Breast Cancer Trial, Recruiting NCT04025164 Sponsor: Fudan University Condition: Breast Cancer
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Breast Cancer Trial, Recruiting

NCT04025164
Recruiting Not Applicable

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • Women between 18 and 70 years old
  • People whose imaging showed a single tumour, or multiple tumours that could all be removed through one section of the breast
  • People who had breast-conserving surgery (where only part of the breast is removed) with clear margins, meaning no cancer cells were found at the edges of what was removed
  • People who had a sentinel lymph node biopsy or underarm lymph node removal, following specific surgical guidelines depending on the results
  • People whose tumour site was marked with small clips that can be seen on treatment planning scans
  • People whose cancer has been confirmed by laboratory testing to be invasive breast cancer
  • People whose cancer stage has been confirmed as T1–T3, N0–N3, M0 (confirm with trial site for what this means in individual cases)
  • People who had specific laboratory tests after surgery to check hormone receptor and protein status of the tumour (ER, PR, HER2, Ki67)
  • People with no cancer spread to distant parts of the body
  • People with no cancer spread to the lymph nodes above the collarbone or behind the breastbone
  • People who did not receive chemotherapy before surgery
  • People who are considered medically suitable for radiation therapy after surgery
  • People with a general health performance score of 80 or above on the KPS scale, which indicates a reasonable level of daily functioning (confirm with trial site)
  • People who have signed a consent form agreeing to take part

Who may not be able to join:

  • People with T4 or M1 stage breast cancer, meaning the cancer has grown extensively locally or spread to other parts of the body
  • People with cancer spread to lymph nodes above the collarbone or behind the breastbone
  • People whose laboratory results showed only a non-invasive type of breast cancer (called DCIS) with no invasive component
  • People with cancer in both breasts, or a history of invasive breast cancer in the other breast
  • People who received chemotherapy or hormone-blocking therapy before surgery
  • People with multiple tumours that could not all be removed through a single section of the breast
  • People with areas of concern in either breast that were not removed during surgery, such as suspicious calcium deposits, unusual tissue densities, or lumps that can be felt
  • People with a general health performance score of 70 or below on the KPS scale
  • People with serious heart or lung conditions that are not related to cancer
  • People who have had, or currently have, another type of cancer, except for certain common skin cancers (basal cell or squamous cell carcinoma)
  • People who have previously had radiation treatment to the chest wall or nearby lymph node areas
  • People with certain medical conditions that make radiation therapy unsafe, such as systemic lupus erythematosus or cirrhosis of the liver
  • People who are pregnant or breastfeeding
  • People whose circumstances suggest they would not be able to complete radiation treatment or attend follow-up appointments
  • People who are unable or unwilling to sign a consent form

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 21 July 2026
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

Contact this trial

Principal Investigator: Xiaoli Yu, MD, PhD, Fudan University

Phone: +86-13817893133

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Not Applicable
Registry
ClinicalTrials.gov
Start date
1 July 2018
Est. completion
30 June 2023

Where this trial is recruiting

🇨🇳 China

Primary endpoints

Loco-regional recurrence (LRR)

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 21 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov