Breast CancerNCT05263570
The Efficiency for Stage II-III HR+/HER2+ Early Breast Cancer Patient With Standard Neoadjuvant Therapy in Real World.
An observational study of Breast Cancer, run by Shengjing Hospital at 1 site in China.
Trial summary
To observe the efficiency for patient with stage II-III HR+/HER2+ early breast cancer with standard neoadjuvant therapy, a retrospective, multicenter study in real world settings. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Standard Therapy
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2022to 31 Dec 2026
- 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: Patients diagnosed with stage II-III HR+/HER2+ early breast cancer.
Who may be able to join
- Age ≥18 years or older
- HR+/HER2- breast cancer diagnosis based on local standards
- Women having stage II-III breast cancer diagnosed based on AJCC cancer staging system (8th edition) who will be admitted because of breast cancer for the first time
- Standard Therapy, determined at the discretion of the investigator, including （TCbHP/THP/EC-THP/AC-THP）
- Complete medical history was available
- Karnofsky Performance Status (KPS) Scale score ≥ 70
Who cannot join
- Women who have received any form of anti-tumor treatment - (chemotherapy, radiotherapy, molecular targeted therapy, or endocrine therapy)
- Pregnant or breast-feeding women
- Those who have bilateral breast cancer, inflammatory breast cancer or occult breast cancer
- Those who have stage IV breast cancer
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Shengjing Hospital of China Medical University
Shenyang, Liaoning, 110004
Cai-Gang Liu, PHD, +86 18940254967, liucg@sj-hospital.org
Cai-Gang Liu, PHD
About this study
Official title: The Efficiency for Patient With Stage II-III HR+/HER2+ Early Breast Cancer With Standard Neoadjuvant Therapy: a Retrospective, Multicenter Study in Real World Settings.
To observe the efficiency for patient with stage II-III HR+/HER2+ early breast cancer with standard neoadjuvant therapy, a retrospective, multicenter study in real world settings.
Read the detailed description
This study collected patients used standard neoadjuvant therapy (TCbHP/THP/EC-THP/AC-THP) among stage II-III HR+/HER2+ early breast cancer, and to describe patient clinical characteristics and clinical outcomes of them in real world settings.
- Conditions
- Breast Cancer
- Being tested
- Standard Therapy
- Keywords
- standard Therapy （TCbHP/THP/EC-THP/AC-THP）
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard TherapyDrug
Also called TCbHP, THP, EC-THP, AC-THP
Standard Therapy, including TCbHP, THP, EC-THP, AC-THP
| Study group | Role | What they receive |
|---|---|---|
| Stage II-III HR+/HER2+ Early Breast Cancer | Stage II-III HR+/HER2+ Early Breast Cancer Receives: Drug: Standard Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total pathological complete response (tpCR)
tpCR is defined as the absence of residual invasive cancer on resected breast specimen and the sampled regional lymph nodes as shown by hematoxylin-eosin staining after completion of the neoadjuvant treatment.
Measured: through study completion, an average of 1 year
Secondary outcomes (2)
Best overall response rate (BORR) [ Time Frame: During neoadjuvant treatment
The proportion of patients who respond to the treatment at any study time point
Measured: through study completion, an average of 1 year
Residual cancer burden (RCB)
RCB score is obtained according to pathological evaluation after completion of neoadjuvant treatment and surgery
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2022
- Study start1 Aug 2022
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Shengjing HospitalThe 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
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shengjing Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Caigang Liu, Shengjing Hospital
- Investigators
- Caigang Liu, PHD, Study chair, Shengjing Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05263570
- Sponsor's protocol ID
- HR-HER2-RWS-01
- Status last verified
- Sep 2022
- First submitted
- 17 Jan 2022
- Last updated
- 13 Sep 2022
- Results posted
- 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 13 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficiency for Patient With Stage II-III HR+/HER2+ Early Breast Cancer With Standard Neoadjuvant Therapy: a Retrospective, Multicenter Study in Real World Settings.
- ClinicalTrials.gov ID
- NCT05263570
- Acronym / sponsor ID
- HR-HER2-RWS-01
- Conditions
- Breast Cancer
- Keywords
- standard Therapy （TCbHP/THP/EC-THP/AC-THP）
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Shengjing HospitalUniversity, hospital or other
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 2 Mar 2022 (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.
To observe the efficiency for patient with stage II-III HR+/HER2+ early breast cancer with standard neoadjuvant therapy, a retrospective, multicenter study in real world settings.
Detailed description
This study collected patients used standard neoadjuvant therapy (TCbHP/THP/EC-THP/AC-THP) among stage II-III HR+/HER2+ early breast cancer, and to describe patient clinical characteristics and clinical outcomes of them in real world settings.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Stage II-III HR+/HER2+ Early Breast Cancer | – | Drug: Standard TherapyStage II-III HR+/HER2+ Early Breast Cancer |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with stage II-III HR+/HER2+ early breast cancer.
Key inclusion criteria (6 listed)
- Age ≥18 years or older
- HR+/HER2- breast cancer diagnosis based on local standards
- Women having stage II-III breast cancer diagnosed based on AJCC cancer staging system (8th edition) who will be admitted because of breast cancer for the first time
- Standard Therapy, determined at the discretion of the investigator, including （TCbHP/THP/EC-THP/AC-THP）
- Complete medical history was available
Key exclusion criteria (4 listed)
- Women who have received any form of anti-tumor treatment - (chemotherapy, radiotherapy, molecular targeted therapy, or endocrine therapy)
- Pregnant or breast-feeding women
- Those who have bilateral breast cancer, inflammatory breast cancer or occult breast cancer
- Those who have stage IV breast cancer
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 |
|---|---|---|
| Standard TherapyAlso: TCbHP, THP, EC-THP, AC-THPStandard Therapy, including TCbHP, THP, EC-THP, AC-THP | Drug | Stage II-III HR+/HER2+ Early Breast Cancer |
Primary outcome
Total pathological complete response (tpCR)
Time frame: through study completion, an average of 1 year
tpCR is defined as the absence of residual invasive cancer on resected breast specimen and the sampled regional lymph nodes as shown by hematoxylin-eosin staining after completion of the neoadjuvant treatment.
2 secondary outcomes
Best overall response rate (BORR) [ Time Frame: During neoadjuvant treatment
Time frame: through study completion, an average of 1 year
Residual cancer burden (RCB)
Time frame: through study completion, an average of 1 year
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 13 Sep 2022.
- 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.
Caigang Liu, PHD study chair
Shengjing Hospital
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 Cancer, run by Shengjing 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 6 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 13 Sep 2022. 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?
Contact Nan Niu, MD (+8618940256668, niunannancy@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total pathological complete response (tpCR) (time frame: through study completion, an average of 1 year). 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 13 Sep 2022; AzTrials last refreshed its copy on 6 Nov 2026.