Single arm phase 2 trial of neoadjuvant trastuzumab deruxtecan (T-DXd) with response-directed definitive therapy in early stage HER2-positive breast cancer: a standard chemotherapy-sparingapproach to curative-intent treatment – SHAMROCK study. - SHAMROCK study

Cancer Trials Ireland0 sites80 target enrollmentNovember 23, 2022

ConditionsHER2-positive breast cancer.MedDRA version: 23.0Level: PTClassification code 10065430Term: HER2 positive breast cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: HER2-positive breast cancer.
Sponsor: Cancer Trials Ireland
Enrollment: 80
Status: Active, not recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

November 23, 2022

End Date

TBD

Last Updated

last year

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

Cancer Trials Ireland

Eligibility Criteria

Inclusion Criteria

•Each patient must meet all of the following inclusion criteria to be eligible for the study:
•1\. Adult women and men \= 18 years of age.
•2\. Histologically confirmed HER2\-positive breast cancer:
•o Documented HER2 overexpression by local laboratory (IHC 3\+ or positive by ISH on diagnostic breast biopsy (per ASCO\-CAP guidelines).
•3\. Newly diagnosed breast cancer, planned for neoadjuvant therapy prior to surgery.
•4\. Stages 2\-3 breast cancer.
•5\. Patients should not have received any prior therapy for breast cancer.
•6\. Patients must be willing to undergo mandatory tumour biopsy at Cycle 2 Day 14 (\+/\- 4 days) and before surgery.
•7\. ECOG performance status 0\-1\.
•8\. Availability of archival tumour biopsy tissue at screening.

Exclusion Criteria

•Patients are excluded from the study if any of the following exclusion criteria apply:
•1\. Known metastatic or stage 4 breast cancer.
•2\. Unstable angina (angina symptoms at rest), new\-onset angina (begun within the last 3 months). Myocardial infarction (MI) less than 6 months before registration, symptomatic congestive heart failure (CHF) (New York Heart Association Class II to IV). Patients with troponin levels above ULN at screening and without any myocardial related symptoms, should have a cardiologic consultation before enrollment to rule out MI.
•3\. Corrected QT interval (QTcF) prolongation to \>470 msec (females) or \>450 msec (males) based on the screening 12\-lead ECG.
•4\. Uncontrolled arterial hypertension despite optimal medical management (per investigator’s opinion).
•5\. Arterial or venous thrombotic or embolic events such as cerebrovascular accident (including transient ischemic attacks), deep vein thrombosis or pulmonary embolism within 3 months before registration.
•6\. Non\-healing wound, ulcer, or bone fracture.
•7\. Active, clinically serious infections \> CTCAE Grade 2 (CTCAE v5\.0\) requiring IV antibiotics, antivirals, or antifungals.
•8\. Patients with evidence or history of bleeding diathesis. Any haemorrhage or bleeding event \=CTCAE Grade 3 within 4 weeks prior to the start of study treatment.
•9\. Active primary immunodeficiency, known human immunodeficiency virus (HIV) infection, or active hepatitis B or C infection. Patients positive for hepatitis C (HCV) antibody are eligible only if polymerase chain reaction is negative for HCV RNA.