Primary breast cancer MedDRA version: 20.0 Level: PT Classification code 10006200 Term: Breast cancer stage II System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 20.0 Level: PT Classification code 10006201 Term: Breast cancer stage III System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 21.1 Level: LLT Classification code 10006191 Term: Breast cancer male NOS System O
Conditions
Sponsors
Karolinska University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Written informed consent 2. Patients with breast cancer confirmed by histology, characterized by immunohistochemistry for ER, PR, HER2 and proliferation marker 3. Tumor and blood samples available. HER2 type confirmed by genomic profiling using Next-Generation Sequencing. 4. Age 18 years or older. Elderly patients in condition adequate for planned therapy 5. Primary breast cancer >20mm in diameter and/or verified lymph node metastases 6. Adequate bone marrow, renal, hepatic and cardiac functions and no other uncontrolled medical or psychiatric disorders 7. LVEF >55% 8. ECOG performance status 0-1 9. Primary breast cancer as defined in p. 5 plus at most 2 morphologically characterized well-defined distant metastases accessible for stereotactic radiotherapy, provided that this treatment is available. 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 200 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 40
Exclusion criteria
Exclusion criteria: 1. Distant metastases, including node metastases in the contralateral thoracic region or in the mediastinum 2. Other malignancy diagnosed within the last five years, except for radically treated basal or squamous cell carcinoma of the skin or CIS of the cervix 3. Patients in child-bearing age without adequate contraception 4. Pregnancy or lactation 4. Uncontrolled hypertension, heart, liver, kidney related or other medical or psychiatric disorders.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Evaluate the impact of response-guided treatment on objective response and long-term outcome.;Secondary Objective: Identify tumor characteristics and treatment-related changes of tumor biology predictive of long-term prognosis.;Primary end point(s): Pathological objective response to primary medical treatment;Timepoint(s) of evaluation of this end point: After neoadjuvant treatment and surgery | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Clinical/radiological objective response during neoadjuvant treatment Morphological, functional and biological characteristics of tumors exposed to cytotoxic and targeted treatment of early breast cancer Event-free survival (EFS), invasive disease-free survival (IDFS), distant disease-free survival (DDFS), breast cancer-specific survival (BCSS) and overall survival (OS) Safety Quality of life Frequency of breast-conserving surgery;Timepoint(s) of evaluation of this end point: After surgery (end of treatment 3 months after surgery) and annual follow-up visits during 10 years | — |
Countries
Sweden
Contacts
Public ContactBreast-sarcoma unit
Dept. of Oncology, Karolinska University Hospital
Outcome results
None listed