Study on Trastuzumab and Pertuzumab for Patients with HER2-Positive Breast Cancer Using a Response-Adapted Strategy

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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. The study is exploring a treatment approach that does not involve traditional chemotherapy. Instead, it uses two medications, trastuzumab and pertuzumab, which are designed to target and treat this specific type of cancer. These medications may be used alone or with additional hormone therapy, depending on the patient’s needs.

The purpose of the study is to understand how effective this treatment is in reducing cancer in the breast and nearby lymph nodes before surgery. The study also aims to see how well patients do over a period of three years without the cancer coming back. To help guide the treatment, doctors will use a special type of scan called FDG-PET, which helps to see how the cancer is responding to the treatment early on. This scan uses a small amount of radioactive sugar to highlight areas of cancer activity in the body.

Participants in the study will receive the treatment over a period of up to 90 days. The study will monitor the effects of the treatment on the cancer and assess the overall health and quality of life of the participants. The goal is to find out if this chemotherapy-free approach can be a successful treatment option for patients with HER2-positive breast cancer.

1 joining the study

Upon joining the study, the patient will provide written informed consent. This is a formal agreement to participate in the trial after understanding its purpose and procedures.

2 initial assessment

The patient will undergo an initial assessment to confirm eligibility. This includes checking liver and kidney function, blood cell counts, and confirming the presence of HER2-positive breast cancer.

3 treatment phase 1

The patient will receive trastuzumab and pertuzumab intravenously. These medications are designed to target HER2-positive cancer cells.

The treatment may include endocrine therapy, which involves taking letrozole or tamoxifen citrate orally, depending on the patient’s hormone receptor status.

4 FDG-PET scan

An FDG-PET scan will be conducted to assess the metabolic response of the tumor to the treatment. This scan helps determine if the treatment is effectively reducing the cancer’s activity.

5 treatment phase 2

Based on the FDG-PET scan results, the treatment plan may be adjusted. If the tumor responds well, the patient will continue with the current treatment regimen.

If necessary, additional medications such as docetaxel or carboplatin may be administered intravenously to enhance treatment effectiveness.

6 surgery

After completing the treatment phases, the patient will undergo surgery to remove any remaining cancerous tissue. The success of the treatment will be evaluated by the absence of invasive disease in the breast and axilla.

7 follow-up

The patient will be monitored for three years to assess disease-free survival. This involves regular check-ups to ensure there is no recurrence of cancer.

Who Can Join the Study?

The patient must provide written informed consent before starting any specific procedures related to the study.
The patient must have certain liver function levels: total bilirubin should be at or below the normal limit (except for a condition called Gilbert’s syndrome); alkaline phosphatase (ALP) should be at or below 2.5 times the normal limit; aspartate transaminase (AST) and alanine transaminase (ALT) should be at or below 1.5 times the normal limit.
The patient must have certain kidney function levels: serum creatinine should be at or below 1.5 times the normal limit, or creatinine clearance should be at or above 50 mL/min/1.73 m² if creatinine levels are higher than normal.
The patient must be available for treatment and follow-up visits.
The patient must be a female or male aged 18 years or older.
The patient must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1, which means they are fully active or have some symptoms but do not need to stay in bed.
The patient must have invasive breast cancer confirmed by a tissue sample.
The patient must have breast cancer that can be operated on, with certain tumor sizes and locations (cT1-3 and/or cN0-2 tumors).
The tumor must be 1.5 centimeters or larger in diameter, as measured by MRI or ultrasound, and show significant uptake of a substance used in imaging tests.
If there are multiple tumors, at least two must be confirmed by tissue samples, all must be HER2-positive, and the largest must be 1.5 centimeters or larger.
The patient must have HER2-positive disease confirmed by specific criteria from 2018.
The patient must have known estrogen receptor (ER) and progesterone receptor (PR) status determined before entering the study.
The patient must have certain blood cell counts: white blood cell (WBC) count above 3.0 x 10⁹/L, absolute neutrophil count (ANC) at or above 1.5 x 10⁹/L, platelet count at or above 100.0 x 10⁹/L, and hemoglobin at or above 10.0 g/dL (or 6.2 mmol/L).

Who Cannot Join the Study?

Patients who do not have HER2-positive breast cancer cannot participate. This type of cancer has a specific protein called HER2 that promotes the growth of cancer cells.
Patients who are not within the specified age range cannot participate. The study is open to certain age groups only.
Patients who are not willing to undergo the specific treatments being studied, such as trastuzumab and pertuzumab, cannot participate. These are medications used to treat HER2-positive breast cancer.
Patients who are not able to follow the study procedures or attend the required visits cannot participate.
Patients who have other medical conditions that might interfere with the study cannot participate.
Patients who are pregnant or breastfeeding cannot participate, as the study treatments may affect the baby.
Patients who have participated in another clinical trial recently may not be eligible to participate.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Oncopole Claudius Regaud	Toulouse	France
Hospital Universitario Y Politecnico La Fe	Valencia	Spain
Institut De Cancerologie De Lorraine	Vandoeuvre Les Nancy	France
Centro Hospitalar Universitario Sao Joao E.P.E.	Porto	Portugal

Other Sites

Site Name	City	Country
Hopital Tenon	Paris	France
Klinikum der Technischen Universitaet Muenchen (TUM Klinikum)	Munich	Germany
Azienda Socio Sanitaria Territoriale Di Cremona	Cremona	Italy
Istituto Europeo Di Oncologia S.r.l.	Milan	Italy
Azienda Unita Sanitaria Locale Di Piacenza	Piacenza	Italy
Fundacion Instituto Valenciano De Oncologia	Valencia	Spain
Hospital Universitario De Jaen	Jaen	Spain
Unidade Local De Saude De Amadora Sintra E.P.E.	Amadora	Portugal
Hospital Clinico Universitario Lozano Blesa	Zaragoza	Spain
Hospital Beatriz Angelo	Loures	Portugal
Fondazione IRCCS San Gerardo Dei Tintori	Monza	Italy
Consorcio Hospitalario Provincial De Castellon	Castello De La Plana	Spain
Unidade Local De Saude Do Alto Ave E.P.E.	Guimaraes	Portugal
Institut De Cancerologie Strasbourg Europe	STRASBOURG, Alsace	France
Virgen del Rocío University Hospital	Sevilla	Spain
Hospital Clinic De Barcelona	Barcelona	Spain
Hospital Da Luz S.A.	Lisbon	Portugal
Hospital General Universitario De Valencia	Valencia	Spain
Hospital Universitari Arnau De Vilanova De La Gerencia Territorial De Lleida	Lleida	Spain
Salut Sant Joan De Reus	Reus	Spain
Area De Salud De Burgos Y Soria	Burgos	Spain
Hospital Universitario Virgen De La Victoria	Malaga	Spain
Iihbqstz Cocepj Dzeucdfyqbbwwtabz	L'hospitalet De Llobregat	Spain
Aframat Uzxyk Swnethywf Laebse Dj Bzyllvi	Bologna	Italy
Mzlevnigduajcjuceyyuzftqys Hcguxwdttnctxfsg	Halle (Saale)	Germany
Fwlpitbdx Pyuy Lt Iosixnvvnikyo Bdmfxynde Det Hpkmhgyn Unojfaflwriff Lm Psv	Madrid	Spain
Kiiyejaq Ebtdapsksfkutmcaitbilazo Hcvdelixyxcbvhxay	Essen	Germany
Hhuytmzj Ufjitnisdomat Hvsnfzrj Tgceq y Pfequw Idfifpmh Czbgsi dqqrecslfbwexopsw (vosy	Badalona	Spain
Hndezpcc Vtpa drqocejt	Barcelona	Spain
Huotigrc Uelfkqrtrvzgg dh A Cplrjs	A Coruna Galicia	Spain

Trial status

Country	Status	Recruitment Start
France	Not recruiting	01.06.2017
Germany	Not recruiting	01.06.2017
Italy	Not recruiting	01.06.2017
Portugal	Not recruiting	01.06.2017
Spain	Not recruiting	01.06.2017

Trial locations

Investigated drugs:

Trastuzumab 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, helping to stop their growth and spread. In this trial, trastuzumab is used as part of a chemotherapy-free treatment strategy to evaluate its effectiveness in shrinking tumors and improving patient outcomes.

Pertuzumab is another medication used alongside trastuzumab for treating HER2-positive breast cancer. It also targets the HER2 protein but works in a slightly different way, complementing the action of trastuzumab. The combination of these two medications aims to enhance the treatment’s effectiveness by more thoroughly blocking the signals that promote cancer cell growth.

Endocrine Therapy may be included in the treatment plan for some patients. This therapy involves using medications that block or lower the amount of hormones in the body, which can help slow or stop the growth of certain types of breast cancer that rely on hormones to grow. The use of endocrine therapy in this trial is to assess its additional benefits when combined with trastuzumab and pertuzumab.

Investigated diseases:

HER2 positive breast cancer

HER2-positive breast cancer – This is a type of breast cancer characterized by the overexpression of the human epidermal growth factor receptor 2 (HER2) protein, which promotes the growth of cancer cells. It tends to be more aggressive than other types of breast cancer. The disease can start in the breast tissue and may spread to nearby lymph nodes or other parts of the body. HER2-positive breast cancer can vary in size and may be detected through imaging or physical examination. The progression of the disease can be influenced by various factors, including the tumor’s response to specific therapies targeting the HER2 protein.

Trial ID:

2023-509923-42-00

Protocol code:

MedOPP096 – MO39229

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on Trastuzumab and Pertuzumab for Patients with HER2-Positive Breast Cancer Using a Response-Adapted Strategy

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?