Study on Trastuzumab Deruxtecan and Drug Combination for Patients with High-Risk HER2-Positive Early Breast Cancer

3 1 1 1

What is this study about?

This clinical trial is focused on studying treatments for HER2-positive early-stage breast cancer, a type of breast cancer that tests positive for a protein called human epidermal growth factor receptor 2 (HER2), which promotes the growth of cancer cells. The study will explore the effectiveness and safety of a new treatment called trastuzumab deruxtecan (T-DXd), used alone or in combination with other medications known as THP, compared to the standard treatment regimen called ddAC-THP.

The purpose of the study is to determine if the new treatment options can provide better outcomes for patients with high-risk HER2-positive early breast cancer. Participants in the study will be randomly assigned to one of three groups: one group will receive T-DXd alone, another group will receive T-DXd followed by THP, and the third group will receive the standard ddAC-THP treatment. The study will monitor the participants’ response to these treatments, focusing on the absence of cancer in the breast and lymph nodes after treatment, known as pathological complete response (pCR).

The trial will also assess the safety and tolerability of the treatments, including any side effects experienced by participants. Additionally, the study will evaluate the impact of the treatments on participants’ quality of life and overall health. The trial is expected to continue until 2027, with the aim of providing valuable information on the potential benefits of T-DXd for patients with HER2-positive early-stage breast cancer.

1 joining the study

Upon joining the study, participants are randomly assigned to one of three groups. Each group receives a different treatment regimen for high-risk HER2-positive early-stage breast cancer.

2 treatment group assignment

Participants are assigned to one of the following groups: T-DXd monotherapy (Arm A), T-DXd followed by THP (Arm B), or ddAC-THP (Arm C).

3 treatment administration

In Arm A, participants receive trastuzumab deruxtecan (T-DXd) as a single treatment.

In Arm B, participants first receive T-DXd, followed by a combination of trastuzumab, pertuzumab, and paclitaxel (THP).

In Arm C, participants receive a standard treatment regimen consisting of doxorubicin, cyclophosphamide, followed by trastuzumab, pertuzumab, and paclitaxel (ddAC-THP).

4 medication details

All medications are administered intravenously as solutions for infusion.

The specific dosage, frequency, and duration of each medication are determined by the study protocol and the assigned treatment group.

5 monitoring and evaluation

Participants undergo regular monitoring to assess the safety and effectiveness of the treatment.

Evaluations include physical examinations, laboratory tests, and imaging studies to track the response to treatment.

6 completion of treatment

Upon completion of the treatment regimen, participants are evaluated for pathological complete response (pCR), which is the absence of invasive cancer in the breast and lymph nodes.

7 follow-up

Participants continue to be monitored for any long-term effects and overall health outcomes after the treatment phase.

Who Can Join the Study?

Patients must be at least 18 years old.
Must have a type of breast cancer called HER2-positive early breast cancer. This means the cancer has a specific protein called HER2 that helps it grow.
The cancer must be confirmed as HER2-positive through specific tests.
If there are multiple tumors in the breast, at least one from each area must be confirmed as HER2-positive.
The cancer can be either HR-positive (hormone receptor-positive) or HR-negative (hormone receptor-negative). This refers to whether the cancer cells have receptors for hormones like estrogen or progesterone.
The cancer must be at a certain stage, which is determined by tests like mammograms or MRIs.
If the cancer has spread to the lymph nodes, it must be confirmed through a biopsy, which is a small sample taken for testing.
Participants need to provide a sample of their tumor for further testing.
Must have a good performance status, which means being able to carry out daily activities without much difficulty.
Must have normal functioning of organs and bone marrow, which is the soft tissue inside bones where blood cells are made.
The heart’s pumping ability, known as LVEF (left ventricular ejection fraction), must be at least 50% within 28 days before joining the study.

Who Cannot Join the Study?

Participants with 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.
Participants with breast cancer that is not in the early stage. Early stage means the cancer is still small and hasn’t spread much.
Participants who are not considered high-risk. High-risk means there is a higher chance of the cancer coming back or spreading.
Participants who are not within the specified age range for the study.
Participants who are not able to follow the study procedures or take the study medications as required.
Participants who have other serious health conditions that might interfere with the study or make it unsafe for them to participate.
Participants who are pregnant or breastfeeding, as the study treatments might affect the baby.
Participants who have had another type of cancer in the past, unless it was a type that is not likely to come back.
Participants who are currently taking other treatments that might interfere with the study medications.
Participants who have had an allergic reaction to any of the study medications or similar drugs in the past.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Fondazione Policlinico Universitario Agostino Gemelli IRCCS	Rome	Italy
IRCCS Humanitas Research Hospital	Rozzano	Italy
Hospital Clinico San Carlos	Madrid	Spain
Azienda Ospedaliera Universitaria Federico II Di Napoli	Naples	Italy
Universitaetsklinikum Heidelberg AöR	Heidelberg	Germany

Other Sites

Site Name	City	Country
Istituto Oncologico Veneto	Padua	Italy
Centrum Onkologii Im. Prof. Franciszka Lukaszczyka W Bydgoszczy	Bydgoszcz	Poland
IRCCS Istituto Nazionale Tumori Fondazione Pascale	Naples	Italy
St. Vincenz-Krankenhaus GmbH	Paderborn	Germany
Universitaetsklinikum Schleswig-Holstein AöR	Kiel	Germany
Hospital General Universitario Gregorio Maranon	Madrid	Spain
Hospital Universitari Dexeus Grupo Quironsalud	Barcelona	Spain
Centrum Onkologii Ziemi Lubelskiej Im. Sw. Jana Z Dukli	Lublin	Poland
Bialostockie Centrum Onkologii Im. Marii Sklodowskiej-Curie W Bialymstoku	Bialystok	Poland
Mammazentrum Hamburg MVZ GbR	Hamburg	Germany
Brustzentrum Rhein-Ruhr Servicegesellschaft mbH	Moenchengladbach	Germany
Wojewodzki Szpital Specjalistyczny W Bialej Podlaskiej	Biala Podlaska	Poland
Virgen del Rocío University Hospital	Sevilla	Spain
Universitaetsklinikum Erlangen AöR	Erlangen	Germany
Universitaetsklinikum Tuebingen AöR	Tuebingen	Germany
Ospedale San Raffaele S.r.l.	Milan	Italy
Istituto Di Candiolo Fondazione Del Piemonte Per Loncologia IRCCS	Candiolo	Italy
Charite Universitaetsmedizin Berlin KöR	Berlin	Germany
Hospital Alvaro Cunqueiro	Vigo	Spain
IRCCS Ospedale Sacro Cuore Don Calabria	Negrar di Valpolicella	Italy
Universitaetsklinikum Leipzig AöR	Leipzig	Germany
Uifvfgpuvkvglttwgturb Aisqeiau	Augsburg	Germany
Acegxnr Uvb Tzpgruw nyly ognys	Leghorn	Italy
Uuqetkufirgqukgaxlcka Mkktiksj Axa	Munster	Germany
Nfzprvfr Izuskhgn Oakdpvegr Ilo Mjpsm Sapfdikovgpqjmxawgtqnvlmftgq Iuntimle Bexbihld	Cracow	Poland
Kggngyjw dzt Ufakdvacgncj Mgisexnk Axl	Munich	Germany
Asorkbk Uoqon Srhbrshgv Lgoktd Dr Bfffhmm	Bologna	Italy
Hazkgssh Vixt dgoujnod	Barcelona	Spain

Trial status

Country	Status	Recruitment Start
Germany	Not recruiting	25.10.2021
Italy	Not recruiting	25.10.2021
Poland	Not recruiting	25.10.2021
Spain	Not recruiting	25.10.2021

Trial locations

Investigated drugs:

Trastuzumab Deruxtecan (T-DXd) is a medication used in this trial as a monotherapy or in combination with other treatments. It is designed to target and destroy cancer cells in patients with HER2-positive early-stage breast cancer. This medication works by attaching to the HER2 protein on cancer cells and delivering a chemotherapy drug directly to them, which helps to kill the cancer cells.

THP is a combination of three medications: Trastuzumab, Pertuzumab, and a taxane chemotherapy drug. This combination is used to treat HER2-positive breast cancer by targeting the HER2 protein and stopping the growth of cancer cells. It is often used in combination with other treatments to improve outcomes for patients.

ddAC-THP is a standard treatment regimen that includes a combination of chemotherapy drugs and the THP regimen. The “ddAC” part refers to dose-dense Doxorubicin and Cyclophosphamide, which are chemotherapy drugs that help kill cancer cells. This regimen is used as a standard of care for patients with high-risk HER2-positive early-stage breast cancer.

HER2-positive breast cancer – This is a type of breast cancer characterized by the overexpression of the HER2 protein, which promotes the growth of cancer cells. It is considered an aggressive form of breast cancer due to its rapid growth and spread. In the early stages, it may present as a lump in the breast or changes in breast shape or size. The cancer can be classified as locally advanced if it has spread to nearby lymph nodes or tissues but not to distant parts of the body. Inflammatory breast cancer, a subtype, may cause redness and swelling of the breast. The progression of HER2-positive breast cancer can vary, with some cases advancing more quickly than others.

Trial ID:

2023-505210-18-00

Protocol code:

D967RC00001

NCT ID:

NCT05113251

Trial Phase:

Therapeutic confirmatory (Phase III)

Other Trials to Consider

#1 Clinical Trials Search in Europe

Study on Trastuzumab Deruxtecan and Drug Combination for Patients with High-Risk HER2-Positive Early Breast Cancer

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?