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ACTIVE NOT RECRUITING

NCT04622319

PHASE3

A Study of Trastuzumab Deruxtecan (T-DXd) Versus Trastuzumab Emtansine (T-DM1) in High-risk HER2-positive Participants With Residual Invasive Breast Cancer Following Neoadjuvant Therapy (DESTINY-Breast05)

Sponsor: Daiichi Sankyo

View on ClinicalTrials.gov

Summary

Patients with HER2-positive primary breast cancer (BC) who do not achieve complete response after appropriate neoadjuvant therapy are at higher risk of disease recurrence. More effective treatment options are needed for this patient population. This study will examine the efficacy and safety of trastuzumab deruxtecan (T-DXd) compared with trastuzumab emtansine (T-DM1) in high-risk patients with residual invasive breast cancer following neoadjuvant therapy.

Official title: A Phase 3, Multicenter, Randomized, Open-Label, Active-Controlled Study of Trastuzumab Deruxtecan (T-DXd) Versus Trastuzumab Emtansine (T-DM1) in Participants With High-Risk HER2-Positive Primary Breast Cancer Who Have Residual Invasive Disease in Breast or Axillary Lymph Nodes Following Neoadjuvant Therapy (DESTINY-Breast05)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

1600

Start Date

2020-12-04

Completion Date

2030-12-31

Last Updated

2025-05-09

Healthy Volunteers

Conditions

HER2-Positive Primary Breast Cancer Residual Invasive Breast Cancer

Interventions

DRUG

DS-8201a

Administered initially as an intravenous (IV) infusion at a dose of 5.4 mg/kg on Day 1 of each 21-day cycle

DRUG

T-DM1

Administered initially as an intravenous (IV) infusion at a dose of 3.6 mg/kg on Day 1 of each 21-day cycle

Key Inclusion Criteria: * Adults ≥18 years old (local regulatory requirements will apply if the legal age of consent for study participation is \>18 years old). * Pathologically documented HER2-positive breast cancer (BC): * HER2-positive expression defined as an immunohistochemistry (IHC) score of 3+ and/or positive by in situ hybridization (ISH) confirmed prior to study randomization. * Histologically confirmed invasive breast carcinoma. * Clinical stage at disease presentation: T1-4, N0-3, M0; patients presenting with T1N0 tumors are not eligible. * Pathologic evidence of residual invasive carcinoma in the breast and/or axillary lymph nodes following completion of neoadjuvant therapy meeting one of the following high-risk criteria: * Inoperable breast cancer at presentation (prior to neoadjuvant therapy), defined as clinical stages T4, N0-3, M0 or T1-3, N2-3, M0. * Operable at presentation, defined as clinical stages T1-3,N0-1,M0, with axillary node positive disease (ypN1-3) following neoadjuvant therapy. * Completion of neoadjuvant systemic therapy, including taxane-based chemotherapy and HER2-directed treatment prior to surgery. * Systemic therapy must consist of at least 6 cycles of neoadjuvant therapy with a total duration of at least 16 weeks, including at least 9 weeks of trastuzumab (± pertuzumab) and at least 9 weeks of taxane-based chemotherapy to be completed prior to surgery. Patients may have received an anthracycline as part of neoadjuvant therapy in addition to taxane chemotherapy. * Adequate excision as confirmed per medical records: surgical removal of all clinically evident disease in the breast and axillary lymph nodes. * An interval of no more than 12 weeks between the date of last surgery and the date of randomization. * Known hormone receptor (HR) status, per local laboratory assessment, as defined by ASCO-CAP guidelines (≥1%): HR positive status defined by either positive estrogen receptor (ER) and/or positive progesterone receptor (PR). status. HR-negative status defined by both known negative ER and known negative PR. * Left ventricular ejection fraction (LVEF) ≥50% within 28 days prior to randomization. * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at Screening. * Has adequate organ function within 14 days before randomization. Key Exclusion Criteria: * Stage IV (metastatic) BC. * History of any prior (ipsi- or contralateral) breast cancer except lobular carcinoma in situ (LCIS). * Evidence of clinically evident gross residual or recurrent disease following neoadjuvant therapy and surgery. * Prior treatment with T-DXd, T-DM1 or other anti-HER2 antibody-drug conjugate (ADC) or prior enrollment in a clinical study of T-DXd (regardless of treatment arm) * History of exposure to the following cumulative doses of anthracyclines: * Doxorubicin \> 240 mg/m\^2 * Epirubicin or Liposomal Doxorubicin-Hydrochloride \> 480 mg/m\^2 * For other anthracyclines, exposure equivalent to doxorubicin \> 240 mg/m\^2 * History of other malignancy within the last 5 years except for appropriately treated CIS of the cervix, nonmelanoma skin carcinoma, Stage I melanoma skin carcinoma, Stage I uterine cancer, or other appropriately treated non-breast malignancies with an outcome similar to those mentioned above. * History of (noninfectious) interstitial lung disease (ILD)/pneumonitis that required steroids and/or has ILD/pneumonitis noted on computed tomography (CT) scan of the chest at Screening (asymptomatic interstitial changes confined to recent radiation therapy fields are not excluded). * Known pulmonary compromise resulting from intercurrent pulmonary illnesses including, but not limited to, any underlying pulmonary disorder (eg, pulmonary emboli within three months prior to randomization, severe asthma, severe chronic obstructive pulmonary disease \[COPD\], restrictive lung disease). * Any autoimmune, connective tissue or inflammatory disorders (eg, Rheumatoid arthritis, Sjogren's, sarcoidosis, etc) where there is documented or a suspicion of pulmonary involvement or pneumonectomy at the time of screening. * Medical history of myocardial infarction (MI) within 6 months before randomization, symptomatic congestive heart failure (CHF) (New York Heart Association Class II to IV), troponin levels consistent with MI as defined according to the manufacturer 28 days prior to randomization.

Locations (481)

The Oncology Institute of Hope & Innovation

Anaheim, California, United States

Kaiser Permanente

Anaheim, California, United States

Kaiser Permanente

Baldwin Park, California, United States

Kaiser Permanente

Bellflower, California, United States

Kaiser Permanente

Fontana, California, United States

Orange Coast Blood and Cancer Care

Fountain Valley, California, United States

Kaiser Permanente

Harbor City, California, United States

Kaiser Permanente

Irvine, California, United States

Long Beach Memorial TCI

Long Beach, California, United States

Kaiser Permanente

Los Angeles, California, United States

Kaiser Permanente

Ontario, California, United States

Kaiser Permanente

Panorama City, California, United States

Kaiser Permanente

Riverside, California, United States

Kaiser Permanente

San Diego, California, United States

Kaiser Permanente

San Marcos, California, United States

Kaiser Permanente

West Los Angeles, California, United States

Kaiser Permanente

Woodland Hills, California, United States

SCRI FCS North- Altamonte

Altamonte Springs, Florida, United States

SCRI FCS South- Bonita

Bonita Springs, Florida, United States

SCRI FCS North- Brandon Cancer Center

Brandon, Florida, United States

SCRI FCS South- North Fort Myers

Cape Coral, Florida, United States

SCRI FCS North- Mease/Clearwater

Clearwater, Florida, United States

SCRI FCS South

Fort Myers, Florida, United States

SCRI FCS South- Colonial

Fort Myers, Florida, United States

SCRI FCS South- Gladiolus

Fort Myers, Florida, United States

SCRI FCS North- Gainesville Cancer Center

Gainesville, Florida, United States

Baptist MD Anderson Cancer Center

Jacksonville, Florida, United States

SCRI FCS North- Villages East

Lady Lake, Florida, United States

SCRI FCS South- Lakewood Ranch

Lakewood Rch, Florida, United States

SCRI FCS North- Largo/Highland

Largo, Florida, United States

SCRI FCS North- Lecanto

Lecanto, Florida, United States

SCRI FCS South- Naples West

Naples, Florida, United States

SCRI FCS South- Naples/Goodlette

Naples, Florida, United States

SCRI FCS North- New Port Richey

New Port Richey, Florida, United States

SCRI FCS North- Ocala

Ocala, Florida, United States

Orlando Health

Ocoee, Florida, United States

SCRI FCS North- Orange City

Orange City, Florida, United States

Orlando Health

Orlando, Florida, United States

SCRI FCS North- Orlando Downtown

Orlando, Florida, United States

SCRI FCS South- Port Charlotte

Port Charlotte, Florida, United States

SCRI FCS South- Sarasota-Cattleman

Sarasota, Florida, United States

SCRI FCS South-Sarasota-Downtown

Sarasota, Florida, United States

SCRI FCS North- Spring Hill

Spring Hill, Florida, United States

SCRI FCS North- St. Anthony's/St. Petersburg

St. Petersburg, Florida, United States

SCRI FCS North

St. Petersburg, Florida, United States

SCRI FCS North- Tampa Cancer Center

Tampa, Florida, United States

SCRI FCS North- Tavares

Tavares, Florida, United States

SCRI FCS South- Venice Healthpark

Venice, Florida, United States

Cleveland Clinic-Weston

Weston, Florida, United States

SCRI FCS North- Winter Park

Winter Park, Florida, United States

Elmhurst Memorial Hospital- Nancy W. Knowles Cancer Center

Elmhurst, Illinois, United States

Edward Cancer Center

Naperville, Illinois, United States

Edward Cancer Center Plainfield

Plainfield, Illinois, United States

University of Kentucky, Markey Cancer Center, Clinical Research Organization

Lexington, Kentucky, United States

Baptist Health Louisville

Louisville, Kentucky, United States

LSU Health Baton Rouge North Clinic

Baton Rouge, Louisiana, United States

Our Lady of the Lake Physician Group-Medical Oncology

Baton Rouge, Louisiana, United States

Mary Bird Perkins Cancer Center

Baton Rouge, Louisiana, United States

Ochsner Hematology Oncology North Shore - Covington (West Region)

Covington, Louisiana, United States

Ochsner Clinic Foundation

New Orleans, Louisiana, United States

MedStar Franklin Square Medical Center-Harry and Jeanette Weinberg Cancer Institute

Baltimore, Maryland, United States

MedStar Franklin Square Cancer Center at Loch Raven Campus

Baltimore, Maryland, United States

Frederick Health-James M Stockman Cancer Center

Frederick, Maryland, United States

Maryland Oncology Hematology

Silver Spring, Maryland, United States

Holy Cross Hospital

Silver Spring, Maryland, United States

Montefiore Medical Center

The Bronx, New York, United States

Waverly Hematology Oncology

Cary, North Carolina, United States

UNC Cancer Care at Nash

Rocky Mount, North Carolina, United States

Wake Forest Baptist Medical Center

Winston-Salem, North Carolina, United States

Cleveland Clinic - Hillcrest

Cleveland, Ohio, United States

Cleveland Clinic-Fairview

Cleveland, Ohio, United States

Cleveland Clinic

Cleveland, Ohio, United States

Cleveland Clinic South Pointe

Warrensville Heights, Ohio, United States

UPMC Upper St. Clair

Bethel Park, Pennsylvania, United States

UPMC Passavant Cranberry/North

Cranberry Township, Pennsylvania, United States

UPMC Erie

Erie, Pennsylvania, United States

AHN Cancer Inst at St Vincent

Erie, Pennsylvania, United States

UPMC Arnold Palmer-Mt View

Greensburg, Pennsylvania, United States

UPMC Pinnacle-Ortenzio Cancer Center

Harrisburg, Pennsylvania, United States

UMPC Pinnacle Pharmacy

Harrisburg, Pennsylvania, United States

AHN Cancer Insititute at Jefferson

Jefferson Hills, Pennsylvania, United States

AHN Cancer Institute at Forbes

Monroeville, Pennsylvania, United States

UPMC Monroeville

Monroeville, Pennsylvania, United States

UPMC Arnold Palmer-Mt Pleasant

Mount Pleasant, Pennsylvania, United States

UPMC Arnold Palmer-Norwin

N. Huntingdon, Pennsylvania, United States

Allegheny General Hospital