Stereotactic Radiation Therapy for HE2-positive Oligometastatic Breast Cancer

March 1, 2024 updated by: N.N. Petrov National Medical Research Center of Oncology

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

58

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Prospective group: STR + trastuzumab emtansine 24 hours after the STR
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.
Drug: Trastuzumab emtansine
SRT for metastatic foci
Other Names:
  • SRT
No Intervention: Retrospective group: STR + trastuzumab emtansine > 24 hours after the STR
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 the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression free survival (PFS)
Time Frame: 6 month
Progression free survival (PFS) is defined as the time from the start of study treatment until the disease progression or death.
6 month
Toxicity profile
Time Frame: 3 month
The assessment of adverse events will be carried out according to the STS AE v.5.0 system.
3 month
Second co-primary outcome measure is quality of life
Time Frame: 3 month
of Cancer (EORTC) Quality of Life Questionnaire for Cancer patients with 30 items (QLQ-C30) sum score
3 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

N.N. Petrov National Medical Research Center of Oncology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2022

Primary Completion (Estimated)

September 1, 2025

Study Completion (Estimated)

September 1, 2025

Study Registration Dates

First Submitted

February 25, 2024

First Submitted That Met QC Criteria

March 1, 2024

First Posted (Actual)

March 8, 2024

Study Record Updates

Last Update Posted (Actual)

March 8, 2024

Last Update Submitted That Met QC Criteria

March 1, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TK01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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