A Study of Surgery and Radiotherapy in People With Breast Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorMemorial Sloan Kettering Cancer Center
About this trial
The researchers are doing this study to see if the combination of surgery, locoregional radiation therapy, SBRT (stereotactic body radiation therapy), and the usual approach is more effective in treating oligometastatic HER2-positive breast cancer than the usual approach alone. The researchers will also study the side effects of the study treatment.
Eligibility criteria
Qualifiers
Age ≥ 18 years.
Pathologically-confirmed metastatic breast cancer.
Oligometastatic breast cancer (≤5 discrete metastatic lesions) without CNS involvement; as seen on standard imaging during initial workup and monitoring prior to registration.
HER2-positive breast cancer per CAP/ASCO guidelines as determined by staff pathologist (any estrogen or progesterone receptor status).
Disqualifiers
Any foci of disease progression during initial 3-12 months of first-line systemic therapy (as determined by treating clinician)
Escalation of systemic therapy line due to progressive disease (i.e. initiated second-line therapy prior to enrollment).
Comorbidities precluding receipt of radiotherapy, surgery or standard systemic therapy.
Intracranial or intrathecal/intramedullary spinal disease (ie. CNS involvement is excluded from the study; epidural/vertebral disease is permitted)
Trial design
Treatments tested in this trial
- Lumpectomy or mastectomy
- Radiotherapy
- Trastuzumab, Pertuzumab, Paclitaxel, or a combination of these drugs
Treatment groups
178 Participants
are divided into 2 treatment groupsLocations
7Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities)07920, Basking RidgeNew Jersey, United States
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)07748, MiddletownNew Jersey, United States
Memorial Sloan Kettering Bergen (Limited Protocol Activities)07645, MontvaleNew Jersey, United States
Memorial Sloan Kettering Suffolk-Commack (Limited Protocol Activities )11725, CommackNew York, United States
Sponsors and collaborators
Memorial Sloan Kettering Cancer Center
Lead sponsor
Gateway for Cancer Research
Collaborator
Source ClinicalTrials.gov