Hormone-receptor-positive Breast CancerNCT06040593
Study of Predictors of Clinical Outcomes in Patients With HR+ and HER2-low/Negative Breast Cancer
An observational study of Hormone-receptor-positive Breast Cancer and HER2-low Breast Cancer, run by Daiichi Sankyo at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hormone-receptor-positive Breast Cancer, HER2-low Breast Cancer, HER2-negative Breast Cancer
- What is being tested?
- No drug
- How many people
- 927 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Jul 2023to 23 Feb 2024
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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)
Who cannot join
- Patients who received HER2-targeted therapies including
- Trastuzumab
- Pertuzumab
- Ado-trastuzumab emtansine
- Neratinib
- Tucatinib
Show all 9Show fewer
- Lapatinib
- Fam-trastuzumab deruxtecan-nxki
- Margetuximab
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the detailed description
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.
- Conditions
- Hormone-receptor-positive Breast Cancer, HER2-low Breast Cancer, HER2-negative Breast Cancer
- Being tested
- No drug
- Keywords
- Hormone-receptor-positive Breast Cancer, HER2-low Breast Cancer, HER2-negative Breast Cancer, Real-world Data
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No drugOther
This is a non-interventional study and no study drug will be provided.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: No drug | |
| 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. Receives: Other: No drug |
What is being measured
The primary outcome is the main question the study is designed to answer.
Event-free survival (EFS) in Participants With HR+ and HER2-Low/Negative Breast Cancer
Events of interest include any other primary cancer, metastases, higher stage, tumor progression, and death due to any cause.
Measured: Index date to the end of the study period (approximately December 31, 2022)
Overall Survival of Participants With HR+ and HER2-Low/Negative Breast Cancer
Measured: 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
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.
Measured: Index date to the end of the study period (approximately December 31, 2022)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2023
- Study start31 Jul 2023
- Primary completion30 Nov 2023
- Study completion23 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hormone-receptor-positive Breast CancerStudies of the same condition, open and under way.
- More trials run by Daiichi SankyoThe 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
- Retrospective
- Enrolment
- 927 participants (actual)
Sponsor and investigators
- Lead sponsor
- Daiichi Sankyo
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06040593
- Sponsor's protocol ID
- U31402-0005-NIS-EPI
- Status last verified
- Feb 2024
- First submitted
- 28 Aug 2023
- Last updated
- 26 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06040593
- Acronym / sponsor ID
- U31402-0005-NIS-EPI
- Conditions
- Hormone-receptor-positive Breast Cancer, HER2-low Breast Cancer, HER2-negative Breast Cancer
- Keywords
- Hormone-receptor-positive Breast Cancer, HER2-low Breast Cancer, HER2-negative Breast Cancer, Real-world Data
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 927 participants (actual)
- Lead sponsor
- Daiichi SankyoIndustry (pharma, biotech, devices)
- Study start
- 31 Jul 2023 (actual)
- Primary completion
- 30 Nov 2023 (actual)
- Study completion
- 23 Feb 2024 (actual)
- First posted
- 15 Sep 2023 (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.
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.
Detailed description
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HR+/HER2-low Breast Cancer | – | Other: No drugParticipants with HR+/HER2-low breast cancer who were treated with neoadjuvant chemotherapy or endocrine therapy identified from the ConcertAI databases. |
| HR+/HER2-negative Breast Cancer | – | Other: No drugParticipants with HR+/HER2-negative breast cancer who were treated with neoadjuvant chemotherapy or endocrine therapy identified from the ConcertAI databases. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (9 listed)
- Patients who received HER2-targeted therapies including
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No drugThis is a non-interventional study and no study drug will be provided. | Other | HR+/HER2-low Breast Cancer, HR+/HER2-negative Breast Cancer |
Primary outcome
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.
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 26 Feb 2024.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hormone-receptor-positive Breast Cancer and HER2-low Breast Cancer, run by Daiichi Sankyo at 1 site in United States.
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 4 inclusion and 9 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 26 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
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)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Feb 2024.