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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Preoperative SABER | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stereotactic Ablative Breast Radiotherapy | Radiation | 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:
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| Measure | Description | Time Frame |
|---|---|---|
| Recommended Phase 2 Dose (RP2D) of Pre-Operative SABER | 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 | Up to 13 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Experiencing Treatment-Related Toxicity | 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. | Up to 13 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zuzel Rodriguez | Contact | 305-243-0124 | z.rodriguez1@med.miami.edu |
| Name | Affiliation | Role |
|---|---|---|
| Cristiane Takita, MD, MBA | University of Miami | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Miami | Recruiting | Miami | Florida | 33136 | United States |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| Percentage of participants with Complete Pathological Response (pCR) |
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. |
| Up to 9 weeks |
| Cosmesis Evaluation | 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). | 1, 6 ,12 and 24 months post-therapy, up to 2.5 years |
| Participant-Reported Health-Related Quality of Life (HR-QoL) | 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. | 1, 6 ,12 and 24 months post-therapy, up to 2.5 years |
| D017437 |
| Skin and Connective Tissue Diseases |