Trastuzumab Deruxtecan (T-DXd) Alone or in Sequence With THP, Versus Standard Treatment (ddAC-THP), in HER2-positive Early Breast Cancer

AstraZeneca logo

AstraZeneca

Status and phase

Active, not recruiting
Phase 3

Conditions

HER2-positive Early Breast Cancer
Breast Cancer
Breast Neoplasms

Treatments

Drug: Pertuzumab
Drug: Paclitaxel
Drug: Doxorubicin
Drug: Trastuzumab
Drug: Trastuzumab Deruxtecan
Drug: cyclophosphamide

Study type

Interventional

Funder types

Industry

Identifiers

NCT05113251
D967RC00001
2021-000603-21 (EudraCT Number)

Details and patient eligibility

About

This study will look at the efficacy and safety of trastuzumab deruxtecan (T-DXd) in a neoadjuvant setting, in high-risk, HER2-positive early non-metastatic breast cancer.

Full description

The target population of interest in this study is participants with high-risk HER2-positive early-stage breast cancer. The purpose of this study is to determine the efficacy and safety of T-DXd neoadjuvant therapy. Participants will be randomised to one of 3 arms: T-DXd monotherapy (Arm A), T-DXd followed by THP (Arm B), or ddAC-THP (Arm C).

Enrollment

912 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria: * Patients must be at least 18 years of age. * Histologically documented HER2-positive early breast cancer (EBC) participants, including 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 * ECOG performance status of 0 or 1 at randomization * Adequate organ and bone marrow function * LVEF ≥ 50% within 28 days before randomization * 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 * stage IV breast cancer (determined by AJCC staging system) * 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 (ie, bilateral breast cancer) * history of DCIS (except those treated with mastectomy \>5 years prior to current diagnosis) * History of, or current, ILD/pneumonitis * Prior systemic therapy for the treatment of breast cancer * Previous treatment with anthracyclines, cyclophosphamide or taxanes for any malignancy

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

912 participants in 3 patient groups

Arm A
Experimental group
Description:
Trastuzumab deruxtecan
Treatment:
Drug: Trastuzumab Deruxtecan
Arm B
Experimental group
Description:
T-DXd, followed by THP
Treatment:
Drug: Trastuzumab Deruxtecan
Drug: Trastuzumab
Drug: Paclitaxel
Drug: Pertuzumab
Arm C
Active Comparator group
Description:
doxorubicin and cyclophosphamide, followed by THP
Treatment:
Drug: cyclophosphamide
Drug: Doxorubicin
Drug: Trastuzumab
Drug: Paclitaxel
Drug: Pertuzumab

Trial contacts and locations

148

Loading...

Central trial contact

AstraZeneca Clinical Study Information Center

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems