Study on Time Savings with Subcutaneous Pertuzumab and Trastuzumab for Patients with HER2-Positive Early Breast Cancer

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What is this study about?

This clinical trial is focused on studying a treatment for . The treatment being tested is a combination of two medications, and , which are given as a fixed dose through an injection under the skin. This combination is known as . The study also involves comparing this new method of administration with the traditional method, where and are given separately through an intravenous infusion, which is a method where the medication is delivered directly into a vein.

The purpose of the study is to understand how much time healthcare providers and patients can save when using the new injection method compared to the traditional infusion method. Participants in the study will receive the treatment over several cycles, and the time taken for each method will be measured. This includes the time spent by healthcare providers in preparing and administering the treatment, as well as the time patients spend in the treatment chair and in the hospital.

The study will also look at the safety and tolerability of the new injection method compared to the traditional infusion method. This means checking for any side effects or reactions that might occur with the new treatment. The study aims to provide valuable information on whether the new method can make the treatment process more efficient and comfortable for patients with .

1 joining the study

Upon joining the study, participants will be required to sign an informed consent form. This document confirms understanding and agreement to participate in the clinical trial.

2 initial health assessment

Participants will undergo a baseline health assessment. This includes an echocardiogram or a multiple-gated acquisition scan to ensure the heart’s left ventricular ejection fraction is at least 55%.

A negative serum pregnancy test is required for women of childbearing potential before starting the trial.

3 treatment administration

Participants will receive a combination of medications for the treatment of HER2-positive early breast cancer. The medications include trastuzumab and pertuzumab.

The treatment involves different administration methods: Phesgo is given as a subcutaneous injection, while Perjeta and Herceptin are administered intravenously.

The specific dosages are: Phesgo 1200 mg/600 mg or 600 mg/600 mg for injection, Perjeta 420 mg for infusion, and Herceptin 600 mg for injection or 150 mg for infusion.

4 treatment cycles

The treatment is administered in cycles, specifically from cycle 2 to cycle 7 in the adjuvant setting. Each cycle involves a visit where the medication is administered.

During each visit, the time spent in the treatment room and the time sitting in the infusion chair will be measured.

5 monitoring and follow-up

Throughout the trial, participants will be monitored for any side effects or adverse events. This includes regular checks of vital signs and laboratory tests.

Participants are required to follow specific guidelines regarding contraception and abstinence to prevent pregnancy during the trial and for seven months after the last dose of the medication.

6 completion of the trial

The trial is expected to end by April 5, 2025. Upon completion, participants may undergo a final health assessment to evaluate the overall impact of the treatment.

Who Can Join the Study?

Signed Informed Consent Form.
Heart function test result showing a Left Ventricular Ejection Fraction (LVEF) of 55% or higher. This is a measure of how well your heart is pumping.
For women who can have children and are sexually active: Agree to either not have heterosexual intercourse or use one highly effective nonhormonal birth control method, or two effective nonhormonal methods during the study and for 7 months after the last dose of HER2-targeted therapy. Also, agree not to donate eggs during this time.
For men: Agree to either not have heterosexual intercourse or use a condom with a spermicidal product during the study and for 7 months after the last dose of HER2-targeted therapy. Also, agree not to donate sperm during this time.
A negative pregnancy test for women who can have children, unless they have had surgery to remove ovaries or uterus.
No major surgery unrelated to breast cancer within 28 days before starting the study, and no plans for major surgery during the study.
Must be 18 years or older at the time of signing the Informed Consent Form.
Ability to follow the study rules, as judged by the study doctor.
Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1, which means you are fully active or have some symptoms but can carry out light work.
Must have locally advanced, inflammatory, or early-stage breast cancer that is in one breast and confirmed by a lab test. The cancer must be node-positive, meaning it has spread to nearby lymph nodes, but not to other parts of the body.
Completed initial treatment with pertuzumab and trastuzumab along with chemotherapy, and have had surgery for breast cancer. Study treatment must start between 2 to 8 weeks after surgery.
Confirmed total pathologic complete response (tpCR), meaning no invasive cancer is found in the breast and lymph nodes after treatment, as assessed by a local pathologist.
HER2-positive breast cancer confirmed by a local lab before joining the study. HER2-positive means the cancer has high levels of a protein that promotes cancer growth.
Hormone receptor status of the primary tumor must be determined by a local lab. It can be either positive (estrogen receptor-positive and/or progesterone receptor-positive) or negative (estrogen receptor-negative and progesterone receptor-negative).

Who Cannot Join the Study?

Patients who do not have HER2-positive early breast cancer cannot participate. This means the cancer must have a specific protein called HER2.
Patients who are not within the specified age range cannot participate. The age range is not specified here, but it is important to check if you fit the required age group.
Both female and male patients can participate, so gender is not a reason for exclusion.
Patients who are considered part of a vulnerable population may not be eligible. This can include groups like children, pregnant women, or those unable to give consent.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

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Other Sites

Site Name	City	Country
Fundacion Instituto Valenciano De Oncologia	Valencia	Spain
Hospital San Pedro De Alcantara	Caceres	Spain
Hospital Universitario Basurto	Bilbao	Spain
Hospital Universitario Quironsalud Madrid	Pozuelo De Alarcon	Spain
Servei De Salut De Les Illes Balears	Palma	Spain
Hospital Universitario Virgen De La Victoria	Malaga	Spain
Phwn Txclm Hbnnkkln Uvtnwicszmru	Sabadell	Spain
Hwohpblf Vdct djoooizn	Barcelona	Spain
Hmafrgts Uuvndavdkjyfd dt A Chhevo	A Coruna Galicia	Spain

Trial status

Country	Status	Recruitment Start
Spain	Not recruiting	21.04.2021

Trial locations

Investigated drugs:

Pertuzumab is a medication used in the treatment of HER2-positive breast cancer. It works by targeting a specific protein on the surface of cancer cells, which helps to slow down or stop the growth of the cancer. In this clinical trial, Pertuzumab is being studied in combination with another medication to see if it can save time for both healthcare providers and patients when given as a subcutaneous injection, which is an injection under the skin.

Trastuzumab is another medication used to treat HER2-positive breast cancer. Like Pertuzumab, it targets the HER2 protein on cancer cells, helping to prevent the cancer from growing and spreading. In this trial, Trastuzumab is being combined with Pertuzumab in a fixed-dose combination that is administered as a subcutaneous injection. The study aims to determine if this method of administration can save time compared to the traditional intravenous method, where the medication is given directly into a vein.

Investigated diseases:

HER2 positive breast cancer

HER2-Positive Early Breast Cancer – HER2-positive early breast cancer is a type of breast cancer characterized by the overexpression of the human epidermal growth factor receptor 2 (HER2) protein. This overexpression leads to rapid growth and division of cancer cells. The disease typically begins in the breast tissue and can spread to nearby lymph nodes. In its early stages, it may not cause noticeable symptoms, but as it progresses, it can lead to changes in breast shape, size, or appearance. The progression of the disease can vary, with some cases remaining localized while others may advance more quickly. Monitoring and management are crucial to address the changes in the disease’s progression.

Trial ID:

2023-509321-50-00

Protocol code:

ML42502

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on Time Savings with Subcutaneous Pertuzumab and Trastuzumab for Patients with HER2-Positive Early Breast Cancer

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?