NCT03590938

Brief Summary

To characterise the development of ADRs of bone marrow depression in patients under actual post-marketing use

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
111

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2018

Typical duration for all trials

Geographic Reach
1 country

31 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 27, 2018

Completed
21 days until next milestone

First Posted

Study publicly available on registry

July 18, 2018

Completed
27 days until next milestone

Study Start

First participant enrolled

August 14, 2018

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 24, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 24, 2022

Completed
Last Updated

March 17, 2023

Status Verified

March 1, 2023

Enrollment Period

3.6 years

First QC Date

June 27, 2018

Last Update Submit

March 15, 2023

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

  • Adverse drug reactions of bone marrow depression

    Bone marrow depression will be investigated as safety specification topics

    One year period

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Investigation sites mainly consisted of department of surgical related department (surgery, mammary gland surgery, and endocrine surgery, etc.) and department of internal medicine.

You may qualify if:

  • Unresectable or recurrent BRCA mutated HER2 negative breast cancer with prior anticancer chemotherapy

You may not qualify if:

  • The patients who are not started on Lymparza for the first time

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (31)

Research Site

Aichi, D0819C00005, Japan

Location

Research Site

Aomori, D0819C00005, Japan

Location

Research Site

Chiba, D0819C00005, Japan

Location

Research Site

Ehime, D0819C00005, Japan

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Research Site

Fukui, D0819C00005, Japan

Location

Research Site

Fukuoka, D0819C00005, Japan

Location

Research Site

Gunma, D0819C00005, Japan

Location

Research Site

Hiroshima, D0819C00005, Japan

Location

Research Site

Hokkaido, D0819C00005, Japan

Location

Research Site

Hyōgo, D0819C00005, Japan

Location

Research Site

Ibaraki, D0819C00005, Japan

Location

Research Site

Ishikawa, D0819C00005, Japan

Location

Research Site

Kagawa, D0819C00005, Japan

Location

Research Site

Kagoshima, D0819C00005, Japan

Location

Research Site

Kanagawa, D0819C00005, Japan

Location

Research Site

Kochi, D0819C00005, Japan

Location

Research Site

Kyoto, D0819C00005, Japan

Location

Research Site

Miyagi, D0819C00005, Japan

Location

Research Site

Nagano, D0819C00005, Japan

Location

Research Site

Nara, D0819C00005, Japan

Location

Research Site

Okayama, D0819C00005, Japan

Location

Research Site

Okinawa, D0819C00005, Japan

Location

Research Site

Osaka, D0819C00005, Japan

Location

Research Site

Saitama, D0819C00005, Japan

Location

Research Site

Shiga, D0819C00005, Japan

Location

Research Site

Shimane, D0819C00005, Japan

Location

Research Site

Shizuoka, D0819C00005, Japan

Location

Research Site

Tokyo, D0819C00005, Japan

Location

Research Site

Toyama, D0819C00005, Japan

Location

Research Site

Yamagata, D0819C00005, Japan

Location

Research Site

Yamaguchi, D0819C00005, Japan

Location

Related Links

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Toshimitsu Tokimoto

    AstraZeneca KK

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 27, 2018

First Posted

July 18, 2018

Study Start

August 14, 2018

Primary Completion

March 24, 2022

Study Completion

March 24, 2022

Last Updated

March 17, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will share

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.

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.
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.
More information

Locations

JP(31)