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Recruiting NCT05020574

Microbiome and Association With Implant Infections

Phase II Interventional Breast Cancer Breast Cancer Female Genetic Predisposition to Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Cephalexin.
Who it may be relevant to
Registry conditions: Breast Cancer, Breast Cancer Female, Genetic Predisposition to Disease. Basic parameters: from 18 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Microbiome and Association With Implant Infections: Investigating the Impact of Antibiotics on the Gut and Breast Microbiomes Post-mastectomy With Implant-based Breast Reconstruction

Overview

The most common tissue expander-related infections are from Staphylococcus and Pseudomonas species. In addition, from breast tissue microbiome studies, Staphylococcus and Pseudomonas show variable abundance across samples. The investigator hypothesizes that participants undergoing mastectomy with high initial abundance of Staphylococcus and/or Pseudomonas are more likely to develop subsequent tissue expander-related infections from these respective organisms.

Detailed description

PRIMARY OBJECTIVE:

I. To determine the feasibility of breast microbiome sampling using the study techniques

SECONDARY OBJECTIVES:

I. To define the differences in the gut and breast microbiomes between participants undergoing mastectomy with implant-based reconstruction who develop post-operative implant infection and those who do not.

II. To determine the effects of post-operative antibiotics on the gut and breast microbiomes after mastectomy with implant-based reconstruction.

OUTLINE: Participants are randomized to 1 of 2 cohorts.

COHORT A: Participants receive postoperative antibiotics to take for at least 7 days post-operatively.

COHORT B: Participants receive no antibiotics post-operatively in the absence of clinical evidence of infection.

Participants are followed up for 90 days.

Interventions

  • Drug Cephalexin
    Given orally (PO)

Primary outcome measures

  • Proportion of tissue samples obtained successfully over time [Time frame: 90 days]
  • Proportion of aspirate samples obtained successfully overall [Time frame: 90 days]
  • Proportion of tissue samples successfully producing microbiome data [Time frame: 90 days]
  • Proportion of aspirate samples successfully producing microbiome data [Time frame: 90 days]
  • Proportion of any samples successfully producing microbiome data [Time frame: 90 days]
  • Correlation of the change in breast microbiome over time with total duration of antibiotics (Cohort A only) [Time frame: 90 days]
Secondary outcome measures (3)
  • Proportion of participants with post-operative infection [Time frame: 90 days]
  • Shannon Diversity Index Score for species of microbiome [Time frame: 90 days]
  • Number of overall identified microbes [Time frame: 90 days]

Eligibility criteria

Inclusion criteria

  • Patients must have histologically confirmed breast malignancy OR genetic predisposition to breast cancer.
  • Age >= 18 years
  • Scheduled to undergo mastectomy with the immediate placement of tissue expanders or implant placement
  • Ability to understand a written informed consent document, and the willingness to sign it
  • At least 4 weeks post-completion of chemotherapy or radiation therapy.

Exclusion criteria

  • Any significant medical condition or laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study
  • Pregnant or breastfeeding
  • Patients who have taken antibiotics within 90 days of the consent date
  • Patients who have taken probiotics within 90 days of the consent date
  • Patients who have a documented or reported allergic reaction to the outlined antibiotics to be used in this study
  • Male patients

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Supportive care

Study locations

United States · 1 center
  • University of California, San Francisco — San Francisco

Identifiers

NCT: NCT05020574 · 217510 · NCI-2021-08985

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗