Breast Cancer Trial, Recruiting NCT03856372 Sponsor: Fudan University Condition: Breast Cancer
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Breast Cancer Trial, Recruiting

NCT03856372
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:

  • People who are female and between 18 and 75 years old
  • People who have been diagnosed with invasive breast cancer, confirmed by a pathology test
  • People who have had a mastectomy (full breast removal) and removal of more than 10 lymph nodes from the armpit area — breast reconstruction on the same side, either at the time of surgery or later, is acceptable
  • People whose surgery removed all the cancer with clear margins (no cancer cells found at the edges of the removed tissue)
  • People whose cancer fits certain staging categories: either a smaller tumour (T1–2) that has spread to 1–3 lymph nodes AND at least one of the following risk factors applies — aged under 40, Grade 3 tumour, cancer found in blood or lymph vessels, hormone receptor negative (ER/PR negative) or HER2 positive; OR a larger tumour (T3–4); OR cancer spread to 4 or more lymph nodes (confirm with trial site)
  • People with no signs of 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 with a good general health and activity level (ECOG score of 0 or 1, meaning largely able to carry out daily activities — confirm with trial site)
  • People who have received or are receiving standard treatments after surgery, such as chemotherapy, hormone therapy, or HER2-targeted therapy
  • People who did not receive chemotherapy before their surgery
  • People who are medically suitable to receive radiotherapy after surgery, with no known reasons that would prevent it
  • People who have signed a consent form agreeing to take part

Who may not be able to join:

  • People who have or have had another cancer, apart from certain common skin cancers (basal cell or squamous cell skin cancer)
  • People who have previously had radiotherapy to the chest wall or nearby lymph node areas
  • People with serious heart or lung conditions unrelated to cancer
  • People with certain medical conditions that make radiotherapy unsafe, such as systemic lupus erythematosus or cirrhosis of the liver
  • People whose cancer has spread to 1–3 lymph nodes (T1–2N1) but does not have any of the specific risk factors listed above (under 40, Grade 3, lymphovascular invasion, ER/PR negative, or HER2 positive)
  • People with cancer spread to the lymph nodes above the collarbone or behind the breastbone
  • People with confirmed evidence that cancer has spread to other parts of the body
  • People with cancer in both breasts, or a history of invasive breast cancer in the other breast
  • People who received chemotherapy before their surgery
  • People with a poor general health and activity level (ECOG score of 3–4, meaning significantly limited in daily activities — confirm with trial site)
  • People who are pregnant or breastfeeding
  • People whose circumstances or health would make it difficult to complete the radiotherapy treatment or attend follow-up appointments
  • People who are unwilling or unable 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 16 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: Jinli Ma, MD, PhD, Fudan University

Phone: +86-15221033376

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 September 2018
Est. completion
30 September 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: 16 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