Could a Chemo-Free cocktail beat early breast cancer?

NCT ID NCT04733118

Disease control Sponsor: MedSIR Source: ClinicalTrials.gov ↗

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This phase 2 trial is testing whether a combination of targeted cancer drugs (trastuzumab, pertuzumab, and T-DM1) can effectively treat HER2-positive early breast cancer without traditional chemotherapy. About 393 patients will receive these drugs as a subcutaneous injection, with surgery after treatment. The goal is to see if this approach can achieve a complete response and reduce the risk of recurrence while avoiding chemotherapy side effects.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: Trastuzumab, pertuzumab, and T-DM1 (targeted cancer drugs)
What this could lead to: If successful, this could offer a chemotherapy-free treatment option for some HER2-positive early breast cancer patients, potentially reducing harsh side effects while still controlling the disease.
What could go wrong: This is a phase 2 trial with no control group, so results are preliminary. The approach may not work for all patients, and targeted drugs still carry risks like heart or liver problems.

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Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

393 people

The number who actually took part.

Started

Aug 2021

Expected to finish

Mar 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion criteria Patients will be included in the study only if they meet ALL of the following criteria: 1. Written informed consent prior to beginning specific protocol procedures. 2. Female or male patients ≥ 18 years of age. 3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. 4. Histologically proven invasive carcinoma of the breast. 5. Tumor size must be between ≥ 5mm and ≤30mm in greatest dimension using breast MRI. Note: Although tumors between ≥ 5mm and ≤ 10mm are not considered target lesions by RECIST v1.1, we will consider these lesions as targets to follow-up. 6. Patients must have node-negative breast cancer by clinical exam, MRI and ultrasound according to the American Joint Committee on Cancer (AJCC) 8th edition. 7. Centrally confirmed HER2\[+\] status with IHC score 3+. 8. Known estrogen receptor (ER) and progesterone receptor (PgR) status prior to study entry that should be performed by immunohistochemical methods according to the local institution standard protocol. 9. Patients with multifocal or multicentric breast cancer are eligible; only patients with a total number of lesions ≤ 2 are eligible and if all lesions sampled meet the inclusion criteria #5, #6, and #7. Note: If two lesions are in such proximity that it is suspected to be the same lesion, it would not be necessary to biopsy both. 10. Normal left ventricular function and diastolic function (left ventricular ejection fraction \[LVEF\] ≥55%) as assessed by echocardiogram or multiple-gated acquisition scan (MUGA) documented within ≤28 days prior to first dose of study treatment. 11. Adequate bone marrow, liver, and renal function: 1. Hematological: White blood cell (WBC) count \> 3.0 × 109/L, absolute neutrophil count (ANC) ≥ 1.5 × 109/L, platelet count ≥ 100.0 × 109/L, and hemoglobin ≥ 10.0 g/dL (≥ 6.2 mmol/L). 2. Hepatic: total bilirubin ≤ institutional upper limit of normal (ULN) (except for Gilbert's syndrome); alkaline phosphatase (ALP) ≤ 2.5 times ULN; aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 1.5 times ULN. 3. Renal: serum creatinine ≤ 1.5 × ULN or creatinine clearance ≥ 50 mL/min/1.73 m2 for patients with creatinine levels above institutional normal. 4. International normalized ratio (INR) and activated partial thromboplastin time (aPTT) ≤ 1.5 × ULN. 12. Patient must be accessible for treatment and follow-up. 13. Willingness and ability to provide blood samples at baseline, C3D1 before treatment infusion, pre-surgery and then after surgery: every 6 months for the first 5 years, and every year thereafter until the EoS. 14. Willingness and ability to provide tumor tissue samples at baseline and at surgery. 15. Women of childbearing potential and men with partners of childbearing potential must be willing to use one highly effective form of nonhormonal contraception or two effective forms of nonhormonal contraception by the patient and/or partner and to continue its use for the duration of study treatment and for seven months after the last dose of study treatment. Note: Acceptable forms of effective contraception should include two of the following: i. Placement of non-hormonal intrauterine device (IUD) ii. Condom with spermicidal foam/gel/film/cream/suppository iii. Diaphragm or cervical/vault caps with spermicidal foam/film/cream/suppository The above contraception is not a requirement in the case the male patient, or male partner of a female patient, is surgically sterilized, the female patient is post-menopausal or the patient remains abstinent and truly abstains from sexual activity (refrains from heterosexual intercourse). 16. Negative serum pregnancy test for premenopausal women including women who have had a tubal ligation and for women less than 12 months after the onset of menopause. Exclusion criteria: Any patient meeting ANY of the following criteria will be excluded from the study: 1. Any previous treatment, including chemotherapy, anti-HER2 therapy, radiation therapy, or ET for invasive breast cancer (except for breast carcinoma in situ of the contralateral breast cancer, in the last five years before treatment initiation in this study). 2. HER2 disease with IHC score 0, 1+ or 2+ and in situ hybridization (ISH) positive result. 3. Evidence of metastatic disease. Note: All patients must be willing to undergo chest and pelvis computed tomography (CT)/MRI scan before enrolment to prove no evidence of metastatic disease. Bone scan will be performed at baseline only if there is suspicion of bone metastases. If a bone scan cannot be performed, an alternative is PET/CT using 18F-labeled sodium fluoride (18F-fluoride PET/CT). 4. Patients with bilateral breast cancer. 5. Known hypersensitivity reaction to any investigational or therapeutic compound or their incorporated substances. 6. History of other malignancy within the last five years prior to first dose of study drug administration, except for curatively treated basal and squamous cell carcinoma of the skin and/or in situ cervical carcinoma. 7. Uncontrolled hypertension (systolic \> 150 mm Hg and/or diastolic \> 100 mm Hg) despite adequate antihypertensive treatment. 8. Serious cardiac illness or medical conditions including, but not confined to, the following: * History of NCI CTCAE v5.0 Grade ≥ 3 symptomatic congestive heart failure (CHF) or New York Heart Association (NYHA) Class ≥ II. * High-risk uncontrolled arrhythmias (i.e., atrial tachycardia with a heart rate ≥ 100/min at rest, significant ventricular arrhythmia \[ventricular tachycardia\], or higher-grade atrioventricular \[AV\]-block, such as second-degree AV-block Type 2 \[Mobitz II\] or third-degree AV-block). * Serious cardiac arrhythmia or severe conduction abnormality not controlled by adequate medication. * Angina pectoris requiring anti-angina medication. * Clinically significant valvular heart disease. * Evidence of transmural infarction on electrocardiogram (ECG). * Evidence of myocardial infarction within the last 12 months prior to study entry. 9. History of ventricular dysrhythmias or risk factors for ventricular dysrhythmias, such as structural heart disease (e.g., severe left ventricular systolic dysfunction \[LVSD\], left ventricular hypertrophy), coronary heart disease (symptomatic or with ischemia demonstrated by diagnostic testing), clinically significant electrolyte abnormalities (e.g., hypokalemia, hypomagnesemia, hypocalcemia), or family history of sudden unexplained death or long QT syndrome. 10. Active uncontrolled infection at the time of enrollment. 11. Current known infection with human immunodeficiency virus (HIV), hepatitis B virus, or hepatitis C virus. 12. Patients with pulmonary disease requiring continuous oxygen therapy. 13. Grade ≥2 neuropathy as per National Cancer Institute - Common Terminology Criteria for Adverse Events (NCI-CTCAE) version (v)5.0. 14. Previous history of bleeding diathesis. 15. Patient is currently receiving chronic treatment with corticosteroids, or another immunosuppressive agent (standard premedication for chemotherapy and local applications are allowed). 16. Major surgical procedure or significant traumatic injury within 14 days prior to study entry or anticipation of need for major surgery within the course of the study treatment. 17. Any other concurrent severe and/or uncontrolled medical condition that would contraindicate patient participation in the clinical study. 18. History of having received any investigational treatment within 28 days prior to study entry. 19. Pregnant or breast-feeding women or patients not willing to apply highly effective contraception as defined in the protocol.

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Conditions

The condition(s) this trial relates to.

breast cancer breast neoplasm HER2 positive breast carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Early breast cancer

Contacts and locations

Locations

AO Ospedale Civile Legnano

Milan, Italy
Azienda Ospedaliero Universitaria Di Bologna - Policlinico S.Orsola-Malpighi

Bologna, Italy
Azienda Ospedaliero-Universitaria di Parma

Parma, Italy
Békés county hospital

Békés, Hungary
Centro Oncológico de Galicia

A Coruña, 15009, Spain
Complejo Asistencial Universitario de León

León, Spain
Complejo Hospitalario de Jaen

Jaén, Spain
Consorcio Hospital General de Valencia

Valencia, Spain
Consorcio Hospitalario Provincial De Castelló

Castellon, 12002, Spain
Evangelisches Krankenhaus Bethesda

Duisburg, Germany
Fondazione Policlinico Universitario Agostino Gemelli

Roma, Italy
Hospital Arnau de Vilanova de Valencia

Valencia, Spain
Hospital Clinico Universitario de Valencia

Valencia, Spain
Hospital Clínico San Carlos

Madrid, 28040, Spain
Hospital General Universitario de Alicante

Alicante, Spain
Hospital La Fe

Valencia, 46026, Spain
Hospital Quirón San Camilo- Ruber Juan Bravo

Madrid, Spain
Hospital Ramón y Cajal

Madrid, Spain
Hospital Universitari Arnau de Vilanova de Lleida

Lleida, Spain
Hospital Universitari Dexeus - Grupo Quirónsalud

Barcelona, Spain
Hospital Universitari San Joan de Reus

Reus, Tarragona, Spain
Hospital Universitario A Coruña

A Coruña, Spain
Hospital Universitario Clínico San Cecilio de Granada

Granada, Spain
Hospital Universitario Reina Sofia

Córdoba, Cordoba, 14004, Spain
Hospital Universitario Virgen del Rocio

Seville, Spain
Hospital Universitario de Basurto

Bilbao, 48013, Spain
Hospital Universitario de Torrejón

Torrejón, Spain
ICO L'Hospitalet - Instituto Catalán de Oncología

L'Hospitalet de Llobregat, Barcelona, 08007, Spain
Institut Català d' Oncologia Badalona (ICO)

Badalona, Spain
Instituto Valenciano de Oncología (IVO)

Valencia, 46009, Spain
Istituto Europeo di Oncologia - NC

Milan, Italy
Kliniken Essen Mitte

Essen, Germany
Klinikum Ernst von Bergmann

Potsdam, Germany
Ospedale Guglielmo da Saliceto

Piacenza, Italy
Ospedale San Gerardo

Monza, Italy
Praxisnetzwerk Hämatologie und intern. Onkologie

Cologne, Germany
Tolna County Balassa János Hospital

Szekszárd, Hungary
UMHAT Sveti Ivan Rilski EAD Department of Medical Oncology

Sofia, Bulgaria
Universitätsklinikum Essen Frauenklinik

Essen, Germany
Universitätsklinikum Mannheim GmbH

Manheim, Germany
VHIO Vall d'Hebron Institute of Oncology

Barcelona, Spain

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