Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
18 participants
INTERVENTIONAL
2020-08-05
2028-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SEQUENTIAL
TREATMENT
NONE
Study Groups
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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.
Stereotactic Ablative Breast Radiotherapy
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)
Interventions
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Stereotactic Ablative Breast Radiotherapy
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)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Oncotype or MammaPrint diagnosis results are required prior to the start of treatment
3. Histologically confirmed invasive breast cancer.
4. Clinical stage T1N0M0.
5. Receptor status: Estrogen-Receptor (ER)/Progesterone-Receptor (PR) positive and Human Epidermal Growth Factor Receptor 2 (HER2) negative.
6. Unifocal breast cancer.
7. Eastern Cooperative Oncology Group (ECOG) 0, 1.
8. Ability to undergo MRI.
9. 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.
10. 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).
Exclusion Criteria
2. Patients without Oncotype or MammaPrint diagnosis results at the start of treatment.
3. Patients with metastatic disease.
4. ECOG 2, 3, 4.
5. Patients that are unable to undergo MRI.
6. Prior history of radiation to the chest.
7. History of collagenous disease (systemic lupus erythematosus, scleroderma, dermatomyositis).
8. Any serious medical or psychiatric illness/condition likely in the judgment of the Investigator(s) to interfere or limit compliance with study requirements/treatment.
9. Diagnosis of another primary malignancy within the last 5 years with the exception of non-melanoma skin cancer.
10. Patients unable to consent, who are pregnant or nursing, or are prisoners.
50 Years
FEMALE
No
Sponsors
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University of Miami
OTHER
Responsible Party
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Cristiane Takita
Professor of Clinical
Principal Investigators
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Cristiane Takita, MD, MBA
Role: PRINCIPAL_INVESTIGATOR
University of Miami
Locations
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University of Miami
Miami, Florida, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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20190283
Identifier Type: -
Identifier Source: org_study_id
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