Phase 2 Breast Cancer Trial, Recruiting NCT07113613 Sponsor: The First Affiliated Hospital with Nanjing Medical University Condition: Breast Cancer
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Phase 2 Breast Cancer Trial, Recruiting

NCT07113613
Recruiting Phase 2

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 willing to take part, are able to follow the trial procedures, and have signed a consent form
  • People whose cancer has been confirmed as invasive breast cancer through a tissue biopsy, and who had a breast MRI or PET/MR scan before starting pre-surgery treatment
  • People who received the standard pre-surgery (neoadjuvant) treatment recommended by medical guidelines based on their cancer type
  • People with a single breast tumour, originally assessed as a certain stage of breast cancer (cT1–3, N0–3a) at first diagnosis (confirm with trial site for exact staging details)
  • People who had breast-conserving surgery (where only part of the breast is removed), where the edges of the removed tissue were clear of cancer (negative margins, at least 1mm distance), and where no cancer cells were found in the breast tissue after pre-surgery treatment (a result called pCR or ypT0)
  • People aged between 30 and 75 years, with a general health and activity level rated 0 or 1 on a standard medical scale (ECOG score — meaning fully active or able to carry out light activity)
  • People whose blood counts, heart, liver, kidney function, and heart rhythm (ECG) results are within acceptable ranges for receiving radiation therapy
  • People who have never had radiation therapy to the chest area before

Who may not be able to join:

  • People who are pregnant, breastfeeding, or who are able to have children but do not have contraception in place
  • People known to carry certain inherited gene mutations linked to breast cancer (specifically BRCA-1 or BRCA-2)
  • People whose cancer was originally classified as a more advanced stage (cT4 or N3b–c), or who have cancer in both breasts, multiple separate tumours, or certain complex tumour patterns on imaging
  • People who did not receive the standard recommended pre-surgery treatment, or whose breast tumour did not fully disappear after pre-surgery treatment (including cases where only non-invasive cells remained, called ypTis)
  • People who have another type of cancer at the same time, or who are already taking part in another clinical trial
  • People who would not be able to begin radiation therapy within 8 weeks of their breast surgery
  • People whose cancer had already spread to other parts of the body (distant metastasis) at the time of diagnosis
  • People with a previous history of breast cancer, or who have previously had radiation therapy to the neck, chest, or the armpit area on the same side as the affected breast
  • People with serious health conditions unrelated to cancer that would make receiving radiation therapy unsafe or impractical
  • People with uncontrolled neurological or mental health conditions that would affect their ability to participate in and report on the treatment

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 13 July 2026
Phase 2: approximately ~30% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: Xinchen Sun, Doctor, The First Affiliated with Nanjing Medical University (Jiangsu Province People's Hospital)

Phone: 13770662828

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
Phase 2
Registry
ClinicalTrials.gov
Start date
1 January 2025
Est. completion
31 December 2026

Where this trial is recruiting

🇨🇳 China

Primary endpoints

5-year ipsilateral breast recurrence rate (IBTR); 5-year local-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: 13 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