Neoadjuvant trastuzumab, pertuzumab and tucatinib without chemotherapy in HER2-positive breast cancer: the TRAIN-4 study

Conditions

Breast cancer

Brief summary

Incidence and severity of adverse events (all grades) until 30 days after last study treatment administration

Detailed description

Incidence of serious adverse events until 30 days after last study treatment administration, Incidence of progressive disease during neoadjuvant treatment -progressive disease: defined as 20% increase ΔFTV or >20% increase measured in the longest diameter on DCE-MRI or unequivocal new lesions on (18)F-FDG PET, Incidence of dose reductions and treatment discontinuations, Radiologic complete response defined as the absence of pathologic enhancement on contrast enhanced MRI breast, Pathological complete response (ypT0/is N0) at surgery in patients treated without chemotherapy, and overall, Residual Cancer burden (RCB, 0-III) at surgery in patients treated without chemotherapy, and overall, Event-free survival (EFS) defined as the interval from registration to disease progression resulting in inoperability, recurrence, or death from any cause, whichever comes first at 3, 5 and 10 years after registration, Overall survival (OS) defined as the time from registration to death from any cause at 3, 5 and 10 years after registration

Related papers

No related papers found yet.

Interventions

DRUGTUCATINIB

DRUGHerceptin 150 mg powder for concentrate for solution for infusion

DRUGPerjeta 420 mg concentrate for solution for infusion

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Incidence and severity of adverse events (all grades) until 30 days after last study treatment administration	—

Secondary

Measure	Time frame
Incidence of serious adverse events until 30 days after last study treatment administration, Incidence of progressive disease during neoadjuvant treatment -progressive disease: defined as 20% increase ΔFTV or >20% increase measured in the longest diameter on DCE-MRI or unequivocal new lesions on (18)F-FDG PET, Incidence of dose reductions and treatment discontinuations, Radiologic complete response defined as the absence of pathologic enhancement on contrast enhanced MRI breast, Pathological complete response (ypT0/is N0) at surgery in patients treated without chemotherapy, and overall, Residual Cancer burden (RCB, 0-III) at surgery in patients treated without chemotherapy, and overall, Event-free survival (EFS) defined as the interval from registration to disease progression resulting in inoperability, recurrence, or death from any cause, whichever comes first at 3, 5 and 10 years after registration, Overall survival (OS) defined as the time from registration to death from any cause a	—

Measure

Time frame

Incidence of serious adverse events until 30 days after last study treatment administration, Incidence of progressive disease during neoadjuvant treatment -progressive disease: defined as 20% increase ΔFTV or >20% increase measured in the longest diameter on DCE-MRI or unequivocal new lesions on (18)F-FDG PET, Incidence of dose reductions and treatment discontinuations, Radiologic complete response defined as the absence of pathologic enhancement on contrast enhanced MRI breast, Pathological complete response (ypT0/is N0) at surgery in patients treated without chemotherapy, and overall, Residual Cancer burden (RCB, 0-III) at surgery in patients treated without chemotherapy, and overall, Event-free survival (EFS) defined as the interval from registration to disease progression resulting in inoperability, recurrence, or death from any cause, whichever comes first at 3, 5 and 10 years after registration, Overall survival (OS) defined as the time from registration to death from any cause a

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Countries

Netherlands

Outcome results

None listed