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Breast CancerPhase 2HALT-DNCT02910219

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

A Phase 2 study testing Crofelemer in people with Breast Cancer, run by Sandra Swain at 4 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Breast Cancer
What is being tested?
Crofelemer
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
53 participants
Where
4 sitesUnited States
Study dates
31 Jan 2017to 23 Nov 2020
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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;
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  • 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

Who cannot join

  • 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;
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  • 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.

Trial locations and contacts

4 sites in 1 country.

United States4 sites

  • MedStar Franklin Square Cancer Center at Loch Raven Campus

    Baltimore, Maryland, 21218

  • Harry and Jeanette Weinberg Cancer Institute

    Baltimore, Maryland, 21237

  • John Theurer Cancer Center at Hackensack Univ

    Hackensack, New Jersey, 07601

  • Lombardi Comprehensive Cancer Center

    Washington D.C., District of Columbia, 20007

Other trials in United States

About this study

Official title: 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

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.

Read the detailed description

Various anti-diarrheal agents, such as loperamide, codeine, octreotide, are available for diarrhea management, but few are used in the prophylactic setting and none provide a targeted approach for treating chemotherapy induced diarrhea (CID).

Pre-clinical studies have suggested that blocking EGFR results in excess chloride secretion and thus diarrhea. Crofelemer is an extract from the blood red bark of Croton lechleri that inhibits luminal chloride efflux by blocking the calcium activated chloride channel (CaCC) and cystic fibrosis transmembrane regulator (CFTR) chloride channels. Due to its size and polarity, it acts only luminally and is not systemically absorbed. It is currently FDA approved for use in preventing diarrhea in HIV/AIDS patients on anti-retroviral therapy.

Conditions
Breast Cancer
Being tested
Crofelemer
Keywords
HER2, pertuzumab, trastuzumab, docetaxel, paclitaxel, carboplatin, crofelemer, chemotherapy induced diarrhea
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CrofelemerDrug

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

Study groups in NCT02910219
Study groupRoleWhat they receive
CrofelemerExperimentalPatients 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.
Receives: Drug: Crofelemer
ControlNo interventionPatients 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

Secondary outcomes (9)

  1. Diarrhea Any Grade

    Incidence of diarrhea of any grade, as measured by CTCAE v4.0, by cycle

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

  2. Grade 3-4 Diarrhea

    number of patients with diarrhea of grade 3 or grade 4, as measured by CTCAE v4.0, by cycle and by stratum

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

  3. Diarrhea Onset

    Time to onset of first episode of diarrhea of any grade, overall

    Measured: from baseline through Cycle 3 (21 day cycles)

  4. Diarrhea Duration

    Duration (days) of any grade diarrhea, defined from day 1 to day 21, by cycle in which the episode started

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

  5. Duration Grade 3-4 Diarrhea

    Duration (days) of grade 3-4 diarrhea during cycle 1 through the end of cycle 2, defined from cycle day 1 to cycle 2 day 21

    Measured: End of Cycle 2 (each cycle is 21 days)

  6. Anti-diarrheal Medications

    Use of anti-diarrheal medications (other than study drug), by cycle and arm

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

  7. FACIT-D Total Score

    Quantitative FACIT-D (FACIT-D Functional Assessment of Chronic Illness Therapy for Patients With Diarrhea) total score, collected day 1 of each cycle and at the time of study completion, cycles 1 and 2 reported; The higher the score the better the QOL; Score range 0-152.

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

  8. FACIT-D Diarrhea Score

    Quantitative FACIT-D (FACIT-D Functional Assessment of Chronic Illness Therapy for Patients With Diarrhea) diarrhea subscale (DS) score, by cycle; Score Range 0-44; the higher the score, the better the QOL.

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

  9. Stool Frequency Based on Consistency (Bristol Stool Scale)

    Frequency of stool consistency of 6-7, as measured by the Bristol Stool scale (minimum 1-separate hard lumps, maximum 7-watery, no solid pieces), by cycle; Median in watery bowel movements (Bristol Stool Form Scale 6-7).

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Sep 2016 (estimated)
  2. Study start31 Jan 2017
  3. Primary completion23 Nov 2020
  4. Study completion23 Nov 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
53 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02910219
Sponsor's protocol ID
MHRI GU 2015-0547
Acronym
HALT-D
Status last verified
Oct 2022
First submitted
19 Sep 2016
Last updated
24 Oct 2022
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No: No plan to make individual participant data available

Publications

  • 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.

    PubMed 27692565

  • 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.

    PubMed 36280642

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Crofelemer in people with Breast Cancer, run by Sandra Swain at 4 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 24 Oct 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Diarrhea for >= 2 Consecutive Days (time frame: Cycle 1, Cycle 2 (each cycle is 21 days)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02910219, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Oct 2022.

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