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Study on Diarrhea Discontinuations in Early-stage HER2+ Breast Cancer Patients Treated with Neratinib, Loperamide, and Colesevelam

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a type of breast cancer known as HER2-positive, hormone receptor-positive early-stage breast cancer. The study is investigating the effects of a medication called neratinib, which is taken as a film-coated tablet. The trial aims to understand how often patients stop taking neratinib due to diarrhea, a common side effect, during the first three cycles of treatment. Each cycle lasts 28 days. The study will compare different ways of managing this side effect using additional medications: loperamide hydrochloride, which is commonly used to treat diarrhea, and colesevelam, which is another medication that can help manage digestive issues.

Participants in the study will receive one of three different treatment plans. The first plan involves taking neratinib along with loperamide from the start. The second plan includes starting with a lower dose of neratinib and increasing it gradually, with loperamide given as needed. The third plan combines neratinib with both loperamide and colesevelam. The purpose of these different approaches is to find the best way to reduce the number of patients who stop taking neratinib due to diarrhea.

The study will last for a maximum of 12 months, during which participants will be monitored for any side effects and how they respond to the treatment. The goal is to improve the management of side effects so that patients can continue their cancer treatment with fewer interruptions. This research is important for finding better ways to support patients with HER2-positive, hormone receptor-positive early-stage breast cancer in their treatment journey.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, the patient will be informed about the trial's objectives and procedures. The patient must provide written consent to participate in the study.

  2. Step 2

    Initial assessment

    An initial assessment will be conducted to confirm eligibility. This includes verifying the patient's medical history, current health status, and any previous treatments for breast cancer.

  3. Step 3

    Treatment initiation

    The patient will begin treatment with neratinib, administered orally in capsule form. The treatment aims to evaluate the incidence of discontinuations due to diarrhea within the first three cycles, each cycle lasting 28 days.

  4. Step 4

    Medication regimen

    The patient will receive neratinib along with loperamide to manage potential diarrhea. The dosage and frequency will be determined by the study protocol and adjusted as needed based on the patient's response.

  5. Step 5

    Monitoring and adjustments

    Throughout the treatment, the patient's health will be closely monitored. Adjustments to the medication dosage may be made based on the occurrence of side effects or other health considerations.

  6. Step 6

    Completion of treatment cycles

    The patient will complete three cycles of treatment, with each cycle lasting 28 days. The primary focus is on the incidence of diarrhea and any necessary discontinuations of neratinib.

  7. Step 7

    Final assessment

    At the end of the treatment cycles, a final assessment will be conducted to evaluate the patient's response to the treatment and any side effects experienced.

Who can join the trial?

12 criteria

  • The patient must be a male or female who is at least 18 years old at the time of signing the consent form.
  • Women who can have children must agree to use a highly effective non-hormonal birth control method, such as an intrauterine device, having their tubes tied, a partner who has had a vasectomy, or abstinence (only if it is their preferred lifestyle), from the time they consent to the study until 30 days after the last dose of the study medication. Men with female partners who can have children must agree to use a highly effective birth control method while on treatment and for 3 months after the last dose of the study medication.
  • The patient must have recovered from any significant side effects from previous treatments to a mild level or back to their normal state, except for hair loss, nerve damage, and nail changes.
  • The patient must provide written consent to participate in the study and agree to follow the study procedures.
  • The patient must have a confirmed diagnosis of early-stage breast cancer, specifically Stage IB through Stage IIIC, according to the 8th edition of the TNM Classification of Breast Cancer by the Union for International Cancer Control (UICC). This means the cancer has been confirmed through a tissue sample.
  • The patient must have a confirmed **HER2-positive** disease, which means the cancer cells have more HER2 protein than normal, based on local laboratory tests following specific criteria.
  • The patient must have a confirmed **hormone receptor-positive (HR+)** disease, meaning the cancer cells have receptors for hormones like estrogen or progesterone, based on local laboratory tests.
  • The patient must have completed previous trastuzumab-based therapy, which is a type of treatment for breast cancer, or stopped it early due to side effects that have since resolved. Other treatments like pertuzumab are allowed but not required.
  • The last dose of trastuzumab-based therapy must have been given more than 2 weeks and less than or equal to 1 year before starting the new study medication, neratinib.
  • The patient must have a **left ventricular ejection fraction (LVEF)** of at least 50%, which is a measure of how well the heart pumps blood, determined by specific heart tests.
  • The patient must have an **Eastern Cooperative Oncology Group (ECOG) status** of 0 or 1, which indicates they are fully active or have some symptoms but can carry out light work.
  • Premenopausal women who can have children and women less than 12 months after menopause must have a negative pregnancy test. Women are considered postmenopausal if they have not had a menstrual period for at least 12 months without any hormone treatments.

Who cannot join the trial?

4 criteria

  • Patients who have not completed treatment with trastuzumab, a medication used for breast cancer.
  • Patients who have a different type of breast cancer that is not early-stage HER2 positive and hormone receptor-positive.
  • Patients who are not within the specified age range for the study.
  • Patients who are part of a vulnerable population, meaning they might need special protection or care.
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Investigated drugs

  • Neratinib

    is a medication used in this study to treat patients with early-stage HER2-positive, hormone receptor-positive breast cancer. It works by blocking certain proteins that promote the growth of cancer cells. The study aims to evaluate how often patients stop taking neratinib due to diarrhea.

  • Loperamide

    is used in this study as a prophylactic treatment to prevent or reduce diarrhea, which is a common side effect of neratinib. It helps to slow down the movement in the gut, which decreases the number of bowel movements and makes the stool less watery.

  • Colesevelam

    is included in the study as an additional prophylactic treatment to help manage diarrhea. It works by binding to certain substances in the intestines, which can help to reduce diarrhea.

What is already known about the treatment

Neratinib – Neratinib is administered orally in tablet form. It is currently being studied in clinical trials for its effectiveness in treating early-stage HER2-positive, hormone receptor-positive breast cancer. The main therapeutic indication is for patients who have completed trastuzumab-based therapy. Neratinib works by inhibiting the HER2 receptor, which is involved in the growth of cancer cells. It belongs to the pharmacological class of tyrosine kinase inhibitors.

Investigated diseases

HER2 Positive, Hormone Receptor Positive Early-stage Breast Cancer – This type of breast cancer is characterized by the overexpression of the HER2 protein and the presence of hormone receptors on the cancer cells. It is considered an early-stage cancer, meaning it has not spread extensively beyond the breast or nearby lymph nodes. The cancer cells grow in response to hormones like estrogen or progesterone, which can fuel their growth. HER2 positive cancers tend to grow and spread more aggressively than other types of breast cancer. Treatment often involves targeted therapies that specifically address the HER2 protein, alongside hormone therapies. The progression of this cancer can vary, but early detection and treatment are crucial for managing its growth.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-514630-21-00Protocol codeGEICAM/2018-06Estimated enrolment175 patientsSponsorFundacion Grupo Espanol De Investigacion En Cancer De Mama

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