Breast Cancer Trial, Recruiting NCT05977036 Sponsor: Washington University School of Medicine Condition: Breast Cancer
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Breast Cancer Trial, Recruiting

NCT05977036
Recruiting Not Applicable

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 have been diagnosed with breast cancer that has spread or cannot be surgically removed, and your cancer is hormone receptor-positive (HR+) and HER2-negative.
  • You are planning to start a standard treatment combining hormone therapy with a type of drug called a CDK4/6 inhibitor (preferably ribociclib, though alternatives may be allowed) as your first treatment for this advanced cancer.
  • You have had previous treatment for early-stage breast cancer, including hormone therapy or chemotherapy — this is still allowed.
  • If you previously took a CDK4/6 inhibitor, you may still be eligible as long as you finished that treatment more than 12 months before joining the study.
  • Your cancer can be measured or tracked using standard imaging guidelines (including cancer that has spread only to the bones).
  • You are at least 18 years old.
  • You are well enough to carry out basic daily activities (confirm with trial site for exact fitness level required).
  • You are post-menopausal, which may include: being age 60 or older; being under 60 with a uterus and no periods for 12 or more months in a row; having had both ovaries or your uterus removed; or being pre- or peri-menopausal but having your ovarian function suppressed through medication or surgery.
  • You are able to understand and sign the study consent form (or have someone authorized to do this on your behalf).

Who may not be able to join:

  • You have already received chemotherapy to treat your cancer after it spread (metastatic stage).
  • You have or have had another type of cancer that could interfere with the study's results or your safety (confirm with trial site for specific situations).
  • You are currently taking part in another clinical trial for the treatment of metastatic breast cancer.

Note: This trial also has specific eligibility requirements for the doctors involved, which do not apply to patients directly.


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 30 June 2026
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

GP referral letter

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Trial details

Status
Recruiting
Phase
Not Applicable
Registry
ClinicalTrials.gov
Start date
25 September 2024
Est. completion
30 September 2034

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Progression-free survival (PFS) in patients who remain on CKD4/6i (patients with suppressed TKa levels at cycle 1 day 15); Clinical benefit rate (CBR) in patients who remain on CDK4/6i; Progression-free survival (PFS) in patients who switch to an alternate therapy (patients with unsuppressed TKa levels at cycle 1 day 15)

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: 30 June 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