Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 82 of 961 for:    bone tumors AND NOT metastatic | Recruiting, Not yet recruiting, Available Studies

Lynparza Breast Cancer Clinical Experience Investigation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03590938
Recruitment Status : Recruiting
First Posted : July 18, 2018
Last Update Posted : March 14, 2019
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

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

Condition or disease
Breast Cancer

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.

Layout table for study information
Study Type : Observational
Estimated Enrollment : 150 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Actual Study Start Date : August 14, 2018
Estimated Primary Completion Date : December 28, 2021
Estimated Study Completion Date : December 28, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
Drug Information available for: Olaparib




Primary Outcome Measures :
  1. Adverse drug reactions of bone marrow depression [ Time Frame: One year period ]
    Bone marrow depression will be investigated as safety specification topics



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-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.
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03590938


Contacts
Layout table for location contacts
Contact: AstraZeneca Clinical Study Information Center 1-877-240-9479 information.center@astrazeneca.com

Locations
Layout table for location information
Japan
Research Site Recruiting
Aichi, Japan
Research Site Active, not recruiting
Aichi, Japan
Research Site Recruiting
Aomori, Japan
Research Site Recruiting
Chiba, Japan
Research Site Recruiting
Ehime, Japan
Research Site Recruiting
Fukui, Japan
Research Site Recruiting
Fukuoka, Japan
Research Site Recruiting
Gunma, Japan
Research Site Recruiting
Hiroshima, Japan
Research Site Recruiting
Hokkaido, Japan
Research Site Withdrawn
Hyogo, Japan
Research Site Recruiting
Hyogo, Japan
Research Site Not yet recruiting
Ibaraki, Japan
Research Site Recruiting
Ishikawa, Japan
Research Site Withdrawn
Iwate, Japan
Research Site Recruiting
Kagoshima, Japan
Research Site Recruiting
Kanagawa, Japan
Research Site Not yet recruiting
Kanagawa, Japan
Research Site Recruiting
Kochi, Japan
Research Site Recruiting
Kumamoto, Japan
Research Site Recruiting
Kyoto, Japan
Research Site Recruiting
Miyagi, Japan
Research Site Not yet recruiting
Nara, Japan
Research Site Recruiting
Okayama, Japan
Research Site Recruiting
Okinawa, Japan
Research Site Recruiting
Osaka, Japan
Research Site Active, not recruiting
Osaka, Japan
Research Site Withdrawn
Osaka, Japan
Research Site Not yet recruiting
Osaka, Japan
Research Site Recruiting
Saitama, Japan
Research Site Not yet recruiting
Saitama, Japan
Research Site Not yet recruiting
Shiga, Japan
Research Site Recruiting
Shimane, Japan
Research Site Recruiting
Shizuoka, Japan
Research Site Recruiting
Tokyo, Japan
Research Site Not yet recruiting
Tokyo, Japan
Research Site Recruiting
Toyama, Japan
Research Site Recruiting
Yamaguchi, Japan
Research Site Not yet recruiting
Yamaguchi, Japan
Research Site Recruiting
Yamanashi, Japan
Sponsors and Collaborators
AstraZeneca

Layout table for additonal information
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT03590938     History of Changes
Other Study ID Numbers: D0819C00005
First Posted: July 18, 2018    Key Record Dates
Last Update Posted: March 14, 2019
Last Verified: March 2019

Additional relevant MeSH terms:
Layout table for MeSH terms
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Olaparib
Poly(ADP-ribose) Polymerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents