SABER Study for Selected Early Stage Breast Cancer

Part of paid clinical trials in Miami, Florida.

Sponsor
University of Miami
Study ID
NCT04360330
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
FEMALE
Age
50 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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: * Dose Level I: 35 Gy (5 fractions of 7 Gy) * Dose Level II (Starting Dose): 40 Gy (5 fractions of 8 Gy) * Dose Level III: 45 Gy (5 fractions of 9 Gy) * Dose Level IV: 50 Gy (5 fractions of 10 Gy)

Study Details

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.

Key Dates

Start date
Aug 5, 2020
Status verified
Jun 2025
Primary completion
May 31, 2026
Completion
May 31, 2028

Study Design

Enrollment
18 participants (estimated)
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Preoperative SABER
    * Experimental: Preoperative Stereotactic Ablative Breast Radiotherapy (SABER). Phase I study testing up to 4 dose levels. * Non-experimental: Participants will undergo standard partial mastectomy and axillary surgery as per discretion of treating physician 4 to 6 weeks (+ at most 1 week delay) after preoperative SABER is completed.

Primary Outcome Measure

Recommended Phase 2 Dose (RP2D) of Pre-Operative SABER [ Time Frame: Up to 13 Weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of MiamiMiamiFlorida33136
Zuzel Rodriguez
[email protected]
305-243-0124
Cristiane Takita, MD, MBA (PRINCIPAL_INVESTIGATOR)

Find similar trials in Miami, FL

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
University of Miami· Miami, FL

Related Studies