"H3RAKLES": Tucatinib and trastuzumab in HER3-mutant and HER2-not amplified metastatic breast cancer

Conditions

HER3-mutant and HER2-not amplified metastatic breast cancer

Brief summary

Clinical benefit rate (CBR), defined as the proportion of patients who achieved a complete response (CR), a partial response (PR), or had stable disease (SD) for 24 weeks or more, according to the investigator-assessed RECIST v1.1 criteria.

Detailed description

Progression-free survival (PFS), defined as the time from inclusion to progression or death; Objective response rate, defined as the proportion of patients who achieved a CR or PR according to the investigator-assessed RECIST v1.1 criteria; and duration of response, defined as the time between the first observation of a PR or a CR, and progressive disease or death, Adverse Events (AEs) and Serious Adverse Events (SAEs), per CTCAE v5.0, considered by the investigator as related to trastuzumab or tucatinib., QLQ-C30 QoL questionnaire with the QLQ-BR42 module will be filled at inclusion, at cycles 1 and 3 and at the end of the treatment., Exploratory: relationship between biomarkers (including, but not limited to, DNA, RNA and proteins analyses) in blood, plasma, and/or tumor and either (1) presence of an ERBB3 mutation and (2) treatment efficacy.

Related papers

No related papers found yet.

Interventions

DRUGOgivri 150 mg powder for concentrate for solution for infusion

DRUGTUKYSA 50 mg film-coated tablets

DRUGTUKYSA 150 mg film-coated tablets

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Clinical benefit rate (CBR), defined as the proportion of patients who achieved a complete response (CR), a partial response (PR), or had stable disease (SD) for 24 weeks or more, according to the investigator-assessed RECIST v1.1 criteria.	—

Secondary

Measure	Time frame
Progression-free survival (PFS), defined as the time from inclusion to progression or death; Objective response rate, defined as the proportion of patients who achieved a CR or PR according to the investigator-assessed RECIST v1.1 criteria; and duration of response, defined as the time between the first observation of a PR or a CR, and progressive disease or death, Adverse Events (AEs) and Serious Adverse Events (SAEs), per CTCAE v5.0, considered by the investigator as related to trastuzumab or tucatinib., QLQ-C30 QoL questionnaire with the QLQ-BR42 module will be filled at inclusion, at cycles 1 and 3 and at the end of the treatment., Exploratory: relationship between biomarkers (including, but not limited to, DNA, RNA and proteins analyses) in blood, plasma, and/or tumor and either (1) presence of an ERBB3 mutation and (2) treatment efficacy.	—

Measure

Time frame

Progression-free survival (PFS), defined as the time from inclusion to progression or death; Objective response rate, defined as the proportion of patients who achieved a CR or PR according to the investigator-assessed RECIST v1.1 criteria; and duration of response, defined as the time between the first observation of a PR or a CR, and progressive disease or death, Adverse Events (AEs) and Serious Adverse Events (SAEs), per CTCAE v5.0, considered by the investigator as related to trastuzumab or tucatinib., QLQ-C30 QoL questionnaire with the QLQ-BR42 module will be filled at inclusion, at cycles 1 and 3 and at the end of the treatment., Exploratory: relationship between biomarkers (including, but not limited to, DNA, RNA and proteins analyses) in blood, plasma, and/or tumor and either (1) presence of an ERBB3 mutation and (2) treatment efficacy.

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Countries

France

Outcome results

None listed