search
Back to results

A Phase 1b/2 Study of T-DXd Combinations in HER2-positive Metastatic Breast Cancer (DB-07)

Primary Purpose

Metastatic Breast Cancer

Status
Active
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
Trastuzumab deruxtecan
Durvalumab
Paclitaxel
Pertuzumab
Tucatinib
Sponsored by
AstraZeneca
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metastatic Breast Cancer focused on measuring Breast Cancer, HER2-positive, Brain Metastases, Trastuzumab Deruxtecan, T-DXd, DS-8201a, DESTINY-Breast07, Anti-HER2 Antibody Drug Conjugate (ADC)

Eligibility Criteria

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

Key Inclusion Criteria:

  • Patients must be at least 18 years of age

  • Pathologically documented breast cancer that:

    1. Is advanced/unresectable (patients that can be treated with curative intent are not eligible) or metastatic
    2. HER2-positive (IHC 3+ or IHC 2+/ISH+) based on local assessment. The local HER2 result must be from a tumour sample obtained in the metastatic setting.
    3. Is documented as hormone receptor-positive (estrogen or progesterone receptor) or negative in the metastatic setting
  • Patient must have adequate tumor sample from the metastatic setting for biomarker assessment
  • ECOG Performance Status of 0 or 1

  • Part 1

    1. Disease progression on or after the last systemic therapy prior to starting study treatment
    2. At least 1 prior treatment line in metastatic setting required.

  • Part 2 (Modules 0 - 5)

    a) No prior lines of therapy for advanced/MBC allowed

  • Part 2 (Module 6 and 7) a) Zero or one prior lines of therapy for advanced/MBC allowed

CNS Inclusion

  • Modules 0 - 5 Patients must have no brain metastases or stable brain metastases.
  • Module 6 and 7 Patients must have untreated brain metastases not needing local therapy or previously treated brain metastases that have progressed since prior local therapy

Key Exclusion Criteria:

  • Uncontrolled or significant cardiovascular disease
  • Active or prior documented (non-infectious) ILD/pneumonitis that required steroids, or suspected ILD/pneumonitis that cannot be ruled out by imaging at screening
  • Lung-specific intercurrent clinically significant illnesses
  • Uncontrolled infection requiring IV antibiotics, antivirals, or antifungals
  • Spinal cord compression or a history of leptomeningeal carcinomatosis
  • Prior treatment with immune checkpoint inhibitors
  • Prior treatment with an ADC containing a topoisomerase I inhibitor
  • Prior treatment with tucatinib

CNS Exclusion

  • Modules 0 - 5: Has untreated brain metastasis
  • Module 6 and 7: Ongoing use of systemic corticosteroids for control of symptoms of brain metastases at a total daily dose of > 2 mg dexamethasone or any brain lesion thought to require immediate local therapy

Sites / Locations

  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Module 1- T-DXd and Durvalumab

Module 2- T-DXd and Pertuzumab

Module 3- T-DXd and Paclitaxel

Module 4- T-DXd and Durvalumab and Paclitaxel

Module 0- T-DXd

Module 5 - T-DXd and Tucatanib

Module 6 - T-DXd and Tucatinib

Module 7 - T-DXd

Arm Description

T-DXd and Durvalumab

T-DXd and Pertuzumab

T-DXd and Paclitaxel

T-DXd and Durvalumab and Paclitaxel

T-DXd

T-DXd and tucatinib

T-DXd and tucatinib in patients with active brain metastases (Part 2 Only)

T-DXd monotherapy in patients with active brain metastases (Part 2 Only)

Outcomes

Primary Outcome Measures

Occurrence of adverse events (AEs)- Part 1
Occurrence of AEs in Part 1 graded according to NCI CTCAE v5.0
Occurrence of serious adverse events (SAEs)- Part 1
Occurrence of SAEs in Part 1 graded according to NCI CTCAE v5.0
Occurrence of adverse events (AEs)- Part 2
Occurrence of AEs in Part 2 graded according to NCI CTCAE v5.0
Occurrence of serious adverse events (SAEs)- Part 2
Occurrence of SAEs in Part 2 graded according to NCI CTCAE v5.0

Secondary Outcome Measures

Objective Response Rate (ORR)- Part 1 and Part 2
ORR is defined as the proportion of patients who have a CR or PR, as determined by the Investigator at local site per RECIST 1.1.
Progression Free Survival (PFS)- Part 1 and Part 2
PFS is defined as time from the date of randomization until the date of progression as assessed by the Investigator at local site per RECIST 1.1, or death due to any cause.
Progression Free Survival 2 (PFS2)- Part 2
PFS2 is defined as time from the date of randomisation until the date of progression on next line treatment (the earliest of the progression event subsequent to first subsequent anticancer therapy) or death; second progression will be defined according to local standard clinical practice.
Duration of Response (DoR)- Part 2
DoR is defined as time from the date of first documented response until the date of documented progression or death in the absence of disease progression.
Overall Survival (OS)- Part 2
OS is defined as time from the date of randomisation until the date of death due to any cause.
Serum Concentration of Trastuzumab Deruxtecan (T-DXd)
Determination of trastuzumab deruxtecan concentration in serum at different time points after trastuzumab deruxtecan administration
Serum Concentration of Durvalumab
Determination of durvalumab concentration in serum at different time points after administration
Serum Concentration of Pertuzumab
Determination of pertuzumab concentration in serum at different time points after administration
Plasma Concentration of Paclitaxel
Determination of paclitaxel concentration in plasma at different time points after administration
Plasma Concentration of Tucatinib
Determination of tucatinib concentration in plasma at different time points after administration
Immunogenicity of trastuzumab deruxtecan
Percentage of patients who develop ADA for trastuzumab deruxtecan
Immunogenicity of Durvalumab
Percentage of patients who develop ADA for durvalumab
Immunogenicity of Pertuzumab
Percentage of patients who develop ADA for pertuzumab

Full Information

First Posted
August 31, 2020
Last Updated
September 4, 2023
Sponsor
AstraZeneca
Collaborators
Daiichi Sankyo Company, Limited
search

1. Study Identification

Unique Protocol Identification Number
NCT04538742
Brief Title
A Phase 1b/2 Study of T-DXd Combinations in HER2-positive Metastatic Breast Cancer
Acronym
DB-07
Official Title
A Phase 1b/2 Multicentre, Open-label, Modular, Dose-finding and Dose-expansion Study to Explore the Safety, Tolerability, and Anti-tumour Activity of Trastuzumab Deruxtecan (T-DXd) in Combination With Other Anti-cancer Agents in Patients With HER2-positive Metastatic Breast Cancer (DESTINY-Breast07)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
December 28, 2020 (Actual)
Primary Completion Date
January 31, 2025 (Anticipated)
Study Completion Date
July 2, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AstraZeneca
Collaborators
Daiichi Sankyo Company, Limited

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
DESTINY-Breast07 will investigate the safety, tolerability, and anti-tumour activity of trastuzumab deruxtecan (T-DXd) in combination with other anti-cancer agents in patients with HER2-positive Metastatic Breast Cancer
Detailed Description
This study is modular in design allowing assessment of safety, tolerability and anti-tumour activity of T-DXd in combination with other anti-cancer agents. Combination-treatment modules will have 2 parts: a dose-finding phase (Part 1), and a dose expansion phase (Part 2); the recommended Phase 2 dose (RP2D) determined in Part 1 will be used for the dose-expansion in Part 2. The target population of interest in this study is patients with HER2-positive (as per ASCO/CAP 2018 guidelines) advanced/MBC inclusive of patients with active and stable brain metastases. Part 1 of each module will enroll patients with locally assessed HER2-positive advanced/MBC in second-line or later patients. Part 2 of each module will enroll patients with locally assessed HER2-positive breast cancer who have not received prior treatment for advanced/metastatic disease.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Breast Cancer
Keywords
Breast Cancer, HER2-positive, Brain Metastases, Trastuzumab Deruxtecan, T-DXd, DS-8201a, DESTINY-Breast07, Anti-HER2 Antibody Drug Conjugate (ADC)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Sequential Assignment
Model Description
The study will consist of 2 phases: a dose escalation phase (Part 1) and a dose expansion phase (Part 2). Part 1 of each module will enroll patients with locally assessed HER2-positive advanced/MBC in second-line or later.Part 2 of each module will enroll patients with locally assessed HER2-positive breast cancer who have not received prior treatment for advanced/metastatic disease.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
245 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Module 1- T-DXd and Durvalumab
Arm Type
Experimental
Arm Description
T-DXd and Durvalumab
Arm Title
Module 2- T-DXd and Pertuzumab
Arm Type
Experimental
Arm Description
T-DXd and Pertuzumab
Arm Title
Module 3- T-DXd and Paclitaxel
Arm Type
Experimental
Arm Description
T-DXd and Paclitaxel
Arm Title
Module 4- T-DXd and Durvalumab and Paclitaxel
Arm Type
Experimental
Arm Description
T-DXd and Durvalumab and Paclitaxel
Arm Title
Module 0- T-DXd
Arm Type
Experimental
Arm Description
T-DXd
Arm Title
Module 5 - T-DXd and Tucatanib
Arm Type
Experimental
Arm Description
T-DXd and tucatinib
Arm Title
Module 6 - T-DXd and Tucatinib
Arm Type
Experimental
Arm Description
T-DXd and tucatinib in patients with active brain metastases (Part 2 Only)
Arm Title
Module 7 - T-DXd
Arm Type
Experimental
Arm Description
T-DXd monotherapy in patients with active brain metastases (Part 2 Only)
Intervention Type
Drug
Intervention Name(s)
Trastuzumab deruxtecan
Other Intervention Name(s)
DS-8201a, T-DXd
Intervention Description
T-DXd: administered as an IV infusion
Intervention Type
Drug
Intervention Name(s)
Durvalumab
Other Intervention Name(s)
MEDI4736
Intervention Description
Durvalumab: administered as an IV infusion
Intervention Type
Drug
Intervention Name(s)
Paclitaxel
Intervention Description
Paclitaxel: administered as an IV infusion
Intervention Type
Drug
Intervention Name(s)
Pertuzumab
Intervention Description
Pertuzumab: administered as an IV infusion
Intervention Type
Drug
Intervention Name(s)
Tucatinib
Other Intervention Name(s)
ONT-380
Intervention Description
Tucatinib administered orally (tablet) twice daily
Primary Outcome Measure Information:
Title
Occurrence of adverse events (AEs)- Part 1
Description
Occurrence of AEs in Part 1 graded according to NCI CTCAE v5.0
Time Frame
Up to follow-up period, approximately 53 months
Title
Occurrence of serious adverse events (SAEs)- Part 1
Description
Occurrence of SAEs in Part 1 graded according to NCI CTCAE v5.0
Time Frame
Up to follow-up period, approximately 53 months
Title
Occurrence of adverse events (AEs)- Part 2
Description
Occurrence of AEs in Part 2 graded according to NCI CTCAE v5.0
Time Frame
Up to follow-up period, approximately 53 months
Title
Occurrence of serious adverse events (SAEs)- Part 2
Description
Occurrence of SAEs in Part 2 graded according to NCI CTCAE v5.0
Time Frame
Up to follow-up period, approximately 53 months
Secondary Outcome Measure Information:
Title
Objective Response Rate (ORR)- Part 1 and Part 2
Description
ORR is defined as the proportion of patients who have a CR or PR, as determined by the Investigator at local site per RECIST 1.1.
Time Frame
Until progression, assessed up to approximately 53 months
Title
Progression Free Survival (PFS)- Part 1 and Part 2
Description
PFS is defined as time from the date of randomization until the date of progression as assessed by the Investigator at local site per RECIST 1.1, or death due to any cause.
Time Frame
Until progression, assessed up to approximately 53 months
Title
Progression Free Survival 2 (PFS2)- Part 2
Description
PFS2 is defined as time from the date of randomisation until the date of progression on next line treatment (the earliest of the progression event subsequent to first subsequent anticancer therapy) or death; second progression will be defined according to local standard clinical practice.
Time Frame
Assessed up to approximately 53 months
Title
Duration of Response (DoR)- Part 2
Description
DoR is defined as time from the date of first documented response until the date of documented progression or death in the absence of disease progression.
Time Frame
Until progression, assessed up to approximately 53 months
Title
Overall Survival (OS)- Part 2
Description
OS is defined as time from the date of randomisation until the date of death due to any cause.
Time Frame
Until death, assessed up to approximately 53 months
Title
Serum Concentration of Trastuzumab Deruxtecan (T-DXd)
Description
Determination of trastuzumab deruxtecan concentration in serum at different time points after trastuzumab deruxtecan administration
Time Frame
While on study drug up to study completion, approximately 53 months
Title
Serum Concentration of Durvalumab
Description
Determination of durvalumab concentration in serum at different time points after administration
Time Frame
While on study drug up to study completion, approximately 53 months
Title
Serum Concentration of Pertuzumab
Description
Determination of pertuzumab concentration in serum at different time points after administration
Time Frame
While on study drug up to study completion, approximately 53 months
Title
Plasma Concentration of Paclitaxel
Description
Determination of paclitaxel concentration in plasma at different time points after administration
Time Frame
While on study drug up to study completion, approximately 53 months
Title
Plasma Concentration of Tucatinib
Description
Determination of tucatinib concentration in plasma at different time points after administration
Time Frame
While on study drug up to study completion, approximately 53 months
Title
Immunogenicity of trastuzumab deruxtecan
Description
Percentage of patients who develop ADA for trastuzumab deruxtecan
Time Frame
Up to follow-up period, approximately 53 months
Title
Immunogenicity of Durvalumab
Description
Percentage of patients who develop ADA for durvalumab
Time Frame
Up to follow-up period, approximately 53 months
Title
Immunogenicity of Pertuzumab
Description
Percentage of patients who develop ADA for pertuzumab
Time Frame
Up to follow-up period, approximately 53 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria: Patients must be at least 18 years of age Pathologically documented breast cancer that: Is advanced/unresectable (patients that can be treated with curative intent are not eligible) or metastatic HER2-positive (IHC 3+ or IHC 2+/ISH+) based on local assessment. The local HER2 result must be from a tumour sample obtained in the metastatic setting. Is documented as hormone receptor-positive (estrogen or progesterone receptor) or negative in the metastatic setting Patient must have adequate tumor sample from the metastatic setting for biomarker assessment ECOG Performance Status of 0 or 1 Part 1 Disease progression on or after the last systemic therapy prior to starting study treatment At least 1 prior treatment line in metastatic setting required. Part 2 (Modules 0 - 5) a) No prior lines of therapy for advanced/MBC allowed Part 2 (Module 6 and 7) a) Zero or one prior lines of therapy for advanced/MBC allowed CNS Inclusion Modules 0 - 5 Patients must have no brain metastases or stable brain metastases. Module 6 and 7 Patients must have untreated brain metastases not needing local therapy or previously treated brain metastases that have progressed since prior local therapy Key Exclusion Criteria: Uncontrolled or significant cardiovascular disease Active or prior documented (non-infectious) ILD/pneumonitis that required steroids, or suspected ILD/pneumonitis that cannot be ruled out by imaging at screening Lung-specific intercurrent clinically significant illnesses Uncontrolled infection requiring IV antibiotics, antivirals, or antifungals Spinal cord compression or a history of leptomeningeal carcinomatosis Prior treatment with immune checkpoint inhibitors Prior treatment with an ADC containing a topoisomerase I inhibitor Prior treatment with tucatinib CNS Exclusion Modules 0 - 5: Has untreated brain metastasis Module 6 and 7: Ongoing use of systemic corticosteroids for control of symptoms of brain metastases at a total daily dose of > 2 mg dexamethasone or any brain lesion thought to require immediate local therapy
Facility Information:
Facility Name
Research Site
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33901
Country
United States
Facility Name
Research Site
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33705
Country
United States
Facility Name
Research Site
City
Commack
State/Province
New York
ZIP/Postal Code
11725
Country
United States
Facility Name
Research Site
City
Harrison
State/Province
New York
ZIP/Postal Code
10604
Country
United States
Facility Name
Research Site
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Research Site
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
Research Site
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43219
Country
United States
Facility Name
Research Site
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Research Site
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Facility Name
Research Site
City
Fairfax
State/Province
Virginia
ZIP/Postal Code
22031
Country
United States
Facility Name
Research Site
City
Melbourne
ZIP/Postal Code
3000
Country
Australia
Facility Name
Research Site
City
Barretos
ZIP/Postal Code
14784-400
Country
Brazil
Facility Name
Research Site
City
Belo Horizonte
ZIP/Postal Code
30150-270
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
01317-001
Country
Brazil
Facility Name
Research Site
City
Sao Paulo
ZIP/Postal Code
04029-000
Country
Brazil
Facility Name
Research Site
City
Sorocaba
ZIP/Postal Code
18030-005
Country
Brazil
Facility Name
Research Site
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2X 0A9
Country
Canada
Facility Name
Research Site
City
Quebec
ZIP/Postal Code
G1S 4L8
Country
Canada
Facility Name
Research Site
City
Toronto
ZIP/Postal Code
M5G 2M9
Country
Canada
Facility Name
Research Site
City
Villejuif Cedex
ZIP/Postal Code
94805
Country
France
Facility Name
Research Site
City
München
ZIP/Postal Code
81675
Country
Germany
Facility Name
Research Site
City
Würzburg
ZIP/Postal Code
97080
Country
Germany
Facility Name
Research Site
City
Delhi
ZIP/Postal Code
110085
Country
India
Facility Name
Research Site
City
Gurgaon
ZIP/Postal Code
122001
Country
India
Facility Name
Research Site
City
Madurai
ZIP/Postal Code
625107
Country
India
Facility Name
Research Site
City
Mumbai
ZIP/Postal Code
400012
Country
India
Facility Name
Research Site
City
Bologna
ZIP/Postal Code
40138
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
Rome
ZIP/Postal Code
168
Country
Italy
Facility Name
Research Site
City
Busan-si
ZIP/Postal Code
602-739
Country
Korea, Republic of
Facility Name
Research Site
City
Seoul
ZIP/Postal Code
02841
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
05505
Country
Korea, Republic of
Facility Name
Research Site
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
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
Lublin
ZIP/Postal Code
20-090
Country
Poland
Facility Name
Research Site
City
Łódź
ZIP/Postal Code
90-242
Country
Poland
Facility Name
Research Site
City
Moscow
ZIP/Postal Code
105229
Country
Russian Federation
Facility Name
Research Site
City
Moscow
ZIP/Postal Code
109240
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
Moscow
ZIP/Postal Code
143423
Country
Russian Federation
Facility Name
Research Site
City
Saint Petersburg
ZIP/Postal Code
195271
Country
Russian Federation
Facility Name
Research Site
City
Sankt-Peterburg
ZIP/Postal Code
196603
Country
Russian Federation
Facility Name
Research Site
City
Sankt-Peterburg
ZIP/Postal Code
197758
Country
Russian Federation
Facility Name
Research Site
City
Barcelona
ZIP/Postal Code
08003
Country
Spain
Facility Name
Research Site
City
L'Hospitalet de Llobregat
ZIP/Postal Code
08908
Country
Spain
Facility Name
Research Site
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Facility Name
Research Site
City
Madrid
ZIP/Postal Code
28050
Country
Spain
Facility Name
Research Site
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Facility Name
Research Site
City
Hualien
ZIP/Postal Code
970
Country
Taiwan
Facility Name
Research Site
City
Tainan
ZIP/Postal Code
704
Country
Taiwan
Facility Name
Research Site
City
Taipei City
ZIP/Postal Code
114
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
Taoyuan City
ZIP/Postal Code
333
Country
Taiwan
Facility Name
Research Site
City
Ankara
ZIP/Postal Code
6100
Country
Turkey
Facility Name
Research Site
City
Edirne
ZIP/Postal Code
22030
Country
Turkey
Facility Name
Research Site
City
Istanbul
ZIP/Postal Code
34662
Country
Turkey
Facility Name
Research Site
City
Istanbul
ZIP/Postal Code
34722
Country
Turkey
Facility Name
Research Site
City
Izmir
ZIP/Postal Code
35100
Country
Turkey
Facility Name
Research Site
City
Buckhurst Hill
ZIP/Postal Code
IG9 5HX
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. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
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 deidentified 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
Related Info

Learn more about this trial

A Phase 1b/2 Study of T-DXd Combinations in HER2-positive Metastatic Breast Cancer

We'll reach out to this number within 24 hrs