Phase 2 Breast Cancer Trial, Recruiting NCT03946202 Sponsor: Institute of Cancer Research, United Kingdom Condition: Breast Cancer
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Phase 2 Breast Cancer Trial, Recruiting

NCT03946202
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:

  • Adults aged 18 years or older
  • People with locally advanced breast cancer that started in the breast, or breast cancer that has come back in the same area, with or without spread to other parts of the body (if the cancer has spread, it must be stable or limited to a small number of areas)
  • People whose doctors have determined they need high-dose radiotherapy to manage the cancer in the long term
  • People who are physically and mentally well enough to receive high-dose radiotherapy
  • People whose tumour can be reached safely with a needle injection directly into it
  • People who are able to undergo MRI scans as part of the study protocol
  • People with at least one tumour that measures between 30mm and 150mm (3cm to 15cm) as seen on ultrasound or MRI
  • People with a life expectancy of 12 months or more
  • Women who could become pregnant must have a negative pregnancy test before radiotherapy starts, and must be willing to use contraception from the time of consent until 3 months after radiotherapy ends
  • People who have given written consent to participate in the trial

Who may not be able to join:

  • People who have previously had radiotherapy to the same area being treated in this trial
  • People whose tumour measures less than 30mm or more than 150mm on ultrasound or MRI
  • People whose tumour is located near major blood vessels or nerves (such as the brachial plexus), making it unsafe to inject directly into it
  • People currently receiving certain cancer treatments at the same time as radiotherapy — some treatments are permitted (including Herceptin, Pertuzumab, Denosumab, hormone therapies, and bisphosphonates), but other chemotherapy or biological therapies must be stopped at least 3 weeks before radiotherapy begins
  • People who are pregnant or currently breastfeeding
  • People who have had an allergic reaction to any ingredient in the study drug (KORTUC)

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

Principal Investigator: Navita Somaiah, The Institute of Cancer Research & The Royal Marsden NHS Foundation Trust

Phone: +44(0)2086613460

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
Sponsor
Institute of Cancer Research, United Kingdom
Registry
ClinicalTrials.gov
Start date
16 June 2020
Est. completion
30 June 2028

Where this trial is recruiting

🇮🇳 India 🇬🇧 United Kingdom

Primary endpoints

Complete tumour response based on best response assessed by contrast enhanced MRI according to criteria outlined in Section 3.2.1 of the trial protocol, performed up to and including 12 months post radiotherapy

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