Evidence map›Paper›PMID 36280642›Full record

Trial reportBreast cancer research and treatment2022

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.

Paula R Pohlmann, Deena Graham, Tianmin Wu, Yvonne Ottaviano, Mahsa Mohebtash, Shweta Kurian, Donna McNamara, Filipa Lynce, Robert Warren, Asma Dilawari and 6 more

2 registry-linked trialsOpen access · hybridAbstract readRandomized Controlled TrialClinical Trial, Phase II
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Breast cancer research and treatment, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
1.0field-weighted citation impact, top 21% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02910219 phase2completednot on this map

Diarrhea Prevention and Prophylaxis With Crofelemer in HER2 Positive Breast Cancer Patients Receiving Trastuzumab, Pertuzumab, and Docetaxel or Paclitaxel With or Without Carboplatin: HALT-D

TypeinterventionalSponsorSandra SwainRan2017 to 2020Enrolled53ConditionsBreast CancerArmsCrofelemer
NCT06721871 phase2 / phase3active not recruitingnot on this mapstarted 2025, after this paper: background citation

Evaluation of Safety, Tolerability and Efficacy of Crofelemer Following Multiple Ascending Doses of Crofelemer Powder for Oral Solution in Pediatric Participants With Microvillus Inclusion Disease (MVID)

TypeinterventionalSponsorNapo Pharmaceuticals, Inc.Ran2025 to 2026Enrolled6ConditionsMicrovillus Inclusion Disease, Congenital Disorders, Rare DiseasesArmsCrofelemer Powder for Oral Solution, Placebo Powder for Oral Solution
3 · Its place in the literature

Who cites it

5 citing papers in PubMed, 11 citations in OpenAlex.

  1. Review
  2. Review
  3. The impact of cancer-related diarrhea on changes in cancer therapy.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2024
    Observational
  4. Review
  5. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

16 authors at 6 institutions in 1 country.

Paula R PohlmannGeorgetown Lombardi Comprehensive Cancer Center, Washington, DC, USA.ORCID http://orcid.org/0000-0001-7914-5162
Deena GrahamGeorgetown Lombardi Comprehensive Cancer Center, Washington, DC, USA.ORCID http://orcid.org/0000-0003-1111-6984
Tianmin WuGeorgetown Lombardi Comprehensive Cancer Center, Washington, DC, USA.ORCID http://orcid.org/0000-0003-3279-3052
Yvonne OttavianoMedstar Franklin Square Medical Center, Baltimore, MD, USA.
Mahsa MohebtashMedstar Franklin Square Medical Center, Baltimore, MD, USA.
Shweta KurianMedstar Franklin Square Medical Center, Baltimore, MD, USA.
Donna McNamaraGeorgetown Lombardi Comprehensive Cancer Center, Washington, DC, USA.
Filipa LynceDana-Farber Cancer Institute, Boston, MA, USA.ORCID http://orcid.org/0000-0001-6615-7076
Robert WarrenGeorgetown Lombardi Comprehensive Cancer Center, Washington, DC, USA.
Asma DilawariGeorgetown Lombardi Comprehensive Cancer Center, Washington, DC, USA.ORCID http://orcid.org/0000-0001-5706-9138
Suman RaoMedstar Franklin Square Medical Center, Baltimore, MD, USA.
Candace MainorGeorgetown Lombardi Comprehensive Cancer Center, Washington, DC, USA.ORCID http://orcid.org/0000-0002-4431-7101
Nicole SwansonClinical Research Management Office, Georgetown University Medical Center, Washington, DC, USA.
Ming TanGeorgetown Lombardi Comprehensive Cancer Center, Washington, DC, USA.ORCID http://orcid.org/0000-0003-2533-8246
Claudine IsaacsGeorgetown Lombardi Comprehensive Cancer Center, Washington, DC, USA.ORCID http://orcid.org/0000-0002-9646-1260
Sandra M SwainGeorgetown Lombardi Comprehensive Cancer Center, Washington, DC, USA. sandra.swain@georgetown.edu.ORCID http://orcid.org/0000-0002-1320-3830
Georgetown University · USMedStar Franklin Square Medical Center · USHackensack University Medical Center · USCenter for Drug Evaluation and Research · USDana-Farber Cancer Institute · USThe University of Texas MD Anderson Cancer Center · US

Funding

Tissue Culture Shared ResourceP30CA051008 · NCI · GEORGETOWN UNIVERSITY · PI Louis M Weiner · 1990 to 2026
$71.5M
NCI NIH HHS P30 CA051008
6 · The paper itself

Abstract

purposeTo assess whether crofelemer would prevent chemotherapy-induced diarrhea (CID) diarrhea in patients with HER2-positive, any-stage breast cancer receiving trastuzumab (H), pertuzumab (P), and a taxane (T; docetaxel or paclitaxel), with/without carboplatin (C; always combined with docetaxel rather than paclitaxel).

methodsPatients scheduled to receive ≥ 3 consecutive TCHP/THP cycles were randomized to crofelemer 125 mg orally twice daily during chemotherapy cycles 1 and 2 or no scheduled prophylactic medication (control). All received standard breakthrough antidiarrheal medication (BTAD) as needed. The primary endpoint was incidence of any-grade CID for ≥ 2 consecutive days. Secondary endpoints were incidence of all-grade and grade 3/4 CID by cycle/stratum; time to onset and duration of CID; stool consistency; use of BTAD; and quality of life (Functional Assessment of Chronic Illness Therapy for Patients With Diarrhea [FACIT-D] score).

resultsFifty-one patients were randomized to crofelemer (n = 26) or control (n = 25). There was no statistically significant difference between arms for the primary endpoint; however, incidence of grade ≥ 2 CID was reduced with crofelemer vs control (19.2% vs 24.0% in cycle 1; 8.0% vs 39.1%, in cycle 2). Patients receiving crofelemer were 1.8 times more likely to see their diarrhea resolved and had less frequent watery diarrhea.

conclusionDespite the choice of primary endpoint being insensitive, crofelemer reduced the incidence and severity of CID in patients with HER2-positive breast cancer receiving P-based therapy. These data are supportive of further testing of crofelemer in CID.

trial registrationClinicaltrials.gov, NCT02910219, prospectively registered September 21, 2016.

Indexed as

Antineoplastic AgentsBreast NeoplasmsAntibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsBridged-Ring CompoundsDiarrheaDocetaxelErb-b2 Receptor Tyrosine KinasesFemaleHumansPaclitaxelProanthocyanidinsQuality of LifeTaxoidsTrastuzumabAntibodies, Monoclonal, HumanizedAntineoplastic AgentsBridged-Ring CompoundscrofelemerDocetaxelErb-b2 Receptor Tyrosine KinasesPaclitaxelpertuzumabProanthocyanidinstaxaneTaxoidsTrastuzumabChemotherapy-induced diarrheaCrofelemerHER2-positive breast cancerPertuzumabTaxaneTrastuzumab

Identifiers

PMID36280642
PMCPMC9633499
OpenAlexW4307229303

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.