Stereotactic radiation therapy combined with trastuzumab emtansine for HER2-positive oligometastatic breast cancer

Stereotactic Radiation Therapy for HE2-positive Oligometastatic Breast Cancer

This study tests if combining a type of radiation therapy with a targeted breast cancer drug can help people with HER2-positive oligometastatic breast cancer feel better and improve their treatment results.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 58 (estimated)
• Ages: 18 Years and up
• Sex: Female
• Sponsor: N.N. Petrov National Medical Research Center of Oncology (Academic / other)
• Drugs / interventions: trastuzumab, radiation
• Locations: 1 site (Saint Petersburg)
• Trial ID: NCT06299852 on ClinicalTrials.gov

What this trial studies

This study investigates the effectiveness of combining stereotactic radiation therapy (SRT) with trastuzumab emtansine in patients with oligometastatic HER2-positive breast cancer. It includes a prospective group of 29 patients who will receive SRT followed by trastuzumab emtansine 24 hours later, and a retrospective comparison group of 29 patients who previously received trastuzumab emtansine after SRT. The study aims to evaluate the combined treatment's efficacy and safety profile, utilizing imaging and clinical assessments to monitor outcomes.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with oligometastatic HER2-positive breast cancer and a limited number of metastases.

Not a fit: Patients with extensive metastatic disease or those who have not previously received taxanes and trastuzumab may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could improve treatment outcomes for patients with oligometastatic HER2-positive breast cancer.

How similar studies have performed: While the combination of SRT and trastuzumab emtansine has not been extensively studied, similar approaches in other cancer types have shown promising results.

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.

Where this trial is running

Saint Petersburg

• N.N. Petrov National Medical Research Center of Oncology — Saint Petersburg, Russian Federation (Recruiting)

Study contacts

• Study coordinator: Tatiana Semiglazova, DSc Med., Prof.

Conditions HER2-positive Metastatic Breast Cancer; Oligometastatic Disease; HER2-positive; Breast cancer; Oligometastatic