Rifaximin for the Treatment of Gastrointestinal Toxicities Related to Pertuzumab-Based Therapy in Patients With Stage I-III HER2 Positive Breast Cancer

Overview

About this study

This phase II trial studies how well rifaximin works for the treatment of gastrointestinal toxicities related to pertuzumab-based therapy in patients with stage I-III HER2 positive breast cancer. Rifaximin may reduce the incidence and severity of pertuzumab induced gastrointestinal toxicities without interrupting or delaying the chemotherapy schedule.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria - Pre-Registration:

  • Age ≥ 18 years.
  • Histological confirmation of HER2 positive breast cancer stage I-III per AJCC staging 8th edition.
  • Provide written informed consent.
  • Breast cancer patients who will be receiving pertuzumab-based chemotherapy with either TCHP (docetaxel, carboplatin, trastuzumab, and pertuzumab) or docetaxel/paclitaxel, trastuzumab, and pertuzumab.
  • ECOG Performance Status (PS) 0, 1, or 2.
  • The following laboratory values obtained ≤ 30 days prior to pre-registration:
    • Hemoglobin ≥ 10.0 g/dL;
    • Absolute neutrophil count (ANC) ≥ 1.5 x 10^9/L;
    • Platelet count ≥ 100 x 109/L;
    • Total Bilirubin ≤ 1.5 x ULN (institutional upper limit of normal);
    • AST (SGOT)/ALT (SGPT) ≤ 2.5 x ULN;
    • Serum or plasma creatinine ≤ 1.5 x ULN;
    • Calculated creatinine clearance ≥ 45 ml/min using the Cockcroft-Gault formula below:

      Cockcroft-Gault Equation:

      Creatinine clearance for males = (140 - age)(weight in kg)(72)(serum creatinine in mg/dL)

      Creatinine clearance for females = (140 - age)(weight in kg)(0.85)(72)(serum creatinine in mg/dL).

  • Negative serum pregnancy test done ≤30 days prior to pre-registration, for person of childbearing potential only.
  • Willingness to return to enrolling institution for follow-up (during the Active Monitoring Phase of the study).
  • Willingness to provide mandatory stool  specimen for correlative research.
  • Ability to complete questionnaire(s) by themselves or with assistance.

Inclusion Criteria - Registration:

  • Received pertuzumab based regimens in the adjuvant or neoadjuvant setting.
  • The following laboratory values obtained ≤ 14 days prior to registration:
    • Hemoglobin ≥ 8.0 g/dL;
    • Absolute neutrophil count (ANC) ≥ 1.5 x 10^9/L;
    • Platelet count ≥ 100 x 10^9/L;
    • Total Bilirubin ≤ 1.5 x ULN (institutional upper limit of normal);
    • AST (SGOT)/ALT (SGPT) ≤ 2.5 x ULN;
    • Serum or plasma creatinine ≤ 1.5 x ULN
    • Calculated creatinine clearance ≥ 45 ml/min using the Cockcroft-Gault formula below:
    • Cockcroft-Gault Equation:

      Creatinine clearance for males = (140 - age)(weight in kg)(72)(serum creatinine in mg/dL);

      Creatinine clearance for females = (140 - age)(weight in kg)(0.85)(72)(serum creatinine in mg/dL).

Exclusion Criteria - Pre-Registration:

  • History of myocardial infarction ≤ 6 months prior to pre-registration, or congestive heart failure requiring use of ongoing maintenance therapy for life-threatening ventricular arrhythmias.
  • Failure to recover from acute, reversible effects of prior therapy regardless of interval since last treatment.
    • EXCEPTION: Grade 1 peripheral (sensory) neuropathy that has been stable for at least 3 months since completion of prior treatment
  • Uncontrolled intercurrent non-cardiac illness including, but not limited to:
    • Ongoing or active infection;
    • Psychiatric illness/social situations; 
    • Dyspnea at rest due to complications of advanced malignancy or other disease that requires continuous oxygen therapy;
    • Any other conditions that would limit compliance with study requirements.
  • Immunocompromised patients and patients known to be human immunodeficiency virus (HIV) positive and currently receiving antiretroviral therapy. 
    • NOTE: Patients known to be HIV positive, but without clinical evidence of an immunocompromised state, are eligible for this trial.
  • Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm (adjust to protocol if applicable).
  • Any of the following because this study involves an agent whose genotoxic, mutagenic and teratogenic effects on the developing fetus and newborn are unknown:
    • Pregnant women;
    • Nursing women;
    • Women of childbearing potential who are unwilling to employ adequate contraception.
  • Current colostomy or ileostomy.
  • History of inflammatory bowel disease.
  • History of irritable bowel syndrome.
  • History of arteriovenous malformations.
  • History of gastrointestinal bleeds.
  • Previous surgical resection of the small bowel or colon.
  • Previous allergy to rifaximin or its derivatives.

Eligibility last updated 8/19/21. Questions regarding updates should be directed to the study team contact.

 

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Jacksonville, Fla.

Mayo Clinic principal investigator

Saranya Chumsri, M.D.

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

More information

Publications

Publications are currently not available

Additional contact information

Cancer-related trials contact form

Phone: 855-776-0015 (toll-free)

International patient clinical studies questions