SABER Study for Selected Early Stage Breast Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age50+
SponsorUniversity of Miami
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Sequential
Treatments tested in this trial
Stereotactic Ablative Breast Radiotherapy
RadiationPreoperative 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)
Treatment groups
18 Participants
are divided into 1 treatment groupGroup A: Preoperative SABERExperimental treatment 1 intervention
Trial outcomes
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
Time frame
Up to 13 WeeksSecondary outcomes
1
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.
Time frame
Up to 13 weeks2
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.
Time frame
Up to 9 weeks3
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).
Time frame
1, 6 ,12 and 24 months post-therapy, up to 2.5 years4
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.
Time frame
1, 6 ,12 and 24 months post-therapy, up to 2.5 yearsSponsors and contacts
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Source ClinicalTrials.gov