Treatment for HER2-positive breast cancer with limited metastases
Basket Study for Oligo-metastatic Breast Cancer Part 1: Trastuzumab-deruxtecan for HER2-positive Oligo-metastatic Breast Cancer
PHASE2 · The Netherlands Cancer Institute · NCT05982678
This study tests if a new treatment can help people with HER2-positive breast cancer that has spread to a few other places in the body and aims to improve their chances of recovery.
Quick facts
| Phase | PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 72 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | The Netherlands Cancer Institute (other) |
| Drugs / interventions | radiation, trastuzumab |
| Locations | 1 site (Amsterdam) |
| Trial ID | NCT05982678 on ClinicalTrials.gov |
What this trial studies
This clinical trial focuses on patients with HER2-positive breast cancer who have 1 to 3 distant metastatic lesions that can be treated with curative intent. Participants will receive trastuzumab-deruxtecan in a basket design, allowing for the inclusion of various breast cancer subtypes and treatment combinations. The treatment regimen consists of 16 cycles over a year, with the first 8 cycles administered in a neo-adjuvant setting followed by 8 cycles in an adjuvant setting after local treatment. The trial aims to address a significant gap in research for oligo-metastatic breast cancer patients, who are often excluded from traditional metastatic trials.
Who should consider this trial
Good fit: Ideal candidates include individuals with histologically confirmed HER2-positive breast cancer and 1 to 3 distant metastatic lesions that are amenable to curative treatment.
Not a fit: Patients with extensive metastatic disease beyond the defined oligo-metastatic criteria or those with certain types of metastases, such as pleuritis carcinomatosa, will not benefit from this study.
Why it matters
Potential benefit: If successful, this trial could provide a new treatment option for patients with HER2-positive oligo-metastatic breast cancer, potentially improving their outcomes.
How similar studies have performed: While there is limited research specifically targeting oligo-metastatic breast cancer, similar approaches in treating localized metastatic disease have shown promise, suggesting potential for success in this novel trial.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Histologic proof of infiltrating HER2-positive breast cancer (as determined by IHC 3+ and/or amplification by ISH)\[8\] * Histologic or cytologic proof of breast cancer metastases (at least one lesion) * Histologic determination of level of ER-expression * Oligo-metastatic disease as determined by standard of care diagnostics. The number of total individual distant metastases is limited to five, either in one organ or in 2-5 organ systems. Clustered lymph nodes that can be irradiated with curative intent in a single field are defined as single lesion. Pleuritis carcinomatosa, miliary spread of metastases (even within one organ), or peritoneal spread of metastases rules out oligo-metastatic disease and is not allowed. Initial staging by PET-CT (whole body) and MRI of breast and brain are mandatory, as is MRI liver or spine and pelvis in case of liver or bone metastases respectively. * In case of recurrent disease, a disease-free interval of 24 months. * Measurable disease according to RECIST1.1 * Patients must be at least 18 years of age and be able to give written informed consent and comply with study procedures. * World Health Organization (WHO) performance status 0 or 1 Exclusion Criteria: * prior line of therapy for metastatic disease. Exceptions are endocrine therapy or radiation considered to be part of the curative treatment, within 3 months before enrolment * leptomeningeal disease or central nervous metastases * clinically relevant obstruction or compression of spinal cord, central nervous, gastro-intestinal or cardiovascular system, that cannot be alleviated before start of treatment. * other malignancy, unless treated with curative intention and a long-term survival probability of \>95%, including in-situ or pre-malignant lesions.
Where this trial is running
Amsterdam
- Antoni van Leeuwenhoek — Amsterdam, Netherlands (RECRUITING)
Study contacts
- Principal investigator: Marleen Kok, MD — Antoni van Leeuwenhoek
- Study coordinator: Marleen Kok, MD
- Email: m.kok@nki.nl
- Phone: +31205129111
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: HER2-positive Breast Cancer, Oligometastatic disease