Breast Cancer Trial, Recruiting NCT05578053 Sponsor: Hebei Medical University Fourth Hospital Condition: Breast Cancer
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Breast Cancer Trial, Recruiting

NCT05578053
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:

  • People aged 18 or older, including men, postmenopausal women, and premenopausal or perimenopausal women (premenopausal or perimenopausal women must be willing to receive hormone-suppressing injections called LHRH agonists during the study)
  • People whose breast cancer has been confirmed by a pathology test to be hormone receptor (HR)-positive, and whose cancer has come back or spread to other parts of the body in a way that cannot be fully treated with surgery or radiation
  • People whose general health and ability to carry out daily activities falls within a certain range, as measured by a standard medical scoring system called ECOG (scores 0–2, meaning fully active to capable of limited self-care)
  • Women of childbearing age whose pregnancy test (done within 28 days before joining) comes back negative, and all participants who are willing to use a highly effective form of contraception throughout the study and for one year after the last dose
  • Women who are not currently pregnant or breastfeeding
  • People who are not currently taking part in another clinical trial at the same time
  • People who have read and signed an informed consent form and are willing and able to attend scheduled visits, follow the treatment plan, and complete required tests and procedures

Who may not be able to join:

  • People with serious or uncontrolled health conditions, such as uncontrolled high blood pressure, active bleeding problems, active infections (including hepatitis B, hepatitis C, or HIV), or significant damage to bone marrow, liver, or kidney function — where the treating doctor believes the risks would outweigh the benefits
  • People who are still experiencing significant side effects (grade 3 or higher on a standard medical scale) from a previous cancer treatment at the time this new treatment would begin
  • People with a known allergy or sensitivity to the study drug (dalpiciclib), its inactive ingredients, or to other drugs with a similar chemical structure
  • People whom the trial investigator considers unsuitable for the study for any other reason

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
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.

Contact this trial

Principal Investigator: Cuizhi Geng Cuizhi Geng, archiater, Hebei Medical University Fourth Hospital

Phone: +8613503216325

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
Not Applicable
Sponsor
Hebei Medical University Fourth Hospital
Registry
ClinicalTrials.gov
Start date
13 September 2024
Est. completion
1 December 2028

Where this trial is recruiting

🇨🇳 China

Primary endpoints

PFS; AE

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