Female patients with early HER2positive breast cancer, neoadjuvantly treated. MedDRA version: 21.1 Level: PT Classification code 10057654 Term: Breast cancer female System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 20.0 Level: PT Classification code 10006199 Term: Breast cancer stage I System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 20.0 Level: PT Classification
Conditions
Interventions
Trade Name: Ontruzant
Product Name: Ontruzant
Pharmaceutical Form: Powder for concentrate for solution for infusion
INN or Proposed INN: TRASTUZUMAB
CAS Number: 180288-69-1
Concentration unit: mg mill
Sponsors
Institut für Frauengesundheit GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: In order to be eligible for participation in this trial subject must fulfil all of the following criteria: 1. Written informed consent prior to beginning of trial specific procedures. 2. Subject must be female and aged = 18 years on day of signing informed consent. 3. ECOG 0-1. 4. Histologically confirmed, early HER2 positive breast cancer determined by core biopsy of breast tumor lesion. 5. 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. 6. Indication for chemotherapy. 7. 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. 8. 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. 9. Subjects must provide a core biopsy from tumor lesion before first chemotherapy and after last neoadjuvant study treatment for biomarker analyses. 10. Adequate organ function defined by laboratory values. 11. Female subjects of childbearing potential must have a negative urine pregnancy test within 72 h prior to study entry and be willing to use highly effective method of contraception for course of the study through 7 months after the last dose of trial treatment. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 85 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 23
Exclusion criteria
Exclusion criteria: The subject must be excluded from participating in the trial in following cases: 1. Concurrent participation in a study with an investigational agent/device or within 14 days of study entry or 5 half-lives of the respective investigational agent/device, whichever is longer. 2. Known hypersensitivity to Ontruzant® or any of the drug excipients. 3. Prior chemotherapy, radiation therapy or small molecule therapy for any reason. 4. 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). 5. Pregnancy or breast-feeding. 6. Prior neoadjuvant therapy. 7. Active infection requiring systemic therapy. 8. History of (non-infectious) pneumonitis that required steroids or current pneumonitis. 9. 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). 10. History of primary or acquired immunodeficiency (including allogenic organ transplant). 11. Active or prior documented inflammatory bowel disease (e.g., Crohn’s disease, ulcerative colitis). 12. Known history or positive antibody test for any of the 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. 13. 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. 14. Pre-existing motor or sensory neuropathy of a severity grade =2 by National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5.0. 15. Any other condition in opinion of the investigator that would interfere with applied systemic treatment or other trial procedures.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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).;Secondary Objective: (1) To evaluate the pCR with other definitions of pCR (e.g. ypT0/is; ypN0) (2) To evaluate the safety and tolerability of Ontruzant® (3) Clinical response, as assessed by routine ultrasound or mammography (4)To assess the frequency of possible combination partners administered together with Ontruzant® (5) To evaluate changes in health related quality of life (QoL) assessments ;Primary end point(s): Primary endpoint will be pCR.;Timepoint(s) of evaluation of this end point: pCR will be assessed at the time of surgery after completion of study treatement. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): pCR will be evaluated according to other definitions (pT0/is; ypN0). Clinical response will be assessed by imaging. The occurrence of AEs, SAEs, fatal SAEs, dose-limiting toxicities, treatment discontinuations and changes in vital signs and laboratory measures will be assessed. Health related quality of life will be assessed as changes from baseline, assessed by EORTC-QLQ-C30 and EORTC-QLQ-BR23. ;Timepoint(s) of evaluation of this end point: pCR will be assessed at the time of surgery after completion of study treatement. Clinical response will be assessed every 3-4 treatment cycles, depending on choice of chemotherapy. Patient safety will be assessed continuously during the trial. Quality of life will be assessed every 3-4 treatment cycles, depending on choice of chemotherapy. | — |
Countries
Germany
Contacts
Public ContactClinical Trials Information
Institut für Frauengesundheit
Outcome results
None listed