Phase 1 Breast Cancer Trial, Recruiting NCT06139107 Sponsor: Mridula George, MD Condition: Breast Cancer
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Phase 1 Breast Cancer Trial, Recruiting

NCT06139107
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:

  • People who have been confirmed through lab testing (biopsy or cell sample) to have invasive breast cancer (ductal, lobular, or mixed type) that cannot be felt by touch, with a tumour measuring at least 1.5 cm in size, and no cancer detected in the lymph nodes at the time of diagnosis
  • People whose breast cancer tests positive for hormone receptors (oestrogen or progesterone receptors) and negative for the HER2 protein, based on standard testing guidelines
  • People whose tumour has been given an Oncotype DX Recurrence Score of less than 25 from a biopsy sample (a score that helps predict the likelihood of cancer returning)
  • People who are post-menopausal — if under 60 years old, this means having had no menstrual periods for at least 12 months (without the use of certain treatments), with hormone levels confirming post-menopausal status
  • People with no signs or suspicion that the cancer has spread to other parts of the body
  • People who are in a reasonably good general state of health, rated 2 or below on a standard medical scale used to measure ability to carry out daily activities (confirm with trial site)
  • People who are medically suitable to undergo either breast-conserving surgery (lumpectomy) or full breast removal (mastectomy)
  • People who are able to swallow oral (tablet or capsule) medications
  • People whose blood counts and organ function (including liver) meet minimum levels set by the trial, as measured by standard blood tests

Who may not be able to join:

  • People who have a history of breast cancer in the same breast being treated
  • People who have previously been treated with CDK4/6 inhibitors or aromatase inhibitors (a class of cancer medicines)
  • People who have previously had radiation therapy to the chest wall or the same breast being treated
  • People diagnosed with inflammatory breast cancer
  • People who require chemotherapy before surgery (neoadjuvant chemotherapy)
  • People whose cancer has spread to distant parts of the body (metastatic disease)
  • People for whom surgery is not medically safe
  • People with uncontrolled high blood pressure (above specific levels set by the trial)
  • People with any medical condition or abnormal lab results that the trial doctor believes would put them at unacceptable risk by participating
  • People with a life expectancy of less than 12 weeks
  • People with a known allergy or sensitivity to any of the study drugs
  • People with any significant medical, laboratory, or psychiatric condition that could affect participation
  • People with serious or uncontrolled ongoing health conditions
  • People who have had major surgery within 14 days before joining the trial
  • People who have participated in another clinical trial within the last 30 days (or longer, depending on the treatment involved), or who are currently enrolled in another medical research study
  • People with an active bacterial infection affecting the whole body
  • People with a personal history of fainting due to a heart-related cause, dangerous heart rhythm problems, or sudden cardiac arrest

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 21 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

Principal Investigator: Mridula A George, MD, Cancer Institute of New Jersey Rutgers

Phone: 732-235-9081

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
Sponsor
Mridula George, MD
Registry
ClinicalTrials.gov
Start date
22 August 2024
Est. completion
30 September 2026

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Safety and tolerability of the combination of abemaciclib and radiation as assessed by adverse events (AEs). Using Common Terminology Criteria for Adverse Events (CTCAE v5.0)

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: 21 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