A Phase 3 Open-label Trial of Neoadjuvant Trastuzumab Deruxtecan (T-DXd) Monotherapy or T-DXd followed by THP Compared to ddAC-THP in Participants with High-risk HER2-positive Early-stage Breast Cancer (DESTINY-Breast11)

AstraZeneca AB0 sites22 target enrollmentNovember 11, 2022

ConditionsC50 Cancer de mama

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: C50 Cancer de mama
Sponsor: AstraZeneca AB
Enrollment: 22
Status: Recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

November 11, 2022

End Date

May 29, 2023

Last Updated

last year

Study Type

Interventional

Sex

All

Investigators

Sponsor

AstraZeneca AB

Eligibility Criteria

Inclusion Criteria

•1 Male or female participants \= 18 years of age.
•Type of Participant and Disease Characteristics
•2 Histologically documented HER2\-positive EBC participants with:
•(a) Locally assessed HER2\-positive (IHC 3\+ or ISH\+) according to ASCO\-CAP Guidelines and prospectively centrally confirmed as HER2\-positiveWolff et al 2018 based on a tumour sample.
•(b) Unifocal and multifocal tumours (\> 1 tumour confined to the same quadrant as the primary tumour) must have 1 focus sampled and centrally confirmed as HER2\-positive.
•(c) Multi\-centric tumours (multiple tumours involving \> 1 quadrant of the breast) must have 1 lesion from each involved quadrant sampled and centrally confirmed as HER2\-positive. All quadrants tested must be centrally confirmed as HER2 positive.
•(d) Tumours documented as HR\-positive (either ER and/or PgR positive \[ER or PgR \= 1%]) or HR\-negative (ER and PgR negative) by local assessment per ASCO\-CAP guidelines
•(e) Clinical stage at presentation (based on mammogram or breast MRI assessment): T0\-4 (inclusive of inflammatory breast cancer), N1\-3, M0 or \= T3, N0, M0 as determined by the AJCC staging system, 8th edition
•(f) Pathologic confirmation of nodal involvement with malignancy as determined by fine\-needle aspiration or core\-needle biopsy, when applicable.
•3 Must have an adequate FFPE tumour tissue sample available for ssessment of HER2 by central laboratory (either from an archival diagnostic biopsy or a newly obtained biopsy). At least 2 cores must be provided in the form of FFPE tissue blocks

Exclusion Criteria

•Medical Conditions
•1 Prior history of invasive breast cancer.
•2 Stage IV breast cancer as determined by AJCC staging system, 8th dition
•3 Any primary malignancy within 3 years, except adequately resected non\-melanoma skin cancer, or curatively treated in situ disease.
•4 History of DCIS, except for participants treated with mastectomy only \> 5 years prior to current diagnosis.
•5 As judged by the investigator, any evidence of diseases (such as severe or uncontrolled systemic diseases, including ongoing or active infection, uncontrolled hypertension, renal transplant and active bleeding diseases, serious chronic gastrointestinal conditions associated with diarrhoea) which, in the investigators opinion, makes it undesirable for the participant to participate in the study or that would jeopardise compliance with the protocol.
•6 Uncontrolled infection requiring IV antibiotics, antivirals, or antifungals.
•7 Active hepatitis C infection. Participants positive for HCV antibody are eligible only if polymerase chain reaction is negative for HCV RNA. Participants with current active or history of hepatitis B infection with either HBsAg(\+) or anti\-HBc(\+) are not eligible.
•8 Active primary immunodeficiency or known to have tested positive for HIV or active tuberculosis infection (clinical evaluation that may include clinical history, physical examination and radiographic findings, or tuberculosis testing in line with local practice).
•9 Participants with a medical history of myocardial infarction within 6 months before enrolment, symptomatic CHF (NYHA Class II to IV), unstable angina pectoris, or a recent (\< 6 months) cardiovascular event including stroke. Participants with troponin