HALT-D: A Phase II Evaluation of Crofelemer for the Prevention and Prophylaxis of Diarrhea in Patients With Breast Cancer on Pertuzumab-Based Regimens. (Record no. 2733)

MARC details
000 -LEADER
fixed length control field 04012nam a22005657a 4500
008 - FIXED-LENGTH DATA ELEMENTS--GENERAL INFORMATION
fixed length control field 170428s20172017 xxu||||| |||| 00| 0 eng d
022 ## - INTERNATIONAL STANDARD SERIAL NUMBER
International Standard Serial Number 1526-8209
040 ## - CATALOGING SOURCE
Original cataloging agency Ovid MEDLINE(R)
099 ## - LOCAL FREE-TEXT CALL NUMBER (OCLC)
PMID 27692565
245 ## - TITLE STATEMENT
Title HALT-D: A Phase II Evaluation of Crofelemer for the Prevention and Prophylaxis of Diarrhea in Patients With Breast Cancer on Pertuzumab-Based Regimens.
251 ## - Source
Source Clinical Breast Cancer. 17(1):76-78, 2017 Feb
252 ## - Abbreviated Source
Abbreviated source Clin Breast Cancer. 17(1):76-78, 2017 Feb
253 ## - Journal Name
Journal name Clinical breast cancer
260 ## - PUBLICATION, DISTRIBUTION, ETC.
Year 2017
260 ## - PUBLICATION, DISTRIBUTION, ETC.
Manufacturer FY2017
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Date added to catalog 2017-05-06
520 ## - SUMMARY, ETC.
Abstract Approximately 40% to 80% of patients receiving pertuzumab-directed therapy for human epidermal growth factor receptor 2 (HER2)-positive breast cancer will develop chemotherapy-induced diarrhea (CID). Loperamide and octreotide are frequently used to treat CID after diarrhea occurs, but neither is used prophylactically or targets the underlying mechanism. Previous studies suggest blocking epidermal growth factor receptor may cause excess chloride secretion, resulting in diarrhea. Crofelemer is derived from the red latex of the Croton lechleri tree, blocks gastrointestinal cystic fibrosis transmembrane regulator and calcium-activated chloride channels, and is U.S. Food and Drug Administration approved for relief of diarrhea in HIV/AIDS patients on anti-retroviral therapy. Crofelemer is not systemically absorbed, has relatively few side effects, and presents a targeted approach at preventing CID in patients receiving pertuzumab-based therapy. HALT-D (DiarrHeA Prevention and ProphyLaxis with Crofelemer in HER2-Positive Breast Cancer Patients Receiving Trastuzumab, Pertuzumab, and Docetaxel or Paclitaxel with or without Carboplatin, NCT02910219) is a phase II, randomized, open-label trial that aims to recruit 46 patients from 3 MedStar sites. Adults with HER2-positive breast cancer being treated with trastuzumab, pertuzumab, and docetaxel or paclitaxel (THP) or trastuzumab, pertuzumab, docetaxel, and carboplatin (TCHP) will be randomized to receive crofelemer or no medication for diarrhea prophylaxis. The primary endpoint is incidence of all grade diarrhea for > 2 consecutive days during cycles 1 to 2 of THP or TCHP. Secondary endpoints include overall incidence, duration, and severity of diarrhea; time to onset of diarrhea; use of other anti-diarrheal medications; stool frequency and consistency; and quality of life. HALT-D will provide important information about the feasibility and tolerability of crofelemer in preventing diarrhea for patients receiving THP or TCHP.
520 ## - SUMMARY, ETC.
Abstract Copyright c 2016 Elsevier Inc. All rights reserved.
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Language note English
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element *Antineoplastic Combined Chemotherapy Protocols/ae [Adverse Effects]
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element *Breast Neoplasms/dt [Drug Therapy]
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element *Diarrhea/pc [Prevention & Control]
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element *Proanthocyanidins/tu [Therapeutic Use]
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element *Quality of Life
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Topical term or geographic name entry element Adolescent
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Topical term or geographic name entry element Adult
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Topical term or geographic name entry element Aged
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Topical term or geographic name entry element Aged, 80 and over
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element Antibodies, Monoclonal, Humanized/ad [Administration & Dosage]
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element Breast Neoplasms/pa [Pathology]
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Topical term or geographic name entry element Carboplatin/ad [Administration & Dosage]
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element Diarrhea/ci [Chemically Induced]
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Topical term or geographic name entry element Diarrhea/ep [Epidemiology]
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Topical term or geographic name entry element Female
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Topical term or geographic name entry element Follow-Up Studies
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Topical term or geographic name entry element Humans
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Topical term or geographic name entry element Middle Aged
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element Neoplasm Staging
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element Paclitaxel/ad [Administration & Dosage]
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element Prognosis
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element Taxoids/ad [Administration & Dosage]
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Topical term or geographic name entry element Trastuzumab/ad [Administration & Dosage]
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element Young Adult
651 ## - SUBJECT ADDED ENTRY--GEOGRAPHIC NAME
Institution Washington Cancer Institute
657 ## - INDEX TERM--FUNCTION
Medline publication type Journal Article
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Local Authors Swain, Sandra M
790 ## - Authors
All authors Gao JJ, Pohlmann PR, Swain SM, Tan M
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DOI <a href="https://dx.doi.org/10.1016/j.clbc.2016.08.005">https://dx.doi.org/10.1016/j.clbc.2016.08.005</a>
Public note https://dx.doi.org/10.1016/j.clbc.2016.08.005
942 ## - ADDED ENTRY ELEMENTS (KOHA)
Koha item type Journal Article
Item type description Article
Holdings
Withdrawn status Lost status Damaged status Not for loan Collection Home library Current library Date acquired Total Checkouts Full call number Barcode Date last seen Price effective from Koha item type
          MedStar Authors Catalog MedStar Authors Catalog 05/06/2017   27692565 27692565 05/06/2017 05/06/2017 Journal Article

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