HER2 Low Breast CancersNCT06433804
Clinicopathological Parameters of HER2 Low Breast Cancers
An observational study of HER2 Low Breast Cancers, run by Vardhman Mahavir Medical College And Safdarjung Hospital at 1 site in India.
Trial summary
This was a retrospective cohort study which included all histologically proven cases of breast cancer in the 2 years from January 2022- December 2023 at a tertiary care centre. This study was performed in line with STROCSS criteria. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- HER2 Low Breast Cancers
- What is being tested?
- HER2 IHC
- How many people
- 70 participants
- Where
- 1 siteIndia
- Study dates
- 1 Jan 2022to 1 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: All histologically proven cases of breast cancer in the 2 years from January 2022- December 2023
Who may be able to join
- All histologically proven cases of breast cancer in the 2 years from January 2022- December 2023
Who cannot join
- Benign breast tumors
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Exploring the Clinicopathological Parameters of HER2 Low Breast Cancers
This was a retrospective cohort study which included all histologically proven cases of breast cancer in the 2 years from January 2022- December 2023 at a tertiary care centre.
This study was performed in line with STROCSS criteria. The following clinicopathological data was retrieved from the histopathological records- age, tumor size, nodal involvement, lymphovascular/ perineural invasion, and Bloom Richardson grading.
Routine histopathological processing was done followed by immunohistochemical analysis for ER, PR, HER2, Ki67 and AR. All the cases were categorised into Luminal A, B, Her2 enriched and triple-negative breast cancer based on the surrogate molecular classification. Further, all the cases were categorised into HER2 negative (no staining or incomplete weak membrane staining in ≤10% tumor cells), HER2 3+ (complete membranous staining) and HER2 low (1-2+ staining without amplification on ISH) based on consensus of two pathology consultants. The present study aims to evaluate the clinicopathological parameters of the HER2 low breast cancers.
- Conditions
- HER2 Low Breast Cancers
- Being tested
- HER2 IHC
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HER2 IHCDiagnostic test
Immunohistochemistry for HER2
| Study group | Role | What they receive |
|---|---|---|
| HER2 low | Not described Receives: Diagnostic Test: HER2 IHC | |
| HER2 negative | Not described Receives: Diagnostic Test: HER2 IHC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Age (in years)
It will be measured for HER2 low breast cancer patients
Measured: JANUARY 2022- DECEMBER 2023
Tumor stage (categorised from T1-T4)
This denotes status of stage of tumor- T1, T2, T3, T4. It will be measured for HER2 low breast cancer patients
Measured: JANUARY 2022- DECEMBER 2023
N stage (categorised from N0-N3)
This denotes status of nodal involevement- N0, N1, N2 or N3. It will be measured for HER2 low breast cancer patients
Measured: JANUARY 2022- DECEMBER 2023
Tumor grade (categorised from G1-G3)
This denotes whether tumor is well, modeartely or porrly differentiated. It will be measured for HER2 low breast cancer patients.
Measured: JANUARY 2022- DECEMBER 2023
Surrogate molecular classification (Categorised as luminal/ triple negative)
This denoted the molecular classification of breast cancer based on ER, PR, Her2 expression.
Measured: JANUARY 2022- DECEMBER 2023
Androgen receptor expression (Denoted as present or absent)
This denoted the immunohistochemical expression of androgen receptor which would be evaluted in all cases of HER2 low breast cancer
Measured: JANUARY 2022- DECEMBER 2023
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2024
- Study start1 Jan 2022
- Primary completion1 Dec 2023
- Study completion1 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HER2 Low Breast CancersStudies of the same condition, open and under way.
- 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
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vardhman Mahavir Medical College And Safdarjung Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, SANA AHUJA, Vardhman Mahavir Medical College And Safdarjung Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06433804
- Sponsor's protocol ID
- CC-229
- Status last verified
- May 2024
- First submitted
- 16 May 2024
- Last updated
- 30 May 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 30 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring the Clinicopathological Parameters of HER2 Low Breast Cancers
- ClinicalTrials.gov ID
- NCT06433804
- Acronym / sponsor ID
- CC-229
- Conditions
- HER2 Low Breast Cancers
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Vardhman Mahavir Medical College And Safdarjung HospitalUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 1 Dec 2023 (actual)
- Study completion
- 1 Feb 2024 (actual)
- First posted
- 30 May 2024 (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.
This was a retrospective cohort study which included all histologically proven cases of breast cancer in the 2 years from January 2022- December 2023 at a tertiary care centre.
This study was performed in line with STROCSS criteria. The following clinicopathological data was retrieved from the histopathological records- age, tumor size, nodal involvement, lymphovascular/ perineural invasion, and Bloom Richardson grading.
Routine histopathological processing was done followed by immunohistochemical analysis for ER, PR, HER2, Ki67 and AR. All the cases were categorised into Luminal A, B, Her2 enriched and triple-negative breast cancer based on the surrogate molecular classification. Further, all the cases were categorised into HER2 negative (no staining or incomplete weak membrane staining in ≤10% tumor cells), HER2 3+ (complete membranous staining) and HER2 low (1-2+ staining without amplification on ISH) based on consensus of two pathology consultants. The present study aims to evaluate the clinicopathological parameters of the HER2 low breast cancers.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HER2 low | – | Diagnostic Test: HER2 IHC |
| HER2 negative | – | Diagnostic Test: HER2 IHC |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All histologically proven cases of breast cancer in the 2 years from January 2022- December 2023
Key inclusion criteria (1 listed)
- All histologically proven cases of breast cancer in the 2 years from January 2022- December 2023
Key exclusion criteria (1 listed)
- Benign breast tumors
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 |
|---|---|---|
| HER2 IHCImmunohistochemistry for HER2 | Diagnostic test | HER2 low, HER2 negative |
Primary outcome
Age (in years)
Time frame: JANUARY 2022- DECEMBER 2023
It will be measured for HER2 low breast cancer patients
Tumor stage (categorised from T1-T4)
Time frame: JANUARY 2022- DECEMBER 2023
This denotes status of stage of tumor- T1, T2, T3, T4. It will be measured for HER2 low breast cancer patients
N stage (categorised from N0-N3)
Time frame: JANUARY 2022- DECEMBER 2023
This denotes status of nodal involevement- N0, N1, N2 or N3. It will be measured for HER2 low breast cancer patients
Tumor grade (categorised from G1-G3)
Time frame: JANUARY 2022- DECEMBER 2023
This denotes whether tumor is well, modeartely or porrly differentiated. It will be measured for HER2 low breast cancer patients.
Surrogate molecular classification (Categorised as luminal/ triple negative)
Time frame: JANUARY 2022- DECEMBER 2023
This denoted the molecular classification of breast cancer based on ER, PR, Her2 expression.
Androgen receptor expression (Denoted as present or absent)
Time frame: JANUARY 2022- DECEMBER 2023
This denoted the immunohistochemical expression of androgen receptor which would be evaluted in all cases of HER2 low breast cancer
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 30 May 2024.
- Individual participant dataSharing planned: No
Related trials for HER2 Low Breast Cancers
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
Active, not recruitingPhase 1/2
Study of Oral MRT-2359 in Selected Cancer Patients
NSCLC, SCLC
RecruitingPhase 2
Study of Patritumab Deruxtecan Plus Pembrolizumab With Other Anticancer Agents in Participants With High-Risk Early-Stage Triple-Negative or Hormone Receptor-Low Positive/HER-2 Negative Breast Cancer (MK-1022-010, HERTHENA-Breast-03)
Breast Neoplasms, Breast Cancer
RecruitingObservational study
Negative/Low Hormone Receptor And/or HER2 POsitive Lobular Invasive Breast Carcinoma - A Real-World International Cohort Study
Lobular Breast Carcinoma
Active, not recruitingPhase 3
A Study of Elacestrant Versus Standard Endocrine Therapy in Women and Men With ER+,HER2-, Early Breast Cancer With High Risk of Recurrence
Breast Cancer
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 HER2 Low Breast Cancers, run by Vardhman Mahavir Medical College And Safdarjung Hospital at 1 site in India.
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 30 May 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 India. 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?
Age (in years) (time frame: JANUARY 2022- DECEMBER 2023). The study lists 6 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 30 May 2024.