Phase 2 Breast Cancer Trial, Recruiting NCT07065435 Sponsor: The First Affiliated Hospital with Nanjing Medical University Condition: Breast Cancer
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Phase 2 Breast Cancer Trial, Recruiting

NCT07065435
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 18 years of age or older.
  • People with breast cancer that has spread or is at an advanced stage, where laboratory testing has confirmed the cancer is HER2-positive at a specific level (IHC 3+, or IHC 2+ with gene amplification confirmed by a further test).
  • People who have previously been treated with a drug called trastuzumab deruxtecan (T-DXd), and whose cancer continued to grow or spread during or after that treatment.
  • People who have at least one tumour that can be measured on scans, using standard measurement guidelines called RECIST v1.1.
  • People whose general health and ability to carry out daily activities is rated as fully active or restricted only in physically strenuous activity (ECOG score of 0 or 1).
  • People whose blood counts, liver function, kidney function, and other organ measures fall within the ranges required by the trial (confirm specific thresholds with trial site).
  • People with an estimated life expectancy of at least 12 weeks.
  • People who are able to understand and are willing to sign a written consent form.

Who may not be able to join:

  • People who have previously been treated with a drug called disitamab vedotin (RC48).
  • People who currently have an active infection (bacterial, viral, or fungal) that requires treatment with systemic medication.
  • People with a history of a lung condition called interstitial lung disease, or inflammation of the lungs (pneumonitis) not caused by infection, that required treatment with corticosteroid medicines.
  • People with heart or cardiovascular conditions that are not well controlled, including uncontrolled high blood pressure, a heart attack within the past 6 months, unstable chest pain (angina), or heart failure.
  • People who are currently pregnant or breastfeeding.
  • People who have, or have had, another type of cancer — unless it was a specific type of skin cancer (basal cell carcinoma) or early-stage cervical cancer that was adequately treated, or unless the person has been cancer-free from the other cancer for 5 or more years.
  • People who are currently participating in another clinical trial that involves an investigational (unapproved) treatment that has not yet been completed.
  • People with any other condition that, in the treating doctor's judgement, could affect the ability to follow the study requirements or could affect safety (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 28 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

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
Recruiting
Phase
Phase 2
Registry
ClinicalTrials.gov
Start date
1 January 2024
Est. completion
1 December 2025

Where this trial is recruiting

🇨🇳 China

Primary endpoints

Objective 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: 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