Stereotactic Radiation Therapy for HE2-positive Oligometastatic Breast Cancer

NCT06299852 | Recruiting

• 1 other identifier: TK01
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

HER2-positive Metastatic Breast Cancer; Oligometastatic Disease

Keywords

HER2-positive; Breast cancer; Oligometastatic

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Progression free survival (PFS)

  6 month

• Toxicity profile

  3 month

• Second co-primary outcome measure is quality of life

  3 month

Study Arms (2)

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.

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.

Interventions

Trastuzumab emtansine DRUG

SRT for metastatic foci

Also known as: SRT

Prospective group: STR + trastuzumab emtansine 24 hours after the STR

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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);
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• N.N. Petrov National Medical Research Center of Oncology: lead

Study Sites (1)

N.N. Petrov National Medical Research Center of Oncology

Saint Petersburg, Russia

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Ado-Trastuzumab Emtansine

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Maytansine; Macrolides; Lactones; Organic Chemicals; Lactams, Macrocyclic; Macrocyclic Compounds; Polycyclic Compounds; Trastuzumab; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Central Study Contacts

Tatiana Semiglazova, DSc Med., Prof.

CONTACT

+79219468072; tsemiglazova@mail.ru

Tatiana Kudryashova

CONTACT

+79632165730; tatyana-kudryashova-98@mail.ru

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 25, 2024
• First Posted: March 8, 2024
• Study Start: July 1, 2022
• Primary Completion: September 1, 2025
• Study Completion: September 1, 2025
• Last Updated: March 8, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)