HER2 Positive Breast CarcinomaNCT06868758
Predictive Value of Tumor Vascular Normalization Scoring in HER-2 Positive Breast Cancer
An observational study of HER2 Positive Breast Carcinoma and Neoadjuvant Therapy, run by Chongqing General Hospital at 1 site in China.
Trial summary
This study aims to evaluate the predictive value of the tumor vascular normalization score for the efficacy of neoadjuvant therapy in HER-2-positive breast cancer and explore its potential as a predictive biomarker. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- HER2 Positive Breast Carcinoma, Neoadjuvant Therapy
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2025to 30 Jun 2026
- How long will I take part?
- 18 Weeks
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Female HER2 positive breast cancer patients
Who may be able to join
- Female breast cancer patients aged ≥18 years planned for neoadjuvant therapy.
- Histopathologically confirmed HER2-positive status (IHC 3+ or IHC 2+ with positive FISH confirmation).
- Mentally competent, no psychiatric disorders, with good compliance to treatment and follow-up.
- Voluntarily participate and provide written informed consent.
Who cannot join
- HER2-negative breast cancer.
- Pregnant, planning pregnancy, or lactating women.
- History of allergic predisposition or known/suspected allergy to study drugs.
- Participation in other clinical trials within the past 4 weeks or planned enrollment.
- Other conditions deemed ineligible by the investigator.
Trial locations and contacts
1 site in 1 country.
China1 site
Chongqing General Hospital
Chongqing, Chongqing Municipality, 401121
About this study
Official title: Predictive Value of Tumor Vascular Normalization Scoring in the Response to Neoadjuvant Therapy in HER-2 Positive Breast Cancer: an Observational Study
This study aims to evaluate the predictive value of the tumor vascular normalization score for the efficacy of neoadjuvant therapy in HER-2-positive breast cancer and explore its potential as a predictive biomarker. Through longitudinal observation of HER-2-positive breast cancer patients receiving standard treatment, we will analyze the correlation between vascular normalization scores and treatment responses (including objective response rate [ORR] and pathological complete response [pCR]) to optimize individualized therapeutic strategies. Additionally, an exploratory investigation will assess the impact of ginsenoside-containing formulations (e.g., Jinxing Capsule, Shenyi Capsule, Yiqi Jianpi Oral Liquid) on tumor vasculature and neoadjuvant therapy outcomes in HER-2-positive breast cancer, providing scientific insights for complementary therapeutic interventions.
- Keywords
- Tumor vascular normalization score, anti-HER2 antibody, Treatment efficacy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| HER2 positive breast cancer | Female breast cancer patients with histopathologically confirmed HER2-positive status (defined as HER2 immunohistochemistry [IHC] 3+ or HER2 IHC 2+ with positive confirmation by fluorescence in situ hybridization [FISH]) who are planned to receive neoadjuvant therapy, including chemotherapy and HER2-targeted regimens. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between VNS and Therapeutic Outcomes
Predictive value of VNI for pCR (ROC curve analysis). Unit of Measure: Statistical correlation coefficients (R²/AUC)
Measured: Patients will be assessed at the third week and fifth week after initiation of anti-HER2 therapy, as well as preoperatively (prior to surgery).
Secondary outcomes (1)
Correlation between Ginsenoside Formulation Exposure and Tumor Vascular Normalization
Ginsenoside Exposure Measurement:
Tool: Plasma concentration via Ultra-Performance Liquid Chromatography-Tandem Mass Spectrometry (UPLC-MS/MS) Parameter: Total ginsenoside plasma concentration (unit: ng/mL) Time Frame: Pre-dose and at Cycle 3 Day 1 (C3D1) of neoadjuvant therapy
Vascular Normalization Measurement:
Tool: Dynamic Contrast-Enhanced MRI (DCE-MRI) with Extended Tofts Model Parameter: Vascular Normalization Index (VNI)
Components:
K<sup>trans</sup> (unit: min<sup>-1</sup>) Plasma volume fraction (v<sub>p</sub>, unit: %) Calculation: Composite score (range 0-1) derived from principal component analysis
Statistical Correlation:
Method: Spearman's rank correlation Unit: Spearman's ρ (range: -1 to 1)
Measured: Patients will be assessed at the third week and fifth week after initiation of anti-HER2 therapy, as well as preoperatively (prior to surgery).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2025
- Study start1 Jan 2025
- Primary completion31 Dec 2025 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HER2 Positive Breast CarcinomaStudies 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
- Prospective
- Enrolment
- 50 participants (estimated)
- Target duration
- 18 Weeks
Sponsor and investigators
- Lead sponsor
- Chongqing General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06868758
- Sponsor's protocol ID
- JRIIT-08-01
- Status last verified
- Mar 2025
- First submitted
- 1 Mar 2025
- Last updated
- 11 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictive Value of Tumor Vascular Normalization Scoring in the Response to Neoadjuvant Therapy in HER-2 Positive Breast Cancer: an Observational Study
- ClinicalTrials.gov ID
- NCT06868758
- Acronym / sponsor ID
- JRIIT-08-01
- Keywords
- Tumor vascular normalization score, anti-HER2 antibody, Treatment efficacy
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Chongqing General HospitalUniversity, hospital or other
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 11 Mar 2025 (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 study aims to evaluate the predictive value of the tumor vascular normalization score for the efficacy of neoadjuvant therapy in HER-2-positive breast cancer and explore its potential as a predictive biomarker. Through longitudinal observation of HER-2-positive breast cancer patients receiving standard treatment, we will analyze the correlation between vascular normalization scores and treatment responses (including objective response rate [ORR] and pathological complete response [pCR]) to optimize individualized therapeutic strategies. Additionally, an exploratory investigation will assess the impact of ginsenoside-containing formulations (e.g., Jinxing Capsule, Shenyi Capsule, Yiqi Jianpi Oral Liquid) on tumor vasculature and neoadjuvant therapy outcomes in HER-2-positive breast cancer, providing scientific insights for complementary therapeutic interventions.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 18 Weeks
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HER2 positive breast cancer | – | –Female breast cancer patients with histopathologically confirmed HER2-positive status (defined as HER2 immunohistochemistry [IHC] 3+ or HER2 IHC 2+ with positive confirmation by fluorescence in situ hybridization [FISH]) who are planned to receive neoadjuvant therapy, including chemotherapy and HER2-targeted regimens. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Female HER2 positive breast cancer patients
Key inclusion criteria (4 listed)
- Female breast cancer patients aged ≥18 years planned for neoadjuvant therapy.
- Histopathologically confirmed HER2-positive status (IHC 3+ or IHC 2+ with positive FISH confirmation).
- Mentally competent, no psychiatric disorders, with good compliance to treatment and follow-up.
- Voluntarily participate and provide written informed consent.
Key exclusion criteria (5 listed)
- HER2-negative breast cancer.
- Pregnant, planning pregnancy, or lactating women.
- History of allergic predisposition or known/suspected allergy to study drugs.
- Participation in other clinical trials within the past 4 weeks or planned enrollment.
- Other conditions deemed ineligible by the investigator.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Correlation between VNS and Therapeutic Outcomes
Time frame: Patients will be assessed at the third week and fifth week after initiation of anti-HER2 therapy, as well as preoperatively (prior to surgery).
Predictive value of VNI for pCR (ROC curve analysis). Unit of Measure: Statistical correlation coefficients (R²/AUC)
1 secondary outcome
Correlation between Ginsenoside Formulation Exposure and Tumor Vascular Normalization
Time frame: Patients will be assessed at the third week and fifth week after initiation of anti-HER2 therapy, as well as preoperatively (prior to surgery).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2025.
- Individual participant dataSharing planned: Undecided
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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 HER2 Positive Breast Carcinoma and Neoadjuvant Therapy, run by Chongqing General Hospital 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 4 inclusion and 5 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: under way, not looking for participants, as of the sponsor's last update on 11 Mar 2025. 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?
This study is still under way. Results are not available in the source record yet.
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?
Correlation between VNS and Therapeutic Outcomes (time frame: Patients will be assessed at the third week and fifth week after initiation of anti-HER2 therapy, as well as preoperatively (prior to surgery).). 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 11 Mar 2025.