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
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Condition or disease | Intervention/treatment |
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Hormone-receptor-positive Breast Cancer HER2-low Breast Cancer HER2-negative Breast Cancer | Other: No drug |
This retrospective, non-interventional study is designed to assess the following primary objectives:
- 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
- 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 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 |
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.
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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.
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Other: No drug
This is a non-interventional study and no study drug will be provided. |
- 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.
- 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) ]
- 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.
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.
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 |
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:
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Patients who received HER2-targeted therapies including
- Trastuzumab
- Pertuzumab
- Ado-trastuzumab emtansine
- Neratinib
- Tucatinib
- Lapatinib
- Fam-trastuzumab deruxtecan-nxki
- Margetuximab
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
United States, Massachusetts | |
ConcertAI database | |
Cambridge, Massachusetts, United States, 02138 |
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 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Hormone-receptor-positive Breast Cancer HER2-low Breast Cancer HER2-negative Breast Cancer Real-world Data |
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases |