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

ASTRAZENECA AB0 sites624 target enrollmentOctober 6, 2021

ConditionsEarly stage HER2-positive breast cancer (T stage >= T3, lymph node positive, or inflammatory)MedDRA version: 21.0Level: LLTClassification code 10025541Term: Malignant breast neoplasmSystem Organ Class: 100000004864 Therapeutic area: Diseases [C] - Cancer [C04]

DrugsBentadax Paclitaxel Amneal 6mg/ml Concentrate for Solution for Infusion Paclitaxel 6 mg/ml Concentrate for Solution for Infusion perjeta

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Early stage HER2-positive breast cancer (T stage >= T3, lymph node positive, or inflammatory)
Sponsor: ASTRAZENECA AB
Enrollment: 624
Status: Active, not recruiting
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

October 6, 2021

End Date

TBD

Last Updated

4 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

ASTRAZENECA AB

Eligibility Criteria

Inclusion Criteria

•\- Patients must be at least 18 years of age.
•\- Histologically documented HER2\-positive EBC participants with:
•(a) locally assessed HER2\-positive (IHC 3\+ or ISH\+) according to ASCOCAP guidelines and prospectively centrally confirmed as HER2 positive
•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 (Allison et al 2020\)
•(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 (Hortobagyi et al 2017\)
•(f) pathologic confirmation of nodal involvement with malignancy as determined by fine\-needle aspiration or core\-needle biopsy, when applicable.
•\- FFPE tissue block (2 cores) or 20 freshly\-cut, serial tumor slides for HER2 assessment by central lab. If blocks are incomplete or fewer than 20 slides are available, participants may be eligible following discussion with the AstraZeneca Study Physician

Exclusion Criteria

•\- Prior history of invasive breast cancer
•\- Any primary malignancy within 3 years, except adequately resected non\-melanoma skin cancer, or curatively treated in situ disease
•\- History of DCIS, except for participants treated with mastectomy only \> 5 years prior to current diagnosis
•\- Prior sentinel lymph node biopsy or axillary lymph node dissection before initiation of neoadjuvant treatment
•\- Prior systemic therapy for the treatment of breast cancer
•\- Previous treatment with anthracyclines, cyclophosphamide or taxanes for any malignancy; cyclophosphamide allowed for non\-cancer treatment if last dose \> 6 months
•\- Ineligible for any medication in the control Arm C
•\- Any concurrent anticancer treatment
•\- History of non\-infectious ILD/pneumonitis that required steroids, has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at screening
•\- Lung\-specific intercurrent clinically significant illnesses including, but not limited to, any pulmonary disorder