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Study of Predictors of Clinical Outcomes in Patients With HR+ and HER2-low/Negative Breast Cancer

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ClinicalTrials.gov Identifier: NCT06040593
Recruitment Status : Completed
First Posted : September 15, 2023
Last Update Posted : February 26, 2024
Sponsor:
Information provided by (Responsible Party):
Daiichi Sankyo

Study Description
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Brief Summary:
There is a lack of data on clinical and patient factors that are associated with poor survival in patients with HR+ and HER2-low/negative breast cancer treated with neoadjuvant chemotherapy or endocrine therapy. This retrospective, non-interventional study is designed to assess the predictors of clinical outcomes in this patient population. No study drug will be provided as part of this study protocol.

Condition or disease Intervention/treatment
Hormone-receptor-positive Breast Cancer HER2-low Breast Cancer HER2-negative Breast Cancer Other: No drug

Detailed Description:

This retrospective, non-interventional study is designed to assess the following primary objectives:

  1. To identify predictors of event-free survival (EFS) in patients with HR+ and HER2-low/negative breast cancer treated with neoadjuvant chemotherapy or endocrine therapy, and
  2. To stratify patients according to event-free survival using different combinations of significant predictors and evaluate the patient characteristics and clinical outcomes such as EFS, overall survival and pathological complete response across patient groups of different risk level.
Study Design
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Study Type : Observational
Actual Enrollment : 927 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Identify Predictors of Clinical Outcomes in Real-world Patients With HR+ and HER2-low/Negative Breast Cancer Treated With Neoadjuvant Chemotherapy or Endocrine Therapy
Actual Study Start Date : July 31, 2023
Actual Primary Completion Date : November 30, 2023
Actual Study Completion Date : February 23, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Groups and Cohorts
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Group/Cohort Intervention/treatment
HR+/HER2-low Breast Cancer
Participants with HR+/HER2-low breast cancer who were treated with neoadjuvant chemotherapy or endocrine therapy identified from the ConcertAI databases.
 Other: No drug
This is a non-interventional study and no study drug will be provided.
HR+/HER2-negative Breast Cancer
Participants with HR+/HER2-negative breast cancer who were treated with neoadjuvant chemotherapy or endocrine therapy identified from the ConcertAI databases.
 Other: No drug
This is a non-interventional study and no study drug will be provided.


Outcome Measures
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Primary Outcome Measures :
  1. Event-free survival (EFS) in Participants With HR+ and HER2-Low/Negative Breast Cancer [ Time Frame: Index date to the end of the study period (approximately December 31, 2022) ]
    Events of interest include any other primary cancer, metastases, higher stage, tumor progression, and death due to any cause.

  2. Overall Survival of Participants With HR+ and HER2-Low/Negative Breast Cancer [ Time Frame: Index date to the end of the study period (approximately December 31, 2022) ]
  3. Pathological Complete Response (pCR) in Participants With HR+ and HER2-Low/Negative Breast Cancer [ Time Frame: Index date to the end of the study period (approximately December 31, 2022) ]
    Pathological complete response (pCR) was defined as ypT0/Tis ypN0 and is the absence of any invasive component in the resected breast specimen and all resected lymph nodes following completion of neoadjuvant therapy.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with HR+ and HER2-low/negative breast cancer diagnosed between January 1, 2010 and December 31, 2022 and treated with neoadjuvant chemotherapy or endocrine therapy will be identified from the ConcertAI database based on the inclusion and exclusion criteria.
Criteria

Inclusion Criteria:

  • Newly diagnosed HR+ and HER2-low/negative breast cancer diagnosed between January 1, 2010 and December 31, 2022 (Aged ≥18 years at the time of diagnosis)
  • Stage I-IIIB at the time of diagnosis
  • Received neoadjuvant chemotherapy and/or endocrine therapy and/or IO therapy
  • Received curative intent surgery (mastectomy after neoadjuvant chemotherapy, endocrine, or IO therapy)

Exclusion Criteria:

  • Patients who received HER2-targeted therapies including

    • Trastuzumab
    • Pertuzumab
    • Ado-trastuzumab emtansine
    • Neratinib
    • Tucatinib
    • Lapatinib
    • Fam-trastuzumab deruxtecan-nxki
    • Margetuximab
Contacts and Locations
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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): NCT06040593


Locations
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United States, Massachusetts
ConcertAI database
Cambridge, Massachusetts, United States, 02138
Sponsors and Collaborators
Daiichi Sankyo
More Information
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Responsible Party: Daiichi Sankyo
ClinicalTrials.gov Identifier: NCT06040593    
Other Study ID Numbers: U31402-0005-NIS-EPI
First Posted: September 15, 2023    Key Record Dates
Last Update Posted: February 26, 2024
Last Verified: February 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Daiichi Sankyo:
Hormone-receptor-positive Breast Cancer
HER2-low Breast Cancer
HER2-negative Breast Cancer
Real-world Data
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases