SABER Study for Selected Early Stage Breast Cancer

NCT04360330 | Recruiting DMC FDA Device

• 1 other identifier: 20190283
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Breast Cancer; Early-stage Breast Cancer

Keywords

Breast Cancer; Early-stage Breast Cancer

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (4)

• Number of Participants Experiencing Treatment-Related Toxicity

  Up to 13 weeks

• Percentage of participants with Complete Pathological Response (pCR)

  Up to 9 weeks

• Cosmesis Evaluation

  1, 6 ,12 and 24 months post-therapy, up to 2.5 years

• Participant-Reported Health-Related Quality of Life (HR-QoL)

  1, 6 ,12 and 24 months post-therapy, up to 2.5 years

Study Arms (1)

Preoperative SABER

EXPERIMENTAL

* 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.

Radiation: Stereotactic Ablative Breast Radiotherapy

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)

Also known as: SABER

Preoperative SABER

Eligibility Criteria

• Age: 50 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female, ≥ 50 years of age.
• Oncotype or MammaPrint diagnosis results are required prior to the start of treatment
• Histologically confirmed invasive breast cancer.
• Clinical stage T1N0M0.
• Receptor status: Estrogen-Receptor (ER)/Progesterone-Receptor (PR) positive and Human Epidermal Growth Factor Receptor 2 (HER2) negative.
• Unifocal breast cancer.
• Eastern Cooperative Oncology Group (ECOG) 0, 1.
• Ability to undergo MRI.
• Women of child-bearing potential (WOCBP) must agree to use adequate contraception or agree to undergo sexual abstinence prior to study entry and for the duration of study participation. WOCBP must have a negative serum or urine pregnancy test at time of enrollment. Should a woman become pregnant or suspect she is pregnant while she is participating in this study, she should inform her treating physician immediately.
• Ability to understand the investigational nature, potential risks and benefits of the research study and willingness to sign the written informed consent and HIPAA document(s).

You may not qualify if:

• Patients without histologically confirmed invasive breast cancer.
• Patients without Oncotype or MammaPrint diagnosis results at the start of treatment.
• Patients with metastatic disease.
• ECOG 2, 3, 4.
• Patients that are unable to undergo MRI.
• Prior history of radiation to the chest.
• History of collagenous disease (systemic lupus erythematosus, scleroderma, dermatomyositis).
• Any serious medical or psychiatric illness/condition likely in the judgment of the Investigator(s) to interfere or limit compliance with study requirements/treatment.
• Diagnosis of another primary malignancy within the last 5 years with the exception of non-melanoma skin cancer.
• Patients unable to consent, who are pregnant or nursing, or are prisoners.

Sponsors & Collaborators

• University of Miami: lead

Study Sites (1)

University of Miami

Miami, Florida, 33136, United States

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Cristiane Takita, MD, MBA

  University of Miami

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zuzel Rodriguez

CONTACT

305-243-0124; z.rodriguez1@med.miami.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Clinical

Study Record Dates

• First Submitted: April 6, 2020
• First Posted: April 24, 2020
• Study Start: August 5, 2020
• Primary Completion: May 1, 2026
• Study Completion (Estimated): May 1, 2028
• Last Updated: June 8, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)