HER2-positive Metastatic Breast CancerNCT06299852
Stereotactic Radiation Therapy for HE2-positive Oligometastatic Breast Cancer
A study testing Trastuzumab emtansine in people with HER2-positive Metastatic Breast Cancer and Oligometastatic Disease, run by N.N. Petrov National Medical Research Center of Oncology at 1 site in Russia.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- HER2-positive Metastatic Breast Cancer, Oligometastatic Disease
- What is being tested?
- Trastuzumab emtansine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteRussia
- Study dates
- 1 Jul 2022to 1 Sep 2025
- Phase
- Interventional
- 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
- Patients must be at least 18 years of age and able to give written informed consent and comply with study procedures;
- Clinical diagnosis: breast cancer, metastatic form;
- 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;
- Possibility of complete elimination of all foci;
- 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);
- Patients with stable metastatic brain foci for at least 4-6 weeks (according to MRI);
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- Patients with HER2+ inoperable locally advanced or metastatic breast cancer who previously received taxanes and trastuzumab;
- ECOG 0-1 status;
- Life expectancy of more than 6 months.
Who cannot join
- T-DM1 therapy in the medical history;
- Autoimmune diseases in the medical history or treatment of exacerbations during the last three months;
- Uncontrolled brain metastases and/or carcinomatous meningitis, causing neurological symptoms;
- Primary multiple malignant tumors: other malignant neoplasms requiring active treatment;
- Acute myocardial infarction, acute cerebrovascular accident, uncorrectable coagulopathy, decompensated concomitant pathology, infectious diseases in the active phase, ECOG status > 2;
- Pregnancy, lactation.
Trial locations and contacts
1 site in 1 country.
Russia1 site, 1 recruiting
- Recruiting
N.N. Petrov National Medical Research Center of Oncology
Saint Petersburg
Tatiana Semiglazova, DSc Med., Prof., tsemiglazova@mail.ru
Tatiana Kudryashova, +79632165730, tatyana-kudryashova-98@mail.ru
About this study
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.
Read the 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.
- Being tested
- Trastuzumab emtansine
- Keywords
- HER2-positive, Breast cancer, Oligometastatic
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trastuzumab emtansineDrug
Also called SRT
SRT for metastatic foci
| Study group | Role | What they receive |
|---|---|---|
| Prospective group: STR + trastuzumab emtansine 24 hours after the STR | Experimental | STR + trastuzumab emtansine. Patients included in the study will will undergo SRT for up to 2 cycles, depending on the location of the irradiated focus, followed by administration of trastuzumab emtansine at a dose of 3.6 mcg/kg once every 3 weeks, up to 4 total cycles. Targeted therapy with trastuzumab emtansine should commence 24 hours after the completion of SRT. Receives: Drug: Trastuzumab emtansine |
| Retrospective group: STR + trastuzumab emtansine > 24 hours after the STR | No intervention | Patients with oligometastatic HER2+ breast cancer who were treated with trastuzumab-emtansine and who had a history of SRT. Retrospectively, using CT and MRI data, the dynamics of the process will be evaluated according to the RECIST 1.1. Based on the data of the medical documentation of patients, the main statistical indicators will be calculated. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3 month
Secondary outcomes (3)
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.
Measured: 6 month
Toxicity profile
The assessment of adverse events will be carried out according to the STS AE v.5.0 system.
Measured: 3 month
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
Measured: 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2024
- Study start1 Jul 2022
- Primary completion1 Sep 2025 (estimated)
- Study completion1 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HER2-positive Metastatic 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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 58 participants (estimated)
Sponsor and investigators
- Lead sponsor
- N.N. Petrov National Medical Research Center of Oncology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06299852
- Sponsor's protocol ID
- TK01
- Status last verified
- Feb 2024
- First submitted
- 25 Feb 2024
- Last updated
- 8 Mar 2024
- 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 8 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stereotactic Radiation Therapy for HE2-positive Oligometastatic Breast Cancer
- ClinicalTrials.gov ID
- NCT06299852
- Acronym / sponsor ID
- TK01
- Keywords
- HER2-positive, Breast cancer, Oligometastatic
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 58 participants (estimated)
- Lead sponsor
- N.N. Petrov National Medical Research Center of OncologyUniversity, hospital or other
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 1 Sep 2025 (estimated)
- Study completion
- 1 Sep 2025 (estimated)
- First posted
- 8 Mar 2024 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prospective group: STR + trastuzumab emtansine 24 hours after the STR | Experimental | Drug: Trastuzumab emtansineSTR + trastuzumab emtansine. Patients included in the study will will undergo SRT for up to 2 cycles, depending on the location of the irradiated focus, followed by administration of trastuzumab emtansine at a dose of 3.6 mcg/kg once every 3 weeks, up to 4 total cycles. Targeted therapy with trastuzumab emtansine should commence 24 hours after the completion of SRT. |
| Retrospective group: STR + trastuzumab emtansine > 24 hours after the STR | No intervention | –Patients with oligometastatic HER2+ breast cancer who were treated with trastuzumab-emtansine and who had a history of SRT. Retrospectively, using CT and MRI data, the dynamics of the process will be evaluated according to the RECIST 1.1. Based on the data of the medical documentation of patients, the main statistical indicators will be calculated. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patients must be at least 18 years of age and able to give written informed consent and comply with study procedures;
- Clinical diagnosis: breast cancer, metastatic form;
- 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;
- Possibility of complete elimination of all foci;
- 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);
Key exclusion criteria (6 listed)
- T-DM1 therapy in the medical history;
- Autoimmune diseases in the medical history or treatment of exacerbations during the last three months;
- Uncontrolled brain metastases and/or carcinomatous meningitis, causing neurological symptoms;
- Primary multiple malignant tumors: other malignant neoplasms requiring active treatment;
- Acute myocardial infarction, acute cerebrovascular accident, uncorrectable coagulopathy, decompensated concomitant pathology, infectious diseases in the active phase, ECOG status > 2;
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 |
|---|---|---|
| Trastuzumab emtansineAlso: SRTSRT for metastatic foci | Drug | Prospective group: STR + trastuzumab emtansine 24 hours after the STR |
Primary outcome
Objective response rate (ORR)
Time frame: 3 month
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 secondary outcomes
Progression free survival (PFS)
Time frame: 6 month
Toxicity profile
Time frame: 3 month
Second co-primary outcome measure is quality of life
Time frame: 3 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2024.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Trastuzumab emtansine in people with HER2-positive Metastatic Breast Cancer and Oligometastatic Disease, run by N.N. Petrov National Medical Research Center of Oncology at 1 site in Russia.
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 9 inclusion and 6 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 8 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. 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.
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 Tatiana Semiglazova, DSc Med., Prof. (+79219468072, tsemiglazova@mail.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate (ORR) (time frame: 3 month). 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 8 Mar 2024.