University of Miami
Miami, Florida, 33136, United States
Location status: Recruiting
Location contact
Cristiane Takita, MD, MBA
PRINCIPAL_INVESTIGATOR
Zuzel Rodriguez
CONTACT
NCT Number: NCT04360330
The purpose of this study is to find the most effective dose of radiation therapy to give to breast tumors in a shorter period of time, prior to standard partial mastectomy/axillary surgery.
Interested in participating?
Request Info50 year and older
Female
Interventional
Not applicable
Miami, Florida, 33136, United States
Location status: Recruiting
Cristiane Takita, MD, MBA
PRINCIPAL_INVESTIGATOR
Zuzel Rodriguez
CONTACT
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Preoperative SABER: Participants will be treated with an assigned dose level of preoperative SABER, delivered in once a day, 5 fractions given on non-consecutive days, over a period of 2 weeks. In this phase I study, starting with dose level II, a dose level of preoperative SABER will be assigned per study dose-escalation design, treating 2 to 6 patients per dose level. The tested doses are the following:
Other names: SABER
Time frame: Up to 13 Weeks
The recommended phase 2 dose (RP2D) of pre-operative SABER therapy will be established as the highest dose level tested for which no more than 1 out of 6 patients experience dose-limiting toxicity (DLT). Adverse Events (AEs) including DLTs will be evaluated by treating physician using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0
Time frame: Up to 13 weeks
Number of participants experiencing treatment-related toxicity by type and grade including adverse event (AEs), serious adverse events (SAEs) and dose-limiting toxicities (DLTs). Toxicity will be evaluated using the NCI CTCAE version 5.0.
Time frame: Up to 9 weeks
pCR will be defined as a negative pathologic specimen for invasive carcinoma. The specimen used for evaluation will be the tissue samples obtained from standard of care partial mastectomy and axillary surgery as per discretion of treating physician.
Time frame: 1, 6 ,12 and 24 months post-therapy, up to 2.5 years
Participant cosmesis will be evaluated-by-physician at 1, 6,12 and 24 months post-SABER therapy and post-surgical follow-up, using the Harvard 4-point ordinal scale (excellent, good, fair, and poor).
Time frame: 1, 6 ,12 and 24 months post-therapy, up to 2.5 years
The Breast Cancer Treatment Outcome Scale (BCTOS) questionnaire will be used to assess participant-reported health-related quality of life (HR-QoL) at 1, 6 12, 24 months post-SABER therapy and post-surgical follow up.
Contact information is provided by the study sponsor or research team.
University of Miami
Other
Phase I Study to Evaluate the Safety and Feasibility of Preoperative Ablative Breast Radiotherapy (SABER) for Selected Early Stage Breast Cancer
Acronym: SABER
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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