Breast CancerSABERNCT04360330
SABER Study for Selected Early Stage Breast Cancer
A study testing Stereotactic Ablative Breast Radiotherapy in people with Breast Cancer and Early-stage Breast Cancer, run by University of Miami at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older, women only
- Conditions the study is for
- Breast Cancer, Early-stage Breast Cancer
- What is being tested?
- Stereotactic Ablative Breast Radiotherapy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Aug 2020to 31 May 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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).
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Miami
Miami, Florida, 33136
Zuzel Rodriguez, 305-243-0124, z.rodriguez1@med.miami.edu
Cristiane Takita, MD, MBA
About this study
Official title: Phase I Study to Evaluate the Safety and Feasibility of Preoperative Ablative Breast Radiotherapy (SABER) for Selected Early Stage Breast Cancer
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
- Being tested
- Stereotactic Ablative Breast Radiotherapy
- Keywords
- Breast Cancer, Early-stage Breast Cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stereotactic Ablative Breast RadiotherapyRadiation
Also called SABER
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: Radiation: Stereotactic Ablative Breast Radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Up to 13 Weeks
Secondary outcomes (4)
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.
Measured: Up to 13 weeks
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.
Measured: 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).
Measured: 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.
Measured: 1, 6 ,12 and 24 months post-therapy, up to 2.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2020
- Study start5 Aug 2020
- Primary completion31 May 2027 (estimated)
- Study completion31 May 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by University of MiamiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cristiane Takita, University of Miami
- Investigators
- Cristiane Takita, MD, MBA, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04360330
- Sponsor's protocol ID
- 20190283
- Acronym
- SABER
- Status last verified
- Jul 2026
- First submitted
- 6 Apr 2020
- Last updated
- 3 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Study to Evaluate the Safety and Feasibility of Preoperative Ablative Breast Radiotherapy (SABER) for Selected Early Stage Breast Cancer
- ClinicalTrials.gov ID
- NCT04360330
- Acronym / sponsor ID
- SABER / 20190283
- Conditions
- Breast Cancer, Early-stage Breast Cancer
- Keywords
- Breast Cancer, Early-stage Breast Cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Study start
- 5 Aug 2020 (actual)
- Primary completion
- 31 May 2027 (estimated)
- Study completion
- 31 May 2029 (estimated)
- First posted
- 24 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Preoperative SABER | Experimental | Radiation: Stereotactic Ablative Breast Radiotherapy* 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. |
Who may qualify
- Ages
- 50 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stereotactic Ablative Breast RadiotherapyAlso: SABERPreoperative 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) | Radiation | Preoperative SABER |
Primary outcome
Recommended Phase 2 Dose (RP2D) of Pre-Operative 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
4 secondary outcomes
Number of Participants Experiencing Treatment-Related Toxicity
Time frame: Up to 13 weeks
Percentage of participants with Complete Pathological Response (pCR)
Time frame: Up to 9 weeks
Cosmesis Evaluation
Time frame: 1, 6 ,12 and 24 months post-therapy, up to 2.5 years
Participant-Reported Health-Related Quality of Life (HR-QoL)
Time frame: 1, 6 ,12 and 24 months post-therapy, up to 2.5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Cristiane Takita, MD, MBA principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stereotactic Ablative Breast Radiotherapy in people with Breast Cancer and Early-stage Breast Cancer, run by University of Miami at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zuzel Rodriguez (305-243-0124, z.rodriguez1@med.miami.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recommended Phase 2 Dose (RP2D) of Pre-Operative SABER (time frame: Up to 13 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2026.