Breast Cancer Trial, Recruiting NCT04360330 Sponsor: University of Miami Condition: Breast Cancer
Back to Breast Cancer

Breast Cancer Trial, Recruiting

NCT04360330
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:

  • Women aged 50 or older
  • People who have received results from an Oncotype or MammaPrint genetic test before starting treatment
  • People with a laboratory-confirmed diagnosis of invasive breast cancer
  • People whose cancer is at an early stage, classified as T1N0M0 (a small tumour with no spread to lymph nodes or other parts of the body)
  • People whose cancer tests positive for estrogen and/or progesterone receptors, and negative for the HER2 protein
  • People with cancer in only one area of the breast (not in multiple spots)
  • People who are reasonably active and able to carry out daily activities, rated 0 or 1 on the ECOG scale (confirm with trial site)
  • People who are able to have an MRI scan
  • Women who could become pregnant must agree to use adequate contraception or abstain from sexual activity during the trial, and must have a negative pregnancy test at enrolment
  • People who are able to understand what the trial involves and are willing to sign a consent form

Who may not be able to join:

  • People who do not have a laboratory-confirmed diagnosis of invasive breast cancer
  • People who do not have Oncotype or MammaPrint test results available before treatment begins
  • People whose cancer has spread to other parts of the body (metastatic disease)
  • People rated 2, 3, or 4 on the ECOG activity scale, meaning their daily functioning is significantly limited
  • People who are unable to have an MRI scan
  • People who have previously had radiation treatment to the chest area
  • People with a history of certain connective tissue diseases, including lupus, scleroderma, or dermatomyositis
  • People with a serious medical or psychiatric condition that the trial investigators believe would interfere with participation
  • People diagnosed with another cancer (other than certain skin cancers) within the last five years
  • People who are unable to give consent, are currently pregnant or breastfeeding, or are incarcerated

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: Cristiane Takita, MD, MBA, University of Miami

Phone: 305-243-0124

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
Registry
ClinicalTrials.gov
Start date
5 August 2020
Est. completion
1 May 2026

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Recommended Phase 2 Dose (RP2D) of Pre-Operative SABER

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