Phase 4 Breast Cancer Trial, Recruiting NCT07220967 Sponsor: Memorial Sloan Kettering Cancer Center Condition: Breast Cancer
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Phase 4 Breast Cancer Trial, Recruiting

NCT07220967
Recruiting Phase 4

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 are female and aged 18 or older
  • People who are planned to have a mastectomy (surgical removal of one or both breasts) due to breast cancer, a genetic risk or strong family history of breast cancer, or another preventive reason
  • People who are planned to have immediate breast reconstruction (reconstruction done at the same time as the mastectomy) using a specific technique called prepectoral tissue expander placement at MSK
  • People with a body mass index (BMI) under 40
  • People who have not smoked or used any nicotine products in the 6 weeks before surgery
  • People without any of the following conditions that would prevent use of a specific antibiotic product called Stimulan beads: high calcium levels in the blood, severe blood vessel or nerve disease, uncontrolled diabetes, pregnancy, or severe degenerative bone disease
  • People with no known allergy to calcium sulfate, vancomycin, or gentamicin (a mineral compound and two types of antibiotics)
  • People who are able to make their own informed decisions about participating

Who may not be able to join:

  • People who are male
  • People under 18 years of age
  • People who are not planning to have a mastectomy with immediate breast reconstruction using the specific technique required by this trial
  • People with a BMI of 40 or higher
  • People who are currently smoking or using nicotine products within 6 weeks of their planned surgery
  • People who have any of the conditions listed above that make the Stimulan antibiotic beads unsuitable for them
  • People with a known allergy to calcium sulfate, vancomycin, or gentamicin
  • People who do not have the capacity to make their own decisions about participating in the trial

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
Phase 4 trials study a drug that has already been approved, monitoring long-term safety and effectiveness in real-world use.

Contact this trial

Principal Investigator: Danielle Rochlin, MD, Memorial Sloan Kettering Cancer Center

Phone: 646-608-8033

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 4
Registry
ClinicalTrials.gov
Start date
21 October 2025
Est. completion
1 October 2027

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Surgical site infections (SSI) incidence (cohort PatientsTissue Expander (TE) + antibiotic beads); Surgical site infections (SSI) incidence (cohort Patients randomized to Tissue Expander (TE) only)

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