Phase 2 Breast Cancer Trial, Not Yet Recruiting NCT07113964 Sponsor: The First Affiliated Hospital with Nanjing Medical University Condition: Breast Cancer
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Phase 2 Breast Cancer Trial, Not Yet Recruiting

NCT07113964
Not Yet Recruiting Phase 2

voxsanity.com.au · Eligibility summary from public government registries · 18 August 2026 · not medical advice

Who may and may not 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 may be able to join

  • Adults aged 18 to 75 years who are in good general health and able to carry out normal daily activities with little or no difficulty (ECOG performance score of 0 or 1).
  • People with a confirmed diagnosis of HER2-negative breast cancer that has spread to nearby tissues or other parts of the body, where the cancer is either hormone receptor-positive (driven by estrogen, progesterone, or both) or triple negative.
  • People who have already received 2 to 4 previous treatment regimens for their metastatic (spread) breast cancer.
  • People with a confirmed result showing HRD positive status, or a known harmful or likely harmful BRCA gene mutation (in inherited genes and/or the tumour), which may allow preferential enrolment into the trial.
  • People who have at least one tumour that can be measured using standard imaging criteria (RECIST version 1.1).
  • People whose bone marrow, kidney, liver, and blood clotting functions meet the specific levels required by the trial protocol.
  • People with a life expectancy of at least 12 weeks.
  • Women who could become pregnant must agree to use a highly effective form of contraception or avoid intercourse during the study and for at least 3 months after the last dose, must have a negative pregnancy test within 7 days before joining the study, and must not be breastfeeding.
  • People who are willing to take part voluntarily and have signed the study's informed consent form.

Who may not be able to join

Each point below is a reason the trial team may not be able to accept someone. It is not a list of requirements to meet.

  • People who have an active autoimmune disease that could get worse when receiving immune-stimulating treatments.
  • People who have previously been treated with certain immune checkpoint inhibitor therapies (such as anti-CTLA-4, anti-PD-1, or anti-PD-L1 drugs) or the drug olaparib for advanced disease.
  • People who still have unresolved side effects from previous cancer treatments.
  • People with uncontrolled or significant heart or blood vessel disease.
  • People who previously had to stop an anti-PD-1, anti-PD-L1, or anti-CTLA-4 therapy because of immune-related side effects.
  • People with a known history or current evidence of interstitial lung disease or active non-infectious inflammation of the lungs.
  • People who have received a live vaccine within 28 days before joining the trial.
  • People with a known history of HIV infection.
  • People with a known history of, or who currently test positive for, Hepatitis B or Hepatitis C.
  • People with severe or poorly managed conditions such as poorly controlled high blood pressure, a tendency for active bleeding, or an active infection, as assessed by the trial doctor.
  • People who have untreated or currently active cancer spread to the brain or central nervous system.
  • Women who are pregnant, currently breastfeeding, or planning to become pregnant during the study.
  • People who have any other condition that the trial protocol or the trial doctor considers unsuitable for participation (confirm with trial site).

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 15 July 2026

Contact this trial

Phone: 025-68307102

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
Not Yet Recruiting
Phase
Phase 2
Registry
ClinicalTrials.gov
Start date
30 August 2025
Est. completion
30 March 2027

Where this trial is recruiting

🇨🇳 China

Primary endpoints

Progression-free Survival (PFS)

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: 15 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