A Phase 1b/2 Multicentre, Open-label, Modular, Dose-finding and Dose-expansion Study to Explore the Safety, Tolerability, and Anti-tumour Activity of Trastuzumab Deruxtecan (T-DXd) in Combination with other Anti-cancer Agents in Patients with HER2-positive Metastatic Breast Cancer (DESTINY-Breast07)

Conditions

HER2-positive Metastatic Breast Cancer

Brief summary

Part 1: AEs, SAEs, DLTs, laboratory findings, Part 2: AEs, SAEs, laboratory findings

Detailed description

Part 1 and Part 2: ORR is defined as the proportion of patients who have a CR or PR, as determined by the Investigator at local site per RECIST 1.1., Part 1 and Part 2: PFS is defined as time from the date of randomisation until the date of progression as assessed by the Investigator at local site per RECIST 1.1, or death due to any cause., Part 2: PFS2 is defined as time from the date of randomisation until the date of progression on next line treatment (the earliest of the progression event subsequent to first subsequent anticancer therapy) or death; second progression will be defined according to local standard clinical practice., Part 2: DoR is defined as time from the date of first documented response until the date of documented progression or death in the absence of disease progression., Part 2: OS is defined as time from the date of randomisation until the date of death due to any cause., Serum concentration of T-DXd, total anti-HER2 antibody, MAAA- 1181a, durvalumab, and pertuzumab; plasma concentration of paclitaxel and tucatinib, Immunogenicity for T-DXd, durvalumab, and pertuzumab

Related papers

No related papers found yet.

Interventions

DRUGPERTUZUMAB

DRUGDS-8201a

DRUGIMFINZI 50 mg/mL concentrate for solution for infusion.

DRUGINFLIXIMAB

DRUGMYCOPHENOLATE MOFETIL

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Part 1: AEs, SAEs, DLTs, laboratory findings, Part 2: AEs, SAEs, laboratory findings	—

Secondary

Measure	Time frame
Part 1 and Part 2: ORR is defined as the proportion of patients who have a CR or PR, as determined by the Investigator at local site per RECIST 1.1., Part 1 and Part 2: PFS is defined as time from the date of randomisation until the date of progression as assessed by the Investigator at local site per RECIST 1.1, or death due to any cause., Part 2: PFS2 is defined as time from the date of randomisation until the date of progression on next line treatment (the earliest of the progression event subsequent to first subsequent anticancer therapy) or death; second progression will be defined according to local standard clinical practice., Part 2: DoR is defined as time from the date of first documented response until the date of documented progression or death in the absence of disease progression., Part 2: OS is defined as time from the date of randomisation until the date of death due to any cause., Serum concentration of T-DXd, total anti-HER2 antibody, MAAA- 1181a, durvalumab, and pertu	—

Measure

Time frame

Part 1 and Part 2: ORR is defined as the proportion of patients who have a CR or PR, as determined by the Investigator at local site per RECIST 1.1., Part 1 and Part 2: PFS is defined as time from the date of randomisation until the date of progression as assessed by the Investigator at local site per RECIST 1.1, or death due to any cause., Part 2: PFS2 is defined as time from the date of randomisation until the date of progression on next line treatment (the earliest of the progression event subsequent to first subsequent anticancer therapy) or death; second progression will be defined according to local standard clinical practice., Part 2: DoR is defined as time from the date of first documented response until the date of documented progression or death in the absence of disease progression., Part 2: OS is defined as time from the date of randomisation until the date of death due to any cause., Serum concentration of T-DXd, total anti-HER2 antibody, MAAA- 1181a, durvalumab, and pertu

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Countries

Germany, Italy, Poland, Spain

Outcome results

None listed