SABER Study for Selected Early Stage Breast Cancer
Phase I Study to Evaluate the Safety and Feasibility of Preoperative Ablative Breast Radiotherapy (SABER) for Selected Early Stage Breast Cancer
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 50 Years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests the most effective dose of radiation given over a shorter time before surgery to remove part of the breast and operate on the armpit area. It is for women age 50 or older with selected types of 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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- You are a woman age 50 or older.
- A tissue test shows invasive breast cancer, meaning cancer has grown into nearby breast tissue.
- You have one breast tumor, stage T1N0M0: no larger than 2 centimeters, with no spread to lymph nodes or distant body parts.
- Your cancer tests positive for estrogen and progesterone receptors and negative for HER2. These are proteins that can affect cancer growth.
- You have Oncotype or MammaPrint results before treatment starts. These tests look at genes in the cancer.
- You can have an MRI scan and are fully active or limited only in hard physical activity.
- If you can become pregnant, you must have a negative pregnancy test and use birth control or avoid sex before joining and during the study. Tell your doctor right away if you think you are pregnant.
- You can understand the study and its possible risks and benefits, and agree to sign consent and health privacy forms.
Who can't join
- You do not have tissue-test proof of invasive breast cancer or lack Oncotype or MammaPrint results before treatment.
- Your cancer has spread to distant parts of the body.
- Your health limits activity enough that you cannot work, need help caring for yourself, or are more disabled.
- You cannot have an MRI scan or have had radiation to the chest.
- You have a history of lupus, scleroderma, or dermatomyositis—diseases that can affect connective tissue, skin, or muscles.
- You have a serious medical or mental health condition that the study doctor thinks could prevent you from following study or treatment requirements.
- You were diagnosed with another cancer in the past 5 years, except for non-melanoma skin cancer.
- You cannot give consent, are pregnant or breastfeeding, or are a prisoner.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
Inclusion Criteria: 1. Female, ≥ 50 years of age. 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: 1. Patients without histologically confirmed invasive breast cancer. 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.
Study sites (1)
FL
- University of Miami · Miami, FL 33136Zuzel Rodriguez · Study contact · 305-243-0124 · z.rodriguez1@med.miami.eduCristiane Takita, MD, MBA · Principal investigatorMore trials in Miami