A Study Assessing Risk Factors for Oral Mucositis/Stomatitis and Ocular Surface Events in NSCLC and Breast Cancer

NCT ID: NCT06686602

Last Updated: 2025-03-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

13759 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-07-09

Study Completion Date

2025-03-18

Brief Summary

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This study will identify risk factors for oral mucositis/stomatitis and ocular surface events (OSE) in patients with advanced/metastatic non-small cell lung cancer (NSCLC) and advanced/metastatic human epidermal growth factor receptor 2 (HER2)-negative breast cancer.

Detailed Description

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It is important to identify risk factors for the onset of oral mucositis/stomatitis and OSE to identify high-risk patients who will be taking Dato-DXd. Understanding these risk factors in patients receiving standard-of-care anti-cancer therapies may also help with mitigation strategies. This objective will be achieved by identifying and describing patient demographics and clinical characteristics of cases with oral mucositis/stomatitis and OSE. No study drug will be provided or administered for this study.

Conditions

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Advanced/Metastatic NSCLC Advanced/Metastatic HER2-negative Breast Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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NSCLC

Adult patients diagnosed with advanced or metastatic (stage IIIB/IIIC or IV) non-small cell lung cancer (NSCLC).

No drug

Intervention Type OTHER

This is a non-interventional study and no study drug will be administered.

HER2-negative Breast Cancer

Adult patients diagnosed with advanced or metastatic (stage IIIB/IIIC or IV) human epidermal growth factor receptor 2 (HER2)-negative breast cancer.

No drug

Intervention Type OTHER

This is a non-interventional study and no study drug will be administered.

Interventions

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No drug

This is a non-interventional study and no study drug will be administered.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

Inclusion Criteria

1. The inclusion criteria for the NSCLC cohort consists of patients with advanced or metastatic (stage IIIB/IIIC or IV) NSCLC diagnosis between January 1, 2015 and December 31, 2023 who are at least 18 years old at the time of first diagnosis (cohort entry date) and treated with at least one line of therapy (LOT) for advanced/metastatic disease.
2. The inclusion criteria for the breast cancer cohort consists of female patients with advanced or metastatic (stage IIIB/IIIC and IV) HER2-negative BC diagnosis between January 1, 2012 and December 31, 2023 who are at least 18 years old at the time of first diagnosis (cohort entry date) and treated with at least one LOT for advanced/metastatic disease.

Exclusion Criteria

1\) The exclusion criteria for both cohorts consist of patients with other primary cancer type prior to the cohort entry date and patients who are pregnant 9 months (275 days) prior to, on, or after the cohort entry date.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Daiichi Sankyo

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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ConcertAI Database

Cambridge, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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DS1062-0008-NIS-EPI

Identifier Type: -

Identifier Source: org_study_id

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