| 000 | 04012nam a22005657a 4500 | ||
|---|---|---|---|
| 008 | 170428s20172017 xxu||||| |||| 00| 0 eng d | ||
| 022 | _a1526-8209 | ||
| 040 | _aOvid MEDLINE(R) | ||
| 099 | _a27692565 | ||
| 245 | _aHALT-D: A Phase II Evaluation of Crofelemer for the Prevention and Prophylaxis of Diarrhea in Patients With Breast Cancer on Pertuzumab-Based Regimens. | ||
| 251 | _aClinical Breast Cancer. 17(1):76-78, 2017 Feb | ||
| 252 | _aClin Breast Cancer. 17(1):76-78, 2017 Feb | ||
| 253 | _aClinical breast cancer | ||
| 260 | _c2017 | ||
| 260 | _fFY2017 | ||
| 266 | _d2017-05-06 | ||
| 520 | _aApproximately 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 | _aCopyright c 2016 Elsevier Inc. All rights reserved. | ||
| 546 | _aEnglish | ||
| 650 | _a*Antineoplastic Combined Chemotherapy Protocols/ae [Adverse Effects] | ||
| 650 | _a*Breast Neoplasms/dt [Drug Therapy] | ||
| 650 | _a*Diarrhea/pc [Prevention & Control] | ||
| 650 | _a*Proanthocyanidins/tu [Therapeutic Use] | ||
| 650 | _a*Quality of Life | ||
| 650 | _aAdolescent | ||
| 650 | _aAdult | ||
| 650 | _aAged | ||
| 650 | _aAged, 80 and over | ||
| 650 | _aAntibodies, Monoclonal, Humanized/ad [Administration & Dosage] | ||
| 650 | _aBreast Neoplasms/pa [Pathology] | ||
| 650 | _aCarboplatin/ad [Administration & Dosage] | ||
| 650 | _aDiarrhea/ci [Chemically Induced] | ||
| 650 | _aDiarrhea/ep [Epidemiology] | ||
| 650 | _aFemale | ||
| 650 | _aFollow-Up Studies | ||
| 650 | _aHumans | ||
| 650 | _aMiddle Aged | ||
| 650 | _aNeoplasm Staging | ||
| 650 | _aPaclitaxel/ad [Administration & Dosage] | ||
| 650 | _aPrognosis | ||
| 650 | _aTaxoids/ad [Administration & Dosage] | ||
| 650 | _aTrastuzumab/ad [Administration & Dosage] | ||
| 650 | _aYoung Adult | ||
| 651 | _aWashington Cancer Institute | ||
| 657 | _aJournal Article | ||
| 700 | _aSwain, Sandra M | ||
| 790 | _aGao JJ, Pohlmann PR, Swain SM, Tan M | ||
| 856 |
_uhttps://dx.doi.org/10.1016/j.clbc.2016.08.005 _zhttps://dx.doi.org/10.1016/j.clbc.2016.08.005 |
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| 942 |
_cART _dArticle |
||
| 999 |
_c2733 _d2733 |
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