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Breast cancer

Destiny Breast - 01 trial
2020
HER2+ advanced
Destiny Breast - 04
2022
HER2+ advanced
Destiny Breast - 03
2022
HER2+ advanced
Tailor-X
2018
HER2+ perioperative
Katherine Trial
2020
HER2+ perioperative Tx
PALOMA-3 trial
2016
HR+ advanced (CDK 4/6 and PIC3CA)
PALOMA-2 Trial
2016
HR+ advanced (CDK 4/6 and PIC3CA)
MONARCH 2 trial
2017
HR+ advanced (CDK 4/6 and PIC3CA)
MONARCH 3 trial
2017
HR+ advanced (CDK 4/6 and PIC3CA)
MONALEESA-7 Trial
2018
HR+ advanced (CDK 4/6 and PIC3CA)
MONALEESA-3 trial
2018
HR+ advanced (CDK 4/6 and PIC3CA)
Solar-1 Trial
2019
HR+ advanced (CDK 4/6 and PIC3CA)
MonarchE trial
2020
HR+ advanced (CDK 4/6 and PIC3CA)
PALLAS trial
2021
HR+ advanced (CDK 4/6 and PIC3CA)
ATAC trial
2002
HR+ endocrine
IES trial
2004
HR+ endocrine
ITA trial
2005
HR+ endocrine
NSABP B-33
2008
HR+ endocrine
BIG 1-98 trial
2009
HR+ endocrine
TEAM trial
2011
HR+ endocrine
ABCG 8 trial
2012
HR+ endocrine
ATLAS trial
2013
HR+ endocrine
ATTOM trial
2013
HR+ endocrine
NCIC CTG MA.27 trial
2013
HR+ endocrine
TEXT trail
2014
HR+ endocrine
Meta-analysis of AI vs TAM in early breast cancer
2015
HR+ endocrine
SOFT trial
2015
HR+ endocrine
MA-17R
2016
HR+ endocrine
FACE trial
2017
HR+ endocrine
IDEAL (BOOG 2006-05) trial
2018
HR+ endocrine
SOLE trial
2018
HR+ endocrine
ABCSG-16 trial (SALSA) trial
2021
HR+ endocrine
NSABP B-06 trial
2002
Miscellaneous
NSABP B-04 trial
2002
Miscellaneous
IMpassion130
2021
TNBC advanced
ASCENT Trial
2021
TNBC advanced
NSABP-B15 trial
1990
TNBC perioperative
CALGB 9344 trial
2003
TNBC perioperative
CALGB 9741 trial
2003
TNBC perioperative
USORTC-9735 trial
2009
TNBC perioperative
CALGB 40101 trial
2012
TNBC perioperative
CALGB 40603 (Alliance) trial
2015
TNBC perioperative
CREATE-X trial
2017
TNBC perioperative
Keynote-522
2020
TNBC perioperative
OlympiA trial
2021
TNBC perioperative

Destiny Breast - 01 trialĀ 
Modi S, 2020, NEJM, PMID: 31825192

HER2+ advanced

Background. Phase II study that included 184 patients with HER-2 positive metastatic breast cancer who previously were treated with trastuzumab emtansine to evaluate dosage safety and efficacy of Trastuzumab Deruxtecan. Median number of previous lines of therapy for metastatic disease was 6 (range 2 to 27) and included trastuzumab emtansine (100%), trastuzumab (100%), pertuzumab (65.8%), and other anti-HER2 therapies (54.3%)

 

Treatment Arm: Trastuzumab Deruxtecan 5.4 mg/kg body weight

 

Primary Endpoint: ORR
Median follow up: 11.1mo

 

ORR: 60.9%, 95%CI 53.4-68.0
Median response duration: 14.8mo 95% CI, 13.8-16.9
mPFS: 16.4 mo with 95% CI, 12.7 to not reached

 

Adverse events: Most common adverse events of grade 3 or higher were a decreased neutrophil count (in 20.7% of the patients), anemia (in 8.7%), and nausea (in 7.6%). Importantly, interstitial lung disease was seen in 13.6% of the patients (grade 1 or 2, 10.9%; grade 3 or 4, 0.5%; and grade 5, 2.2%).

 

Conclusions: Trastuzumab Deruxtecan has durable anti-tumor activity in pretreated HER-2 positive metastatic breast cancer patients with close monitoring of pulmonary function given risk of Interstitial lung disease.

 

Summarized by Pragnan Kancharla, MD

 

 

 

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Trastuzumab deruxtecan (Enhertu)
Mechanism:Targets HER-2 trastuzumab and a topoisomerase I inhibitor conjugate deruxtecan (a derivative of exatecan) very potent inhibitor of topo I, x10fold than SN38 (irinotecan).
Tox: cardiotoxicity>>↓LVEF, do baseline TTE, hold if EF<40% or drops >20%, myelosuppression, fatigue, infusion related reactions, pulmonary tox with cough, SOB, infiltrated similar >> ILD in ~9% of the patients.

 

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