Phase 2 Breast Cancer Trial, Recruiting NCT07405801 Sponsor: Hoffmann-La Roche Condition: Breast Cancer
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Phase 2 Breast Cancer Trial, Recruiting

NCT07405801
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 are a man or woman diagnosed with breast cancer that has spread locally or to other parts of the body, and surgery or radiation to cure it is not possible
  • Your breast cancer has been confirmed by a lab test (biopsy or cell sample) to be positive for estrogen receptors (ER) and/or progesterone receptors (PR), meaning the cancer is fuelled by hormones
  • You have not received any previous systemic (whole-body) treatment for advanced or metastatic breast cancer, but your cancer did come back or get worse either during or within 12 months of finishing hormone therapy (specifically an aromatase inhibitor or tamoxifen) after earlier treatment
  • A central laboratory test of your tumour tissue has confirmed a specific genetic profile: no mutation in a gene called PIK3CA, and a particular change on chromosome 8p (confirm with trial site if unfamiliar with these terms)
  • Your cancer can be measured using standard imaging scans, according to specific medical measurement guidelines

Who may not be able to join:

  • You have a specific rare type of breast cancer called metaplastic breast cancer
  • You have had radiotherapy within the 2 weeks before joining the trial
  • Based on national or local treatment guidelines, chemotherapy is considered the most appropriate treatment for you right now (for example, if your cancer is causing a serious organ crisis)
  • You have Type 1 diabetes (any history), or you have Type 2 diabetes that currently requires ongoing medication
  • You have brain or central nervous system (CNS) metastases (cancer that has spread to the brain) that have not been treated or are currently active — however, if your CNS metastases were previously treated and are stable, you may still be eligible
  • You have ever had cancer spread to the membranes surrounding the brain or spinal cord (called leptomeningeal disease or carcinomatous meningitis)

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 14 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: Clinical Trials, Hoffmann-La Roche

Phone: 888-662-6728

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
7 April 2026
Est. completion
19 December 2028

Where this trial is recruiting

🇦🇷 Argentina 🇧🇷 Brazil 🇨🇦 Canada 🇫🇷 France 🇩🇪 Germany 🇮🇹 Italy 🇲🇽 Mexico 🇵🇱 Poland 🇰🇷 South Korea 🇪🇸 Spain 🇬🇧 United Kingdom 🇺🇸 United States

Primary endpoints

Percentage of Participants With Confirmed Objective Response (cORR)

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: 14 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