The Association of Lunula Status With the Efficacy and Safety of Neoadjuvant Therapy in Breast Cancer

May 10, 2026 updated by: Wenjin Yin
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 Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

188

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Shanghai, China, 200127
        • Renji Hospital, School of Medicine, Shanghai Jiaotong University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Breast cancer patients who have received or plan to receive neoadjuvant therapy.

Description

Inclusion Criteria:

  • Aged 18 years or older
  • Pathologically confirmed invasive primary breast cancer
  • Patients who have received or are scheduled to receive neoadjuvant therapy

Exclusion Criteria:

  • De novo stage IV breast cancer

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
retrospective
no requirements for therapy
Drug: neoadjuvant therapy
patients receiving neoadjuvant therapy
prospective
no requirements for therapy
Drug: neoadjuvant therapy
patients receiving neoadjuvant therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pathological Complete Response (pCR) Rate
Time Frame: at surgery
ypT0 ypN0
at surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disease-free Survival
Time Frame: From surgery until time of event up to 8 years
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.
From surgery until time of event up to 8 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wenjin Yin

Investigators

  • Principal Investigator: Wenjin Yin, Renji Hospital, School of Medicine, Shanghai Jiaotong University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2026

Primary Completion (Estimated)

January 1, 2031

Study Completion (Estimated)

January 1, 2033

Study Registration Dates

First Submitted

May 10, 2026

First Submitted That Met QC Criteria

May 10, 2026

First Posted (Actual)

May 15, 2026

Study Record Updates

Last Update Posted (Actual)

May 15, 2026

Last Update Submitted That Met QC Criteria

May 10, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LY2026-056-B

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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