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Study of Trastuzumab Deruxtecan (T-DXd) vs Investigator's Choice Chemotherapy in HER2-low, Hormone Receptor Positive, Metastatic Breast Cancer (DB-06)

Primary Purpose

Advanced or Metastatic Breast Cancer

Status

Active

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Trastuzumab deruxtecan

Capecitabine

Paclitaxel

Nab-Paclitaxel

About this trial

This is an interventional treatment trial for Advanced or Metastatic Breast Cancer focused on measuring Breast Cancer, HR positive, HER2-Low, HER2-Negative, Trastuzumab Deruxtecan (T-DXd; DS-8201a), Anti-HER2-Antibody Drug Conjugate (ADC), DESTINY-Breast06

Eligibility Criteria

18 Years - 105 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Key Inclusion Criteria:

Patients must be ≥18 years of age
Pathologically documented breast cancer that:
1. is advanced or metastatic
2. has a history of HER2-low or negative expression by local test, defined as IHC 2+/ISH- or IHC 1+ (ISH- or untested) or HER2 IHC 0 (ISH- or untested)
3. has HER2-low or HER2 IHC >0 <1+ expression as determined by the central laboratory result established on a tissue sample taken in the metastatic setting
4. was never previously HER2-positive
5. is documented HR+ disease in the metastatic setting.
No prior chemotherapy for advanced or metastatic breast cancer.
Has adequate tumor samples for assessment of HER2 status
Must have either:
1. disease progression within 6 months of starting first line metastatic treatment with an endocrine therapy combined with a CDK4/6 inhibitor or
2. disease progression on at least 2 previous lines of endocrine therapy with or without a targeted therapy in the metastatic setting. Of note with regards to the ≥2 lines of previous ET requirement: disease recurrence while on the first 24 months of starting adjuvant ET, will be considered a line of therapy; these patients will only require 1 line of ET in the metastatic setting.
Has protocol-defined adequate organ and bone marrow function

Key Exclusion Criteria:

Ineligible for all options in the investigator's choice chemotherapy arm
Lung-specific intercurrent clinically significant illnesses
Uncontrolled or significant cardiovascular disease or infection
Prior documented interstitial lung disease (ILD)/ pneumonitis that required steroids, current ILD/ pneumonitis, or suspected ILD/ pneumonitis that cannot be ruled out by imaging at screening.
Patients with spinal cord compression or clinically active central nervous system metastases
Prior randomization or treatment in a previous trastuzumab deruxtecan study regardless of treatment arm assignment
Concurrent enrolment in another clinical study, unless it is an observational (non-interventional) clinical study during the follow up period of a prior interventional study (prescreening for this study while a patient is on treatment in another clinical study is acceptable)

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Trastuzumab deruxtecan

Standard of Care

Arm Description

Trastuzumab deruxtecan (T-DXd; DS-8201a) arm

Investigator's choice standard of care chemotherapy (capecitabine, paclitaxel, nab-paclitaxel) arm

Outcomes

Primary Outcome Measures

Progression Free Survival (PFS) - in HR+, HER2-low populaton

Defined as time from date of randomization until the date of objective radiological disease progression by blinded independent central review (BICR) assessment according to RECIST 1.1 or death.

Secondary Outcome Measures

Overall Survival (OS) - in HR+, HER2-low population

Defined as the time from randomization to death due to any cause

Progression Free Survival (PFS) - in intent to treat (ITT) population (HER2-Low and HER2 IHC >0<1+)

PFS by BICR according to RECIST 1.1 in ITT population

Overall Survival - in intent to treat (ITT) population (HER2-Low and HER2 IHC >0<1+)

OS in the ITT population

Objective Response Rate (ORR) in HR+, HER-2 low populaton

ORR defined as the percentage of patients with at least one visit response of complete or partial response (CR or PR) by BICR and Investigator assessment according to RECIST 1.1.

Duration of response (DoR) - in HR+, HER-2 low populaton

DoR defined as the time from the date of first documented response (CR/PR) until the first progression or death in the absence of disease progression by BICR and Investigator assessment according to RECIST 1.1

Progression Free Survival by Investigator assessment - in the HR+, HER2-low population

PFS using investigator assessments according to RECIST 1.1 in the HER2-low population

Objective Response Rate (ORR) in the ITT population

ORR by BICR and by Investigator assessment according to RECIST 1.1 in the ITT population

Duration of response (DoR) - in the ITT population

DoR by BICR and by Investigator assessment according to RECIST 1.1 in the ITT population

PFS2 by Investigator assessment, time to first subsequent therapy (TFST) and time to second subsequent treatment or death (TSST) - in HR+, HER2-low and the ITT population

PFS2 defined as time from randomisation to second progression or death. TFST defined as a time elapsed from randomization to first subsequent therapy or death. TSST defined as a time elapsed from randomization to second subsequent therapy or death.

Safety and tolerability of drugs; number of adverse events (AEs)

Number of AEs according to NCI-CTCAE Version 5.0 per each treatment arm

Serum concentration of trastuzumab deruxtecan

Determination of trastuzumab deruxtecan concentration in serum at different time points after trastuzumab deruxtecan administration

Immunogenicity of trastuzumab deruxtecan

Percentage of patients who develop ADA for trastuzumab deruxtecan

Health-related quality of life - EORTC-QLQ-C30

Change from baseline in the physical functioning subscale of the European Organisation for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) scores. Scale scores range from 0-100. For functioning and global health status/ QoL scales, higher scores indicate better functioning or global health status/QoL. For symptom scales, higher scores indicate greater symptom burden.

Time to deterioration in EORTC-QLQ-C30 scores

Time to deterioration from baseline in European Organisation for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) scores. Scale scores range from 0-100. For functioning and global health status/QoL scales, higher scores indicate better functioning or global health status/QoL. For symptom scales, higher scores indicate greater symptom burden.

Health-related quality of life - EORTC QLQ-BR45

Change from baseline in the European Organisation for the Research and Treatment of Cancer Quality of Life Questionnaire Breast Cancer Module (EORTC QLQ-BR45) score. Scale scores range from 0-100. For functioning and global health status/QoL scales, higher scores indicate better functioning or global health status/QoL. For symptom scales, higher scores indicate greater symptom burden.

Full Information

NCT ID

NCT04494425

First Posted

July 20, 2020

Last Updated

August 1, 2023

Sponsor

AstraZeneca

Collaborators

Daiichi Sankyo Company, Limited 3-5-1 Nihonbashihoncho, Chuo-ku, Tokyo

1. Study Identification

Unique Protocol Identification Number

NCT04494425

Brief Title

Study of Trastuzumab Deruxtecan (T-DXd) vs Investigator's Choice Chemotherapy in HER2-low, Hormone Receptor Positive, Metastatic Breast Cancer

Acronym

DB-06

Official Title

A Phase 3, Randomized, Multi-center, Open-label Study of Trastuzumab Deruxtecan (T-DXd) Versus Investigator's Choice Chemotherapy in HER2-Low, Hormone Receptor Positive Breast Cancer Patients Whose Disease Has Progressed on Endocrine Therapy in the Metastatic Setting (DESTINY-Breast06)

Study Type

Interventional

2. Study Status

Record Verification Date

July 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

July 24, 2020 (Actual)

Primary Completion Date

December 29, 2023 (Anticipated)

Study Completion Date

July 20, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

AstraZeneca

Collaborators

Daiichi Sankyo Company, Limited 3-5-1 Nihonbashihoncho, Chuo-ku, Tokyo

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

This study will evaluate the efficacy, safety and tolerability of trastuzumab deruxtecan compared with investigator's choice chemotherapy in human epidermal growth factor receptor (HER)2-low, hormone receptor (HR) positive breast cancer patients whose disease has progressed on endocrine therapy in the metastatic setting.

Detailed Description

Eligible patients will be those patients who have had disease progression on at least 2 previous lines of endocrine therapies given for the treatment of metastatic disease or disease progression within 6 months of starting first line treatment for metastatic disease with an endocrine therapy combined with a CDK4/6 inhibitor. All patients must have historically confirmed HR positive (either estrogen receptor and/or progesterone receptor positive), HER2-low (defined as IHC2+/ISH- and IHC 1+) or HER2 IHC >0 <1+ expression, as determined by central laboratory testing results, advanced or metastatic breast cancer. The study aims to evaluate the efficacy, safety and tolerability of trastuzumab deruxtecan compared with investigator's choice chemotherapy. This study aims to see if trastuzumab deruxtecan allows patients to live longer without the cancer getting worse, or simply to live longer, compared to patients receiving standard of care chemotherapy. This study is also looking to see how the treatment and the cancer affects patients' quality of life.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Advanced or Metastatic Breast Cancer

Keywords

Breast Cancer, HR positive, HER2-Low, HER2-Negative, Trastuzumab Deruxtecan (T-DXd; DS-8201a), Anti-HER2-Antibody Drug Conjugate (ADC), DESTINY-Breast06

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Model Description

The study consists of 2 independent open label treatment arms: trastuzumab deruxtecan and Investigator's choice chemotherapy (paclitaxel, nab-paclitaxel or capecitabine).

Masking

None (Open Label)

Masking Description

This study is an open-label study that will be conducted "Sponsor-blind". To maintain the integrity of the study, Sponsor personnel directly involved in study conduct will not undertake or have access to efficacy data aggregated by treatment group prior to final data readout for the primary endpoint.

Allocation

Randomized

Enrollment

866 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Trastuzumab deruxtecan

Arm Type

Experimental

Arm Description

Trastuzumab deruxtecan (T-DXd; DS-8201a) arm

Arm Title

Standard of Care

Arm Type

Active Comparator

Arm Description

Investigator's choice standard of care chemotherapy (capecitabine, paclitaxel, nab-paclitaxel) arm

Intervention Type

Drug

Intervention Name(s)

Trastuzumab deruxtecan

Other Intervention Name(s)

DS-8201a; T-DXd

Intervention Description

Trastuzumab deruxtecan by intravenous infusion

Intervention Type

Drug

Intervention Name(s)

Capecitabine

Intervention Description

Investigator's choice standard of care single agent chemotherapy; capecitabine tablets will be given orally.

Intervention Type

Drug

Intervention Name(s)

Paclitaxel

Intervention Description

Investigator's choice standard of care single agent chemotherapy; paclitaxel by intravenous infusion.

Intervention Type

Drug

Intervention Name(s)

Nab-Paclitaxel

Intervention Description

Investigator's choice standard of care single agent chemotherapy; nab-paclitaxel by intravenous infusion

Primary Outcome Measure Information:

Title

Progression Free Survival (PFS) - in HR+, HER2-low populaton

Description

Defined as time from date of randomization until the date of objective radiological disease progression by blinded independent central review (BICR) assessment according to RECIST 1.1 or death.

Time Frame

Until progression or death, assessed up to approximately 60 months

Secondary Outcome Measure Information:

Title

Overall Survival (OS) - in HR+, HER2-low population

Description

Defined as the time from randomization to death due to any cause

Time Frame

Until death, assessed up to approximately 60 months

Title

Progression Free Survival (PFS) - in intent to treat (ITT) population (HER2-Low and HER2 IHC >0<1+)

Description

PFS by BICR according to RECIST 1.1 in ITT population

Time Frame

Until progression or death, assessed up to approximately 60 months

Title

Overall Survival - in intent to treat (ITT) population (HER2-Low and HER2 IHC >0<1+)

Description

OS in the ITT population

Time Frame

Until death, assessed up to approximately 60 months

Title

Objective Response Rate (ORR) in HR+, HER-2 low populaton

Description

ORR defined as the percentage of patients with at least one visit response of complete or partial response (CR or PR) by BICR and Investigator assessment according to RECIST 1.1.

Time Frame

Until progression, assessed up to approximately 60 months

Title

Duration of response (DoR) - in HR+, HER-2 low populaton

Description

Time Frame

Until progression, assessed up to approximately 60 months

Title

Progression Free Survival by Investigator assessment - in the HR+, HER2-low population

Description

PFS using investigator assessments according to RECIST 1.1 in the HER2-low population

Time Frame

Until progression or death, assessed up to approximately 60 months

Title

Objective Response Rate (ORR) in the ITT population

Description

ORR by BICR and by Investigator assessment according to RECIST 1.1 in the ITT population

Time Frame

Until progression, assessed up to approximately 60 months

Title

Duration of response (DoR) - in the ITT population

Description

DoR by BICR and by Investigator assessment according to RECIST 1.1 in the ITT population

Time Frame

Until progression, assessed up to approximately 60 months

Title

PFS2 by Investigator assessment, time to first subsequent therapy (TFST) and time to second subsequent treatment or death (TSST) - in HR+, HER2-low and the ITT population

Description

Time Frame

Assessed up to approximately 60 months

Title

Safety and tolerability of drugs; number of adverse events (AEs)

Description

Number of AEs according to NCI-CTCAE Version 5.0 per each treatment arm

Time Frame

Up to follow-up period, approximately 60 months

Title

Serum concentration of trastuzumab deruxtecan

Description

Determination of trastuzumab deruxtecan concentration in serum at different time points after trastuzumab deruxtecan administration

Time Frame

Up to Cycle 8, approximately Week 24; each cycle is 21 days

Title

Immunogenicity of trastuzumab deruxtecan

Description

Percentage of patients who develop ADA for trastuzumab deruxtecan

Time Frame

Up to follow-up period, approximately 60 months

Title

Health-related quality of life - EORTC-QLQ-C30

Description

Time Frame

Assessed up to approximately 60 months

Title

Time to deterioration in EORTC-QLQ-C30 scores

Description

Time Frame

Assessed up to approximately 60 months

Title

Health-related quality of life - EORTC QLQ-BR45

Description

Time Frame

Assessed up to approximately 60 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

105 Years

Accepts Healthy Volunteers

Eligibility Criteria

Key Inclusion Criteria: Patients must be ≥18 years of age Pathologically documented breast cancer that: is advanced or metastatic has a history of HER2-low or negative expression by local test, defined as IHC 2+/ISH- or IHC 1+ (ISH- or untested) or HER2 IHC 0 (ISH- or untested) has HER2-low or HER2 IHC >0 <1+ expression as determined by the central laboratory result established on a tissue sample taken in the metastatic setting was never previously HER2-positive is documented HR+ disease in the metastatic setting. No prior chemotherapy for advanced or metastatic breast cancer. Has adequate tumor samples for assessment of HER2 status Must have either: disease progression within 6 months of starting first line metastatic treatment with an endocrine therapy combined with a CDK4/6 inhibitor or disease progression on at least 2 previous lines of endocrine therapy with or without a targeted therapy in the metastatic setting. Of note with regards to the ≥2 lines of previous ET requirement: disease recurrence while on the first 24 months of starting adjuvant ET, will be considered a line of therapy; these patients will only require 1 line of ET in the metastatic setting. Has protocol-defined adequate organ and bone marrow function Key Exclusion Criteria: Ineligible for all options in the investigator's choice chemotherapy arm Lung-specific intercurrent clinically significant illnesses Uncontrolled or significant cardiovascular disease or infection Prior documented interstitial lung disease (ILD)/ pneumonitis that required steroids, current ILD/ pneumonitis, or suspected ILD/ pneumonitis that cannot be ruled out by imaging at screening. Patients with spinal cord compression or clinically active central nervous system metastases Prior randomization or treatment in a previous trastuzumab deruxtecan study regardless of treatment arm assignment Concurrent enrolment in another clinical study, unless it is an observational (non-interventional) clinical study during the follow up period of a prior interventional study (prescreening for this study while a patient is on treatment in another clinical study is acceptable)

Facility Information:

Facility Name

Research Site

City

Scottsdale

State/Province

Arizona

ZIP/Postal Code

85259

Country

United States

Facility Name

Research Site

City

Springdale

State/Province

Arkansas

ZIP/Postal Code

72762

Country

United States

Facility Name

Research Site

City

Duarte

State/Province

California

ZIP/Postal Code

91010

Country

United States

Facility Name

Research Site

City

Los Angeles

State/Province

California

ZIP/Postal Code

90017

Country

United States

Facility Name

Research Site

City

Aurora

State/Province

Colorado

ZIP/Postal Code

80045

Country

United States

Facility Name

Research Site

City

Lakewood

State/Province

Colorado

ZIP/Postal Code

80228

Country

United States

Facility Name

Research Site

City

Washington

State/Province

District of Columbia

ZIP/Postal Code

20016

Country

United States

Facility Name

Research Site

City

Jacksonville

State/Province

Florida

ZIP/Postal Code

32224

Country

United States

Facility Name

Research Site

City

Kansas City

State/Province

Kansas

ZIP/Postal Code

66160

Country

United States

Facility Name

Research Site

City

Louisville

State/Province

Kentucky

ZIP/Postal Code

40202

Country

United States

Facility Name

Research Site

City

Bethesda

State/Province

Maryland

ZIP/Postal Code

20817

Country

United States

Facility Name

Research Site

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02114

Country

United States

Facility Name

Research Site

City

Detroit

State/Province

Michigan

ZIP/Postal Code

48202

Country

United States

Facility Name

Research Site

City

Rochester

State/Province

Minnesota

ZIP/Postal Code

55905

Country

United States

Facility Name

Research Site

City

Saint Louis

State/Province

Missouri

ZIP/Postal Code

63110

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United States

Facility Name

Research Site

City

Summit

State/Province

New Jersey

ZIP/Postal Code

07901

Country

United States

Facility Name

Research Site

City

Westbury

State/Province

New York

ZIP/Postal Code

11590

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United States

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Research Site

City

Columbus

State/Province

Ohio

ZIP/Postal Code

43210

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United States

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Research Site

City

Pittsburgh

State/Province

Pennsylvania

ZIP/Postal Code

15212

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United States

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Research Site

City

Nashville

State/Province

Tennessee

ZIP/Postal Code

37232

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United States

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Research Site

City

Austin

State/Province

Texas

ZIP/Postal Code

78731

Country

United States

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Research Site

City

Dallas

State/Province

Texas

ZIP/Postal Code

75246

Country

United States

Facility Name

Research Site

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

Facility Name

Research Site

City

Houston

State/Province

Texas

ZIP/Postal Code

77090

Country

United States

Facility Name

Research Site

City

Norfolk

State/Province

Virginia

ZIP/Postal Code

23502

Country

United States

Facility Name

Research Site

City

Seattle

State/Province

Washington

ZIP/Postal Code

98104

Country

United States

Facility Name

Research Site

City

Madison

State/Province

Wisconsin

ZIP/Postal Code

53792-5666

Country

United States

Facility Name

Research Site

City

Caba

ZIP/Postal Code

1414

Country

Argentina

Facility Name

Research Site

City

Caba

ZIP/Postal Code

C1012AAR

Country

Argentina

Facility Name

Research Site

City

Caba

ZIP/Postal Code

C1019ABS

Country

Argentina

Facility Name

Research Site

City

Ciudad Autonoma De Buenos Aire

ZIP/Postal Code

C1125ABD

Country

Argentina

Facility Name

Research Site

City

Ciudad de Buenos Aires

ZIP/Postal Code

1280

Country

Argentina

Facility Name

Research Site

City

Cordoba

ZIP/Postal Code

5000

Country

Argentina

Facility Name

Research Site

City

La Plata

ZIP/Postal Code

1900

Country

Argentina

Facility Name

Research Site

City

Mar del Plata

ZIP/Postal Code

7600

Country

Argentina

Facility Name

Research Site

City

Rosario

ZIP/Postal Code

S2000DEJ

Country

Argentina

Facility Name

Research Site

City

Rosario

ZIP/Postal Code

S2002KDS

Country

Argentina

Facility Name

Research Site

City

Adelaide

ZIP/Postal Code

5000

Country

Australia

Facility Name

Research Site

City

Birtinya

ZIP/Postal Code

4575

Country

Australia

Facility Name

Research Site

City

Darlinghurst

ZIP/Postal Code

2010

Country

Australia

Facility Name

Research Site

City

Murdoch

ZIP/Postal Code

6150

Country

Australia

Facility Name

Research Site

City

South Brisbane

ZIP/Postal Code

4101

Country

Australia

Facility Name

Research Site

City

St Leonards

ZIP/Postal Code

2065

Country

Australia

Facility Name

Research Site

City

Waratah

ZIP/Postal Code

2298

Country

Australia

Facility Name

Research Site

City

Graz

ZIP/Postal Code

8036

Country

Austria

Facility Name

Research Site

City

Innsbruck

ZIP/Postal Code

6020

Country

Austria

Facility Name

Research Site

City

Anderlecht

ZIP/Postal Code

1070

Country

Belgium

Facility Name

Research Site

City

Bruxelles

ZIP/Postal Code

1200

Country

Belgium

Facility Name

Research Site

City

Charleroi

ZIP/Postal Code

6000

Country

Belgium

Facility Name

Research Site

City

Edegem

ZIP/Postal Code

2650

Country

Belgium

Facility Name

Research Site

City

Gent

ZIP/Postal Code

9000

Country

Belgium

Facility Name

Research Site

City

Leuven

ZIP/Postal Code

3000

Country

Belgium

Facility Name

Research Site

City

Liège

ZIP/Postal Code

4000

Country

Belgium

Facility Name

Research Site

City

Namur

ZIP/Postal Code

5000

Country

Belgium

Facility Name

Research Site

City

Roeselare

ZIP/Postal Code

8800

Country

Belgium

Facility Name

Research Site

City

Sint-Niklaas

ZIP/Postal Code

9100

Country

Belgium

Facility Name

Research Site

City

Barretos

ZIP/Postal Code

14784-400

Country

Brazil

Facility Name

Research Site

City

Belo Horizonte

ZIP/Postal Code

30110-022

Country

Brazil

Facility Name

Research Site

City

Natal

ZIP/Postal Code

59075-740

Country

Brazil

Facility Name

Research Site

City

Porto Alegre

ZIP/Postal Code

90610-000

Country

Brazil

Facility Name

Research Site

City

Porto Alegre

ZIP/Postal Code

91350-200

Country

Brazil

Facility Name

Research Site

City

Rio de Janeiro

ZIP/Postal Code

20560-120

Country

Brazil

Facility Name

Research Site

City

Sao Paulo

ZIP/Postal Code

1323001

Country

Brazil

Facility Name

Research Site

City

Sorocaba

ZIP/Postal Code

18030-510

Country

Brazil

Facility Name

Research Site

City

São Paulo

ZIP/Postal Code

04038-034

Country

Brazil

Facility Name

Research Site

City

Calgary

State/Province

Alberta

ZIP/Postal Code

T2N 4N2

Country

Canada

Facility Name

Research Site

City

Edmonton

State/Province

Alberta

ZIP/Postal Code

T6G 1Z2

Country

Canada

Facility Name

Research Site

City

Vancouver

State/Province

British Columbia

ZIP/Postal Code

V5Z 4E6

Country

Canada

Facility Name

Research Site

City

Toronto

State/Province

ZIP/Postal Code

M5G 2M9

Country

Canada

Facility Name

Research Site

City

London

State/Province

Ontario

ZIP/Postal Code

N6A 5W9

Country

Canada

Facility Name

Research Site

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M4N 3M5

Country

Canada

Facility Name

Research Site

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M5G 1X5

Country

Canada

Facility Name

Research Site

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H3T 1E2

Country

Canada

Facility Name

Research Site

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H4A 3J1

Country

Canada

Facility Name

Research Site

City

Sherbrooke

State/Province

Quebec

ZIP/Postal Code

J1H 5N4

Country

Canada

Facility Name

Research Site

City

Baoding

ZIP/Postal Code

071000

Country

China

Facility Name

Research Site

City

Beijing

ZIP/Postal Code

100006

Country

China

Facility Name

Research Site

City

Beijing

ZIP/Postal Code

100044

Country

China

Facility Name

Research Site

City

Changchun

ZIP/Postal Code

130021

Country

China

Facility Name

Research Site

City

Changsha

ZIP/Postal Code

410008

Country

China

Facility Name

Research Site

City

Changsha

ZIP/Postal Code

410013

Country

China

Facility Name

Research Site

City

Dalian

ZIP/Postal Code

116001

Country

China

Facility Name

Research Site

City

Foshan

ZIP/Postal Code

528000

Country

China

Facility Name

Research Site

City

Fuzhou

ZIP/Postal Code

350011

Country

China

Facility Name

Research Site

City

Guangzhou

ZIP/Postal Code

510060

Country

China

Facility Name

Research Site

City

Guangzhou

ZIP/Postal Code

510080

Country

China

Facility Name

Research Site

City

Guangzhou

ZIP/Postal Code

510120

Country

China

Facility Name

Research Site

City

Hangzhou

ZIP/Postal Code

310003

Country

China

Facility Name

Research Site

City

Hangzhou

ZIP/Postal Code

310020

Country

China

Facility Name

Research Site

City

Hangzhou

ZIP/Postal Code

310022

Country

China

Facility Name

Research Site

City

Harbin

ZIP/Postal Code

150001

Country

China

Facility Name

Research Site

City

Hefei

ZIP/Postal Code

230001

Country

China

Facility Name

Research Site

City

Jinan

ZIP/Postal Code

250001

Country

China

Facility Name

Research Site

City

Linyi

ZIP/Postal Code

276000

Country

China

Facility Name

Research Site

City

Nanchang

ZIP/Postal Code

330006

Country

China

Facility Name

Research Site

City

Nanchang

ZIP/Postal Code

330009

Country

China

Facility Name

Research Site

City

Nanjing

ZIP/Postal Code

210009

Country

China

Facility Name

Research Site

City

Nanjing

ZIP/Postal Code

210029

Country

China

Facility Name

Research Site

City

Nanning

ZIP/Postal Code

530021

Country

China

Facility Name

Research Site

City

Shanghai

ZIP/Postal Code

200032

Country

China

Facility Name

Research Site

City

Shenyang

Country

China

Facility Name

Research Site

City

Tianjin

ZIP/Postal Code

300060

Country

China

Facility Name

Research Site

City

Urumqi

ZIP/Postal Code

830000

Country

China

Facility Name

Research Site

City

Wuhan

ZIP/Postal Code

430079

Country

China

Facility Name

Research Site

City

Xi'an

ZIP/Postal Code

710004

Country

China

Facility Name

Research Site

City

Xi'an

ZIP/Postal Code

710061

Country

China

Facility Name

Research Site

City

Zhengzhou

ZIP/Postal Code

450008

Country

China

Facility Name

Research Site

City

Aalborg

ZIP/Postal Code

9000

Country

Denmark

Facility Name

Research Site

City

Copenhagen Ø

ZIP/Postal Code

2100

Country

Denmark

Facility Name

Research Site

City

Odense C

ZIP/Postal Code

5000

Country

Denmark

Facility Name

Research Site

City

Vejle

ZIP/Postal Code

7100

Country

Denmark

Facility Name

Research Site

City

Avignon Cedex 09

ZIP/Postal Code

84918

Country

France

Facility Name

Research Site

City

Besançon

ZIP/Postal Code

25000

Country

France

Facility Name

Research Site

City

Bordeaux

ZIP/Postal Code

33000

Country

France

Facility Name

Research Site

City

Brest

ZIP/Postal Code

29609

Country

France

Facility Name

Research Site

City

Caen Cedex 05

ZIP/Postal Code

14076

Country

France

Facility Name

Research Site

City

Dijon

ZIP/Postal Code

21079

Country

France

Facility Name

Research Site

City

Le Mans

ZIP/Postal Code

72000

Country

France

Facility Name

Research Site

City

Marseille

ZIP/Postal Code

13273

Country

France

Facility Name

Research Site

City

Montpellier

ZIP/Postal Code

34298

Country

France

Facility Name

Research Site

City

Nice

ZIP/Postal Code

06100

Country

France

Facility Name

Research Site

City

Paris

ZIP/Postal Code

75005

Country

France

Facility Name

Research Site

City

Pierre Benite

ZIP/Postal Code

69495

Country

France

Facility Name

Research Site

City

Plerin SUR MER

ZIP/Postal Code

22190

Country

France

Facility Name

Research Site

City

Rennes

ZIP/Postal Code

35000

Country

France

Facility Name

Research Site

City

Saint Herblain Cedex

ZIP/Postal Code

44805

Country

France

Facility Name

Research Site

City

Saint-cloud

ZIP/Postal Code

92210

Country

France

Facility Name

Research Site

City

Tours

ZIP/Postal Code

37000

Country

France

Facility Name

Research Site

City

Villejuif Cedex

ZIP/Postal Code

94805

Country

France

Facility Name

Research Site

City

Berlin

ZIP/Postal Code

10117

Country

Germany

Facility Name

Research Site

City

Dresden

ZIP/Postal Code

01307

Country

Germany

Facility Name

Research Site

City

Freiburg

ZIP/Postal Code

79110

Country

Germany

Facility Name

Research Site

City

Hannover

ZIP/Postal Code

30625

Country

Germany

Facility Name

Research Site

City

München

ZIP/Postal Code

80337

Country

Germany

Facility Name

Research Site

City

München

ZIP/Postal Code

81675

Country

Germany

Facility Name

Research Site

City

Münster

ZIP/Postal Code

48149

Country

Germany

Facility Name

Research Site

City

Velbert

ZIP/Postal Code

42551

Country

Germany

Facility Name

Research Site

City

Budapest

ZIP/Postal Code

1062

Country

Hungary

Facility Name

Research Site

City

Budapest

ZIP/Postal Code

1122

Country

Hungary

Facility Name

Research Site

City

Budapest

ZIP/Postal Code

1145

Country

Hungary

Facility Name

Research Site

City

Győr

ZIP/Postal Code

9024

Country

Hungary

Facility Name

Research Site

City

Kecskemét

ZIP/Postal Code

6000

Country

Hungary

Facility Name

Research Site

City

Nyíregyháza

ZIP/Postal Code

4400

Country

Hungary

Facility Name

Research Site

City

Szolnok

ZIP/Postal Code

5004

Country

Hungary

Facility Name

Research Site

City

Tatabánya

ZIP/Postal Code

2800

Country

Hungary

Facility Name

Research Site

City

Bengaluru

ZIP/Postal Code

560099

Country

India

Facility Name

Research Site

City

Calicut

ZIP/Postal Code

673601

Country

India

Facility Name

Research Site

City

Kolkata

ZIP/Postal Code

700160

Country

India

Facility Name

Research Site

City

Marg Jaipur

ZIP/Postal Code

302004

Country

India

Facility Name

Research Site

City

New Delhi

ZIP/Postal Code

110 085

Country

India

Facility Name

Research Site

City

New Delhi

ZIP/Postal Code

110005

Country

India

Facility Name

Research Site

City

New Delhi

ZIP/Postal Code

110017

Country

India

Facility Name

Research Site

City

New Delhi

ZIP/Postal Code

110075

Country

India

Facility Name

Research Site

City

Surat

ZIP/Postal Code

395002

Country

India

Facility Name

Research Site

City

Thiruvananthapuram

ZIP/Postal Code

695011

Country

India

Facility Name

Research Site

City

Haifa

ZIP/Postal Code

3109601

Country

Israel

Facility Name

Research Site

City

Jerusalem

ZIP/Postal Code

9103102

Country

Israel

Facility Name

Research Site

City

Jerusalem

ZIP/Postal Code

91120

Country

Israel

Facility Name

Research Site

City

Kfar-Saba

ZIP/Postal Code

44281

Country

Israel

Facility Name

Research Site

City

Petah Tikva

ZIP/Postal Code

49100

Country

Israel

Facility Name

Research Site

City

Ramat Gan

ZIP/Postal Code

52621

Country

Israel

Facility Name

Research Site

City

Tel-Aviv

ZIP/Postal Code

64239

Country

Israel

Facility Name

Research Site

City

Aviano

ZIP/Postal Code

33081

Country

Italy

Facility Name

Research Site

City

Bergamo

ZIP/Postal Code

24127

Country

Italy

Facility Name

Research Site

City

Candiolo

ZIP/Postal Code

10060

Country

Italy

Facility Name

Research Site

City

Cona

ZIP/Postal Code

44124

Country

Italy

Facility Name

Research Site

City

Genova

ZIP/Postal Code

16132

Country

Italy

Facility Name

Research Site

City

Livorno

ZIP/Postal Code

57124

Country

Italy

Facility Name

Research Site

City

Messina

ZIP/Postal Code

98158

Country

Italy

Facility Name

Research Site

City

Milano

ZIP/Postal Code

20132

Country

Italy

Facility Name

Research Site

City

Milan

ZIP/Postal Code

20141

Country

Italy

Facility Name

Research Site

City

Napoli

ZIP/Postal Code

80131

Country

Italy

Facility Name

Research Site

City

Padova

ZIP/Postal Code

35128

Country

Italy

Facility Name

Research Site

City

Parma

Country

Italy

Facility Name

Research Site

City

Prato

ZIP/Postal Code

59100

Country

Italy

Facility Name

Research Site

City

Tricase, Lecce

ZIP/Postal Code

73039

Country

Italy

Facility Name

Research Site

City

Udine

ZIP/Postal Code

33100

Country

Italy

Facility Name

Research Site

City

Akashi-shi

ZIP/Postal Code

673-8558

Country

Japan

Facility Name

Research Site

City

Bunkyo-ku

ZIP/Postal Code

113-8431

Country

Japan

Facility Name

Research Site

City

Chiba-shi

ZIP/Postal Code

260-8717

Country

Japan

Facility Name

Research Site

City

Chuo-ku

ZIP/Postal Code

104-0045

Country

Japan

Facility Name

Research Site

City

Fukuoka-shi

ZIP/Postal Code

811-1395

Country

Japan

Facility Name

Research Site

City

Gifu-shi

ZIP/Postal Code

501-1194

Country

Japan

Facility Name

Research Site

City

Hidaka-shi

ZIP/Postal Code

350-1298

Country

Japan

Facility Name

Research Site

City

Hiroshima-shi

ZIP/Postal Code

730-8518

Country

Japan

Facility Name

Research Site

City

Isehara

ZIP/Postal Code

259-1193

Country

Japan

Facility Name

Research Site

City

Kagoshima-shi

ZIP/Postal Code

892-0833

Country

Japan

Facility Name

Research Site

City

Kashiwa

ZIP/Postal Code

277-8577

Country

Japan

Facility Name

Research Site

City

Kawasaki-shi

ZIP/Postal Code

216-8511

Country

Japan

Facility Name

Research Site

City

Kitaadachi-gun

ZIP/Postal Code

362-0806

Country

Japan

Facility Name

Research Site

City

Koto-ku

ZIP/Postal Code

135-8550

Country

Japan

Facility Name

Research Site

City

Matsuyama-shi

ZIP/Postal Code

791-0280

Country

Japan

Facility Name

Research Site

City

Nagoya

ZIP/Postal Code

460-0001

Country

Japan

Facility Name

Research Site

City

Naha-shi

ZIP/Postal Code

901-0154

Country

Japan

Facility Name

Research Site

City

Niigata-shi

ZIP/Postal Code

951-8566

Country

Japan

Facility Name

Research Site

City

Nishinomiya-shi

ZIP/Postal Code

663-8501

Country

Japan

Facility Name

Research Site

City

Okayama-shi

ZIP/Postal Code

700-8558

Country

Japan

Facility Name

Research Site

City

Osaka-shi

ZIP/Postal Code

541-8567

Country

Japan

Facility Name

Research Site

City

Osakasayama-shi

ZIP/Postal Code

589-8511

Country

Japan

Facility Name

Research Site

City

Sagamihara-shi

ZIP/Postal Code

252-0375

Country

Japan

Facility Name

Research Site

City

Sapporo-shi

ZIP/Postal Code

060-8648

Country

Japan

Facility Name

Research Site

City

Shinagawa-ku

ZIP/Postal Code

142-8666

Country

Japan

Facility Name

Research Site

City

Shinjuku-ku

ZIP/Postal Code

160-0023

Country

Japan

Facility Name

Research Site

City

Shizuoka

ZIP/Postal Code

420-8527

Country

Japan

Facility Name

Research Site

City

Tsu-shi

ZIP/Postal Code

514-8507

Country

Japan

Facility Name

Research Site

City

Yokohama-shi

ZIP/Postal Code

241-8515

Country

Japan

Facility Name

Research Site

City

Daegu

ZIP/Postal Code

41404

Country

Korea, Republic of

Facility Name

Research Site

City

Goyang-si

ZIP/Postal Code

10408

Country

Korea, Republic of

Facility Name

Research Site

City

Incheon

ZIP/Postal Code

22332

Country

Korea, Republic of

Facility Name

Research Site

City

Seongnam-si

ZIP/Postal Code

13620

Country

Korea, Republic of

Facility Name

Research Site

City

Seoul

ZIP/Postal Code

03080

Country

Korea, Republic of

Facility Name

Research Site

City

Seoul

ZIP/Postal Code

03722

Country

Korea, Republic of

Facility Name

Research Site

City

Seoul

ZIP/Postal Code

05505

Country

Korea, Republic of

Facility Name

Research Site

City

Seoul

ZIP/Postal Code

06351

Country

Korea, Republic of

Facility Name

Research Site

City

Seoul

ZIP/Postal Code

136-705

Country

Korea, Republic of

Facility Name

Research Site

City

Alc. Cuauhtémoc

ZIP/Postal Code

06700

Country

Mexico

Facility Name

Research Site

City

Guadalajara Jalisco

ZIP/Postal Code

44280

Country

Mexico

Facility Name

Research Site

City

Guadalajra

ZIP/Postal Code

44260

Country

Mexico

Facility Name

Research Site

City

Mexico City

ZIP/Postal Code

'14080

Country

Mexico

Facility Name

Research Site

City

Mexico City

ZIP/Postal Code

0 3100

Country

Mexico

Facility Name

Research Site

City

Mexico, D.F.

ZIP/Postal Code

6760

Country

Mexico

Facility Name

Research Site

City

Monterrey

ZIP/Postal Code

64460

Country

Mexico

Facility Name

Research Site

City

México

ZIP/Postal Code

04700

Country

Mexico

Facility Name

Research Site

City

Nuevo Leon

ZIP/Postal Code

66278

Country

Mexico

Facility Name

Research Site

City

Amsterdam

ZIP/Postal Code

1066 CX

Country

Netherlands

Facility Name

Research Site

City

Breda

ZIP/Postal Code

4818 CK

Country

Netherlands

Facility Name

Research Site

City

Hengelo

ZIP/Postal Code

7555 DL

Country

Netherlands

Facility Name

Research Site

City

Leeuwarden

ZIP/Postal Code

8934 AD

Country

Netherlands

Facility Name

Research Site

City

Rotterdam

ZIP/Postal Code

3015 GD

Country

Netherlands

Facility Name

Research Site

City

Sittard-Geleen

ZIP/Postal Code

6162 BG

Country

Netherlands

Facility Name

Research Site

City

Bydgoszcz

ZIP/Postal Code

85-796

Country

Poland

Facility Name

Research Site

City

Koszalin

ZIP/Postal Code

75-581

Country

Poland

Facility Name

Research Site

City

Kraków

ZIP/Postal Code

31-501

Country

Poland

Facility Name

Research Site

City

Rzeszów

ZIP/Postal Code

35-021

Country

Poland

Facility Name

Research Site

City

Warszawa

ZIP/Postal Code

02-781

Country

Poland

Facility Name

Research Site

City

Wroclaw

ZIP/Postal Code

53-413

Country

Poland

Facility Name

Research Site

City

Łódź

ZIP/Postal Code

90-302

Country

Poland

Facility Name

Research Site

City

Lisboa

ZIP/Postal Code

1500-650

Country

Portugal

Facility Name

Research Site

City

Lisboa

ZIP/Postal Code

1649-035

Country

Portugal

Facility Name

Research Site

City

Lisboa

ZIP/Postal Code

1998-018

Country

Portugal

Facility Name

Research Site

City

Krasnodar

ZIP/Postal Code

350040

Country

Russian Federation

Facility Name

Research Site

City

Moscow

ZIP/Postal Code

111123

Country

Russian Federation

Facility Name

Research Site

City

Moscow

ZIP/Postal Code

115478

Country

Russian Federation

Facility Name

Research Site

City

Moscow

ZIP/Postal Code

117997

Country

Russian Federation

Facility Name

Research Site

City

Moscow

ZIP/Postal Code

121205

Country

Russian Federation

Facility Name

Research Site

City

Saint Petersburg

ZIP/Postal Code

195271

Country

Russian Federation

Facility Name

Research Site

City

Saint Petersburg

ZIP/Postal Code

197758

Country

Russian Federation

Facility Name

Research Site

City

Saint-Petersburg

ZIP/Postal Code

190103

Country

Russian Federation

Facility Name

Research Site

City

Sankt-Peterburg

ZIP/Postal Code

197758

Country

Russian Federation

Facility Name

Research Site

City

Yaroslavl

ZIP/Postal Code

150054

Country

Russian Federation

Facility Name

Research Site

City

Ar Riyāḑ

ZIP/Postal Code

11426

Country

Saudi Arabia

Facility Name

Research Site

City

Dammam

ZIP/Postal Code

31444

Country

Saudi Arabia

Facility Name

Research Site

City

Jeddah

ZIP/Postal Code

21423

Country

Saudi Arabia

Facility Name

Research Site

City

Jeddah

ZIP/Postal Code

23214

Country

Saudi Arabia

Facility Name

Research Site

City

Riyadh

ZIP/Postal Code

11525

Country

Saudi Arabia

Facility Name

Research Site

City

Riyadh

ZIP/Postal Code

12713

Country

Saudi Arabia

Facility Name

Research Site

City

Bukit Merah

ZIP/Postal Code

169610

Country

Singapore

Facility Name

Research Site

City

Singapore

ZIP/Postal Code

119074

Country

Singapore

Facility Name

Research Site

City

Singapore

ZIP/Postal Code

258499

Country

Singapore

Facility Name

Research Site

City

Singapore

ZIP/Postal Code

308433

Country

Singapore

Facility Name

Research Site

City

Singapore

ZIP/Postal Code

329563

Country

Singapore

Facility Name

Research Site

City

Barcelona

ZIP/Postal Code

08035

Country

Spain

Facility Name

Research Site

City

Barcelona

ZIP/Postal Code

08036

Country

Spain

Facility Name

Research Site

City

Barcelona

ZIP/Postal Code

08907

Country

Spain

Facility Name

Research Site

City

Cordoba

ZIP/Postal Code

14004

Country

Spain

Facility Name

Research Site

City

El Palmar

ZIP/Postal Code

30120

Country

Spain

Facility Name

Research Site

City

La Coruña

ZIP/Postal Code

15006

Country

Spain

Facility Name

Research Site

City

Madrid

ZIP/Postal Code

28005

Country

Spain

Facility Name

Research Site

City

Madrid

ZIP/Postal Code

28007

Country

Spain

Facility Name

Research Site

City

Madrid

ZIP/Postal Code

28046

Country

Spain

Facility Name

Research Site

City

San Sebastián

ZIP/Postal Code

20014

Country

Spain

Facility Name

Research Site

City

Sevilla

ZIP/Postal Code

41013

Country

Spain

Facility Name

Research Site

City

Valencia

ZIP/Postal Code

46026

Country

Spain

Facility Name

Research Site

City

Göteborg

ZIP/Postal Code

413 45

Country

Sweden

Facility Name

Research Site

City

Stockholm

ZIP/Postal Code

118 83

Country

Sweden

Facility Name

Research Site

City

Uppsala

ZIP/Postal Code

751 85

Country

Sweden

Facility Name

Research Site

City

Växjö

ZIP/Postal Code

35185

Country

Sweden

Facility Name

Research Site

City

Örebro

ZIP/Postal Code

701 85

Country

Sweden

Facility Name

Research Site

City

Taichung

ZIP/Postal Code

40447

Country

Taiwan

Facility Name

Research Site

City

Tainan

ZIP/Postal Code

70403

Country

Taiwan

Facility Name

Research Site

City

Tainan

ZIP/Postal Code

710

Country

Taiwan

Facility Name

Research Site

City

Taipei

ZIP/Postal Code

10048

Country

Taiwan

Facility Name

Research Site

City

Taipei

ZIP/Postal Code

10449

Country

Taiwan

Facility Name

Research Site

City

Taipei

ZIP/Postal Code

11217

Country

Taiwan

Facility Name

Research Site

City

Taipei

ZIP/Postal Code

235

Country

Taiwan

Facility Name

Research Site

City

Tao-Yuan

ZIP/Postal Code

333

Country

Taiwan

Facility Name

Research Site

City

Cambridge

ZIP/Postal Code

CB2 0QQ

Country

United Kingdom

Facility Name

Research Site

City

Cardiff

ZIP/Postal Code

CF14 2TL

Country

United Kingdom

Facility Name

Research Site

City

Edinburgh

ZIP/Postal Code

EH4 2XR

Country

United Kingdom

Facility Name

Research Site

City

Guildford

Country

United Kingdom

Facility Name

Research Site

City

Leeds

ZIP/Postal Code

LS9 7TF

Country

United Kingdom

Facility Name

Research Site

City

London

ZIP/Postal Code

SE1 9RT

Country

United Kingdom

Facility Name

Research Site

City

Manchester

ZIP/Postal Code

M20 4BX

Country

United Kingdom

Facility Name

Research Site

City

Northwood

ZIP/Postal Code

HA6 2RN

Country

United Kingdom

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

IPD Sharing Time Frame

AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

IPD Sharing Access Criteria

When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

IPD Sharing URL

https://astrazenecagroup-dt.pharmacm.com/DT/Home

Links:

URL

http://BreastCancerStudyLocator.com

Description

AZ Breast Cancer Study Navigators

URL

http://CTRinfo@dsi.com

Description

Daiichi Sankyo Contact for Clinical Trial Information Phone: 908-992-6400

Learn more about this trial

Study of Trastuzumab Deruxtecan (T-DXd) vs Investigator's Choice Chemotherapy in HER2-low, Hormone Receptor Positive, Metastatic Breast Cancer

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Study of Trastuzumab Deruxtecan (T-DXd) vs Investigator's Choice Chemotherapy in HER2-low, Hormone Receptor Positive, Metastatic Breast Cancer (DB-06)

Advanced or Metastatic Breast Cancer

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial