interest is the hazard ratio [HR] of TFST.
10. Time to Second Subsequent Therapy (TSST) (Time Frame - From randomisation until the start date of the second subsequent anti cancer therapy after discontinuation of first subsequent treatment, or death due to any cause (anticipated to be up to 26 months)): TSST is defined as the time from randomisation until the start date of the second subsequent anti cancer therapy after discontinuation of first subsequent treatment, or death due to any cause.
The analysis will include all randomised participants as randomised, regardless of progression status on study treatment or first subsequent treatment.
The measure of interest is the hazard ratio [HR] of TSST.
11. Progression Free Survival 2 (PFS2) (Time Frame - From randomisation to the earliest of the progression event (following the initial progression), subsequent to first subsequent therapy, or death (anticipated to be up to 26 months)): PFS2 will be defined as the time from randomisation to the earliest of the progression event (following the initial progression), subsequent to first subsequent therapy, or death. The date of second progression will be recorded by the investigator in the eCRF and defined according to local standard clinical practice.
The analysis will include all randomised participants as randomised regardless of whether the participant withdraws from subsequent therapy and regardless of missed visits.
The measure of interest is the hazard ratio [HR] of PFS2.
12. Pharmacokinetics of Dato-DXd (Time Frame - From first dose to end of treatment (anticipated to be up to 26 months)): Concentration of Dato DXd, total anti-TROP2 antibody, and MAAA-1181a in plasma.
13. Immunogenicity of Dato-DXd (Time Frame - From first dose to end of treatment safety follow-up (anticipated to be up to 26 months)): Presence of ADAs for Dato-DXd (confirmatory results: positive or negative, titres).
14. Safety of Dato-DXd (Time Frame - From first dose to end of treatment safety follow-up (anticipated to be up to 26 months)): Safety will be evaluated in terms of AEs (graded by CTCAE version 5.0)
Active Comparator: Investigator's Choice of Chemotherapy (ICC) Arm 2:
If no prior taxane, or prior taxane in the (neo)adjuvant setting and DFI > 12 months, paclitaxel or nab-paclitaxel
If prior taxane and DFI ≤ 12 months: capecitabine, carboplatin, or eribulin.
Dato-DXd (Datopotamab deruxtecan (Dato-DXd, DS-1062a)): Experimental drug. Provided in 100mg vials. IV infusion.
Paclitaxel: IV Infusion. Active comparator
Nab-paclitaxel: IV infusion. Active comparator
Carboplatin: IV infusion. Active comparator
Capecitabine: Tablet. Oral route of administration. Active comparator
Eribulin mesylate: IV infusion. Active comparator
Quelle: ClinicalTrials.gov
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"A Study of Dato-DXd Versus Investigator's Choice Chemotherapy in Patients With Locally Recurrent Inoperable or Metastatic Triple-negative Breast Cancer, Who Are Not Candidates for PD-1/PD-L1 Inhibitor Therapy (TROPION-Breast02)"
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