Phase 1 Breast Cancer Trial, Recruiting NCT07604571 Sponsor: Novartis Pharmaceuticals Condition: Breast Cancer
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Phase 1 Breast Cancer Trial, Recruiting

NCT07604571
Recruiting Phase 1

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 hormone receptor-positive, HER2-negative advanced breast cancer (HR+/HER2- aBC) whose cancer has grown or spread during or after at least one hormonal treatment combined with a specific type of targeted therapy called a CDK4/6 inhibitor, plus at least one other treatment, and for whom no standard treatment options remain (this applies to the dose escalation part of the trial).
  • People with HR+/HER2- advanced breast cancer whose cancer has grown or spread during or after hormonal treatment combined with a CDK4/6 inhibitor, who have had no more than two prior hormonal treatment regimens for advanced disease, and who have not previously received chemotherapy or antibody-drug treatments for advanced disease (this applies to the dose expansion part of the trial).

Who may not be able to join:

  • People whose bone marrow or organ function (such as liver or kidneys) is not working well enough, based on blood test results.
  • People with serious heart problems or significantly reduced heart function.
  • People currently using hormone replacement therapy.
  • Women who could become pregnant but are unwilling to use highly effective contraception, as well as women who are pregnant or breastfeeding.
  • For the combination treatment parts of the trial: people whose cancer has spread to internal organs and is causing symptoms, or whose overall disease burden means hormonal treatment would not be appropriate (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 8 July 2026
Phase 1: approximately ~10% 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: 1-888-669-6682

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 1
Registry
ClinicalTrials.gov
Start date
28 May 2026
Est. completion
8 June 2032

Where this trial is recruiting

🇯🇵 Japan 🇸🇬 Singapore 🇺🇸 United States

Primary endpoints

Incidence and severity of dose-limiting toxicities (DLTs); Incidence and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs); Frequency of dose interruptions, reductions and discontinuations; Dose intensity

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: 8 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