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

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What is this study about?

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.

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 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 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 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 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 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 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 Study?

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 Study?

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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Hospital Universitario Y Politecnico La Fe	Valencia	Spain
Hospital Universitario De Salamanca	Salamanca	Spain
Hospital Clinico San Carlos	Madrid	Spain
Azienda Ospedaliera Universitaria Federico II Di Napoli	Naples	Italy
Centre Hospitalier Regional Et Universitaire De Brest	Brest	France
Hospital Jerez de la Frontera	Jerez De La Frontera	Spain

Other Sites

Site Name	City	Country
KBC Zagreb	Zagreb	Croatia
IRCCS Istituto Nazionale Tumori Fondazione Pascale	Naples	Italy
Hospital General Universitario Gregorio Maranon	Madrid	Spain
Hospital Universitario Puerta De Hierro De Majadahonda	Majadahonda	Spain
Hospital Universitario Puerta Del Mar	Cadiz	Spain
Hospital Del Mar	Barcelona	Spain
Fundacion Instituto Valenciano De Oncologia	Valencia	Spain
Consorci Sanitari Del Maresme	Mataró	Spain
Hospital San Pedro De Alcantara	Caceres	Spain
Hospital Universitario De Jaen	Jaen	Spain
Hospital Clinico Universitario Lozano Blesa	Zaragoza	Spain
Centre De Cancerologue Du Grand Montpellier	Montpellier	France
Hospital Universitario Basurto	Bilbao	Spain
Hospital Quironsalud Sagrado Corazon	Sevilla	Spain
Hospital Universitario Virgen De Las Nieves	Granada	Spain
Consorcio Hospitalario Provincial De Castellon	Castello De La Plana	Spain
Hospital Clinico Universitario De Valladolid	Valladolid	Spain
Hospital Universitario De Fuenlabrada	Fuenlabrada	Spain
Hospital De Galdakao Usansolo	Galdakao	Spain
Althaia Xarxa Assistencial Universitaria De Manresa Fundacio Privada	Manresa	Spain
Hospital General Universitario De Albacete	Albacete	Spain
Azienda Socio Sanitaria Territoriale Della Valtellina E Dell Alto Lario	Sondrio	Italy
Azienda Ospedaliera Papardo	Messina	Italy
Hospital Universitario Infanta Sofía	San Sebastian De Los Reyes	Spain
Virgen del Rocío University Hospital	Sevilla	Spain
Hospital Clinic De Barcelona	Barcelona	Spain
Hospital Universitario De Cruces	Barakaldo	Spain
Hospital Universitario Fundacion Jimenez Diaz	Madrid	Spain
IRCCS Ospedale Policlinico San Martino	Genoa	Italy
University Clinical Hospital Virgen De La Arrixaca	Murcia	Spain
Hospital General Universitario De Valencia	Valencia	Spain
Salut Sant Joan De Reus	Reus	Spain
Institut De Cancerologie De Bourgogne	Dijon	France
Hospital Alvaro Cunqueiro	Vigo	Spain
Servei De Salut De Les Illes Balears	Palma	Spain
Area De Salud De Burgos Y Soria	Burgos	Spain
Immobiliere De Nancy	Nancy	France
Hospital Costa del Sol	Marbella	Spain
Centro Oncologico De Galicia	A Coruna Galicia	Spain
Iubreqlp Cpizjd Djupwxgazgknrnqmo	L'hospitalet De Llobregat	Spain
Hsimwspg Uhxmaheeropzu Dq Bxjlgfy	Badajoz	Spain
Aizlbad Squsyzsao Lmuzkg Nugqgb 2 Nivl	Pozzuoli	Italy
Hrxxywkx Du Lo Sbdaa Cnaj I Stmt Pjs	Barcelona	Spain
Fwpzbalza Pjza Le Ioyyizjyqsuab Bmgwrrdrz Dgh Htpisznv Ucsjcbqelsmpr Ly Pcv	Madrid	Spain
Hlpxwmfh Uwzcbcgkvatas do A Cvotan	A Coruna Galicia	Spain

Trial status

Country	Status	Recruitment Start
Croatia	Not recruiting	17.01.2022
France	Not recruiting	17.01.2022
Italy	Not recruiting	17.01.2022
Spain	Not recruiting	17.01.2022

Trial locations

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.

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 ID:

2024-514630-21-00

Protocol code:

GEICAM/2018-06

NCT ID:

NCT05252988

Trial Phase:

Therapeutic exploratory (Phase II)

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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?