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โ† Trials
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A Study of Surgery and Radiotherapy in People With Breast Cancer

RecruitingPhase 2Ages 18 Years - anyAllMemorial Sloan Kettering Cancer Center
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Age โ‰ฅ 18 years. * Pathologically-confirmed metastatic breast cancer. * Oligometastatic breast cancer (โ‰ค5 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). * Based on size and location, all metastatic sites can be safely treated with either SBRT or resection. * Enrolled at least 3 months (and up to 12 months) after initiation of first-line systemic therapy AND without evidence of progression as determined by treating clinician (whether clinically or radiographically) during this window. (ie. in the judgement of the treating clinician, based on standard evaluations, all known disease must be controlled prior to enrollment). * ECOG performance status 0-2; KPS 60-100 Exclusion Criteria: * 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) * Prior cancer history requiring chemotherapy within the past 10 years (ie. prior cancers are permitted provided no chemotherapy was administered). Inclusion of Underrepresented Populations * Individuals of all races and ethnic groups are eligible for this trial. There is no bias towards age or race in the clinical trial outlined. This trial is open to the accrual of men and women.
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What it tests

  • Lumpectomy or mastectomy
  • Radiotherapy
  • Trastuzumab, Pertuzumab, Paclitaxel, or a combination of these drugs
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Where

7 sites
Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities)
Basking Ridge, United States
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
Middletown, United States
Memorial Sloan Kettering Bergen (Limited Protocol Activities)
Montvale, United States
Memorial Sloan Kettering Suffolk-Commack (Limited Protocol Activities )
Commack, United States
Memorial Sloan Kettering Westchester (Limited Protocol Activities)
Harrison, United States
Memorial Sloan Kettering Cancer Center (All protocol activites)
New York, United States
Memorial Sloan Kettering Nassau (Limited protocol activities)
Rockville Centre, United States
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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