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A Study of Novel Anti-cancer Agents in Patients With Metastatic Triple Negative Breast Cancer (BEGONIA)

Primary Purpose

Triple Negative Breast Neoplasms

Status
Recruiting
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
Durvalumab
Capivasertib
Oleclumab
Paclitaxel
Trastuzumab deruxtecan
Datopotamab deruxtecan
Sponsored by
AstraZeneca
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Triple Negative Breast Neoplasms focused on measuring Breast Cancer, TNBC, Triple Negative, Triple Negative Breast Cancer, Triple-Negative Breast Cancer, Triple-Negative Breast Neoplasm, ER-Negative PR-Negative HER2-Negative Breast Cancer, ER-Negative PR-Negative HER2-Negative Breast Neoplasms, PD-L1 high TNBC

Eligibility Criteria

18 Years - 130 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion criteria

  1. Female
  2. At least 18 years of age at the time of screening
  3. Patient must have locally confirmed advanced/unresectable or metastatic TNBC.
  4. No prior treatment for metastatic (Stage IV) TNBC
  5. Patient must have at least 1 lesion, not previously irradiated, that can be accurately measured
  6. WHO/ECOG status at 0 or 1 at enrollment

Patients enrolled to Arm 6 (durvalumab and DS-8201a) Must provide documentation of locally determined advanced/unresectable or metastatic TNBC with HER2 low tumor expression (IHC 2+/ISH-, IHC 1+/ISH-, or IHC 1+/ISH untested)

Exclusion criteria

  1. History of allogeneic organ transplantation
  2. Active or prior documented autoimmune or inflammatory disorders
  3. Active infection including tuberculosis, hepatitis B (known positive HBV surface antigen [HBsAg] result), hepatitis C virus (HCV), or human immunodeficiency virus (positive HIV 1/2 antibodies)
  4. Untreated CNS metastases
  5. Known allergy or hypersensitivity to any of the study drugs or any of the study drug excipients
  6. Any concurrent chemotherapy, IP, or biologic therapy for cancer treatment
  7. Female patients who are pregnant, breastfeeding
  8. Cardiac Ejection Fraction less than 50%

Patients enrolled in Arm 2 only:

  1. Potent inhibitors or inducers or substrates of CYP3A4 or substrates of CYP2C9 or CYP2D6 within 2 weeks before the first dose of study treatment (3 weeks for St John's Wort)
  2. Diagnosis of diabetes mellitus Type I or diabetes mellitus Type II requiring insulin treatment.
  3. Any factors that increase the risk of QTc prolongation or risk of arrhythmic events, such as heart failure, hypokalemia, potential for torsades de pointes, congenital long QT syndrome, family history of long QT syndrome or unexplained sudden death under 40 years of age, or any concomitant medication known to prolong the QT interval
  4. Prior treatment with PI3K inhibitors, AKT inhibitors, or mammalian target of rapamycin (mTOR) inhibitors.

Patients enrolled in Arm 5 only: History of venous thromboembolism in the past 3 months

Patients enrolled in Arm 7 only: Clinically significant corneal disease in the opinion of the Investigator.

Patients enrolled in Arm 6 and 7 only:

  1. History of or active interstitial lung disease/pneumonitis
  2. Use of chloroquine or hydroxychloroquine in <14 days prior to Day 1 of DS-8201a (Arm 6) or Dato-DXd (DS-1062a; Arm 7) treatment
  3. Patients enrolled in Arm 6 only: Previously been diagnosed as HER2+ or received HER2-targeted therapy.

Sites / Locations

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  • Research SiteRecruiting
  • Research Site
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  • Research Site
  • Research SiteRecruiting
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  • Research SiteRecruiting
  • Research SiteRecruiting
  • Research SiteRecruiting
  • Research Site
  • Research Site
  • Research Site
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  • Research Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Arm 1

Arm 2

Arm 5

Arm 6

Arm 7

Arm 8

Arm Description

durvalumab + paclitaxel

durvalumab + paclitaxel + capivasertib

durvalumab + paclitaxel + oleclumab

durvalumab + trastuzumab deruxtecan

durvalumab + datopotamab deruxtecan

durvalumab + datopotomab deruxtecan (patients with PD-L1 positive status)

Outcomes

Primary Outcome Measures

Incidence of adverse events
Part 1: Assessment of safety and tolerability of each treatment arm Part 2: Endpoints based on Investigator assessment according to RECIST 1.1: ORR (objective response rate): The percentage of evaluable patients with a confirmed Investigator-assessed visit response of CR (complete response) or PR (partial response).
Laboratory findings
Assessment of safety and tolerability of each treatment arm

Secondary Outcome Measures

Objective response rate (ORR)
Assessment of the efficacy of each treatment arm according to RECIST 1.1. ORR: The percentage of evaluable patients with a confirmed Investigator-assessed response of CR (complete response) or PR (partial response) Applicable for Part 1 and Part 2.
Progression-free survival (PFS).
Assessment of the efficacy of each treatment arm according to RECIST 1.1. PFS: Time from date of first dose until the date of objective radiological disease progression or death (by any cause in the absence of progression) Applicable for Part 1 and Part 2
Duration of response (DoR)
Assessment of the efficacy of each treatment arm according to RECIST 1.1. DoR: Time from date of first detection of objective response (which is subsequently confirmed) until the date of objective radiological disease progression Applicable for Part 1 and Part 2
Overall survival (OS)
OS: Time from date of first dose until the date of death by any cause Applicable for Part 1 and Part 2
Serum concentration of durvalumab and serum or plasma concentration of novel oncology therapies
Assessment of pharmacokinetics (PK) Applicable for Part 1 (Arms 1-8) and for Part 2 (Arm 7)
Presence of anti-drug antibodies (ADAs) for durvalumab and applicable novel oncology therapies
Investigation of the immunogenicity of durvalumab and novel oncology therapies in all applicable treatment arms Applicable for Part 1 (Arms 1-8) and for Part 2 (Arm 7)
Progression-free survival (PFS 6)
PFS at 6 months following date of first dose Applicable for Part 2

Full Information

First Posted
October 25, 2018
Last Updated
September 14, 2023
Sponsor
AstraZeneca
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1. Study Identification

Unique Protocol Identification Number
NCT03742102
Brief Title
A Study of Novel Anti-cancer Agents in Patients With Metastatic Triple Negative Breast Cancer
Acronym
BEGONIA
Official Title
A Phase IB/II, 2-stage, Open-label, Multicenter Study to Determine the Efficacy and Safety of Durvalumab (MEDI4736) + Paclitaxel and Durvalumab (MEDI4736) in Combination With Novel Oncology Therapies With or Without Paclitaxel for First-line Metastatic Triple Negative Breast Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 21, 2018 (Actual)
Primary Completion Date
August 15, 2024 (Anticipated)
Study Completion Date
August 15, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AstraZeneca

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
This study is designed to determine the efficacy and safety of durvalumab in combination with novel oncology therapies with or without paclitaxel and durvalumab + paclitaxel for first-line metastatic triple negative breast cancer
Detailed Description
This is a Phase IB/II, 2-stage, open-label, multicenter study to determine the efficacy and safety of durvalumab in combination with novel oncology therapies (i.e. therapies designed for immune modulation) with or without paclitaxel and durvalumab + paclitaxel as first-line treatment in patients with metastatic triple negative breast cancer (TNBC). The study is designed to concurrently evaluate potential novel treatment combinations with clinical promise using a 2-stage approach. The study will use a Simon 2-Stage design to evaluate which cohorts may proceed to expansion. Part 1 is a Phase IB study of safety and initial efficacy, and Part 2 may expand patient enrollment if adequate efficacy signal is observed in Part 1. The treatment regimens evaluated in Part 2 will depend on the evaluation of safety and efficacy outcomes in Part 1.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Triple Negative Breast Neoplasms
Keywords
Breast Cancer, TNBC, Triple Negative, Triple Negative Breast Cancer, Triple-Negative Breast Cancer, Triple-Negative Breast Neoplasm, ER-Negative PR-Negative HER2-Negative Breast Cancer, ER-Negative PR-Negative HER2-Negative Breast Neoplasms, PD-L1 high TNBC

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Part 1: At least 20 patients in the durvalumab-paclitaxel arm and at least 30 patients in each of the other novel treatment combination arms will be enrolled, for a total of approximately 140 patients (durvalumab + paclitaxel arm and 4 novel treatment combination arms). Additional patients may be enrolled in order to have 20 or 30 evaluable (i.e. dosed) patients per durvalumab - paclitaxel arm or novel treatment combination arm, respectively. Part 2: Approximately 27 patients will be assigned to each treatment arm, for an anticipated total of 57 response-evaluable patients per arm (ie, 30 patients in Part 1 and 27 patients in Part 2 per treatment arm, with the exception of Arm 1, which will enroll 20 patients in Part 1 and will not be expanded to Part 2). Patient expansion from 30 patients in Part 1 to an additional 27 patients from Part 2 will be determined based on a futility analysis utilizing a Simon 2 Stage design.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
240 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Arm 1
Arm Type
Experimental
Arm Description
durvalumab + paclitaxel
Arm Title
Arm 2
Arm Type
Experimental
Arm Description
durvalumab + paclitaxel + capivasertib
Arm Title
Arm 5
Arm Type
Experimental
Arm Description
durvalumab + paclitaxel + oleclumab
Arm Title
Arm 6
Arm Type
Experimental
Arm Description
durvalumab + trastuzumab deruxtecan
Arm Title
Arm 7
Arm Type
Experimental
Arm Description
durvalumab + datopotamab deruxtecan
Arm Title
Arm 8
Arm Type
Experimental
Arm Description
durvalumab + datopotomab deruxtecan (patients with PD-L1 positive status)
Intervention Type
Drug
Intervention Name(s)
Durvalumab
Other Intervention Name(s)
MEDI4736
Intervention Description
Durvalumab iv Every 4 weeks (q4w) or 3 weeks (q3w) Arm 6, 7 and 8
Intervention Type
Drug
Intervention Name(s)
Capivasertib
Other Intervention Name(s)
AZD5363
Intervention Description
Capivasertib oral bid 4-week cycles; 3 weeks on (dosing on days 2,3,4 and 5) and 1 week off
Intervention Type
Drug
Intervention Name(s)
Oleclumab
Other Intervention Name(s)
MEDI9447
Intervention Description
Oleclumab iv Every 2 weeks (q2w) for first 2 cycles (days 1 and 15 in cycles 1 and 2), then every 4 weeks (q4w) starting at cycle 3 day 1
Intervention Type
Drug
Intervention Name(s)
Paclitaxel
Intervention Description
Paclitaxel iv 4-week cycles: 3 weeks once weekly (q1w) and 1 week off
Intervention Type
Drug
Intervention Name(s)
Trastuzumab deruxtecan
Other Intervention Name(s)
DS-8201a
Intervention Description
Trastuzumab deruxtecan iv 3-week cycles (once weekly) q3w
Intervention Type
Drug
Intervention Name(s)
Datopotamab deruxtecan
Other Intervention Name(s)
Dato-DXd; DS-1062a
Intervention Description
Datopotamab deruxtecan iv 3-week cycles (once weekly) q3w
Primary Outcome Measure Information:
Title
Incidence of adverse events
Description
Part 1: Assessment of safety and tolerability of each treatment arm Part 2: Endpoints based on Investigator assessment according to RECIST 1.1: ORR (objective response rate): The percentage of evaluable patients with a confirmed Investigator-assessed visit response of CR (complete response) or PR (partial response).
Time Frame
Part1: From informed consent until the safety follow-up visit 3 months after the last dose of study drug. Part 2: From informed consent until the safety follow-up visit 3 months after the last dose of study drug.
Title
Laboratory findings
Description
Assessment of safety and tolerability of each treatment arm
Time Frame
Part 1: From informed consent until the safety follow-up visit 3 months after the last dose of study drug. Part 2:From informed consent until the safety follow-up visit 3 months after the last dose of study drug.
Secondary Outcome Measure Information:
Title
Objective response rate (ORR)
Description
Assessment of the efficacy of each treatment arm according to RECIST 1.1. ORR: The percentage of evaluable patients with a confirmed Investigator-assessed response of CR (complete response) or PR (partial response) Applicable for Part 1 and Part 2.
Time Frame
Approx. 30 months
Title
Progression-free survival (PFS).
Description
Assessment of the efficacy of each treatment arm according to RECIST 1.1. PFS: Time from date of first dose until the date of objective radiological disease progression or death (by any cause in the absence of progression) Applicable for Part 1 and Part 2
Time Frame
On-study tumor assessments occur every 8 weeks (Arms 1-5),every 6 weeks (Arms 6-8) until week 48 and then every 12 weeks thereafter until radiological progression, death, withdrawal of consent or study completion up to approx. 30 months
Title
Duration of response (DoR)
Description
Assessment of the efficacy of each treatment arm according to RECIST 1.1. DoR: Time from date of first detection of objective response (which is subsequently confirmed) until the date of objective radiological disease progression Applicable for Part 1 and Part 2
Time Frame
On-study tumor assessments occur every 8 weeks (Arms 1-5), every 6 weeks (Arms 6-8) until week 48 and then every 12 weeks thereafter until radiological progression, death, withdrawal of consent or study completion up to approx. 30 months
Title
Overall survival (OS)
Description
OS: Time from date of first dose until the date of death by any cause Applicable for Part 1 and Part 2
Time Frame
Approx. 30 months
Title
Serum concentration of durvalumab and serum or plasma concentration of novel oncology therapies
Description
Assessment of pharmacokinetics (PK) Applicable for Part 1 (Arms 1-8) and for Part 2 (Arm 7)
Time Frame
From cycle 1 day 1 until cycle 7 day 1 (Arms 1-5), from cycle 1 day 1 until cycle 8 day 1 (Arms 6-8) (each cycle is 28 days) and every 12 weeks thereafter until study completion approx. 30 months
Title
Presence of anti-drug antibodies (ADAs) for durvalumab and applicable novel oncology therapies
Description
Investigation of the immunogenicity of durvalumab and novel oncology therapies in all applicable treatment arms Applicable for Part 1 (Arms 1-8) and for Part 2 (Arm 7)
Time Frame
From cycle 1 day 1 until cycle 7 day 1 (Arms 1-5), from cycle 1 day 1 until cycle 8 day 1 (Arms 6-8) (each cycle is 28 days) and every 12 weeks thereafter until study completion approx. 30 months
Title
Progression-free survival (PFS 6)
Description
PFS at 6 months following date of first dose Applicable for Part 2
Time Frame
On-study tumor assessments occur every 8 weeks until week 48 (Arms 1-5), every 6 weeks until week 48 (Arms 6-8) and then every 12 weeks thereafter until radiological progression, death, withdrawal of consent or study completion up to approx. 30 months

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
130 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria Female At least 18 years of age at the time of screening Patient must have locally confirmed advanced/unresectable or metastatic TNBC. No prior treatment for metastatic (Stage IV) TNBC Patient must have at least 1 lesion, not previously irradiated, that can be accurately measured WHO/ECOG status at 0 or 1 at enrollment Patients enrolled to Arm 6 (durvalumab and DS-8201a) Must provide documentation of locally determined advanced/unresectable or metastatic TNBC with HER2 low tumor expression (IHC 2+/ISH-, IHC 1+/ISH-, or IHC 1+/ISH untested) Patients enrolled in Arm 8 (durvalumab + Dato-DXd) Must have PD-L1 positive tumor as determined by an IHC based assay Exclusion criteria History of allogeneic organ transplantation Active or prior documented autoimmune or inflammatory disorders Active infection including tuberculosis, hepatitis B (known positive HBV surface antigen [HBsAg] result), hepatitis C virus (HCV), or human immunodeficiency virus (positive HIV 1/2 antibodies) Untreated CNS metastases Known allergy or hypersensitivity to any of the study drugs or any of the study drug excipients Any concurrent chemotherapy, IP, or biologic therapy for cancer treatment Female patients who are pregnant, breastfeeding Cardiac Ejection Fraction less than 50% Patients enrolled in Arm 2 only: Potent inhibitors or inducers or substrates of CYP3A4 or substrates of CYP2C9 or CYP2D6 within 2 weeks before the first dose of study treatment (3 weeks for St John's Wort) Diagnosis of diabetes mellitus Type I or diabetes mellitus Type II requiring insulin treatment. Any factors that increase the risk of QTc prolongation or risk of arrhythmic events, such as heart failure, hypokalemia, potential for torsades de pointes, congenital long QT syndrome, family history of long QT syndrome or unexplained sudden death under 40 years of age, or any concomitant medication known to prolong the QT interval Prior treatment with PI3K inhibitors, AKT inhibitors, or mammalian target of rapamycin (mTOR) inhibitors. Patients enrolled in Arm 5 only: History of venous thromboembolism in the past 3 months Patients enrolled in Arm 7 and 8 only: Clinically significant corneal disease in the opinion of the Investigator. Patients enrolled in Arm 6, 7 and 8 only: History of or active interstitial lung disease/pneumonitis Use of chloroquine or hydroxychloroquine in <14 days prior to Day 1 of DS-8201a (Arm 6) or Dato-DXd (DS-1062a; Arm 7 and 8) treatment Patients enrolled in Arm 6 only: Previously been diagnosed as HER2+ or received HER2-targeted therapy.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
AstraZeneca Clinical Study Information Center
Phone
1-877-240-9479
Email
information.center@astrazeneca.com
First Name & Middle Initial & Last Name or Official Title & Degree
AZ Breast Cancer Study Navigators AZ Breast Cancer Study Navigators
Phone
+1-877-400-4656
Email
AstraZeneca@CareboxHealth.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter Schmid, MD, PhD
Organizational Affiliation
Barts Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Research Site
City
Goodyear
State/Province
Arizona
ZIP/Postal Code
85395
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85715
Country
United States
Individual Site Status
Terminated
Facility Name
Research Site
City
West Hollywood
State/Province
California
ZIP/Postal Code
90048
Country
United States
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Columbia
State/Province
Maryland
ZIP/Postal Code
21044
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49503
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Saint Paul
State/Province
Minnesota
ZIP/Postal Code
55102
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89128
Country
United States
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Eugene
State/Province
Oregon
ZIP/Postal Code
97401
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19124
Country
United States
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Flower Mound
State/Province
Texas
ZIP/Postal Code
75028
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Withdrawn
Facility Name
Research Site
City
McAllen
State/Province
Texas
ZIP/Postal Code
78503
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78240
Country
United States
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Fairfax
State/Province
Virginia
ZIP/Postal Code
22031
Country
United States
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Williamsburg
State/Province
Virginia
ZIP/Postal Code
23188
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Kelowna
State/Province
British Columbia
ZIP/Postal Code
V1Y 5L3
Country
Canada
Individual Site Status
Terminated
Facility Name
Research Site
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5W9
Country
Canada
Individual Site Status
Active, not recruiting
Facility Name
Research Site
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Greenfield Park
State/Province
Quebec
ZIP/Postal Code
J4V 2H1
Country
Canada
Individual Site Status
Active, not recruiting
Facility Name
Research Site
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H4A 3J1
Country
Canada
Individual Site Status
Recruiting
Facility Name
Research Site
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Research Site
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Research Site
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Research Site
City
Gdańsk
ZIP/Postal Code
80-214
Country
Poland
Individual Site Status
Active, not recruiting
Facility Name
Research Site
City
Gliwice
ZIP/Postal Code
44-101
Country
Poland
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Kraków
ZIP/Postal Code
30-688
Country
Poland
Individual Site Status
Active, not recruiting
Facility Name
Research Site
City
Lublin
ZIP/Postal Code
20-090
Country
Poland
Individual Site Status
Active, not recruiting
Facility Name
Research Site
City
Opole
ZIP/Postal Code
45-060
Country
Poland
Individual Site Status
Recruiting
Facility Name
Research Site
City
Poznań
ZIP/Postal Code
61-848
Country
Poland
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Rzeszów
ZIP/Postal Code
35-021
Country
Poland
Individual Site Status
Active, not recruiting
Facility Name
Research Site
City
Warszawa
ZIP/Postal Code
02-781
Country
Poland
Individual Site Status
Active, not recruiting
Facility Name
Research Site
City
Warszawa
ZIP/Postal Code
04-141
Country
Poland
Individual Site Status
Active, not recruiting
Facility Name
Research Site
City
Kaohsiung
ZIP/Postal Code
80756
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Taichung
ZIP/Postal Code
40447
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Tainan City
ZIP/Postal Code
70403
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Taipei
ZIP/Postal Code
10002
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Taipei
ZIP/Postal Code
112
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Taoyuan
ZIP/Postal Code
333
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Cambridge
ZIP/Postal Code
CB2 0QQ
Country
United Kingdom
Individual Site Status
Active, not recruiting
Facility Name
Research Site
City
London
ZIP/Postal Code
EC1M 6BQ
Country
United Kingdom
Individual Site Status
Active, not recruiting
Facility Name
Research Site
City
London
ZIP/Postal Code
W1T 7HA
Country
United Kingdom
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Manchester
ZIP/Postal Code
M20 4BX
Country
United Kingdom
Individual Site Status
Active, not recruiting
Facility Name
Research Site
City
Oxford
ZIP/Postal Code
OX3 7LE
Country
United Kingdom
Individual Site Status
Active, not recruiting

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
https://breastcancerstudylocator.com/
Description
https://breastcancerstudylocator.com/

Learn more about this trial

A Study of Novel Anti-cancer Agents in Patients With Metastatic Triple Negative Breast Cancer

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