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)

NCT ID: NCT04622319

Last Updated: 2025-05-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE3

Total Enrollment

1600 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-12-04

Study Completion Date

2030-12-31

Brief Summary

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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.

Detailed Description

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This study will examine trastuzumab deruxtecan (T-DXd) versus trastuzumab emtansine (T-DM1) in patients with HER2-positive primary BC who have residual invasive disease in breast or axillary lymph nodes with higher risk of recurrence, which includes patients who were inoperable at disease presentation or had pathological node-positive status after neoadjuvant therapy.

The primary objective is to compare invasive disease-free survival (IDFS) between T-DXd and T-DM1 treatment arms in this population. The key secondary objective of the study is to evaluate disease-free survival (DFS).

Conditions

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HER2-Positive Primary Breast Cancer Residual Invasive Breast Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Trastuzumab deruxtecan (T-DXd)

Participants who will be randomized to receive trastuzumab deruxtecan (T-DXd) at a starting dose of 5.4 mg/kg.

Group Type EXPERIMENTAL

DS-8201a

Intervention Type DRUG

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

Trastuzumab ematansine (T-DM1)

Participants who will be randomized to receive trastuzumab ematansine (T-DM1) at a starting dose of 3.6 mg/kg.

Group Type ACTIVE_COMPARATOR

T-DM1

Intervention Type DRUG

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

Interventions

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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

Intervention Type 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

Intervention Type DRUG

Other Intervention Names

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Trastuzumab deruxtecan (T-DXd) Trastuzumab emtansine (T-DM1)

Eligibility Criteria

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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.

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role collaborator

NSABP Foundation Inc

NETWORK

Sponsor Role collaborator

GBG Forschungs GmbH

OTHER

Sponsor Role collaborator

Spanish Breast Cancer Research Group (SOLTI)

UNKNOWN

Sponsor Role collaborator

Daiichi Sankyo

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Global Clinical Leader

Role: STUDY_DIRECTOR

Daiichi Sankyo

Locations

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Klinikum Esslingen GmbH

Esslingen am Neckar, , Germany

Site Status

The Oncology Institute of Hope & Innovation

Anaheim, California, United States

Site Status

Kaiser Permanente

Anaheim, California, United States

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Kaiser Permanente

Baldwin Park, California, United States

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Kaiser Permanente

Bellflower, California, United States

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Kaiser Permanente

Fontana, California, United States

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Orange Coast Blood and Cancer Care

Fountain Valley, California, United States

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Kaiser Permanente

Harbor City, California, United States

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Kaiser Permanente

Irvine, California, United States

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Long Beach Memorial TCI

Long Beach, California, United States

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Kaiser Permanente

Los Angeles, California, United States

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Kaiser Permanente

Ontario, California, United States

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Kaiser Permanente

Panorama City, California, United States

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Kaiser Permanente

Riverside, California, United States

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Kaiser Permanente

San Diego, California, United States

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Kaiser Permanente

San Marcos, California, United States

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Kaiser Permanente

West Los Angeles, California, United States

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Kaiser Permanente

Woodland Hills, California, United States

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SCRI FCS North- Altamonte

Altamonte Springs, Florida, United States

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SCRI FCS South- Bonita

Bonita Springs, Florida, United States

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SCRI FCS North- Brandon Cancer Center

Brandon, Florida, United States

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SCRI FCS South- North Fort Myers

Cape Coral, Florida, United States

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SCRI FCS North- Mease/Clearwater

Clearwater, Florida, United States

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SCRI FCS South

Fort Myers, Florida, United States

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SCRI FCS South- Colonial

Fort Myers, Florida, United States

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SCRI FCS South- Gladiolus

Fort Myers, Florida, United States

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SCRI FCS North- Gainesville Cancer Center

Gainesville, Florida, United States

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Baptist MD Anderson Cancer Center

Jacksonville, Florida, United States

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SCRI FCS North- Villages East

Lady Lake, Florida, United States

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SCRI FCS South- Lakewood Ranch

Lakewood Rch, Florida, United States

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SCRI FCS North- Largo/Highland

Largo, Florida, United States

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SCRI FCS North- Lecanto

Lecanto, Florida, United States

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SCRI FCS South- Naples West

Naples, Florida, United States

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SCRI FCS South- Naples/Goodlette

Naples, Florida, United States

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SCRI FCS North- New Port Richey

New Port Richey, Florida, United States

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SCRI FCS North- Ocala

Ocala, Florida, United States

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Orlando Health

Ocoee, Florida, United States

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SCRI FCS North- Orange City

Orange City, Florida, United States

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Orlando Health

Orlando, Florida, United States

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SCRI FCS North- Orlando Downtown

Orlando, Florida, United States

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SCRI FCS South- Port Charlotte

Port Charlotte, Florida, United States

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SCRI FCS South- Sarasota-Cattleman

Sarasota, Florida, United States

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SCRI FCS South-Sarasota-Downtown

Sarasota, Florida, United States

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SCRI FCS North- Spring Hill

Spring Hill, Florida, United States

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

St. Petersburg, Florida, United States

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SCRI FCS North

St. Petersburg, Florida, United States

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SCRI FCS North- Tampa Cancer Center

Tampa, Florida, United States

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SCRI FCS North- Tavares

Tavares, Florida, United States

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SCRI FCS South- Venice Healthpark

Venice, Florida, United States

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Cleveland Clinic-Weston

Weston, Florida, United States

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SCRI FCS North- Winter Park

Winter Park, Florida, United States

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Elmhurst Memorial Hospital- Nancy W. Knowles Cancer Center

Elmhurst, Illinois, United States

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Edward Cancer Center

Naperville, Illinois, United States

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Edward Cancer Center Plainfield

Plainfield, Illinois, United States

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University of Kentucky, Markey Cancer Center, Clinical Research Organization

Lexington, Kentucky, United States

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Baptist Health Louisville

Louisville, Kentucky, United States

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LSU Health Baton Rouge North Clinic

Baton Rouge, Louisiana, United States

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Our Lady of the Lake Physician Group-Medical Oncology

Baton Rouge, Louisiana, United States

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Mary Bird Perkins Cancer Center

Baton Rouge, Louisiana, United States

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Ochsner Hematology Oncology North Shore - Covington (West Region)

Covington, Louisiana, United States

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Ochsner Clinic Foundation

New Orleans, Louisiana, United States

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

Baltimore, Maryland, United States

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MedStar Franklin Square Cancer Center at Loch Raven Campus

Baltimore, Maryland, United States

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Frederick Health-James M Stockman Cancer Center

Frederick, Maryland, United States

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Maryland Oncology Hematology

Silver Spring, Maryland, United States

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Holy Cross Hospital

Silver Spring, Maryland, United States

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Montefiore Medical Center

The Bronx, New York, United States

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Waverly Hematology Oncology

Cary, North Carolina, United States

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UNC Cancer Care at Nash

Rocky Mount, North Carolina, United States

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Wake Forest Baptist Medical Center

Winston-Salem, North Carolina, United States

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Cleveland Clinic - Hillcrest

Cleveland, Ohio, United States

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Cleveland Clinic-Fairview

Cleveland, Ohio, United States

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Cleveland Clinic

Cleveland, Ohio, United States

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Cleveland Clinic South Pointe

Warrensville Heights, Ohio, United States

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UPMC Upper St. Clair

Bethel Park, Pennsylvania, United States

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UPMC Passavant Cranberry/North

Cranberry Township, Pennsylvania, United States

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UPMC Erie

Erie, Pennsylvania, United States

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AHN Cancer Inst at St Vincent

Erie, Pennsylvania, United States

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UPMC Arnold Palmer-Mt View

Greensburg, Pennsylvania, United States

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UPMC Pinnacle-Ortenzio Cancer Center

Harrisburg, Pennsylvania, United States

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UMPC Pinnacle Pharmacy

Harrisburg, Pennsylvania, United States

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AHN Cancer Insititute at Jefferson

Jefferson Hills, Pennsylvania, United States

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AHN Cancer Institute at Forbes

Monroeville, Pennsylvania, United States

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UPMC Monroeville

Monroeville, Pennsylvania, United States

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UPMC Arnold Palmer-Mt Pleasant

Mount Pleasant, Pennsylvania, United States

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UPMC Arnold Palmer-Norwin

N. Huntingdon, Pennsylvania, United States

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Allegheny General Hospital

Pittsburgh, Pennsylvania, United States

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Magee

Pittsburgh, Pennsylvania, United States

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UPMC St. Margaret

Pittsburgh, Pennsylvania, United States

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AHN Cancer Inst at West Penn

Pittsburgh, Pennsylvania, United States

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UPMC Hillman Cancer Center

Pittsburgh, Pennsylvania, United States

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UPMC Passavant HOA

Pittsburgh, Pennsylvania, United States

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UPMC Passavant OHA

Pittsburgh, Pennsylvania, United States

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UPMC Uniontown

Uniontown, Pennsylvania, United States

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UPMC Washington

Washington, Pennsylvania, United States

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Reading Hospital, McGlinn Cancer Institute

West Reading, Pennsylvania, United States

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AHN Cancer Institute at Wexford

Wexford, Pennsylvania, United States

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UPMC Pinnacle-Memorial Cancer Center

York, Pennsylvania, United States

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SCRI TO Nashville- Franklin Tennessee Oncology, PLLC

Franklin, Tennessee, United States

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SCRI TO Nashville- Gallatin Tennessee Oncology, PLLC

Gallatin, Tennessee, United States

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SCRI TO Nashville- Hendersonville Tennessee Oncology, PLLC

Hendersonville, Tennessee, United States

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SCRI TO Nashville- Summit Tennessee Oncology, PLLC

Hermitage, Tennessee, United States

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Regional Cancer Center at Indian Path Community Hospital

Kingsport, Tennessee, United States

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SCRI TO Nashville- Lebanon Tennessee Oncology, PLLC

Lebanon, Tennessee, United States

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SCRI TO Nashville- St. Thomas Midtown Tennessee Oncology, PLLC

Nashville, Tennessee, United States

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Tennessee Oncology Nashville / Sarah Cannon

Nashville, Tennessee, United States

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SCRI TO Nashville- St. Thomas West Tennessee Oncology, PLLC

Nashville, Tennessee, United States

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SCRI TO Nashville- Skyline Tennessee Oncology, PLLC

Nashville, Tennessee, United States

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SCRI TO Nashville- Southern Hills Tennessee Oncology, PLLC

Nashville, Tennessee, United States

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SCRI TO Nashville- Smyrna Tennessee Oncology, PLLC

Smyrna, Tennessee, United States

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Houston Methodist Baytown

Baytown, Texas, United States

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Houston Methodist

Houston, Texas, United States

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Houston Methodist Willowbrook

Houston, Texas, United States

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Houston Methodist West

Houston, Texas, United States

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Houston Methodist Clear Lake

Nassau Bay, Texas, United States

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Houston Methodist Sugarland

Sugar Land, Texas, United States

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Houston Methodist Woodlands

The Woodlands, Texas, United States

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Wellmont Medical Associates Oncology & Hematology

Bristol, Virginia, United States

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University of Virginia

Charlottesville, Virginia, United States

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Virginia Commonwealth University Massey Cancer Center

Richmond, Virginia, United States

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MultiCare Cancer Center Aurburn

Auburn, Washington, United States

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MultiCare Regional Cancer Center - Gig Harbor

Gig Harbor, Washington, United States

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MultiCare Cancer Center Puyallup

Puyallup, Washington, United States

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MultiCare Institute for Research & Innovation

Spokane, Washington, United States

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MultiCare Institute for Research & Innovation

Spokane, Washington, United States

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MultiCare Cancer Center Tacoma

Tacoma, Washington, United States

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West Virginia University

Morgantown, West Virginia, United States

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Centro Oncologico Riojano Integral

Capital, La Rioja Province, Argentina

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Sanatorio Británico de Rosario

Rosario, Santa Fe Province, Argentina

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Instituto de Oncología de Rosario

Rosario, Santa Fe Province, Argentina

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COIBA

Buenos Aires, , Argentina

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Instituto Alexander Fleming

Caba, , Argentina

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CER San Juan

San Juan, , Argentina

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Royal Adelaide Hospital

Adelaide, , Australia

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Chris O Brien Lifehouse

Camperdown, , Australia

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Monash Health

Clayton, , Australia

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Austin Hospital- Olivia Newto-John Cancer and Wellness Centre

Heidelberg, , Australia

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Peter MacCallum Cancer Centre

Melbourne, , Australia

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Breast Cancer Research Centre - WA

Nedlands, , Australia

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Genesis Care Northern Cancer

Saint Leonards, , Australia

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St John of God Hospital - Bendat Family Comprehensive Cancer Centre (BFCCC)

Subiaco, , Australia

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Southern Medical Day Care Centre

Wollongong, , Australia

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Antwerp University Hospital

Edegem, Antwerpen, Belgium

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UZ Gent

Ghent, O. VL., Belgium

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Algemeen Ziekenhuis AZ Klina - Borstkliniek

Brasschaat, , Belgium

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Institut Jules Bordet Brussels Belgium

Brussels, , Belgium

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Cliniques Universitaires Saint-Luc

Brussels, , Belgium

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UZ Leuven - Campus Gasthuisberg

Leuven, , Belgium

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CHU Liege

Liège, , Belgium

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GZA Hospitals Campus Sint- Augustinus

Wilrijk, , Belgium

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Hospital Sirio-Libanes HSL - Centro de Oncologia - Brasilia

Brasília, Federal District, Brazil

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Hospital Erasto Gaertner

Curitiba, Paraná, Brazil

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Fundação Universidade de Caxias do Sul Instituto de Pesquisas em Saúde IPS-UCS

Caxias do Sul, Rio Grande do Sul, Brazil

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Hospital Sao Lucas PUCRS

Porto Alegre, Rio Grande do Sul, Brazil

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Fundacao Pio XII-Hospital de Cancer de Barretos

Barretos, São Paulo, Brazil

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CEPHO - Centro de Estudos e Pesquisas de Hematologia e Oncologia

Santo André, São Paulo, Brazil

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Hospital de Base de Sao Jose do Rio Preto

São José do Rio Preto, São Paulo, Brazil

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INCA - Instituto Nacional do Cancer / Hospital do Cancer HCIII

Rio de Janeiro, , Brazil

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Instituto do Cancer do Estado de Sao Paulo (ICESP)

São Paulo, , Brazil

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Tom Baker Cancer Centre

Calgary, Alberta, Canada

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The Ottawa Hospital Cancer Centre

Ottawa, Ontario, Canada

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CIUSSSS de l'Est-de-l'Ile-de-Montréal - Installation Hôpital Maisonneuve-Rosemont

Montreal, Quebec, Canada

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CHUM

Montreal, Quebec, Canada

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Jewish General Hospital Segal Cancer Centre

Montreal, Quebec, Canada

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McGill University Health Centre - Cedars Cancer Centre

Montreal, Quebec, Canada

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CHU de Quebec - Hopital du Saint-Sacrement

Québec, Quebec, Canada

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Hospital Clinico Universidad de Chile

Santiago, RM, Chile

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Fundacion Arturo Lopez Perez

Santiago, , Chile

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SIM CRC

Temuco, , Chile

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Peking University Cancer Hospital

Beijing, , China

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Peking University Third Hospital

Beijing, , China

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Jilin University JLU - First Affiliated Hospital

Changchun, , China

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Sichuan University - West China Hospital

Chengdu, , China

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Chongqing Medical University - The First Affiliated Hospital

Chongqing, , China

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Union Hospital of Fujian Medical University

Fuzhou, , China

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Sun Yat-sen Memorial Hospital

Guangzhou, , China

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Guangdong Academy of Medical Science

Guangzhou, , China

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Zhejiang Cancer Hospital

Hangzhou, , China

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Second Affiliated Hospital of Zhejiang University

Hangzhou, , China

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Harbin Medical University Cancer Hospital

Harbin, , China

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Shandong Cancer Hospital

Jinan, , China

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Nanchang University - The First Affiliated Hospital

Nanchang, , China

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Nanjing Medical University NMU - Jiangsu Province Hospital

Nanjing, , China

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Fudan University Cancer Hospital

Shanghai, , China

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The 4th Hospital of Heibei Medical University

Shijiazhuang, , China

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The First Affiliated Hospital of Xiamen University

Xiamen, , China

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University Hospital Brno

Brno, , Czechia

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Fakultni nemocnice Kralovske Vinohrady

Prague, , Czechia

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Aalborg University Hospital

Aalborg, , Denmark

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Aarhus University Hospital

Aarhus, , Denmark

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Rigshospitalet

Copenhagen, , Denmark

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Odense University Hospital

Odense, , Denmark

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Soenderborg sygehus

Syddanmark, , Denmark

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Clinique Tivoli Ducos - Centre dOncologie et de Radiotherapie a Bordeaux

Bordeaux, Gironde, France

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Institut Claudius Regaud

Toulouse, Haute Garonne, France

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CHR Metz-Thionville

Metz, Lorraine, France

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Institut De Cancerologie De La Loire

Saint-Priest-en-Jarez, Pays de la Loire Region, France

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Institut Bergonie

Bordeaux, , France

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Centre Georges François Leclerc

Dijon, , France

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CHD Vendee

La Roche-sur-Yon, , France

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Centre Hosp Univ de Grenoble CHUG

La Tronche, , France

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Centre Oscar Lambret

Lille, , France

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Centre Leon Berard

Lyon, , France

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Institut Paoli-Calmettes

Marseille, , France

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Centre de Cancérologie du Grand Montpellier

Montpellier, , France

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The Sel of Centre dOncologie de Gentilly

Nancy, , France

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Centre Antoine Lacassagne

Nice, , France

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Hospital St Louis

Paris, , France

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Hopital Georges Pompidou

Paris, , France

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IUC AP-HP. Sorbonne Université, Hôpital Tenon

Paris, , France

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CHU de Poitiers

Poitiers, , France

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Centre Eugene Marquis

Rennes, , France

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Institut de cancerologie de l'ouest

Saint-Herblain, , France

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Strasbourg Europe Cancer Institute

Strasbourg, , France

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Gemeinschaftspraxis Dres. Halder / Bangerter

Augsburg, , Germany

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Cahrité Campus Mitte

Berlin, , Germany

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Praxis Dr. med. J. Schilling

Berlin, , Germany

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MediOnko-Institut GbR, Praxisklinik Krebsheilkunde

Berlin, , Germany

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DRK Kliniken Berlin Köpenick

Berlin, , Germany

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Helios Klinikum Berlin-Buch

Berlin, , Germany

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Onkologische Schwerpunktpraxis

Berlin, , Germany

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Onkologische Schwerpunktpraxis

Bielefeld, , Germany

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Klinikverbund Südwest Kliniken Böblingen Frauenklinik Böblingen

Böblingen, , Germany

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Studien GbR Braunschweig

Braunschweig, , Germany

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Klinikum Bremen Mitte

Bremen, , Germany

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Frauenklinik DIAKO Bremen

Bremen, , Germany

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Klinikum Chemnitz gGmbH

Chemnitz, , Germany

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Unifrauenklinik Köln - Studienzentrum Gynäkologie

Cologne, , Germany

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St. Elisabeth Hospital

Cologne, , Germany

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Kliniken der Stadt Köln / Brustzentrum Holweide

Cologne, , Germany

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DONAUISAR Klinikum

Deggendorf, , Germany

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Klinikum Dortmund gGmbH

Dortmund, , Germany

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St.-Johannes-Hospital Dortmund, Dept. of Obstetrics/Gynecology

Dortmund, , Germany

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Onkologische Schwerpunktpraxis

Dresden, , Germany

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University Hospital Dresden

Dresden, , Germany

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Onkozentrum Dresden

Dresden, , Germany

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Universitätsklinikum Düsseldorf, Klinik für Frauenheilkunde & Geburtshilfe

Düsseldorf, , Germany

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Frauenklinik der Universität Erlangen

Erlangen, , Germany

Site Status

Kliniken Essen-Mitte, Klinik für Senologie/ Interdisziplinäres Brustzentrum

Essen, , Germany

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Universitätsklinikum Essen, Frauenklinik

Essen, , Germany

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Frankfurt University Department of Gynecology and Obstetrics

Frankfurt, , Germany

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AGAPLESION Markus Krankenhaus

Frankfurt am Main, , Germany

Site Status

Centrum for Haematology and Oncology

Frankurt Am Main, , Germany

Site Status

Universitätsklinik Freiburg, Klinik für Frauenheilkunde

Freiburg im Breisgau, , Germany

Site Status

Evangelische Kliniken Gelsenkirchen

Gelsenkirchen, , Germany

Site Status

MVZ II der Niels-Stensen-Kliniken

Georgsmarienhütte, , Germany

Site Status

SRH Waldklinikum Gera, Brustzentrum Ostthüringen

Gera, , Germany

Site Status

MVZ Onkologische Kooperation Harz

Goslar, , Germany

Site Status

Krankenhaus St. Elisabeth und St. Barbara Halle/Saale

Halle, , Germany

Site Status

University Medical Center

Hamburg, , Germany

Site Status

Mammazentrum HH am Krankenhaus Jerusalem

Hamburg, , Germany

Site Status

Albertinen Krankenhaus

Hamburg, , Germany

Site Status

Gynäkologisch-Ontologische Praxis Hannover

Hanover, , Germany

Site Status

DIAKOVERE Henriettenstift Frauenklinik

Hanover, , Germany

Site Status

Gemeinschaftspraxis Frauenärzte am Bahnhofsplatz

Hildesheim, , Germany

Site Status

Department of Gyencology and Obstetrics, Saarland University Hospital

Homburg, , Germany

Site Status

ViDia Christliche Kliniken Karlsruhe

Karlsruhe, , Germany

Site Status

Elisabethkrankenhaus Kassel, Brustzentrum

Kassel, , Germany

Site Status

Klinikum Kassel

Kassel, , Germany

Site Status

University Hospital Schleswig-Holstein

Kiel, , Germany

Site Status

Institut für Versorgungsforschung in der Onkologie

Koblenz, , Germany

Site Status

St. Vincenz KH Limburg

Limburg, , Germany

Site Status

UKSH Campus Lübeck

Lübeck, , Germany

Site Status

Universitäts-Frauenklinik

Magdeburg, , Germany

Site Status

Department of Obstetrics and Gynecology

Mainz, , Germany

Site Status

Medzinische Fakultät Mannheim, Universität Heidelberg

Mannheim, , Germany

Site Status

Klinikum Memmingen

Memmingen, , Germany

Site Status

Johannes Wesling Klinikum Minden, Hämatologie-Onkologie/Brustzentrum

Minden, , Germany

Site Status

Brustzentrum Niederrhein

Mönchengladbach, , Germany

Site Status

Gynaekologie Arabella

Munich, , Germany

Site Status

Rotkreuzklinikum München, Frauenklinik

München, , Germany

Site Status

Medizinisches Versorgungszentrum für Hämatologie und Onkologie München MVZ GmbH

München, , Germany

Site Status

LMU Klinikum/ Klinik und Poliklinik für Frauenheilkunde und Geburtshilfe

München, , Germany

Site Status

Dept. OB/GYN Johanna Etienne Krankenhaus

Neuss, , Germany

Site Status

Ortenau Klinikum Offenburg-Kehl

Offenburg, , Germany

Site Status

Klinikum Oldenburg AöR

Oldenburg, , Germany

Site Status

Frauenklinik St. Louise - St. Vincenz- Krankenhaus GmbH

Paderborn, , Germany

Site Status

Klinikum Ernst von Bergmann

Potsdam, , Germany

Site Status

Studienzentrum Onkologie Ravensburg

Ravensburg, , Germany

Site Status

Oncologianova GmbH

Recklinghausen, , Germany

Site Status

RoMed Klinikum Rosenheim

Rosenheim, , Germany

Site Status

Univ-Hospital, Dept Ob/Gyn

Rostock, , Germany

Site Status

CaritasKlinikum St. Theresia

Saarbrücken, , Germany

Site Status

Onkologische Schwerpunktpraxis Speyer

Speyer, , Germany

Site Status

G.SUND Gynäkologie Kompetenzzentrum

Stralsund, , Germany

Site Status

KKH Torgau

Torgau, , Germany

Site Status

Klinikum Mutterhaus

Trier, , Germany

Site Status

Praxisnetzwerk Hämatologie/Internistische Onkologie

Troisdorf, , Germany

Site Status

Frauenklinik

Tübingen, , Germany

Site Status

Universitätsfrauenklinik Ulm

Ulm, , Germany

Site Status

Schwarzwald - Baar Klinikum Frauenklinik

Villingen-Schwenningen, , Germany

Site Status

Harzklinikum Dorothea Christiane Erxleben

Wernigerode, , Germany

Site Status

St. Anna Hospital Brustzentrum

Witten, , Germany

Site Status

Klinikum Worms gGmbH

Worms, , Germany

Site Status

General Hospital of Athens Alexandra Clinic

Athens, Attica, Greece

Site Status

University General Hospital of Heraklion

Heraklion, Crete, Greece

Site Status

University General Hospital of Patras

Pátrai, West Greece, Greece

Site Status

General Hospital of Patras Agios Andreas

Pátrai, , Greece

Site Status

Pamela Youde Nethersole Eastern Hospital PYNEH

Hong Kong, , Hong Kong

Site Status

The Chinese University of Hong Kong (CUHK) - Prince of Wales Hospital (PWH)

Hong Kong, , Hong Kong

Site Status

The University of Hong Kong (HKU) - Queen Mary Hospital (QMH)

Pok Fu Lam, , Hong Kong

Site Status

Saint Vincents University Hospital

Dublin, IE-D, Ireland

Site Status

St. James Hospital

Dublin, Leinster, Ireland

Site Status

University College Cork

Cork, , Ireland

Site Status

Mater Misericordiae University Hospital

Dublin, , Ireland

Site Status

University Hospital Limerick

Limerick, , Ireland

Site Status

Soroka MC

Beersheba, Southern District, Israel

Site Status

Sheba Medical Center

Ramat Gan, Tel Aviv, Israel

Site Status

Hadassah Medical Center

Jerusalem, , Israel

Site Status

Rabin Medical Center

Petah Tikva, , Israel

Site Status

Azienda Ospedaliera Garibaldi-Nesima

Catania, CT, Italy

Site Status

Istituto Europeo di Oncologia

Milan, MI, Italy

Site Status

Clinica Oncologica, Ospedali Riuniti Umberto 1

Ancona, , Italy

Site Status

Centro di Riferimento Oncologico di Aviano - SOC Oncologia Medica e Prevenzione Oncologica

Aviano, , Italy

Site Status

Istituto Oncologico di Bari

Bari, , Italy

Site Status

Azienda ULSS n. 1 Dolomiti

Belluno, , Italy

Site Status

Policlinico S.Orsola-Malpighi SSD Oncologia Medica Addarii

Bologna, , Italy

Site Status

SSD Oncologia Medica

Bologna, , Italy

Site Status

Presidio Ospedaliero di Summa - Antonio Perrino

Brindisi, , Italy

Site Status

Istituto di Candiolo - IRCCS

Candiolo, , Italy

Site Status

Ospedale Poli SAN MARTINO

Genova, , Italy

Site Status

Area Vasta Sud Est Sede Operativa Grosseto

Grosseto, , Italy

Site Status

Azienda Usl Toscana sud est

Grosseto, , Italy

Site Status

IRCCS Ospedale San Raffaele

Milan, , Italy

Site Status

University Hospital of Modena

Modena, , Italy

Site Status

INT Fondazione Pascale

Napoli, , Italy

Site Status

Istituto Oncologico Veneto IRCCS

Padua, , Italy

Site Status

ICS Maugeri IRCCS

Pavia, , Italy

Site Status

Azienda Ospedaliera di Perugia

Perugia, , Italy

Site Status

A.O.U. Citta della Salute e della Scienza di Torino

Torino, , Italy

Site Status

Hyogo Cancer Center

Akashi, , Japan

Site Status

National Cancer Center (NCC) - Tsukiji Campus - National Cancer Center Hospital (NCCH)

Chūōku, , Japan

Site Status

National Hospital Organization - National Kyushu Cancer Center

Fukuoka, , Japan

Site Status

Hiroshima City Hiroshima Citizens Hospital

Hiroshima, , Japan

Site Status

Tokai University Hospital - Isehara Campus

Isehara, , Japan

Site Status

Sagara Hospital

Kagoshima, , Japan

Site Status

National Cancer Center Hospital East (NCCHE) - Kashiwa Campus

Kashiwa, , Japan

Site Status

Japanese Foundation for Cancer Research (JFCR) - The Cancer Institute Hospital - Breast Oncology Center

Kōtoku, , Japan

Site Status

Kyoto University Hospital

Kyoto, , Japan

Site Status

National Hospital Organization (NHO) - Shikoku Cancer Center

Matsuyama, , Japan

Site Status

Aichi Cancer Center Hospital

Nagoya, , Japan

Site Status

Niigata Cancer Center Hospital

Niigata, , Japan

Site Status

Hyogo College of Medicine Hospital

Nishinomiya, , Japan

Site Status

Okayama University Hospital

Okayama, , Japan

Site Status

National Hospital Organization - Osaka National Hospital (ONH)

Osaka, , Japan

Site Status

Osaka International Cancer Institute (OICI)

Osaka, , Japan

Site Status

Saitama Cancer Center

Saitama, , Japan

Site Status

National Hospital Organization - Hokkaido Cancer Center

Sapporo, , Japan

Site Status

Kindai University (Kinki University) - Faculty of Medicine (Kinki University School of Medicine (KUSM)) - Kindai University Hospital (Kinki University Hospital) - Cancer Center

Sayama, , Japan

Site Status

Tohoku University Hospital (TUH) - Clinical Research, Innovation and Education Center (CRIETO)

Sendai, , Japan

Site Status

Showa University Hospital - Breast Center

Shinagawa-Ku, , Japan

Site Status

Tokyo Medical University Hospital

Shinjuku-Ku, , Japan

Site Status

Shizuoka Cancer Center (SCC)

Shizuoka, , Japan

Site Status

Kanagawa Cancer Center Hospital - Kanagawa Cancer Center (Kanagawa Cancer Centre Research Institute)

Yokohama, , Japan

Site Status

CIMAB S.A. de C.V

Torreón, Coahuila, Mexico

Site Status

Hospital Civil de Guadalajara Fray Antonio Alcalde

Guadalajara, Jalisco, Mexico

Site Status

Consultorio del Dr. Joaqun Gabriel Reinoso Toledo

Monterrey, Nuevo León, Mexico

Site Status

Amsterdam UMC - VU Medisch Centrum

Amsterdam, North Holland, Netherlands

Site Status

Amphia Hospital Breda

Breda, , Netherlands

Site Status

Erasmus MC - Daniel den Hoed Oncologisch Centrum

Rotterdam, , Netherlands

Site Status

Hospital Nacional Arzobispo Loayza

Lima, , Peru

Site Status

Clinica Ricardo Palma

Lima, , Peru

Site Status

Instituto Nacional de Enfermedades Neoplasicas INEN

Lima, , Peru

Site Status

Centro de Investigación Clinica Trujillo EIRL

Trujillo, , Peru

Site Status

Centrum Medyczne HCP Sp. z o.o.

Poznan, Greater Poland Voivodeship, Poland

Site Status

SP Zoz Opolskie Centrum Onkologii IM

Opole, Opole Voivodeship, Poland

Site Status

Uniwersyteckie Centrum Kliniczne

Gdansk, Pomeranian Voivodeship, Poland

Site Status

Instytut Centrum Zdrowia Matki Polki

Lodz, , Poland

Site Status

MSCM Cancer Center and Institute of Oncology Department of Breast Cancer and Reconstructive Surgery

Warsaw, , Poland

Site Status

Hospital da Senhora da Oliveira, Guimarães EPE

Guimarães, , Portugal

Site Status

Instituto Português de Oncologia de Lisboa Francisco Gentil, EPE

Lisbon, , Portugal

Site Status

Fundação Champalimaud

Lisbon, , Portugal

Site Status

Centro Hospitalar de Lisboa Ocidental, EPE

Lisbon, , Portugal

Site Status

Hospital da Luz

Lisbon, , Portugal

Site Status

Hospital CUF Descobertas

Lisbon, , Portugal

Site Status

Hospital Beatriz Ângelo

Loures, , Portugal

Site Status

Unidade Local de Saúde de Matosinhos, EPE

Matosinhos Municipality, , Portugal

Site Status

Instituto Português de Oncologia do Porto Francisco Gentil, EPE

Porto, , Portugal

Site Status

Centro Hospitalar de Vila Nova de Gaia/Espinho, EPE

Vila Nova de Gaia, , Portugal

Site Status

Institutul Oncologic Prof. Dr. Ion Chiricuta

Cluj-Napoca, Cluj, Romania

Site Status

Onco Clinic Consult SA

Craiova, Dolj, Romania

Site Status

Centrul de Oncologie Sfantu Nectarie

Craiova, Dolj, Romania

Site Status

Institutul Oncologic Bucuresti IOB

Bucharest, , Romania

Site Status

SBHI Arkhangelsk Region - Arkhangelsk Clinical Oncological Dispensary

Arkhangelsk, , Russia

Site Status

State Budgetary Healthcare Institution Oncological Dispensary No. 2 of the Ministry of Health of Krasnodar Region

Sochi, , Russia

Site Status

National University Cancer Institute

Singapore, , Singapore

Site Status

National Cancer Center Singapore

Singapore, , Singapore

Site Status

Kyungpook National University Hospital

Daegu, , South Korea

Site Status

National Cancer Center

Gyeonggi-do, , South Korea

Site Status

CHA Bundang Medical Center CHA University

Gyeonggi-do, , South Korea

Site Status

Seoul National University Bundang Hospital

Gyeonggi-do, , South Korea

Site Status

Gachon University Gil Medical Center

Incheon, , South Korea

Site Status

Samsung Medical Center

Irwon-dong, , South Korea

Site Status

Korea University Anam Hospital

Seoul, , South Korea

Site Status

Seoul National University Hospital

Seoul, , South Korea

Site Status

Severance Hospital

Seoul, , South Korea

Site Status

Asan Medical Center

Songpa-gu, , South Korea

Site Status

Soon Chun Hyang Central Medical Center (SCHMC)

Yongsan, , South Korea

Site Status

Hospital Universitario de Basurto

Bilbao, Bizkaia, Spain

Site Status

Hospital Clínico Universitario Virgen de la Arrixaca

El Palmar, Murcia, Spain

Site Status

Hospital Universitario Sant Joan Reus

Reus, Tarragona, Spain

Site Status

Complejo Hospitalario Universitario A Coruña (CHUA)

A Coruña, , Spain

Site Status

Hospital Universitario Fundación Alcorcón

Alcorcón, , Spain

Site Status

Hospital General Universitario de Alicante

Alicante, , Spain

Site Status

Hospital de San Juan de Alicante

Alicante, , Spain

Site Status

Hospital Universitario de Badajoz

Badajoz, , Spain

Site Status

Hospital del Mar

Barcelona, , Spain

Site Status

IOB Institute Of Oncology-Hospital Quironsalud Barcelona

Barcelona, , Spain

Site Status

Hospital Universitari Vall d'Hebron

Barcelona, , Spain

Site Status

Hospital Clínic de Barcelona

Barcelona, , Spain

Site Status

Hospital Universitari Mútua Terrassa

Barcelona, , Spain

Site Status

ALTHAIA, Xarxa Assistencial Universitària de Manresa F.P.

Barcelona, , Spain

Site Status

Hospital de Mataró

Barcelona, , Spain

Site Status

ICO Hospitalet

Barcelona, , Spain

Site Status

ICO Badalona

Barcelona, , Spain

Site Status

Consorcio Hospitalario Provincial de Castelló

Castellon, , Spain

Site Status

Hospital Universitario San Pedro de Alcantara

Cáceres, , Spain

Site Status

ICO Girona

Girona, , Spain

Site Status

Hospital Universitario Clínico San Cecilio

Granada, , Spain

Site Status

Complejo Hospitalario de Jaen

Jaén, , Spain

Site Status

Complejo Asistencial Universitario de León

León, , Spain

Site Status

Hospital Arnau de Vilanova de Lleida

Lleida, , Spain

Site Status

Clinica Universidad De Navarra, Madrid

Madrid, , Spain

Site Status

Hospital MD Anderson Cancer Center Madrid

Madrid, , Spain

Site Status

Hospital Universitario Ramón y Cajal

Madrid, , Spain

Site Status

Hospital Universitario Fundación Jiménez Díaz

Madrid, , Spain

Site Status

Hospital Universitario 12 de Octubre

Madrid, , Spain

Site Status

Hospital Universitario La Paz

Madrid, , Spain

Site Status

HM Sanchinarro (CIOCC)

Madrid, , Spain

Site Status

Hospital Universitario Puerta de Hierro de Majadahonda

Madrid, , Spain

Site Status

Hospital Universitario HM Puerta del Sur

Madrid, , Spain

Site Status

Hospital Universitario de Fuenlabrada

Madrid, , Spain

Site Status

Hospital Universitario Virgen de la Victoria

Málaga, , Spain

Site Status

Hospital Universitario Rey Juan Carlos

Móstoles, , Spain

Site Status

Hospital General Universitario Morales Meseguer

Murcia, , Spain

Site Status

Complejo Hospitalario de Navarra

Navarro, , Spain

Site Status

Hospital Universitari Son Espases

Palma de Mallorca, , Spain

Site Status

Hospital Son Llatzer

Palma de Mallorca, , Spain

Site Status

Hospital Universitario de Canarias

San Cristóbal de La Laguna, , Spain

Site Status

Hospital General de Catalunya

Sant Cugat del Vallès, , Spain

Site Status

Complejo Hospitalario Clínico Universitario de Santiago de Compostela (CHUS)

Santiago de Compostela, , Spain

Site Status

Hospital Universitario Virgen Macarena

Seville, , Spain

Site Status

Hospital Quirón Salud Sagrado Corazón

Seville, , Spain

Site Status

Hospital Universtiario Virgen del Rocio

Seville, , Spain

Site Status

Fundación Instituto Valenciano de Oncologia (IVO)

Valencia, , Spain

Site Status

Hospital Clínico Universitario de Valencia

Valencia, , Spain

Site Status

Hospital Arnau de Vilanova de Valencia

Valencia, , Spain

Site Status

Hospital Clínico Universitario Lozano Blesa

Zaragoza, , Spain

Site Status

E-Da Cancer Hospital

Kaohsiung City, Yanchao District, Taiwan

Site Status

Koo Foundation Sun Yat-Sen Cancer Center

Beitou, , Taiwan

Site Status

Changhua Christian Hospital (CCH)

Chang-hua, , Taiwan

Site Status

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, , Taiwan

Site Status

China Medical University Hospital

Taichung, , Taiwan

Site Status

Taichung Veterans General Hospital

Taichung, , Taiwan

Site Status

National Cheng Kung University Hospital

Tainan City, , Taiwan

Site Status

Chi Mei Medical Center CMMC - Yongkang Branch

Tainan City, , Taiwan

Site Status

National Taiwan University Hospital NTUH

Taipei, , Taiwan

Site Status

MacKay Memorial Hospital

Taipei, , Taiwan

Site Status

Taipei Veterans General Hospital TPVGH

Taipei, , Taiwan

Site Status

Tri-Service General Hospital

Taipei, , Taiwan

Site Status

Chang Gung Memorial Hospital CGMH

Taipei, , Taiwan

Site Status

Hacettepe University Cancer Institute

Ankara, İç Anadolu, Turkey (Türkiye)

Site Status

Trakya University Medical Faculty

Edirne, , Turkey (Türkiye)

Site Status

Istanbul Medeniyet University Medical Faculty

Istanbul, , Turkey (Türkiye)

Site Status

Medical Park - Izmir Hastanesi

Izmir, , Turkey (Türkiye)

Site Status

Peterborough City Hospital

Peterborough, Cambridgeshire, United Kingdom

Site Status

Kent Oncology Centre Maidstone Hospital

Maidstone, Kent, United Kingdom

Site Status

The Christie Hospital

Manchester, Lancashire, United Kingdom

Site Status

Clatterbridge Cancer Centre

Metropolitan Borough of Wirral, Merseyside, United Kingdom

Site Status

Nottingham University Hospitals

Nottingham, Nottinghamshire, United Kingdom

Site Status

Royal United Hospital Bath NHS Trust - Royal United Hospital RUH

Bath, Somerset, United Kingdom

Site Status

Somerset NHS Foundation Trust

Taunton, Somerset, United Kingdom

Site Status

St. James University Hospital

Leeds, West Yorkshire, United Kingdom

Site Status

Univeristy Hospitals Bristol NHS Foundation Trust

Bristol, , United Kingdom

Site Status

Colchester Hospital, East Suffolk & North Essex NHS Foundation Trust

Colchester, , United Kingdom

Site Status

Royal Devon Exeter NHS Foundation Trust

Exeter, , United Kingdom

Site Status

Beatson West of Scotland Cancer Centre

Glasgow, , United Kingdom

Site Status

Guys and St Thomas NHS Foundation Trust

London, , United Kingdom

Site Status

Charing Cross Hospital

London, , United Kingdom

Site Status

Oxford University Hospitals NHS Foundation Trust

Oxford, , United Kingdom

Site Status

Blackpool Victoria Hospital

Peterborough, , United Kingdom

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States Argentina Australia Belgium Brazil Canada Chile China Czechia Denmark France Germany Greece Hong Kong Ireland Israel Italy Japan Mexico Netherlands Peru Poland Portugal Romania Russia Singapore South Korea Spain Taiwan Turkey (Türkiye) United Kingdom

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2020-003982-20

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

DESTINY-Breast05

Identifier Type: OTHER

Identifier Source: secondary_id

NSABP B-60

Identifier Type: OTHER

Identifier Source: secondary_id

GBG-103

Identifier Type: OTHER

Identifier Source: secondary_id

SOLTI-2001

Identifier Type: OTHER

Identifier Source: secondary_id

DS8201-A-U305

Identifier Type: -

Identifier Source: org_study_id

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