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Study of T-DXd monotherapy or T-DXd followed by THP as neoadjuvant treatment vs ddAC-THP in patients with high-risk HER2 positive early BC

Study of T-DXd monotherapy or T-DXd followed by THP as neoadjuvant treatment vs ddAC-THP in patients with high-risk HER2 positive early BC1

A Phase III, open-label trial of neoadjuvant T-DXd monotherapy or T-DXd followed by THP compared with ddAC-THP in patients with high-risk HER2 positive early stage BC (North America, South America, Europe, Asia)1

Study Design1,2

Study Design1,2

Endpoints2

Primary:

  • Rate of pCR

Secondary:

  • Event-Free Survival
  • IDFS
  • OS
  • Physical functioning
  • Safety and Tolerability
  • Immunogenicity
  • PK

Tertiary:

  • ORR
  • DMFS
  • Rate of breast-conserving surgery
  • Biomarkers
  • Patient-reported outcomes
  • Healthcare resource utilization 

Key Eligibility Criteria

Key Eligibility Criteria1

Key Eligibility Criteria in DESTINY-Breast11.1
Key Inclusion CriteriaKey Exclusion Criteria

Patients must be at least 18 years of age 

Prior history of invasive BC 
Histologically documented HER2 positive early BC participants, including clinical stage at presentation (based on mammogram or breast MRI assessment): T0-4 (inclusive of inflammatory BC), N1-3, M0 or ≥T3, N0, M0 as determined by the AJCC staging system, 8th editionStage IV BC (determined by AJCC staging system) 

ECOG PS of 0 or 1 at randomization 

Any primary malignancy within 3 years (except resected non-melanoma skin cancer, curatively treated in situ disease)

  • Note: This includes a second current breast primary malignancy (i.e., bilateral BC) 

Adequate organ and bone marrow function

History of DCIS (except those treated with mastectomy >5 years prior to current diagnosis)

LVEF ≥50% within 28 days before randomization 

History of, current, or suspected ILD/pneumonitis

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 eligible following discussion with the AstraZeneca Study Physician

Prior systemic therapy for the treatment of BC
 Previous treatment with anthracyclines, cyclophosphamide or taxanes for any malignancy

Abbreviations

AJCC = American Joint Committee on Cancer

;

BC = breast cancer

;

DCIS = ductal carcinoma in situ

;

DMFS = distant metastasis-free survival

;

ddAC = dose dense adriamycin [doxorubicin] plus cyclophosphamide

;

ECOG = Eastern Cooperative Oncology Group

;

FFPE = formalin-fixed paraffin-embedded

;

HER2 = human epidermal growth factor receptor 2

;

HR = hormone receptor

;

IDFS = invasive disease-free survival

;

IHC = immunohistochemistry

;

ILD = interstitial lung disease

;

LVEF = left ventricular ejection fraction

;

MRI = magnetic resonance imaging

;

ORR = objective response rate

;

OS = overall survival 

;

pCR = pathological complete response

;

PK = pharmacokinetics

;

PS = performance status

;

q2w = every 2 weeks

;

q3w = every 3 weeks

;

T-DXd = trastuzumab deruxtecan

;

THP = docetaxel, trastuzumab, and pertuzumab

References

1. AstraZeneca. Trastuzumab deruxtecan (T-DXd) alone or in sequence with THP, versus standard treatment (ddAC-THP), in HER2-positive early breast cancer. ClinicalTrials.gov website. https://www.clinicaltrials.gov/ct2/show/NCT05113251
2. Harbeck N, Boileau JF, Kelley CM, et al. A phase 3, open label trial of neoadjuvant trastuzumab deruxtecan (T-DXd) monotherapy or T-DXd followed by THP compared with ddAC-THP in patinets with high-risk HER2-positive early-stage breast cancer (DESTINY-Breast11) [poster and abstract]. Poster presented at: San Antonio Breast Cancer Symposium (SABCS) 2021 Virtual Meeting. December 7-10, 2021. Cancer Res. 2022;82(suppl 4). Poster OT1-12-04.

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