Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06299852
Other study ID # TK01
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date July 1, 2022
Est. completion date September 1, 2025

Study information

Verified date February 2024
Source N.N. Petrov National Medical Research Center of Oncology
Contact Tatiana Semiglazova, DSc Med., Prof.
Phone +79219468072
Email tsemiglazova@mail.ru
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study involves two non-randomized groups of patients: the observation group and the comparison group. The comparison group will retrospectively include data on 29 patients with oligometastatic HER2-positive breast cancer who received treatment with trastuzumab-emtansine and had a history of SRT. The prospective part of this study aims to include 29 patients with oligometastatic HER2-positive breast cancer. These patients will undergo SRT followed by the administration of trastuzumab emtansine 24 hours after the SRT. The combined effect of stereotactic radiation therapy on a metastatic lesion followed by anti-HER2 therapy in the 2nd line - trastuzumab emtansine, remains unexplored. This study plans to evaluate the effectiveness of combining systemic therapy and local control methods (SRT) in patients with oligometastatic HER2-positive breast cancer. It will be the first time the efficacy and toxic profile of this new combined treatment method in this patient population will be studied. This basket trial evaluates trastuzumab emtansine for oligo-metastatic breast cancer with the aim of inducing deep responses, long-lasting disease remissions, and potentially cure.


Description:

This study involves two non-randomized groups of patients: the observation group and the comparison group. The comparison group will retrospectively include data on 29 patients with oligometastatic HER2-positive breast cancer who were treated with trastuzumab-emtansine and had a history of SRT. The dynamics of the process will be evaluated retrospectively using CT and MRI data according to RECIST 1.1 criteria. The main statistical indicators will be calculated based on the patients' medical documentation. The prospective part of this study aims to include 29 patients with oligometastatic HER2-positive breast cancer. These patients will undergo SRT for up to 2 cycles, depending on the location of the irradiated focus, followed by administration of trastuzumab emtansine 3.6 mcg/kg once every 3 weeks, up to 4 total cycles. Trastuzumab emtansine therapy will be initiated 24 hours after the end of the course of SRT. Tumor foci will be assessed according to RECIST 1.1 criteria. Objective response, general condition, and adverse events will be evaluated before, during, and after treatment. Patients will be stratified by age, location of metastatic foci, and treatment. Outpatient patient records, medical histories, clinical and laboratory examination data, morphological examination data, CT findings, MRI findings will be used as sources of information for analyzing the results of diagnosis and treatment.


Recruitment information / eligibility

Status Recruiting
Enrollment 58
Est. completion date September 1, 2025
Est. primary completion date September 1, 2025
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria: 1. Patients must be at least 18 years of age and able to give written informed consent and comply with study procedures; 2. Clinical diagnosis: breast cancer, metastatic form; 3. Oligo-metastatic disease as determined by standard of care diagnostics, limited to 5 total individual distant metastases, either in one organ or in 2-3 organ systems. Clustered lymph nodes that can be irradiated with curative intent in a single field are defined as single lesion; 4. Possibility of complete elimination of all foci; 5. HER2 expression level of 3+ points according to immunohistochemical analysis (IHC) and/or degree of amplification =2.0 according to the results of in situ hybridization (ISH); 6. Patients with stable metastatic brain foci for at least 4-6 weeks (according to MRI); 7. Patients with HER2+ inoperable locally advanced or metastatic breast cancer who previously received taxanes and trastuzumab; 8. ECOG 0-1 status; 9. Life expectancy of more than 6 months. Exclusion Criteria: 1. T-DM1 therapy in the medical history; 2. Autoimmune diseases in the medical history or treatment of exacerbations during the last three months; 3. Uncontrolled brain metastases and/or carcinomatous meningitis, causing neurological symptoms; 4. Primary multiple malignant tumors: other malignant neoplasms requiring active treatment; 5. Acute myocardial infarction, acute cerebrovascular accident, uncorrectable coagulopathy, decompensated concomitant pathology, infectious diseases in the active phase, ECOG status > 2; 6. Pregnancy, lactation.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Trastuzumab emtansine
SRT for metastatic foci

Locations

Country Name City State
Russian Federation N.N. Petrov National Medical Research Center of Oncology Saint Petersburg

Sponsors (1)

Lead Sponsor Collaborator
N.N. Petrov National Medical Research Center of Oncology

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type Measure Description Time frame Safety issue
Primary Objective response rate (ORR) Objective response rate is defined as the proportion of participants who have a confirmed CR or PR, as determined by investigator assessment, per RECIST 1.1 3 month
Secondary Progression free survival (PFS) Progression free survival (PFS) is defined as the time from the start of study treatment until the disease progression or death. 6 month
Secondary Toxicity profile The assessment of adverse events will be carried out according to the STS AE v.5.0 system. 3 month
Secondary Second co-primary outcome measure is quality of life of Cancer (EORTC) Quality of Life Questionnaire for Cancer patients with 30 items (QLQ-C30) sum score 3 month
See also
  Status Clinical Trial Phase
Recruiting NCT06190782 - Local Therapy for Oligometastatic ESCC Patients Treated With PD-1 Inhibitor Phase 3
Not yet recruiting NCT06373497 - Real-Time Atherosclerosis Activity After Thoracic Radiotherapy Using Sodium Fluoride Positron Emission Tomography Early Phase 1
Recruiting NCT05377047 - Stereotactic Ablative Radiotherapy for OligoMetastatic Breast Cancer N/A
Recruiting NCT05223803 - TERPS Trial for de Novo Oligometastic Prostate Cancer Phase 2
Recruiting NCT04617457 - Chemotherapy and Surgical Resection in Patients With Hepatic Oligometastatic Adenocarcinoma of the Pancreas Phase 2
Recruiting NCT04821765 - Study of PD-1 Antibody Combined With Chemoradiotherapy in Oligometastatic Esophageal Cancer Phase 2
Recruiting NCT05679427 - Ablative Radiosurgery vs Stereotactic RT in 5 Fractions With SIB for Oligometastatic Bone Lesions N/A
Recruiting NCT05277844 - Local Consolidative Radiation Therapy Plus TKI Versus TKI Alone in Driver Mutated OM-NSCLC Phase 2
Active, not recruiting NCT05951127 - Additional Consolidative Esophagectomy for the Patients With Oligometastatic Resectable ESCC N/A
Active, not recruiting NCT05101824 - Bony M - Stereotactic Ablative Radiotherapy (SABR) of Bony Metastases in Patients With Oligometastatic Disease N/A
Not yet recruiting NCT06430411 - Outcomes of Local Treatment for Oligometastatic Prostate Cancer Diagnosed Using PSMA PET Imaging: OLIGOMET Study
Recruiting NCT04748042 - Focal Radiation With Pulsed Systemic Therapy of Abiraterone, Androgen Deprivation Therapy (ADT), Lynparza Towards Castration Sensitive Oligometastatic Prostate Cancer (FAALCON) Phase 2
Recruiting NCT06122480 - Surgical Resection of Synchronous Pulmonary or Hepatic Oligometastatic Pancreatic Ductal Adenocarcinoma N/A
Not yet recruiting NCT05784428 - Single vs. Multiple Fraction Trial of Stereotactic Ablative Radiotherapy for Comprehensive Treatment of Oligometastases/Progression N/A
Completed NCT04593381 - Efficacy and Safety of SBRT in Oligo-metastatic/Persistent/Recurrent Ovarian Cancer N/A
Terminated NCT01345539 - Radiosurgery for Patients With Oligometastatic Disease at Initial Presentation Phase 2
Recruiting NCT05846646 - Study of PULSAR-ICI +/- IMSA101 in Patients With Oligometastatic NSCLC and RCC Phase 2
Recruiting NCT04973007 - Comparison of Contrast Agents in Liver MR for the Detection of Hepatic Metastases Phase 4
Recruiting NCT06439888 - Lymphocyte Support to SBRT in Patients With Oligo-metastatic Solid Cancer Phase 1/Phase 2
Recruiting NCT05917431 - Phase 2 Study of SBRT Plus Tislelizumab and Regorafenib in Unresectable or Oligometastatic HCC Phase 2