Breast CancerPhase 4NeoONNCT05036005
Neoadjuvant Ontruzant (SB3) in Patients With HER2-positive Early Breast Cancer: An Open-Label (NeoON)
A Phase 4 study testing Ontruzant, Chemotherapy and Pertuzumab in people with Breast Cancer and Breast Neoplasms, run by Institut fuer Frauengesundheit at 11 sites in Germany.
Trial summary
The treatment of patients with HER2 positive early breast cancer has continuously improved over the last decades. Up to now both, trastuzumab and pertuzumab are approved in combination with chemotherapy (CTX) not only for the adjuvant but also for the neoadjuvant treatment of early breast cancer patients. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer, Breast Neoplasms, Breast Cancer Female
- What is being tested?
- Ontruzant, Chemotherapy and Pertuzumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 11 sitesGermany
- Study dates
- 11 Jul 2021to Jul 2023
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written informed consent prior to beginning of trial specific procedures.
- Subject must be female and aged ≥ 18 years on day of signing informed consent.
- ECOG 0-1.
- Histologically confirmed, early HER2 positive breast cancer determined by core biopsy of breast tumor lesion.
- Measurable tumor lesion with a size of ≥ 1 cm assessed by sonography or magnetic resonance imaging (MRI) within ≤ 28 days prior to entry. In case of inflammatory disease, the extent of inflammation will be measured.
- Indication for chemotherapy.
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- Multicentric and/or multifocal disease as well as synchronous bilateral breast cancer is eligible as long as one measurable lesion meets all inclusion criteria. The investigator has to determine which lesion will be used for tumor evaluation before initiation of treatment.
- Complete staging within 8 weeks prior to entry with no evidence of distant disease, including bilateral mammography, breast ultrasound, chest-X-ray (or chest CT-scan), liver ultrasound (or liver CT-scan or liver MRI) and bone scan.
- Subjects must provide a core biopsy from tumor lesion before first chemotherapy, after 3 cycles of chemotherapy and after last neoadjuvant study treatment for biomarker analyses.
- Adequate organ function defined as: Absolute neutrophile count ≥1500/µL, Platelets ≥100 000/µL, Hemoglobin ≥10.0 g/dL or ≥6.2 mmol/L, Creatinine ≤1.5 × ULN OR measured or calculated creatinine clearance ≥30 mL/min for participant with creatinine levels >1.5 × institutional ULN (GFR can also be used in place of creatinine or CrCl), Total bilirubin ≤1.5 ×ULN OR direct bilirubin ≤ULN for participants with total bilirubin levels >1.5 × ULN, AST (SGOT) and ALT (SGPT) ≤2.5 × ULN (≤5 × ULN for participants with liver metastases), International normalized ratio (INR) OR prothrombin time (PT) ≤1.5 × ULN unless participant is receiving anticoagulant therapy as long as PT or aPTT is within therapeutic range of intended use of anticoagulants, LVEF > 50 %
- Female subjects of childbearing potential must have a negative urine pregnancy test within 72 h prior to study entry and be willing to use an adequate method of contraception for course of the study through 7 months after the last dose of trial treatment.
Who cannot join
- Concurrent participation in a study with an investigational agent/device or within 14 days of study entry.
- Prior chemotherapy, radiation therapy or small molecule therapy for any reason.
- Previous malignant disease being disease-free for less than 3 years (except in situ carcinoma of the cervix and basal cell carcinoma of the skin).
- Pregnancy or lactation.
- Prior neoadjuvant therapy.
- Active infection requiring systemic therapy.
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- History of (non-infectious) pneumonitis that required steroids or current pneumonitis.
- Active autoimmune disease or other diseases that requires systemic treatment with corticosteroids or immunosuppressive drugs (physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency is allowed).
- History of primary or acquired immunodeficiency (including allogenic organ transplant).
- Active or prior documented inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis).
- Known history of following infections: Human immunodeficiency virus (HIV), History of acute or chronic Hepatitis B or Hepatitis C, has received a live-virus vaccination within 30 days of planned treatment start. Seasonal flu vaccines that do not contain live virus are permitted.
- Known congestive heart failure > NYHA I and/or coronary heart disease, angina pectoris, previous history of myocardial infarction, uncontrolled or poorly controlled arterial hypertension (e.g. blood pressure >160/90 mmHg under treatment with two or more antihypertensive drugs), rhythm disorders with clinically significant valvular heart disease.
- Pre-existing motor or sensory neuropathy of a severity grade ≥2 by National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
- Any other condition in opinion of the investigator that would interfere with applied systemic treatment or other trial procedures.
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
Germany11 sites, 11 recruiting
- Recruiting
Hämato-Onkologische Schwerpunktpraxis am Klinikum Aschaffenburg
Aschaffenburg, Bavaria, 63739
Manfred Welslau, MD, +49 6021 4527300, info@onkologie-ab.de
- Not yet recruiting
Department for Hematology, Oncology and Tumor Immunology Charité Campus Benjamin Franklin
Berlin, 122000
Diana Lüftner, MD, Prof., +49 30 450513524, diana.lueftner@charite.de
- Not yet recruiting
Department of Gynecology and Obstetrics, HELIOS Hospital Berlin Buch GmbH
Berlin, 13125
Michael Untch, MD, Prof., +49 30 940153300, michael.untch@helios-gesundheit.de
- Recruiting
Department for Gynecology and Obstetrics, Marienhospital Bottrop gGmbH
Bottrop, North Rhine-Westphalia, 46236
Hans-Christian Kolberg, MD, +49 2041 1061601, hans-christian.kolberg@mhb-bottrop.de
- Not yet recruiting
Department of Gynecology and Obstetrics, Dresden University Hospital Carl-Gustav Carus
Dresden, Saxony, 01307
Pauline Wimberger, MD, Prof., +49 351 4583420, pauline.wimberger@uniklinikum-dresden.de
- Recruiting
Department of Gynecology and Obstetrics, Erlangen University Hospital
Erlangen, Bavaria, 91054
Peter A Fasching, MD, Prof., +49 9131 8543470, peter.fasching@uk-erlangen.de
- Not yet recruiting
Center for Hematology and Oncology Bethanien
Frankfurt am Main, Hesse, 60389
Hans Tesch, MD, Prof., +49 69 451080, info@onkologie-bethanien.de
- Not yet recruiting
Department of Gynecology, University Hospital Hamburg-Eppendorf
Hamburg, Haburg, 20246
Volkmar Müller, MD, Prof., +49 40 7410 - 52510, vmueller@uke.de
- Recruiting
Division Gynecologic Oncology, Heidelberg University Hospital (UKHD)
Heidelberg, Baden-Wurttemberg, 69120
Andreas Schneeweiss, MD, Prof., +49 (0) 6221 563 6051, andreas.schneeweiss@med.uni-heidelberg.de
- Not yet recruiting
Department of Gynecology and Obstetrics, University Medicine Mainz
Mainz, Hesse, 55131
Marcus Schmidt, MD, Prof., +49 6131 176884, marcus.schmidt@unimedizin-mainz.de
- Not yet recruiting
Department of Gynecology, Tübingen University Hospital
Tübingen, Baden-Wurttemberg, 72076
Andreas Hartkopf, MD, Prof., +49 70712982211, andreas.hartkopf@med.uni-tuebingen.de
About this study
Official title: Neoadjuvant Treatment of Ontruzant (SB3) in Patients With HER2-positive Early Breast Cancer: An Open-Label, Multicenter, Phase IV Study
The treatment of patients with HER2 positive early breast cancer has continuously improved over the last decades. Up to now both, trastuzumab and pertuzumab are approved in combination with chemotherapy (CTX) not only for the adjuvant but also for the neoadjuvant treatment of early breast cancer patients. A high pCR rate in the neoadjuvant setting was shown in several trials and observational studies with CTX+ trastuzumab and with CTX+ pertuzumab. The efficacy is dependent on a variety of mechanisms including the blocking of the important PI3K/Akt and MAPK pathways, and ADCC (antibody dependent cellular toxicity).
Recently the biosimilar Ontruzant® (SB3) has been introduced into the treatment of HER2 positive breast cancer as a biosimilar. Efficacy and toxicity have been shown to be equivalent to the first approved antibody, however, data from the real-world setting have not been published like it has for the originally approved antibody. Therefore, the aim of this study is to establish safety and efficacy for Ontruzant® in the real world setting. Patients can be included if they are treated with Ontruzant® in the neoadjuvant setting. Additionally, the study will be accompanied by a comprehensive immune monitoring program and biomarker program to explore immune oncology potential for the neoadjuvant treatment.
- Being tested
- Ontruzant, Chemotherapy, Pertuzumab
- Keywords
- Ontruzant, Trastuzumab, Pertuzumab, neoadjuvant chemotherapy
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OntruzantDrug
Also called SB3
All patients will receive an initial dose of Ontruzant® i.v. 8 mg/kg b.w in combination with standard chemotherapy with or without pertuzumab i.v. 480 mg followed by 5 cycles of Ontruzant® i.v. 6 mg/kg b.w. q21d in combination with standard chemotherapy with or without pertuzumab i.v. 420 mg. Addition of pertuzumab is at the discretion of investigator's decision.
ChemotherapyDrug
All patients will receive an initial dose of Ontruzant® i.v. 8 mg/kg b.w in combination with standard chemotherapy with or without pertuzumab i.v. 480 mg followed by 5 cycles of Ontruzant® i.v. 6 mg/kg b.w. q21d in combination with standard chemotherapy with or without pertuzumab i.v. 420 mg. Choice of chemotherapy is at the discretion of the investigator
PertuzumabDrug
All patients will receive an initial dose of Ontruzant® i.v. 8 mg/kg b.w in combination with standard chemotherapy with or without pertuzumab i.v. 480 mg followed by 5 cycles of Ontruzant® i.v. 6 mg/kg b.w. q21d in combination with standard chemotherapy with or without pertuzumab i.v. 420 mg. Addition of pertuzumab is at the discretion of investigator's decision.
| Study group | Role | What they receive |
|---|---|---|
| Ontruzant + Pertuzumab (optional) + Chemotherapy | Experimental | All patients will receive 6 cycles of Ontruzant® i.v. q21d in combination with standard chemotherapy with or without pertuzumab, at the discretion of investigator's decision. Initial dose of Ontruzant® i.v. will be 8 mg/kg b.w. followed by 5 cycles of Ontruzant® i.v. 6 mg/kg b.w. q21d. Clinical and bioptic tumor assessment will be performed during baseline and during surgery.
Study treatment will be applied until state of the art surgery, onset of unacceptable toxicities, progression or withdrawal of consent. A safety follow-up is planned for 30 days after the last administration of study medication. Receives: Drug: Ontruzant; Drug: Chemotherapy; Drug: Pertuzumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathological complete response (pCR) rate
Pathological complete response (pCR) rate, defined as the complete absence of tumor cells (ypT0; ypN0) after neoadjuvant study treatment of HER2-positive early breast cancer patients treated with Ontruzant® (SB3) in combination with pertuzumab (optional) and a standard chemotherapy.
Measured: Pathological complete response will be assessed at final surgery.
Secondary outcomes (4)
Pathological complete response (pCR) rate in patients without pertuzumab
Pathological complete response (pCR) rate, defined as the complete absence of tumor cells (ypT0; ypN0) after neoadjuvant study treatment of HER2-positive early breast cancer patients treated with Ontruzant® (SB3) and a standard chemotherapy who were not treated with pertuzumab.
Measured: Pathological complete response will be assessed at final surgery.
Number of participants wuth treatment-related adverse events as assessed by CTCAE v5.0
The safety endpoints for the study will include rate of AE/SAEs and fatal SAEs, causality and outcome of AE/SAEs, rate of treatment discontinuations and reasons, Changes in vital signs, laboratory values etc. Grading of AE/SAEs will be based on NCI CTCAE v5.0.
Measured: Adverse ebents will be assessed from first administration of trial treatment until 30 days after last administration of trial treatment.
EORTC-QLQ-C30
To evaluate changes in health related quality of life (QoL) assessments from baseline in all subjects using Quality of Life Questionnaire Core 30 (EORTC QLQ-C30).
Measured: Every nine weeks from first administration of trial medication through study completion, up to 30 days after administration of last medication.
EORTC-QLQ-BR23
To evaluate changes in health related quality of life (QoL) assessments from baseline in all subjects using Quality of Life Questionnaire Breast Cancer-Specific Quality of Life (EORTC QLQ-BR23).
Measured: Every nine weeks from first administration of trial medication through study completion, up to 30 days after administration of last medication.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2021
- Study start11 Jul 2021
- Primary completionApr 2023 (estimated)
- Study completionJul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 108 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut fuer Frauengesundheit
- Sponsor type
- University, hospital or other
- Collaborators
- Samsung Bioepis Co., Ltd.
- Responsible party
- Sponsor
- Investigators
- Diana Lüftner, MD, Prof., Study chair, Department for Hematology, Oncology and Tumor Immunology Charité Campus Benjamin Franklin, BerlinAndreas Schneeweiss, MD, Prof., Study chair, National Center for Tumor Diseases (NCT), Head of Division Head of Division Gynecologic Oncology, Heidelberg University Hospital (UKHD)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05036005
- Sponsor's protocol ID
- IFG-08-2019
- Acronym
- NeoON
- Status last verified
- Apr 2023
- First submitted
- 30 Aug 2021
- Last updated
- 18 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neoadjuvant Treatment of Ontruzant (SB3) in Patients With HER2-positive Early Breast Cancer: An Open-Label, Multicenter, Phase IV Study
- ClinicalTrials.gov ID
- NCT05036005
- Acronym / sponsor ID
- NeoON / IFG-08-2019
- Keywords
- Ontruzant, Trastuzumab, Pertuzumab, neoadjuvant chemotherapy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 108 participants (estimated)
- Lead sponsor
- Institut fuer FrauengesundheitUniversity, hospital or other
- Collaborators
- Samsung Bioepis Co., Ltd.
- Study start
- 11 Jul 2021 (actual)
- Primary completion
- Apr 2023 (estimated)
- Study completion
- Jul 2023 (estimated)
- First posted
- 5 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The treatment of patients with HER2 positive early breast cancer has continuously improved over the last decades. Up to now both, trastuzumab and pertuzumab are approved in combination with chemotherapy (CTX) not only for the adjuvant but also for the neoadjuvant treatment of early breast cancer patients. A high pCR rate in the neoadjuvant setting was shown in several trials and observational studies with CTX+ trastuzumab and with CTX+ pertuzumab. The efficacy is dependent on a variety of mechanisms including the blocking of the important PI3K/Akt and MAPK pathways, and ADCC (antibody dependent cellular toxicity).
Recently the biosimilar Ontruzant® (SB3) has been introduced into the treatment of HER2 positive breast cancer as a biosimilar. Efficacy and toxicity have been shown to be equivalent to the first approved antibody, however, data from the real-world setting have not been published like it has for the originally approved antibody. Therefore, the aim of this study is to establish safety and efficacy for Ontruzant® in the real world setting. Patients can be included if they are treated with Ontruzant® in the neoadjuvant setting. Additionally, the study will be accompanied by a comprehensive immune monitoring program and biomarker program to explore immune oncology potential for the neoadjuvant treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ontruzant + Pertuzumab (optional) + Chemotherapy | Experimental | Drug: Ontruzant, Drug: Chemotherapy, Drug: PertuzumabAll patients will receive 6 cycles of Ontruzant® i.v. q21d in combination with standard chemotherapy with or without pertuzumab, at the discretion of investigator's decision. Initial dose of Ontruzant® i.v. will be 8 mg/kg b.w. followed by 5 cycles of Ontruzant® i.v. 6 mg/kg b.w. q21d. Clinical and bioptic tumor assessment will be performed during baseline and during surgery. Study treatment will be applied until state of the art surgery, onset of unacceptable toxicities, progression or withdrawal of consent. A safety follow-up is planned for 30 days after the last administration of study medication. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Written informed consent prior to beginning of trial specific procedures.
- Subject must be female and aged ≥ 18 years on day of signing informed consent.
- ECOG 0-1.
- Histologically confirmed, early HER2 positive breast cancer determined by core biopsy of breast tumor lesion.
- Measurable tumor lesion with a size of ≥ 1 cm assessed by sonography or magnetic resonance imaging (MRI) within ≤ 28 days prior to entry. In case of inflammatory disease, the extent of inflammation will be measured.
Key exclusion criteria (14 listed)
- Concurrent participation in a study with an investigational agent/device or within 14 days of study entry.
- Prior chemotherapy, radiation therapy or small molecule therapy for any reason.
- Previous malignant disease being disease-free for less than 3 years (except in situ carcinoma of the cervix and basal cell carcinoma of the skin).
- Pregnancy or lactation.
- Prior neoadjuvant therapy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OntruzantAlso: SB3All patients will receive an initial dose of Ontruzant® i.v. 8 mg/kg b.w in combination with standard chemotherapy with or without pertuzumab i.v. 480 mg followed by 5 cycles of Ontruzant® i.v. 6 mg/kg b.w. q21d in combination with standard chemotherapy with or without pertuzumab i.v. 420 mg. Addition of pertuzumab is at the discretion of investigator's decision. | Drug | Ontruzant + Pertuzumab (optional) + Chemotherapy |
| ChemotherapyAll patients will receive an initial dose of Ontruzant® i.v. 8 mg/kg b.w in combination with standard chemotherapy with or without pertuzumab i.v. 480 mg followed by 5 cycles of Ontruzant® i.v. 6 mg/kg b.w. q21d in combination with standard chemotherapy with or without pertuzumab i.v. 420 mg. Choice of chemotherapy is at the discretion of the investigator | Drug | Ontruzant + Pertuzumab (optional) + Chemotherapy |
| PertuzumabAll patients will receive an initial dose of Ontruzant® i.v. 8 mg/kg b.w in combination with standard chemotherapy with or without pertuzumab i.v. 480 mg followed by 5 cycles of Ontruzant® i.v. 6 mg/kg b.w. q21d in combination with standard chemotherapy with or without pertuzumab i.v. 420 mg. Addition of pertuzumab is at the discretion of investigator's decision. | Drug | Ontruzant + Pertuzumab (optional) + Chemotherapy |
Primary outcome
Pathological complete response (pCR) rate
Time frame: Pathological complete response will be assessed at final surgery.
Pathological complete response (pCR) rate, defined as the complete absence of tumor cells (ypT0; ypN0) after neoadjuvant study treatment of HER2-positive early breast cancer patients treated with Ontruzant® (SB3) in combination with pertuzumab (optional) and a standard chemotherapy.
4 secondary outcomes
Pathological complete response (pCR) rate in patients without pertuzumab
Time frame: Pathological complete response will be assessed at final surgery.
Number of participants wuth treatment-related adverse events as assessed by CTCAE v5.0
Time frame: Adverse ebents will be assessed from first administration of trial treatment until 30 days after last administration of trial treatment.
EORTC-QLQ-C30
Time frame: Every nine weeks from first administration of trial medication through study completion, up to 30 days after administration of last medication.
EORTC-QLQ-BR23
Time frame: Every nine weeks from first administration of trial medication through study completion, up to 30 days after administration of last medication.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Diana Lüftner, MD, Prof. study chair
Department for Hematology, Oncology and Tumor Immunology Charité Campus Benjamin Franklin, Berlin
Andreas Schneeweiss, MD, Prof. study chair
National Center for Tumor Diseases (NCT), Head of Division Head of Division Gynecologic Oncology, Heidelberg University Hospital (UKHD)
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ontruzant, Chemotherapy and Pertuzumab in people with Breast Cancer and Breast Neoplasms, run by Institut fuer Frauengesundheit at 11 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact NeoON Study Manager (+49 9131 9279136, neo.on@ifg-erlangen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathological complete response (pCR) rate (time frame: Pathological complete response will be assessed at final surgery.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2023.