Breast NeoplasmsNCT05673850
Association Between HER2 Status and pCR Rate in ER-positive Breast Cancer Receiving Neoadjuvant Endocrine or Chemotherapy
An observational study of Breast Neoplasms, run by Peking University at 1 site in China.
Trial summary
In estrogen receptor (ER)-positive breast cancer (BC), human epidermal growth factor receptor-2 (HER2)-low ones are reported to have distinct clinical and molecular features from those with HER2-zero or HER2-positive status. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Breast Neoplasms
- What is being tested?
- NET or NCT
- How many people
- 518 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2022to 1 Oct 2022
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: In this retrospective cohort study, we sourced data from the electronic database of Peking university cancer hospital to identify patients diagnosed with invasive breast cancer and who received surgery from 2015 to 2021. Patients were excluded by the fol-lowing criteria: (1) patients who were ER-negative; (2) patients who were HER2 posi-tive defined as IHC3+ or IHC2+/fluorescence in situ hybridization (FISH)-positive; (3) patients who were HER2 (IHC2+) but did not evaluate by further FISH;(4) patients who did not receive neoadjuvant therapy; (5) patients who received concurrent neo-adjuvant endocrine and chemotherapy. Patients who remained were further divided into two groups: those receiving neoadjuvant endocrine therapy (the NET group) and those receiving neoadjuvant chemotherapy (the NCT group).
Who may be able to join
- patients diagnosed with invasive breast cancer and who received surgery from 2015 to 2021
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
China1 site
Peking University Cancer Hospital
Haidian, Beijing Municipality, 000013
About this study
In estrogen receptor (ER)-positive breast cancer (BC), human epidermal growth factor receptor-2 (HER2)-low ones are reported to have distinct clinical and molecular features from those with HER2-zero or HER2-positive status. However, the association between HER2-low status with response to endocrine therapy is largely unknown. In this study, we included 518 ER-positive BC patients who received either neoadjuvant endocrine therapy (NET) or neoadjuvant chemotherapy (NCT). The pathologic complete response rate (pCR) of HER2-low and HER2-zero tumors re-sponding to neoadjuvant therapies were compared. The difference in disease-free survival (DFS) and overall survival (OS) between the two groups was also analyzed. The pCR (defined as ypT0/isNx) in HER2-low BCs and in HER2-zero BCs for NET cohort and NCT cohort were compared.
- Conditions
- Breast Neoplasms
- Being tested
- NET or NCT
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NET or NCTDrug
In this study, we included 518 ER-positive BC patients who received either neoadjuvant endo-crine therapy (NET) or neoadjuvant chemotherapy (NCT).
| Study group | Role | What they receive |
|---|---|---|
| NET | Not described Receives: Drug: NET or NCT | |
| NCT | Not described Receives: Drug: NET or NCT |
What is being measured
The primary outcome is the main question the study is designed to answer.
pathologic complete response rate (pCR)
ypT0/isNx
Measured: through study completion, an average of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2023
- Study start1 May 2022
- Primary completion1 Aug 2022
- Study completion1 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast NeoplasmsStudies of the same condition, open and under way.
- More trials run by Peking UniversityThe 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
- 518 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05673850
- Sponsor's protocol ID
- ASSOCIHER
- Status last verified
- Nov 2022
- First submitted
- 27 Nov 2022
- Last updated
- 6 Jan 2023
- Results posted
- 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 6 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between HER2 Status and pCR Rate in ER-positive Breast Cancer Receiving Neoadjuvant Endocrine or Chemotherapy
- ClinicalTrials.gov ID
- NCT05673850
- Acronym / sponsor ID
- ASSOCIHER
- Conditions
- Breast Neoplasms
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 518 participants (actual)
- Lead sponsor
- Peking UniversityUniversity, hospital or other
- Study start
- 1 May 2022 (actual)
- Primary completion
- 1 Aug 2022 (actual)
- Study completion
- 1 Oct 2022 (actual)
- First posted
- 6 Jan 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.
In estrogen receptor (ER)-positive breast cancer (BC), human epidermal growth factor receptor-2 (HER2)-low ones are reported to have distinct clinical and molecular features from those with HER2-zero or HER2-positive status. However, the association between HER2-low status with response to endocrine therapy is largely unknown. In this study, we included 518 ER-positive BC patients who received either neoadjuvant endocrine therapy (NET) or neoadjuvant chemotherapy (NCT). The pathologic complete response rate (pCR) of HER2-low and HER2-zero tumors re-sponding to neoadjuvant therapies were compared. The difference in disease-free survival (DFS) and overall survival (OS) between the two groups was also analyzed. The pCR (defined as ypT0/isNx) in HER2-low BCs and in HER2-zero BCs for NET cohort and NCT cohort were compared.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NET | – | Drug: NET or NCT |
| NCT | – | Drug: NET or NCT |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- In this retrospective cohort study, we sourced data from the electronic database of Peking university cancer hospital to identify patients diagnosed with invasive breast cancer and who received surgery from 2015 to 2021. Patients were excluded by the fol-lowing criteria: (1) patients who were ER-negative; (2) patients who were HER2 posi-tive defined as IHC3+ or IHC2+/fluorescence in situ hybridization (FISH)-positive; (3) patients who were HER2 (IHC2+) but did not evaluate by further FISH;(4) patients who did not receive neoadjuvant therapy; (5) patients who received concurrent neo-adjuvant endocrine and chemotherapy. Patients who remained were further divided into two groups: those receiving neoadjuvant endocrine therapy (the NET group) and those receiving neoadjuvant chemotherapy (the NCT group).
Key inclusion criteria (1 listed)
- patients diagnosed with invasive breast cancer and who received surgery from 2015 to 2021
Key exclusion criteria (1 listed)
- none
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 |
|---|---|---|
| NET or NCTIn this study, we included 518 ER-positive BC patients who received either neoadjuvant endo-crine therapy (NET) or neoadjuvant chemotherapy (NCT). | Drug | NCT, NET |
Primary outcome
pathologic complete response rate (pCR)
Time frame: through study completion, an average of 6 months
ypT0/isNx
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 6 Jan 2023.
- 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 Breast Neoplasms, run by Peking University at 1 site in China.
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 1 inclusion and 1 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 6 Jan 2023. 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 China. 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?
pathologic complete response rate (pCR) (time frame: through study completion, an average of 6 months). 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 6 Jan 2023.