Phase 2 Breast Cancer Trial, Recruiting NCT05594095 Sponsor: Fudan University Condition: Breast Cancer
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Phase 2 Breast Cancer Trial, Recruiting

NCT05594095
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:

  • Women aged 18 or older
  • People with a confirmed diagnosis of invasive breast cancer that is hormone receptor positive (HR+) and HER2 negative, based on tissue testing
  • People whose breast cancer is locally advanced and cannot be fully treated with surgery or radiation, or whose cancer has come back or spread to other parts of the body
  • People with HR+/HER2- advanced breast cancer who have previously been treated with a type of drug called a CDK4/6 inhibitor
  • People who have at least one tumour that can be measured on a scan, and that has not previously been treated with radiotherapy
  • People whose blood counts and organ function (including liver and kidneys) meet certain minimum levels set by the trial (confirm with trial site for exact values)
  • People who have not received radiotherapy, targeted therapy, or surgery in the 3 weeks before starting the trial, and whose side effects from previous treatments have settled — with no or only very mild nerve-related side effects
  • People with a general health score (called an ECOG score) of 2 or lower, and a life expectancy of at least 3 months
  • People who are capable of becoming pregnant and agree to use a medically approved method of contraception during the trial and for at least 3 months after the last dose of the study drug
  • People who agree to participate voluntarily, sign a consent form, and commit to attending follow-up appointments

Who may not be able to join:

  • People who have received chemotherapy, radiotherapy (other than for pain relief), or immunotherapy in the 3 weeks before starting the trial (bone-strengthening drugs called bisphosphonates are allowed)
  • People with brain or central nervous system metastases that are not well controlled, or that require ongoing medication such as steroids to manage symptoms
  • People who have had a significant heart condition in the past 6 months, such as heart failure, chest pain (angina), heart attack, or serious irregular heart rhythms
  • People who still have ongoing side effects rated grade 1 or higher from previous cancer treatments (with some exceptions, such as hair loss, that researchers may decide do not apply — confirm with trial site)
  • People who have had major surgery within 3 weeks before the trial starts (minor procedures such as fitting a port or line are generally not included in this)
  • People who are currently pregnant or breastfeeding
  • People who have had another type of cancer in the past 5 years, other than fully cured skin basal cell carcinoma or cervical carcinoma in situ

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 2 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.

GP referral letter

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Trial details

Status
Recruiting
Phase
Phase 2
Registry
ClinicalTrials.gov
Start date
30 December 2022
Est. completion
1 December 2025

Where this trial is recruiting

🇨🇳 China

Primary endpoints

Overall response rate (ORR)

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: 2 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