Study Comparing DB-1303 and Chemotherapy for Patients with HER2-low, Hormone Receptor Positive, Metastatic 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-low, Hormone Receptor Positive, Metastatic Breast Cancer. This form of cancer is characterized by low levels of a protein called HER2 and the presence of hormone receptors. The study will compare the effectiveness of a new treatment called DB-1303 with standard chemotherapy options chosen by the doctor. DB-1303 is an experimental medication that is given through an intravenous infusion, which means it is administered directly into the bloodstream through a vein.

The purpose of the study is to evaluate how well DB-1303 works in slowing down the progression of the cancer compared to the usual chemotherapy treatments. Participants in the study will be randomly assigned to receive either DB-1303 or one of the standard chemotherapy drugs, which may include Capecitabine, Paclitaxel, or Paclitaxel Albumin-Bound. These chemotherapy drugs are commonly used to treat breast cancer and are administered either orally or through intravenous infusion, depending on the specific medication.

The study will take place over a period of time, during which participants will receive their assigned treatment and be monitored for any changes in their condition. The goal is to determine which treatment is more effective in extending the time before the cancer progresses. Participants will also be observed for any side effects or changes in their overall health. This study aims to provide valuable information that could help improve treatment options for patients with this specific type of breast cancer.

1 joining the study

Upon joining the study, the patient will be randomly assigned to receive either the experimental drug DB-1303 or a chemotherapy treatment chosen by the investigator.

The study is designed to compare the effectiveness of DB-1303 with other chemotherapy options for patients with a specific type of breast cancer.

2 treatment administration

If assigned to the DB-1303 group, the patient will receive the medication through an intravenous infusion. The frequency and dosage will be determined by the study protocol.

If assigned to the chemotherapy group, the patient may receive one of the following treatments: capecitabine (oral), paclitaxel (intravenous infusion), or paclitaxel albumin-bound (intravenous infusion). The specific medication, dosage, and frequency will be chosen by the investigator.

3 monitoring and assessments

Throughout the study, the patient’s health and response to treatment will be closely monitored. This includes regular physical examinations, laboratory tests, and imaging studies.

The patient’s progress will be evaluated using criteria for measuring tumor response, and any side effects will be documented.

4 completion of treatment

The treatment phase will continue until the patient experiences disease progression, unacceptable side effects, or chooses to withdraw from the study.

After completing the treatment, follow-up assessments will be conducted to monitor the patient’s health and gather additional data on the long-term effects of the treatment.

Who Can Join the Study?

Must be an adult, which means being 18 years or older.
Must have good functioning of organs and bone marrow within 14 days before starting the study.
Must have a sufficient break from previous treatments before starting the study.
For women who can have children, they must either be post-menopausal or have a negative pregnancy test if they are sexually active with a male partner who is not sterilized.
Women who can have children and are sexually active with a non-sterilized male partner must use a highly effective birth control method from the time of screening and continue for 7 months after the last dose of the study treatment.
Men who are not sterilized and are sexually active with a woman who can have children must use a condom with spermicide from screening and throughout the study and washout period (4 months after the last dose of DB-1303, 6 months after the last dose of paclitaxel or nab-paclitaxel, and 3 months after the last dose of capecitabine).
Must have breast cancer that is advanced or has spread to other parts of the body, shows low levels of a protein called HER2, and is hormone receptor positive (HR+), meaning it has receptors for hormones like estrogen or progesterone.
Must provide a sample of tumor tissue for testing HER2 levels, preferably from the time when the cancer spread or later.
Must have an ECOG performance status of 0 or 1, which means being fully active or having some symptoms but still able to carry out light work.
Must have experienced disease progression on hormone therapy and a CDK4/6 inhibitor within 6 months of starting first-line treatment for metastatic disease and be considered suitable for chemotherapy, or have disease progression on at least two previous lines of hormone therapy with or without targeted therapy.
Must not have had chemotherapy for advanced or metastatic breast cancer, but can have had chemotherapy in earlier stages if there was a disease-free period of more than 12 months.
Must have a life expectancy of at least 12 weeks at the time of screening.
Must have at least one measurable lesion, which is a tumor that can be measured by imaging tests like CT or MRI. For bone-only disease, only certain types of bone lesions are eligible.
Must have a left ventricular ejection fraction (LVEF) of 50% or higher, which is a measure of heart function, checked by echocardiography or a MUGA scan within 28 days before starting the study.

Who Cannot Join the Study?

Patients who have a different type of cancer than the one being studied cannot participate.
Patients who have received certain treatments for their cancer recently may not be eligible.
Patients with serious health conditions that could interfere with the study may be excluded.
Patients who are pregnant or breastfeeding cannot take part in the study.
Patients who are unable to follow the study procedures or attend required visits may not be eligible.
Patients who have participated in another clinical trial recently may be excluded.
Patients with allergies to the study medication or similar drugs cannot participate.
Patients with certain infections or diseases that could affect the study results may be excluded.

Where you can join this trial?

Verified and Recommended Sites

Site Name	City	Country	Status
Wojskowy Instytut Medyczny Państwowy Instytut Badawczy	Warsaw	Poland

Verified Sites

Site Name	City	Country
Oncopole Claudius Regaud	Toulouse	France
Technische Universitaet Dresden	Dresden	Germany
Katholieke Universiteit te Leuven	Leuven	Belgium
Hospital Universitario Hm Sanchinarro	Madrid	Spain
Hospital Universitario De Navarra	Pamplona	Spain
Comite Entreprise Paul Papin	Angers	France
Futuremeds Sp. z o.o.	Wroclaw	Poland

Other Sites

Site Name	City	Country
Ospedale San Raffaele S.r.l.	Milan	Italy
Istituto Europeo Di Oncologia S.r.l.	Milan	Italy
IRCCS Istituto Nazionale Tumori Fondazione Pascale	Naples	Italy
Hopital Beaujon	Clichy	France
Hospital Del Mar	Barcelona	Spain
Polyclinique Bordeaux Nord Aquitaine	Bordeaux	France
Centre De Cancerologue Du Grand Montpellier	Montpellier	France
Centre Hospitalier Groupe Hospitalier De La Rochelle Re Aunis	La Rochelle	France
Institut Sainte Catherine	Avignon	France
Mruk-Med I Sp. z o.o.	Rzeszow	Poland
Mnfzrzowl Ikgaoxgkbx Cammdqdc Sjktgfkc Ssr z oitz	Warsaw	Poland
Cuuenocfg Ujluspizhpfzhw Sxpkubsiv	Woluwe-Saint-Lambert	Belgium
Holonkqd Uktqlwsafjrr Gxkdgqn Ds Ciwlxzwtk	Sant Cugat Del Valles	Spain
Vtgnft dsc Rnbmq Udxqwznein Hbfwsbpk	Sevilla	Spain
Uqnovdzdft Hforaemi Cmtzrls	Cologne	Germany
Uikdrlowusngkgkngyisv Ettuyxug Atp	Erlangen	Germany
Fcluhqenhn Ivfix Pezskgzzvvl Smn Mrbyzi	Pavia	Italy
Adcegiiarz Pobpbwex Hplkcqhf Dg Mukiabkmf	Marseille	France
Ukktpqumespeuzmip Dhlmb Sdadu Dw Vkcgie	Verona	Italy
Hzgfmqqu Ccthvr Dm Byjgaoecv	Barcelona	Spain
Hhdbbfae Utltrdavwlejn Fgloqtqpq Jaosbxi Dyyh	Madrid	Spain
Uxwvtmvrffgz Dx Sgzenbyt De Cbolhyejwc	Santiago De Compostela	Spain
Hodbrixi Ctbutcw Sfd Cgnpyi	Madrid	Spain
Sqqdbuqjqsu Plzyqmqlw Zchibk Otkzia Zezqniptjl Sntyime Umstjjcaaswks W Kmqvzgjj	Cracow	Poland
Ctvaiq Hqmtfvzunhn Dz Ln Cgfj Bdsabw	Bayonne	France
Cfsaye hzqgdkotokv unixyozduwbug dt Ludxm	Liege	Belgium
Uypdbteryasv Zvbfttqjxm Gpib	Gent	Belgium
Mqpyqjoampbzmo Bkrjbsi gtikd	Bottrop	Germany
Cvwzsw Hrytmldigne Llao Sjd	Pierre Benite	France
Hyqijetd Umtgtpqyykahv Ppishi Do Hgqpvy Dh Mdzbdupuivr	Majadahonda	Spain
Usgzcopyha Dpscx Sqamf Di Bbklnxi	Brescia	Italy
Auckejre Znvomihqkt Dbxez	Roeselare	Belgium
Mggkuq Hcmqomel Wctxpo	Witten	Germany
Fmflkfygop Iywpuryass Iajrkhim Nlmajbtwjdv Bllwx	Milan	Italy
Huthnmbk Uhsraedhtwwcj Vijouk Do Le Vpfgmuuk	Malaga	Spain
Prftbnzaepjr Dj Lttibkd	Limoges	France
Ctcicl Hxsol Baexocqcv	Rouen	France
Hcsxir Drd Hzvab Sbtaavk Kkikxsll Wzighjrce Gtto	Wiesbaden	Germany
Akacrvv Oapdxtmxpfejxcvomvwngognf Pmqrscequrz Gi Rfdqkfzbynsj Msios Dd Cshmnxg	Catania	Italy
Bbuuevudkdv Vyticrmpt Ojymyntqyrkh	Kecskemet	Hungary
Swimozdkmo Eefbvbf	Budapest	Hungary
Cbchos Onagu Lnlalpm	Lille	France
Obttmghid Cpebxf Ompbqskh	Nimes	France
Bagvbyyx Usxyjlgtyn Hghwokfg Cqhenj	Besançon	France
Hiimjxlj Ulxxgqozcrwnb Qetsuhscpcl Mzcpuu	Pozuelo De Alarcon	Spain
Gursysqhdjkudbueo Vsrvazlqh Pctf Ayggne Evylwhuj Odxmqo Kqjdss	Gyor	Hungary
Zecy Midvta Sbhtr Rdkenn Kriaqp	Zalaegerszeg	Hungary
Hgzybjfz Vxvwdm Ptczxm Syt Aafscva	Malaga	Spain
Cykjmpqv Gkjgpvicg Swyfut	Bergamo	Italy
Vsevilns Nboztwms ftov Gtyotazfna Gwqs	Berlin	Germany
Ueudwtcxxw Mvozm Geonzgi Oy Ctmojevmd	Catanzaro	Italy
Wbgjauxudvfsc Cclaeml Otshepwkb Ihz Maemu Sztycsgrwgpgszlxfp	Poznan	Poland
Kcrlnyzszimutojdj Vjdeiehtj Srdlk Bklaejt Kmjwpp	Tatabanya	Hungary
Nphpip Viwxibuse Snsee Ldzay Kuruqt	Salgotarjan	Hungary
Hjpfuatz Qmhjairdrqb Bdmbosjyd	Barcelona	Spain
Ijbfdhbm Mve Sae z ocov	Lodz	Poland

Trial status

Country	Status	Recruitment Start
Belgium	Not recruiting	23.03.2024
France	Not recruiting	23.03.2024
Germany	Not recruiting	23.03.2024
Hungary	Not recruiting	23.03.2024
Italy	Not recruiting	23.03.2024
Poland	Not recruiting	23.03.2024
Spain	Not recruiting	23.03.2024

Trial locations

Investigated Drugs:

DB-1303 is an experimental medication being tested for its effectiveness in treating a specific type of breast cancer. This medication is being studied in patients with metastatic breast cancer that is hormone receptor positive (HR+) and has low levels of a protein called HER2. The goal is to see if DB-1303 can help slow down the progression of the disease in patients whose cancer has worsened despite previous hormone therapy.

Investigator’s Choice Chemotherapy refers to a selection of standard chemotherapy treatments chosen by the doctor overseeing the patient’s care. These treatments are used to try to control the cancer and improve the patient’s quality of life. The specific chemotherapy drugs used can vary, depending on what the doctor believes will be most effective for the individual patient.

Metastatic Breast Cancer – This is a type of breast cancer that has spread beyond the breast to other parts of the body, such as the bones, liver, lungs, or brain. It is characterized by the presence of cancer cells in distant organs, which can lead to various symptoms depending on the organs affected. The progression of metastatic breast cancer can vary, with some patients experiencing rapid spread while others may have a slower progression. The disease is often classified based on hormone receptor status, such as hormone receptor-positive, which means the cancer cells grow in response to hormones like estrogen or progesterone. Additionally, HER2-low status indicates that the cancer cells have low levels of the HER2 protein, which can influence the behavior and treatment response of the cancer.

Trial ID:

2023-507333-17-00

Protocol code:

DB-1303-O-3002

NCT ID:

NCT06018337

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study Comparing DB-1303 and Chemotherapy for Patients with HER2-low, Hormone Receptor Positive, Metastatic Breast Cancer

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?