Breast Cancer InvasiveNCT07590570
The Association of Lunula Status With the Efficacy and Safety of Neoadjuvant Therapy in Breast Cancer
An observational study of Breast Cancer Invasive, run by Wenjin Yin at 1 site in China.
Trial summary
This is a multicentre study to investigate the association of fingernail lunula status with the efficacy and safety of neoadjuvant therapy in breast cancer patients. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer Invasive
- What is being tested?
- neoadjuvant therapy
- How many people
- 188 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2026to Jan 2033
- 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: Breast cancer patients who have received or plan to receive neoadjuvant therapy.
Who may be able to join
- Aged 18 years or older
- Pathologically confirmed invasive primary breast cancer
- Patients who have received or are scheduled to receive neoadjuvant therapy
Who cannot join
- De novo stage IV breast cancer
Trial locations and contacts
1 site in 1 country.
China1 site
Renji Hospital, School of Medicine, Shanghai Jiaotong University
Shanghai, 200127
About this study
This is a multicentre study to investigate the association of fingernail lunula status with the efficacy and safety of neoadjuvant therapy in breast cancer patients.
- Conditions
- Breast Cancer Invasive
- Being tested
- neoadjuvant therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
patients receiving neoadjuvant therapy
| Study group | Role | What they receive |
|---|---|---|
| retrospective | no requirements for therapy Receives: Drug: neoadjuvant therapy | |
| prospective | no requirements for therapy Receives: Drug: neoadjuvant therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathological Complete Response (pCR) Rate
ypT0 ypN0
Measured: at surgery
Secondary outcomes (1)
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 posted15 May 2026
- Study start1 May 2026
- Primary completionJan 2031 (estimated)
- Study completionJan 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer InvasiveStudies 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
- Other
- Enrolment
- 188 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wenjin Yin
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Wenjin Yin, RenJi Hospital
- Investigators
- Wenjin Yin, Principal investigator, Renji Hospital, School of Medicine, Shanghai Jiaotong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07590570
- Sponsor's protocol ID
- LY2026-056-B
- Status last verified
- May 2026
- First submitted
- 10 May 2026
- Last updated
- 15 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Association of Lunula Status With the Efficacy and Safety of Neoadjuvant Therapy in Breast Cancer
- ClinicalTrials.gov ID
- NCT07590570
- Acronym / sponsor ID
- LY2026-056-B
- Conditions
- Breast Cancer Invasive
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 188 participants (estimated)
- Lead sponsor
- Wenjin YinUniversity, hospital or other
- Study start
- 1 May 2026 (actual)
- Primary completion
- Jan 2031 (estimated)
- Study completion
- Jan 2033 (estimated)
- First posted
- 15 May 2026 (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 multicentre study to investigate the association of fingernail lunula status with the efficacy and safety of neoadjuvant therapy in breast cancer patients.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| retrospective | – | Drug: neoadjuvant therapyno requirements for therapy |
| prospective | – | Drug: neoadjuvant 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
- Breast cancer patients who have received or plan to receive neoadjuvant therapy.
Key inclusion criteria (3 listed)
- Aged 18 years or older
- Pathologically confirmed invasive primary breast cancer
- Patients who have received or are scheduled to receive neoadjuvant therapy
Key exclusion criteria (1 listed)
- De novo 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 |
|---|---|---|
| neoadjuvant therapypatients receiving neoadjuvant therapy | Drug | prospective, retrospective |
Primary outcome
Pathological Complete Response (pCR) Rate
Time frame: at surgery
ypT0 ypN0
1 secondary outcome
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 15 May 2026.
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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.
Wenjin Yin principal investigator
Renji Hospital, School of Medicine, Shanghai Jiaotong University
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 Invasive, run by Wenjin Yin 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 3 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: under way, not looking for participants, as of the sponsor's last update on 15 May 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?
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?
Pathological Complete Response (pCR) Rate (time frame: at 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 15 May 2026.