Breast CancerNCT05621564
Pre-operative Therapy in Breast Cancer
An observational study of Breast Cancer, run by RenJi Hospital at 1 site in China.
Trial summary
This is a prospective and retrospective study to evaluate the effect of pre-operative therapy on response and survival, and compare the difference in response and survival by pre-operative regimen or by patient's clinicopathological characteristic in early or advanced breast cancer. 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?
- pre-operative therapy
- How many people
- 6,032 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2022to Nov 2030
- 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: The study population will be selected from the hospital where they are treated
Who may be able to join
- Female, Aged ≥18 years
- Histologically confirmed primary breast cancer
- Plan to receive pre-operative therapy
- Adequate organ function
Who cannot join
- History of neurological or psychological disease, including epilepsy or dementia
- Not suitable to participate in this study judged by investigators
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
Renji Hospital, School of Medicine, Shanghai Jiaotong University
Shanghai, 200127
Wenjin Yin, 86(21)68385569, yinwenjin@renji.com
About this study
Official title: The Effect of Pre-operative Therapy on Response and Survival in Breast Cancer
This is a prospective and retrospective study to evaluate the effect of pre-operative therapy on response and survival, and compare the difference in response and survival by pre-operative regimen or by patient's clinicopathological characteristic in early or advanced breast cancer.
- Conditions
- Breast Cancer
- Being tested
- pre-operative therapy
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pre-operative therapyDrug
pre-operative therapy includes pre-operative chemotherapy, radiation, endocrine therapy, target therapy and other anti-tumor therapy
| Study group | Role | What they receive |
|---|---|---|
| early breast cancer | no requirements for therapy Receives: Drug: pre-operative therapy | |
| advanced breast cancer | no requirements for therapy Receives: Drug: pre-operative therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathologic Complete Response
ypT0 ypN0, ypT0/is ypN0
Measured: at surgery
Secondary outcomes (2)
Objective response rate
the rate of complete response and partial response
Measured: from the start of pre-operative treatment until the completion of surgery up to 6 months
Disease-free Survival
Disease-free survival time is defined as the time from date of randomization until the first occurrence of disease recurrence, distant metastasis and death from any cause.
Measured: From surgery until time of event up to 8 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2022
- Study start1 Nov 2022
- Primary completionNov 2030 (estimated)
- Study completionNov 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by RenJi 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
- Other
- Enrolment
- 6,032 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wenjin Yin, RenJi Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05621564
- Sponsor's protocol ID
- LY2022-028-B
- Status last verified
- Aug 2026
- First submitted
- 8 Nov 2022
- Last updated
- 4 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Chen X, Zhao Y, Wang Y, Ye Y, Xu S, Zhou L, Lin Y, Lu J, Yin W. Serum lipid ratios as novel prognostic biomarkers for patients with locally advanced breast cancer treated with neoadjuvant therapy. Postgrad Med. 2024 Jun;136(5):541-550. doi: 10.1080/00325481.2024.2370235. Epub 2024 Jun 24.
PubMed 38912905
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Pre-operative Therapy on Response and Survival in Breast Cancer
- ClinicalTrials.gov ID
- NCT05621564
- Acronym / sponsor ID
- LY2022-028-B
- Conditions
- Breast Cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 6,032 participants (estimated)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- Nov 2030 (estimated)
- Study completion
- Nov 2030 (estimated)
- First posted
- 18 Nov 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.
This is a prospective and retrospective study to evaluate the effect of pre-operative therapy on response and survival, and compare the difference in response and survival by pre-operative regimen or by patient's clinicopathological characteristic in early or advanced breast cancer.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| early breast cancer | – | Drug: pre-operative therapyno requirements for therapy |
| advanced breast cancer | – | Drug: pre-operative therapyno requirements for therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will be selected from the hospital where they are treated
Key inclusion criteria (4 listed)
- Female, Aged ≥18 years
- Histologically confirmed primary breast cancer
- Plan to receive pre-operative therapy
- Adequate organ function
Key exclusion criteria (2 listed)
- History of neurological or psychological disease, including epilepsy or dementia
- Not suitable to participate in this study judged by investigators
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 |
|---|---|---|
| pre-operative therapypre-operative therapy includes pre-operative chemotherapy, radiation, endocrine therapy, target therapy and other anti-tumor therapy | Drug | advanced breast cancer, early breast cancer |
Primary outcome
Pathologic Complete Response
Time frame: at surgery
ypT0 ypN0, ypT0/is ypN0
2 secondary outcomes
Objective response rate
Time frame: from the start of pre-operative treatment until the completion of surgery up to 6 months
Disease-free Survival
Time frame: From surgery until time of event up to 8 years
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 4 Aug 2026.
- Derived from this study: PubMed 38912905Chen X, Zhao Y, Wang Y, Ye Y, Xu S, Zhou L, Lin Y, Lu J, Yin W. Serum lipid ratios as novel prognostic biomarkers for patients with locally advanced breast cancer treated with neoadjuvant therapy. Postgrad Med. 2024 Jun;136(5):541-550. doi: 10.1080/00325481.2024.2370235. Epub 2024 Jun 24.
- 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.
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 RenJi 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 2 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 4 Aug 2026. 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 Wenjin Yin (86(21)68385569, yinwenjin@renji.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathologic Complete Response (time frame: at surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05621564, which also lists 1 linked publication.
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 4 Aug 2026.