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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-18

Study Completion Date

2022-12-27

Brief Summary

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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.

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Detailed Description

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PRIMARY OBJECTIVE:

I. To evaluate the reduction rate of grade \>= 2 abdominal toxicities, including abdominal distension, abdominal pain, diarrhea, dyspepsia, stomach pain, and typhlitis according to the National Cancer Institute Common Terminology for Adverse Events version 5.0 (NCI CTCAE v5.0) with the use of rifaximin in stage II-III HER-2 positive breast cancer patients with pertuzumab induced gastrointestinal toxicities.

SECONDARY OBJECTIVES:

I. Evaluate dose reductions, dose delays and discontinuation of treatment with pertuzumab due to gastrointestinal side effects.

II. Evaluate and measure the change in the Bristol stool scale before and after rifaximin treatment.

III. Evaluate and measure the change in the 4-point Likert scale patient questionnaire before and after rifaximin treatment.

CORRELATIVE STUDY OBJECTIVES:

I. Evaluate changes in the fecal microbiome, hydrogen breath test, and permeability test before and after rifaximin.

II. Evaluate changes in the fecal microbiome, hydrogen breath test, and permeability test before and after pertuzumab-based chemotherapy.

III. Evaluate the difference in the fecal microbiome, hydrogen breath test, and permeability test among patients with or without pertuzumab induced gastrointestinal toxicities (PIGT).

OUTLINE: Patients are assigned to 1 of 2 arms.

ARM I (GRADE \>= 2 PIGT): Patients that experience PIGT after receiving first standard of care cycle of pertuzumab-based chemotherapy receive rifaximin orally (PO) twice daily (BID) on days 1-5 and standard of care pertuzumab-based chemotherapy on day 1. Treatment repeats every 21 days for up to 5 cycles in the absence of disease progression or unacceptable toxicity.

ARM II (GRADE =\< 1 PIGT): Patients that do not experience PIGT after receiving first standard of care cycle of pertuzumab-based chemotherapy continue receiving standard of care pertuzumab-based chemotherapy on day 1. Treatment repeats every 21 days for up to 5 cycles in the absence of disease progression or unacceptable toxicity.

Conditions

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Anatomic Stage I Breast Cancer AJCC v8 Anatomic Stage IA Breast Cancer AJCC v8 Anatomic Stage IB Breast Cancer AJCC v8 Anatomic Stage II Breast Cancer AJCC v8 Anatomic Stage IIA Breast Cancer AJCC v8 Anatomic Stage IIB Breast Cancer AJCC v8 Anatomic Stage III Breast Cancer AJCC v8 Anatomic Stage IIIA Breast Cancer AJCC v8 Anatomic Stage IIIB Breast Cancer AJCC v8 Anatomic Stage IIIC Breast Cancer AJCC v8 HER2 Positive Breast Carcinoma Prognostic Stage I Breast Cancer AJCC v8 Prognostic Stage IA Breast Cancer AJCC v8 Prognostic Stage IB Breast Cancer AJCC v8 Prognostic Stage II Breast Cancer AJCC v8 Prognostic Stage IIA Breast Cancer AJCC v8 Prognostic Stage IIB Breast Cancer AJCC v8 Prognostic Stage III Breast Cancer AJCC v8 Prognostic Stage IIIA Breast Cancer AJCC v8 Prognostic Stage IIIB Breast Cancer AJCC v8 Prognostic Stage IIIC Breast Cancer AJCC v8

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Arm I (rifaximin, pertuzumab-based chemotherapy)

Patients that experience PIGT after receiving first standard of care cycle of pertuzumab-based chemotherapy receive rifaximin PO BID on days 1-5 and standard of care pertuzumab-based chemotherapy on day 1. Treatment repeats every 21 days for up to 5 cycles in the absence of disease progression or unacceptable toxicity.

Group Type EXPERIMENTAL

Best Practice

Intervention Type OTHER

Given standard of care pertuzumab-based chemotherapy

Questionnaire Administration

Intervention Type OTHER

Ancillary studies

Rifaximin

Intervention Type DRUG

Given PO

Arm II (pertuzumab-based chemotherapy)

Patients that do not experience PIGT after receiving first standard of care cycle of pertuzumab-based chemotherapy continue receiving standard of care pertuzumab-based chemotherapy on day 1. Treatment repeats every 21 days for up to 5 cycles in the absence of disease progression or unacceptable toxicity.

Group Type ACTIVE_COMPARATOR

Best Practice

Intervention Type OTHER

Given standard of care pertuzumab-based chemotherapy

Questionnaire Administration

Intervention Type OTHER

Ancillary studies

Interventions

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Best Practice

Given standard of care pertuzumab-based chemotherapy

Intervention Type OTHER

Questionnaire Administration

Ancillary studies

Intervention Type OTHER

Rifaximin

Given PO

Intervention Type DRUG

Other Intervention Names

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standard of care standard therapy Xifaxan

Eligibility Criteria

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Inclusion Criteria

* Age \>= 18 years
* Histological confirmation of HER2 positive breast cancer stage I-III per American Joint Committee on Cancer (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
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1, or 2
* Hemoglobin \>= 10.0 g/dL (obtained =\< 30 days prior to pre-registration)
* Absolute neutrophil count (ANC) \>= 1.5 x 10\^9/L (obtained =\< 30 days prior to pre-registration)
* Platelet count \>= 100 x 10\^9/L (obtained =\< 30 days prior to pre-registration)
* Total bilirubin =\< 1.5 x ULN (institutional upper limit of normal) (obtained =\< 30 days prior to pre-registration)
* Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SGPT\]) =\< 2.5 x ULN (obtained =\< 30 days prior to pre-registration)
* Serum or plasma creatinine =\< 1.5 x ULN (obtained =\< 30 days prior to pre-registration)
* Calculated creatinine clearance \>= 45 ml/min using the Cockcroft-Gault formula (obtained =\< 30 days prior to pre-registration)
* 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
* Received pertuzumab based regimens in the adjuvant or neoadjuvant setting
* Hemoglobin \>= 8.0 g/dL (obtained =\< 14 days prior to registration)
* Absolute neutrophil count (ANC) \>= 1.5 x 10\^9/L (obtained =\< 14 days prior to registration)
* Platelet count \>= 100 x 10\^9/L (obtained =\< 14 days prior to registration)
* Total bilirubin =\< 1.5 x ULN (institutional upper limit of normal) (obtained =\< 14 days prior to registration)
* AST (SGOT)/ALT (SGPT) =\< 2.5 x ULN (obtained =\< 14 days prior to registration)
* Serum or plasma creatinine =\< 1.5 x ULN (obtained =\< 14 days prior to registration)
* Calculated creatinine clearance \>= 45 ml/min using the Cockcroft-Gault formula (obtained =\< 14 days prior to registration)

Exclusion Criteria

* 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No