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Trial Title:
Stereotactic Radiation Therapy for HE2-positive Oligometastatic Breast Cancer
NCT ID:
NCT06299852
Condition:
HER2-positive Metastatic Breast Cancer
Oligometastatic Disease
Conditions: Official terms:
Breast Neoplasms
Trastuzumab
Ado-Trastuzumab Emtansine
Maytansine
Conditions: Keywords:
HER2-positive
Breast cancer
Oligometastatic
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Single (Investigator)
Intervention:
Intervention type:
Drug
Intervention name:
Trastuzumab emtansine
Description:
SRT for metastatic foci
Arm group label:
Prospective group: STR + trastuzumab emtansine 24 hours after the STR
Other name:
SRT
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.
Detailed 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.
Criteria for eligibility:
Criteria:
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.
Gender:
Female
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
N.N. Petrov National Medical Research Center of Oncology
Address:
City:
Saint Petersburg
Country:
Russian Federation
Status:
Recruiting
Contact:
Last name:
Tatiana Semiglazova, DSc Med., Prof.
Email:
tsemiglazova@mail.ru
Contact backup:
Last name:
Tatiana Kudryashova
Phone:
+79632165730
Email:
tatyana-kudryashova-98@mail.ru
Start date:
July 1, 2022
Completion date:
September 1, 2025
Lead sponsor:
Agency:
N.N. Petrov National Medical Research Center of Oncology
Agency class:
Other
Source:
N.N. Petrov National Medical Research Center of Oncology
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06299852