Phase 2 Breast Cancer Trial, Recruiting NCT07164976 Sponsor: Nagoya City University Condition: Breast Cancer
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Phase 2 Breast Cancer Trial, Recruiting

NCT07164976
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 have been diagnosed with invasive breast cancer confirmed through a laboratory tissue test.
  • People whose cancer is hormone receptor-positive (meaning the cancer cells respond to the hormones oestrogen and/or progesterone) and HER2-negative (a specific protein is not overactive on the cancer cells), based on specific test measurements (confirm with trial site for exact values).
  • People whose breast cancer has spread, come back, or cannot be removed by surgery (also called advanced, recurrent, or Stage IV breast cancer).
  • People aged 18 or older at the time of registration.
  • People who are generally well enough to carry out daily activities, as measured by a standard medical scale called the ECOG Performance Status of 0 or 1 — roughly meaning fully active or able to do light activity (confirm with trial site).

Who may not be able to join:

  • People whose cancer has spread to internal organs and is causing symptoms, or for whom hormone-based treatment has been judged unsuitable by their doctor.
  • People who have previously received hormone therapy or chemotherapy specifically for advanced or recurrent breast cancer.
  • People who have previously taken a type of cancer medicine called a CDK4/6 inhibitor, either before or after surgery, or for advanced disease.
  • People who have taken hormone-based therapy after surgery within the 35 days before the study start date.
  • People who have another active cancer diagnosis, with some exceptions such as certain skin cancers that have been removed, or other cancers where the person has been cancer-free for five or more years (confirm with trial site for full list of exceptions).
  • People who have had a serious allergic reaction to ribociclib, anastrozole, or any ingredients in these medicines, including those with soy or peanut allergies, or certain sugar intolerances.

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 22 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: Hiroji Iwata, MD. PhD., Nagoya City University

Phone: +81-52-853-8020

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
Nagoya City University
Registry
ClinicalTrials.gov
Start date
1 October 2025
Est. completion
1 September 2029

Where this trial is recruiting

🇯🇵 Japan

Primary endpoints

Phase 1b part: Dose Limiting Toxicity; Phase 2 part: Overall response rate

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: 22 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