What side effects are associated with this type of intervention?

Common treatments for breast cancer include surgery, chemotherapy, radiation therapy, hormone therapy, and targeted therapy. Surgery can lead to infections, pain, and lymphedema. Chemotherapy often causes nausea, hair loss, fatigue, and increased risk of infections. Radiation therapy can result in skin irritation, fatigue, and breast swelling. Hormone therapy may cause hot flashes, mood swings, and increased risk of blood clots. Targeted therapies, such as HER2 inhibitors, can lead to heart problems and diarrhea. In the context of microbiome modulation, reducing Staphylococcus and Pseudomonas abundance aims to prevent infections, which are a common complication in breast cancer treatments involving surgery and immunosuppressive therapies.

What prior FDA approvals exist?

FDA-approved treatments for breast cancer include a variety of chemotherapeutic agents, hormone therapies, and targeted therapies such as trastuzumab (Herceptin) for HER2-positive breast cancer, and aromatase inhibitors like anastrozole (Arimidex) for hormone receptor-positive breast cancer. While these treatments focus on targeting cancer cells, infection prevention, particularly in post-surgical settings like mastectomy with tissue expanders, is crucial. Strategies to reduce infections from pathogens like Staphylococcus and Pseudomonas include prophylactic antibiotics and careful surgical techniques. Although direct microbiome modulation to prevent infections is not a standard FDA-approved treatment for breast cancer, ongoing research in this area may offer new preventive strategies in the future.

What other types of research exist?

Promising novel alternatives to microbiome modulation for preventing infections in breast cancer patients include the use of triclosan-coated sutures, which have been shown to reduce the incidence of wound infections, and the gentamicin-collagen sponge, which has demonstrated efficacy in surgical site infection prophylaxis. Additionally, the use of vancomycin powder in surgical procedures has been effective in reducing infection rates. These methods offer targeted antimicrobial action and have been supported by recent clinical evidence.

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Antibiotic

Cephalexin for Surgical Infection Prevention

Phase 2

Recruiting

Led By Merisa Piper, MD

Research Sponsored by University of California, San Francisco

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients must have histologically confirmed breast malignancy OR genetic predisposition to breast cancer

Age >= 18 years

Must not have

Male patients

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 90 days

Awards & highlights

No Placebo-Only Group

Summary

This trial is studying whether giving antibiotics after breast reconstruction surgery can prevent infections. It focuses on patients who have had a mastectomy and are getting implants. The study aims to see if antibiotics make a difference in preventing infections.

Who is the study for?

This trial is for adults over 18 with breast cancer or a genetic risk for it, who are planning to have mastectomy and immediate tissue expander or implant placement. They must be able to consent and at least 4 weeks post-chemo or radiation. Excluded are those with significant health risks, recent antibiotic use, pregnancy, breastfeeding, allergy to study antibiotics, males, and recent probiotic use.

What is being tested?

The trial studies the link between the abundance of Staphylococcus/Pseudomonas in breast tissue microbiome before mastectomy and the risk of infection after placing tissue expanders/implants. Cephalexin's effectiveness against these infections is being tested.

What are the potential side effects?

Cephalexin may cause side effects like digestive issues (diarrhea), allergic reactions (rashes), nausea, vomiting, dizziness, tiredness but varies from person to person.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have a confirmed diagnosis of breast cancer or a genetic risk for it.

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I am 18 years old or older.

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I am scheduled for a mastectomy with immediate tissue expander or implant placement.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am a male.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 90 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~90 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 90 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Correlation of the change in breast microbiome over time with total duration of antibiotics (Cohort A only)

Proportion of any samples successfully producing microbiome data

Proportion of aspirate samples obtained successfully overall

+3 more

Secondary study objectives

Number of overall identified microbes

Proportion of participants with post-operative infection

Shannon Diversity Index Score for species of microbiome

Side effects data

From 2013 Phase 2 & 3 trial • 2265 Patients • NCT00729937

21%

Nausea

16%

Headache

15%

Diarrhoea

14%

Abscess

10%

Vomiting

Dizziness

Abdominal pain upper

Constipation

Pyrexia

Rash

Cellulitis

100%

80%

60%

40%

20%

Study treatment Arm

Abscess, Placebo

Abscess, TMP/SMX

Infected Wound, TMP/SMX

Infected Wound, Clindamycin

Cellulitis, Cephalexin and TMP/SMX

Cellulitis, Cephalexin

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Cohort A: Standard antibioticsExperimental Treatment1 Intervention

Receive standard pre-incision antibiotics and 24-hour perioperative antibiotics - Prescribed standard postoperative antibiotics to take for at least 7 days post-operatively

Group II: Cohort B: No antibioticsActive Control1 Intervention

Receive standard pre-incision antibiotics and 24-hour perioperative antibiotics - No antibiotics post-operatively, unless patient develops clinical evidence of infection

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cephalexin

2012

Completed Phase 4

~4070

0 / 4Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for breast cancer include surgery, chemotherapy, radiation therapy, hormone therapy, and targeted therapy. Surgery involves the physical removal of the tumor, while chemotherapy uses drugs to kill rapidly dividing cancer cells. Radiation therapy uses high-energy rays to destroy cancer cells. Hormone therapy blocks hormones like estrogen that can promote cancer growth, and targeted therapy uses drugs to target specific molecules involved in cancer cell growth and survival. In the context of microbiome modulation, reducing the abundance of Staphylococcus and Pseudomonas is crucial as these bacteria can cause infections, particularly in immunocompromised patients undergoing cancer treatment. Preventing such infections can improve treatment outcomes and overall patient health.