Phase 2 Breast Cancer Trial, Recruiting NCT05076682 Sponsor: Fudan University Condition: Breast Cancer
Back to Breast Cancer

Phase 2 Breast Cancer Trial, Recruiting

NCT05076682
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:

  • You have a general health/activity level that is rated as fully active, restricted in strenuous activity but able to do light work, or capable of self-care but unable to work (confirm with trial site)
  • You have been diagnosed with triple-negative breast cancer (TNBC) — a type of breast cancer that tests negative for three specific markers — that has spread or cannot be surgically removed, confirmed by a tissue test
  • There is medical imaging evidence that your cancer has come back or gotten worse after receiving immunotherapy (possibly combined with other cancer treatments) for breast cancer that has spread
  • Your blood counts and organ function (such as liver and kidneys) are within acceptable levels, tested within 14 days before starting the study
  • If you are a woman who could become pregnant, you agree to either abstain from sex or use contraception as required by the specific treatment group you are assigned to
  • Your cancer can be measured on scans according to standard medical measurement guidelines
  • You are able to understand the study and are willing to take part and attend follow-up appointments

Who may not be able to join:

  • You have brain or spinal cord cancer spread (metastases) that is causing symptoms, has not been treated, or is getting worse
  • You have an active autoimmune disease, a history of autoimmune disease, or a weakened immune system
  • You have serious heart or blood vessel disease
  • You have had another type of cancer in the past 5 years (apart from breast cancer), unless it was a type with very low risk of spreading or causing death
  • You have received chemotherapy, radiation, immunotherapy, or major surgery within 3 weeks before starting the study
  • You are pregnant, breastfeeding, or planning to become pregnant during the study
  • You have a history of allergic reactions to the drugs used in this trial
  • You have a history of a condition involving too many eosinophils or mast cells in the body (confirm with trial site)
  • You are currently taking or have been taking steroid tablets regularly for a long time — if you have only taken them occasionally, you may need to stop for 4 weeks before joining (confirm with trial site)
  • If you are assigned to the Mecapegfilgrastim treatment group, you have previously received a similar drug (PEG-rhG-CSF) together with immunotherapy

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 30 June 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.

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
30 June 2022
Est. completion
31 December 2026

Where this trial is recruiting

🇨🇳 China

Primary endpoints

Objective Response Rate (ORR); Immune changes in peripheral blood

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: 30 June 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