Breast Cancer Trial, Recruiting NCT04072653 Sponsor: Fudan University Condition: Breast Cancer
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Breast Cancer Trial, Recruiting

NCT04072653
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:

Stage 1 of the trial — people who:

  • Are female and aged 18 or older
  • Have been diagnosed with a specific type of breast cancer (invasive ductal carcinoma or DCIS) confirmed by a needle biopsy
  • Have a tumour measuring 5cm or smaller
  • Have had pre-surgery checks of the armpit area (physical exam, ultrasound, and MRI) showing no signs of cancer spread there
  • Are able to undergo armpit-area surgery and tissue testing as part of the trial, including a sentinel lymph node biopsy and possible lymph node removal

Stage 2 of the trial — people who:

  • Are female and aged 18 or older
  • Have been diagnosed with invasive breast cancer confirmed by a needle biopsy
  • Have a planned treatment that includes breast-conserving surgery (removing only the tumour, not the whole breast) followed by radiation therapy
  • Have had pre-surgery checks of the armpit area (physical exam, ultrasound, and a specialised PET scan result below a certain level) showing no signs of cancer spread there
  • Are able to attend follow-up appointments as required by the trial

Who may not be able to join:

Applies to both Stage 1 and Stage 2:

  • People whose cancer has spread to other parts of the body
  • People currently receiving pre-surgery treatment (such as chemotherapy given before an operation)
  • People whose pre-surgery armpit checks showed signs that cancer may have spread there
  • People who are pregnant or breastfeeding
  • People who have already had a biopsy or surgery involving the armpit area before the trial's specialised PET scan
  • People with diabetes that is not well controlled
  • People who have had a different cancer in the past
  • People who are allergic to the tracer substance used in the trial's specialised PET scan

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 28 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: Zhi-Min Shao, Fudan University

Phone: 086-021-64175590

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
4 September 2019
Est. completion
1 September 2027

Where this trial is recruiting

🇨🇳 China

Primary endpoints

stage 1: negative predictive value; stage 2: D-DFS(distant disease-free survival); stage 2: LRFS(local-regional free survival)

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: 28 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