DESTINY-Breast 08 will investigate the safety, tolerability, PK and preliminary anti-tumour activity of T-DXd in combination with other therapies in patients with Metastatic HER2-low Advanced or Metastatic Breast Cancer
This study is modular in design allowing assessment of the safety, tolerability, PK and preliminary anti-tumour activity of T-DXd in combination with other therapies. Combination-treatment modules will have 2 parts: a dose-finding phase (Part 1), and a dose expansion phase (Part 2); the Part 2 dose-expansion phase will use the RP2D determined in Part 1. The target population of interest in this study is patients with HER2-low (IHC 1+ or IHC 2+/ISH -) (as per ASCO/CAP 2018 guidelines) advanced/MBC. Part 1 of each module will enroll patients with locally confirmed HER2-low advanced/MBC in second-line or later (≥ 2L) settings Part 2 of each module will enroll patients with HER2-low MBC who have either not received prior treatment, or received only 1 prior treatment (depending on the module-specific exclusion criteria) for advanced/metastatic disease
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
138
T-DXd: administered as an IV infusion
Durvalumab: administered as an IV infusion
Paclitaxel: administered as an IV infusion
Occurrence of adverse events (AEs)- Part 1
Occurrence of AEs in Part 1 graded according to NCI CTCAE v5.0
Time frame: Up to follow-up period, approximately 24 months
Occurrence of serious adverse events (SAEs)- Part 1
Occurrence of SAEs in Part 1 graded according to NCI CTCAE v5.0
Time frame: Up to follow-up period, approximately 24 months
Occurrence of adverse events (AEs)- Part 2
Occurrence of AEs in Part 2 graded according to NCI CTCAE v5.0
Time frame: Up to follow-up period, approximately 24 months
Occurrence of serious adverse events (SAEs)- Part 2
Occurrence of SAEs in Part 2 graded according to NCI CTCAE v5.0
Time frame: Up to follow-up period, approximately 24 months
Objective Response Rate (ORR)- Part 2
ORR defined as the proportion of patients who have a confirmed CR or PR, as determined by the investigator at local site per RECIST 1.1
Time frame: Until progression, assessed up to approximately 24 months
Progression Free Survival (PFS)- Part 2
PFS defined as time from the date of first dose until the date of progression as determined by the investigator at local site per RECIST 1.1, or death due to any cause
Time frame: Until progression or death, assessed up to approximately 24 months
Duration of Response (DoR)- Part 2
DoR defined as time from the date of first documented response (which is subsequently confirmed) until the date of documented progression or death in the absence of disease progression
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Capivasertib: administered orally
Anastrozole: administered orally
Fulvestrant: administered as an IM injection
Capecitabine: administered orally
Research Site
Commack, New York, United States
Research Site
Harrison, New York, United States
Research Site
New York, New York, United States
Research Site
New York, New York, United States
Research Site
Uniondale, New York, United States
Research Site
Chapel Hill, North Carolina, United States
Research Site
Chattanooga, Tennessee, United States
Research Site
Germantown, Tennessee, United States
Research Site
Fort Worth, Texas, United States
Research Site
Melbourne, Australia
...and 27 more locations
Time frame: Until progression or death, assessed up to approximately 24 months
Overall Survival (OS)- Part 2
OS defined as time from the date of first dose until the date of death by any cause
Time frame: Until death, assessed up to approximately 24 months
Serum concentration of T-DXd, total anti-HER2 antibody and MAAA-1181a
Determination of trastuzumab deruxtecan concentration in serum at different time points after trastuzumab deruxtecan administration
Time frame: While on study drug up to study completion, approximately 24 months
Immunogenicity of trastuzumab deruxtecan
Percentage of patients who develop ADA for trastuzumab deruxtecan
Time frame: Up to follow-up period, approximately 24 months
Serum Concentration of durvalumab
Determination of durvalumab concentration in serum at different time points after administration
Time frame: While on study drug up to study completion, approximately 24 months
Immunogenicity of durvalumab
Percentage of patients who develop ADAs for durvalumab
Time frame: Up to follow-up period, approximately 24 months