Phase II trial of trastuzumab deruxtecan in first-line treatment HER2-positive locally advanced or metastatic breast cancer (MBC) patients considered resistant to trastuzumab + pertuzumab + taxane due to early relapse. “TRANSCENDER Study”

Conditions

Metastatic breast cancer

Brief summary

Objective Response Rate (ORR) is defined as the rate of complete response (CR) plus partial response (PR) based on the investigator’s assessment using the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1., out of the patients who received at least 1 dose of treatment.

Detailed description

Other efficacy endpoints: Progression-Free Survival (PFS) is defined as the time from the date of enrollment to the date of disease progression, based on the investigator’s assessment using RECIST version 1.1., or death from any cause, whichever occurs first., Other efficacy endpoints: Overall Survival (OS) is defined as the time from the date of enrollment to the date of death from any cause., Other efficacy endpoints: Time to treatment response (TTR) is defined as the time from the date of enrollment to the date of first documentation of objective tumor response (CR or PR)., Other efficacy endpoints: Duration of response (DoR) is defined as the time from the date of first documentation of objective tumor response (CR or PR) to the date of first documented progressive disease based on the investigator’s assessment using RECIST version 1.1., or death from any cause, whichever occurs first., Safety: Incidence and severity of Adverse Events (AEs) and clinical lab abnormalities. AEs grades will be defined by the National Cancer Institute Common Terminology Criteria for AEs (NCI-CTCAE) version 5.0. AE terms will be coded according to the MedDRA dictionary., Tolerability: Incidence of T-DXd dose modifications, discontinuations due to AEs, number of administered cycles, dose intensity, etc., Changes (mean score) and time to deterioration on EORTC QLQ-C30 Global Health Status/QoL from baseline.

Related papers

No related papers found yet.

Interventions

DRUGDS-8201a

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Objective Response Rate (ORR) is defined as the rate of complete response (CR) plus partial response (PR) based on the investigator’s assessment using the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1., out of the patients who received at least 1 dose of treatment.	—

Secondary

Measure	Time frame
Other efficacy endpoints: Progression-Free Survival (PFS) is defined as the time from the date of enrollment to the date of disease progression, based on the investigator’s assessment using RECIST version 1.1., or death from any cause, whichever occurs first., Other efficacy endpoints: Overall Survival (OS) is defined as the time from the date of enrollment to the date of death from any cause., Other efficacy endpoints: Time to treatment response (TTR) is defined as the time from the date of enrollment to the date of first documentation of objective tumor response (CR or PR)., Other efficacy endpoints: Duration of response (DoR) is defined as the time from the date of first documentation of objective tumor response (CR or PR) to the date of first documented progressive disease based on the investigator’s assessment using RECIST version 1.1., or death from any cause, whichever occurs first., Safety: Incidence and severity of Adverse Events (AEs) and clinical lab abnormalities. AEs grade	—

Measure

Time frame

Other efficacy endpoints: Progression-Free Survival (PFS) is defined as the time from the date of enrollment to the date of disease progression, based on the investigator’s assessment using RECIST version 1.1., or death from any cause, whichever occurs first., Other efficacy endpoints: Overall Survival (OS) is defined as the time from the date of enrollment to the date of death from any cause., Other efficacy endpoints: Time to treatment response (TTR) is defined as the time from the date of enrollment to the date of first documentation of objective tumor response (CR or PR)., Other efficacy endpoints: Duration of response (DoR) is defined as the time from the date of first documentation of objective tumor response (CR or PR) to the date of first documented progressive disease based on the investigator’s assessment using RECIST version 1.1., or death from any cause, whichever occurs first., Safety: Incidence and severity of Adverse Events (AEs) and clinical lab abnormalities. AEs grade

—

Countries

Spain

Outcome results

None listed