Study on Home Administration of Pertuzumab and Trastuzumab for Patients with Early or Locally Advanced HER2-Positive Breast Cancer

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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 breast cancer, which can be either early-stage or locally advanced, including a form called inflammatory breast cancer. The study is evaluating a treatment that combines two medications, pertuzumab and trastuzumab, which are given together as a fixed-dose combination. This combination is administered under the skin, a method known as subcutaneous administration. The study aims to understand patient preferences for receiving this treatment at home compared to a hospital setting.

Participants in the study will receive the fixed-dose combination of pertuzumab and trastuzumab at different stages of their treatment. The study will also involve other medications, such as Kadcyla (containing trastuzumab emtansine), Phesgo, and Herceptin, which are used in various forms of administration, including injections and infusions. The trial will explore how patients feel about the convenience and comfort of receiving their treatment at home versus in a hospital environment.

The study will take place over several weeks, during which participants will receive their treatments and provide feedback on their experiences. The goal is to gather information on whether patients prefer home administration and how it impacts their quality of life. This information will help in understanding the best ways to deliver treatment to patients with HER2-positive breast cancer, aiming to improve their overall treatment experience.

1 joining the study

Upon joining the study, eligibility is confirmed based on specific criteria such as performance status and tumor characteristics.

Participants must have HER2-positive breast cancer confirmed by a laboratory test.

2 initial treatment phase

The initial treatment involves the administration of a combination of medications.

Medications include trastuzumab emtansine given through an intravenous infusion.

3 neoadjuvant phase

During this phase, participants receive a fixed-dose combination of pertuzumab and trastuzumab for subcutaneous administration.

The treatment is administered in a hospital setting.

4 adjuvant phase

Participants continue to receive the fixed-dose combination of pertuzumab and trastuzumab.

This phase includes a cross-over period where the administration setting may change to home.

5 treatment continuation

Participants may choose to continue receiving the fixed-dose combination at home or in the hospital.

Preference is evaluated through a questionnaire.

6 monitoring and assessment

Throughout the trial, health and quality of life are monitored using questionnaires and clinical assessments.

Adverse events and treatment responses are recorded and evaluated.

7 completion of the study

The study is estimated to conclude by September 2025.

Final assessments and data collection occur at the end of the study period.

Who Can Join the Study?

Participants must have an ECOG performance status of 0-1. This is a scale used to assess how well a person can perform daily activities. A score of 0 means fully active, and 1 means some restrictions but still able to do light work.
Both female and male participants with stage II to IIIC early or locally advanced/inflammatory HER2-positive breast cancer can join. HER2-positive means the cancer has a protein that promotes the growth of cancer cells.
The primary tumor must be larger than 2 centimeters in diameter, or the disease must be node-positive. Node-positive means cancer has spread to nearby lymph nodes.
The HER2-positive breast cancer must be confirmed by a local laboratory before joining the study.
The hormone receptor status of the primary tumor must be determined by local assessment. This status shows whether hormones like estrogen or progesterone are helping the cancer to grow.
Participants must have adequate wound healing after breast cancer surgery, as assessed by the investigator, to start the study treatment within 9 weeks of the last systemic neoadjuvant therapy. Neoadjuvant therapy is treatment given before the main treatment to shrink a tumor.

Who Cannot Join the Study?

Patients who have a different type of breast cancer that is not HER2-Positive. HER2-Positive means the cancer cells have more of a protein called HER2, which can make the cancer grow faster.
Patients who have breast cancer that is not in the early or locally advanced stages. Early stage means the cancer is small and has not spread much. Locally advanced means the cancer is larger and may have spread to nearby areas but not to distant parts of the body.
Patients who are not able to receive treatment at home. This study involves giving medication at home, so patients need to be comfortable with this.
Patients who are not able to receive the specific combination of medications called pertuzumab and trastuzumab. These are medications used to treat HER2-Positive breast cancer.
Patients who are not in the age range specified for the study. The study is looking for patients within certain age groups.
Patients who are not willing to participate in the study’s specific procedures and requirements.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Hospital Universitario De Salamanca	Salamanca	Spain

Other Sites

Site Name	City	Country
KBC Zagreb	Zagreb	Croatia
Hospital Universitario De Jaen	Jaen	Spain
Mbal Za Zhensko Zdrave Nadezhda OOD	Sofia	Bulgaria
University Clinical Hospital Virgen De La Arrixaca	Murcia	Spain
Complex Oncological Center Plovdiv EOOD	Plovdiv	Bulgaria
Multiprofile Hospital For Active Treatment-Uni Hospital Ltd.	Panagyurishte	Bulgaria

Trial status

Country	Status	Recruitment Start
Bulgaria	Not recruiting	01.08.2022
Croatia	Not recruiting	01.08.2022
Spain	Not recruiting	01.08.2022

Trial locations

Investigated drugs:

Pertuzumab is a medication used in the treatment of HER2-positive breast cancer. It works by targeting the HER2 protein on the surface of cancer cells, which helps to stop the growth and spread of the cancer. In this trial, it is combined with trastuzumab for subcutaneous administration.

Trastuzumab is another medication used to treat HER2-positive breast cancer. Like pertuzumab, it targets the HER2 protein on cancer cells. This medication helps to slow or stop the growth of these cancer cells. In this study, it is administered together with pertuzumab in a fixed-dose combination for subcutaneous use.

HER2-Positive Breast Cancer – This type of breast cancer is characterized by the overexpression of the HER2 protein, which promotes the growth of cancer cells. It can be classified as early or locally advanced, and in some cases, it may present as inflammatory breast cancer, which is a rare and aggressive form. The disease typically progresses by spreading from the breast to nearby lymph nodes and potentially to other parts of the body. Symptoms may include a lump in the breast, changes in breast shape, or skin changes. The progression of HER2-positive breast cancer can vary, with some cases advancing more rapidly than others.

Trial ID:

2023-506380-33-00

Protocol code:

MO43110

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on Home Administration of Pertuzumab and Trastuzumab for Patients with Early or Locally Advanced HER2-Positive Breast Cancer

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?