Image-guided de-escalation of neoadjuvant chemotherapy in HER2-positive breast cancer: the TRAIN-3 study

Conditions

Breast cancer

Brief summary

Three-year event-free survival

Detailed description

Overall survival (OS), defined as the time from registration to death from any cause., Pathologic complete response in breast and axilla, defined as the absence of invasive tumor cells, irrespective of the presence of in-situ lesions, Radiologic complete response, defined as the absence of pathologic enhancement on MRI and normalization of possible lymph node involvement at ultrasound and FNA examination, Concordance between radiologic response and pathologic response: difference in EFS and OS between patient with rCR after 3, 6, and 9 cycles, Difference in EFS and OS between patient with pCR after 3, 6, and 9 cycles, Difference in radical resections in rCR and no‐rCR, Health‐related quality of life

Related papers

No related papers found yet.

Interventions

DRUGHerceptin 150 mg powder for concentrate for solution for infusion

DRUGKadcyla 160 mg powder for concentrate for solution for infusion.

DRUGHerceptin 600 mg solution for injection in vial

DRUGKadcyla 100 mg powder for concentrate for solution for infusion.

DRUGPACLITAXEL

DRUGCARBOPLATIN

DRUGPerjeta 420 mg concentrate for solution for infusion

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Three-year event-free survival	—

Secondary

Measure	Time frame
Overall survival (OS), defined as the time from registration to death from any cause., Pathologic complete response in breast and axilla, defined as the absence of invasive tumor cells, irrespective of the presence of in-situ lesions, Radiologic complete response, defined as the absence of pathologic enhancement on MRI and normalization of possible lymph node involvement at ultrasound and FNA examination, Concordance between radiologic response and pathologic response: difference in EFS and OS between patient with rCR after 3, 6, and 9 cycles, Difference in EFS and OS between patient with pCR after 3, 6, and 9 cycles, Difference in radical resections in rCR and no‐rCR, Health‐related quality of life	—

Measure

Time frame

Overall survival (OS), defined as the time from registration to death from any cause., Pathologic complete response in breast and axilla, defined as the absence of invasive tumor cells, irrespective of the presence of in-situ lesions, Radiologic complete response, defined as the absence of pathologic enhancement on MRI and normalization of possible lymph node involvement at ultrasound and FNA examination, Concordance between radiologic response and pathologic response: difference in EFS and OS between patient with rCR after 3, 6, and 9 cycles, Difference in EFS and OS between patient with pCR after 3, 6, and 9 cycles, Difference in radical resections in rCR and no‐rCR, Health‐related quality of life

—

Countries

Netherlands

Outcome results

None listed