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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Lumpectomy or mastectomy
Procedure/SurgeryResection of the primary breast tumor (ie. lumpectomy when possible or mastectomy when breast conservation not possible). Surgical resection of the primary breast tumor is to be performed per standard guidelines as applied to localized disease. Breast conserving surgery (ie. lumpectomy) is allowable per patient preference when supported by standard surgical practice. Mastectomy is preferred when breast conservation is declined by the patient, or if breast conservation would otherwise not be feasible in the early-stage setting (e.g. large tumor:breast volume ratio, inability to achieve negative margins with breast conservation, etc)
Radiotherapy
RadiationRadiotherapy will be delivered using external beam radiation per the guidelines.Radiotherapy will be delivered using external beam radiation per the guidelines set forth below, targeting two main compartments: 1. Patients will undergo radiotherapy to the breast/chest wall, and regional nodal basins (including the axilla, supraclavicular fossa and internal mammary chain) per the standard adjuvant approach for locally advanced disease, and 2. Patient will undergo stereotactic body radiotherapy (SBRT) or similarly-ablative approaches to sites of distant disease, including all observable foci and those that may have since resolved radiographically during systemic therapy
Trastuzumab, Pertuzumab, Paclitaxel, or a combination of these drugs
DrugContinue to receive the standard treatment you have already started, which includes trastuzumab, pertuzumab, paclitaxel, or a combination of these drugs. This treatment is not part of the study and will be decided by your regular treating physician.
Treatment groups
178 Participants
are divided into 2 treatment groupsGroup A: Standard of care armActive comparator 1 intervention
Group B: Consolidation armExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Progression-free survival (PFS)
with PFS defined as the time of randomization to the date of clinical or radiographic disease progression or death (by any cause in the absence of progression).
Time frame
3 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Memorial Sloan Kettering Cancer Center
Lead sponsor
Gateway for Cancer Research
Collaborator
Source ClinicalTrials.gov