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Recruiting NCT05621564

Pre-operative Therapy in Breast Cancer

Observational Breast Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: pre-operative therapy.
Who it may be relevant to
Registry conditions: Breast Cancer. Basic parameters: from 18 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

The Effect of Pre-operative Therapy on Response and Survival in Breast Cancer

Overview

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.

Interventions

  • Drug pre-operative therapy
    pre-operative therapy includes pre-operative chemotherapy, radiation, endocrine therapy, target therapy and other anti-tumor therapy

Primary outcome measures

  • Pathologic Complete Response [Time frame: at surgery]
Secondary outcome measures (2)
  • 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]

Eligibility criteria

Inclusion criteria

  • Female, Aged ≥18 years
  • Histologically confirmed primary breast cancer
  • Plan to receive pre-operative therapy
  • Adequate organ function

Exclusion criteria

  • History of neurological or psychological disease, including epilepsy or dementia
  • Not suitable to participate in this study judged by investigators

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

China · 1 center
  • Renji Hospital, School of Medicine, Shanghai Jiaotong University — Shanghai

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. PMID 38912905

Identifiers

NCT: NCT05621564 · LY2022-028-B

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗