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NCT Number: NCT05621564

Pre-operative Therapy 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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Renji Hospital, School of Medicine, Shanghai Jiaotong University

Shanghai, 200127, China

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

pre-operative therapy

Drug

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

Primary outcomes

  1. Pathologic Complete Response

    Time frame: at surgery

    ypT0 ypN0, ypT0/is ypN0

Secondary outcomes

  1. Objective response rate

    Time frame: from the start of pre-operative treatment until the completion of surgery up to 6 months

    the rate of complete response and partial response

  2. 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.

Interested in participating?

Recruiting

Interested in participating?

Request Info

Sponsors and collaborators

Lead sponsor

RenJi Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2030
Study completion
2030
First posted
Nov 18, 2022
Registry last updated
Aug 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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