Lynparza Breast Cancer Clinical Experience Investigation

An observational study of Breast Cancer, run by AstraZeneca at 31 sites in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

To characterise the development of ADRs of bone marrow depression in patients under actual post-marketing use Read more about this study

Who is it for?: Any age
Conditions the study is for: Breast Cancer
How many people: 111 participants
Where: 31 sitesJapan
Study dates: 14 Aug 2018to 24 Mar 2022
Phase: Observational
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages Any age
All sexes
No healthy volunteers
Child, Adult, Older adult

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.

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

31 sites in 1 country.

City, postcode or hospital

31 sites in 1 country

Japan31 sites

Research Site
Aichi, D0819C00005
Research Site
Aomori, D0819C00005
Research Site
Chiba, D0819C00005
Research Site
Ehime, D0819C00005
Research Site
Fukui, D0819C00005
Research Site
Fukuoka, D0819C00005
Research Site
Gunma, D0819C00005
Research Site
Hiroshima, D0819C00005
Research Site
Hokkaido, D0819C00005
Research Site
Hyōgo, D0819C00005
Research Site
Ibaraki, D0819C00005
Research Site
Ishikawa, D0819C00005
Research Site
Kagawa, D0819C00005
Research Site
Kagoshima, D0819C00005
Research Site
Kanagawa, D0819C00005
Research Site
Kochi, D0819C00005
Research Site
Kyoto, D0819C00005
Research Site
Miyagi, D0819C00005
Research Site
Nagano, D0819C00005
Research Site
Nara, D0819C00005
Research Site
Okayama, D0819C00005
Research Site
Okinawa, D0819C00005
Research Site
Osaka, D0819C00005
Research Site
Saitama, D0819C00005
Research Site
Shiga, D0819C00005
Research Site
Shimane, D0819C00005
Research Site
Shizuoka, D0819C00005
Research Site
Tokyo, D0819C00005
Research Site
Toyama, D0819C00005
Research Site
Yamagata, D0819C00005
Research Site
Yamaguchi, D0819C00005

Other trials in Japan

About this study

Official title: Lynparza Tablets 100mg, 150mg CEI, Investigation on Development of Bone Marrow Depression in Patients With Unresectable or Recurrent BRCA Mutated HER2 Negative Breast Cancer Who Have Previously Received Anticancer Chemotherapy

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

Read the detailed description

To characterise the development of adverse drug reactions (ADRs) of bone marrow depression in patients with unresectable or recurrent BRCA mutated HER2 negative breast cancer who have previously received anticancer chemotherapy under actual post-marketing use.

Conditions: Breast Cancer
Medical subject headings: Breast Neoplasms

What is being measured

The primary outcome is the main question the study is designed to answer.

Adverse drug reactions of bone marrow depression
Bone marrow depression will be investigated as safety specification topics
Measured: One year period

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

14 Aug 201824 Mar 2022

First posted18 Jul 2018
Study start14 Aug 2018
Primary completion24 Mar 2022
Study completion24 Mar 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Breast CancerStudies of the same condition, open and under way.
More trials run by AstraZenecaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 111 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03590938
Sponsor's protocol ID: D0819C00005
Status last verified: Mar 2023
First submitted: 27 Jun 2018
Last updated: 17 Mar 2023
Results posted: No
Individual data sharing: Yes: 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.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
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Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
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A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8

All Breast Cancer trials

Study at a glance

From the registry record, last updated by the sponsor on 17 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Lynparza Tablets 100mg, 150mg CEI, Investigation on Development of Bone Marrow Depression in Patients With Unresectable or Recurrent BRCA Mutated HER2 Negative Breast Cancer Who Have Previously Received Anticancer Chemotherapy
ClinicalTrials.gov ID: NCT03590938
Acronym / sponsor ID: D0819C00005
Conditions: Breast Cancer
Study type: Observational
Recruitment status: Completed
Enrolment: 111 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: 14 Aug 2018 (actual)
Primary completion: 24 Mar 2022 (actual)
Study completion: 24 Mar 2022 (actual)
First posted: 18 Jul 2018 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Detailed description

Study design

Observational model: Cohort
Time perspective: Prospective

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult
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.

Key inclusion criteria (1 listed)

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

Key exclusion criteria (1 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

Adverse drug reactions of bone marrow depression
Time frame: One year period
Bone marrow depression will be investigated as safety specification topics

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2023.
Related InfoLink provided by the sponsor.
Individual participant dataSharing planned: Yes. 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.

Related trials for Breast Cancer

Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Toshimitsu Tokimoto study director

AstraZeneca KK

31 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Breast Cancer, run by AstraZeneca at 31 sites in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 31 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Adverse drug reactions of bone marrow depression (time frame: One year period). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03590938.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2023.