Diarrhea Prevention and Prophylaxis With Crofelemer in HER2 Positive Breast Cancer Patients

NCT02910219 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: MHRI GU 2015-0547
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 4

Brief Summary

Chemotherapy induced diarrhea is seen in up to 40-80% of patients receiving this treatment for HER2 positive locally advanced or metastatic breast cancer. This diarrhea can significantly impact a patient's quality of life and ability to tolerate chemo/anti-HER2 therapy. This study will look at the efficacy of the drug crofelemer in preventing diarrhea in breast cancer patients.

Conditions

Breast Cancer

Keywords

HER2; pertuzumab; trastuzumab; docetaxel; paclitaxel; carboplatin; crofelemer; chemotherapy induced diarrhea

Outcome Measures

Primary Outcomes (1)

• Diarrhea for >= 2 Consecutive Days

  Percentage of participants with any grade (based on CTCAE 4.0) diarrhea lasting 2 or more consecutive days during cycles 1 and 2 of chemotherapy.

  Cycle 1, Cycle 2 (each cycle is 21 days)

Secondary Outcomes (9)

• Diarrhea Any Grade

  Cycle 1, Cycle 2 (each cycle is 21 days)

• Grade 3-4 Diarrhea

  Cycle 1, Cycle 2 (each cycle is 21 days)

• Diarrhea Onset

  from baseline through Cycle 3 (21 day cycles)

• Diarrhea Duration

  Cycle 1, Cycle 2 (each cycle is 21 days)

• Duration Grade 3-4 Diarrhea

  End of Cycle 2 (each cycle is 21 days)

Study Arms (2)

Crofelemer

EXPERIMENTAL

Patients on the treatment arm will take one tablet of crofelemer twice a day (each tablet is 125 mg), to be swallowed whole without chewing or crushing, during cycles 1-2 of chemotherapy with THP or TCHP. Patient will be monitored off crofelemer during cycle 3 of chemotherapy.

Drug: Crofelemer

Control

NO INTERVENTION

Patients on the control arm will be on the study for cycles 1-3 of THP or TCHP. Patients on the control arm will not receive crofelemer at any time on this study.

Interventions

Crofelemer DRUG

Crofelemer 125 mg BID during cycles 1-2 of THP or TCHP

Crofelemer

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Willing and able to provide written informed consent;
• Men and women ≥18 years of age;
• Pathologically confirmed diagnosis of HER2 positive breast cancer of any stage (previous treatment is allowed without limits on lines of prior therapy);
• Scheduled to receive at least 3 consecutive cycles of THP or TCHP;
• Performance status of 0-2 according to the ECOG scale;
• Negative pregnancy test at time of informed consent for women of childbearing potential;
• Able to read, understand, follow the study procedure and complete crofelemer, rescue medication, and bowel movement diaries;
• Patients may enroll simultaneously on this study and other studies, including but not limited to NSABP B52;
• Patients with brain metastases (including concurrent steroid treatment) are allowed on this study.
• Left Ventricular Ejection Fraction (LVEF) greater or equal to 50% at baseline as determined by either ECHO or MUGA

You may not qualify if:

• Pregnant and/or breastfeeding;
• Ongoing irritable bowel syndrome (IBS) or colitis (including but not limited to ulcerative colitis, Crohn's disease, microscopic colitis, etc.);
• Use of investigational drugs within 3 weeks of signing consent or foreseen use during the study;
• Use of chemotherapy, trastuzumab, or pertuzumab within the past 3 weeks;
• Use of antibiotics within the past 7 days (up to 2 prophylactic doses of antibiotics for procedures including, but not limited to port placement, is permitted);
• Any type of ostomy;
• Total colectomy;
• Fecal incontinence;
• Ongoing radiation induced diarrhea or constipation or planned radiotherapy to the abdomen or pelvis while on study;
• Active systemic infection requiring ongoing intervention, including but not limited to oral and intravenous antibiotics, anti-fungals, anti-parasites, anti-virals;
• Abdominal or pelvic surgery without recovery of bowel function;
• Inadequate organ function for starting THP or TCHP, which may include the following laboratory results within 28 days prior to signing consent:
• Total bilirubin \> upper limit of normal (ULN) (unless the patient has documented Gilbert's syndrome)
• Serum creatinine \> 2.0 mg/dL or 177 μmol/L
• AST (SGOT) and ALT (SPGT) \> 2.5 ULN.

Sponsors & Collaborators

• Sandra Swain: lead
• Lombardi Comprehensive Cancer Center: collaborator
• Medstar Health Research Institute: collaborator
• Genentech, Inc.: collaborator
• Napo Pharmaceuticals, Inc.: collaborator

Study Sites (4)

Lombardi Comprehensive Cancer Center

Washington D.C., District of Columbia, 20007, United States

Location

MedStar Franklin Square Cancer Center at Loch Raven Campus

Baltimore, Maryland, 21218, United States

Location

Harry and Jeanette Weinberg Cancer Institute

Baltimore, Maryland, 21237, United States

Location

John Theurer Cancer Center at Hackensack Univ

Hackensack, New Jersey, 07601, United States

Location

Related Publications (2)

• Gao JJ, Tan M, Pohlmann PR, Swain SM. HALT-D: A Phase II Evaluation of Crofelemer for the Prevention and Prophylaxis of Diarrhea in Patients With Breast Cancer on Pertuzumab-Based Regimens. Clin Breast Cancer. 2017 Feb;17(1):76-78. doi: 10.1016/j.clbc.2016.08.005. Epub 2016 Aug 27.

  PMID: 27692565 BACKGROUND

• Pohlmann PR, Graham D, Wu T, Ottaviano Y, Mohebtash M, Kurian S, McNamara D, Lynce F, Warren R, Dilawari A, Rao S, Mainor C, Swanson N, Tan M, Isaacs C, Swain SM. HALT-D: a randomized open-label phase II study of crofelemer for the prevention of chemotherapy-induced diarrhea in patients with HER2-positive breast cancer receiving trastuzumab, pertuzumab, and a taxane. Breast Cancer Res Treat. 2022 Dec;196(3):571-581. doi: 10.1007/s10549-022-06743-9. Epub 2022 Oct 25.

  PMID: 36280642 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Interventions

crofelemer

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Sandra M. Swain, MD, FACP, FASCO
• Organization: Georgetown University

Sandra.Swain@georgetown.edu

202-687-4600

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Medical Oncologist

Study Record Dates

• First Submitted: September 19, 2016
• First Posted: September 21, 2016
• Study Start: January 31, 2017
• Primary Completion: November 23, 2020
• Study Completion: November 23, 2020
• Last Updated: October 24, 2022
• Results First Posted: October 24, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)