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NCT04360330 | RECRUITING | Breast Cancer

SABER Study for Selected Early Stage Breast Cancer
Sponsor:

University of Miami

Information provided by (Responsible Party):

Cristiane Song

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.

Condition or disease

Breast Cancer

Early-stage Breast Cancer

Intervention/treatment

Stereotactic Ablative Breast Radiotherapy

Phase

NA

Study Type : INTERVENTIONAL
Estimated Enrollment : 18 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : Phase I Study to Evaluate the Safety and Feasibility of Preoperative Ablative Breast Radiotherapy (SABER) for Selected Early Stage Breast Cancer
Actual Study Start Date : 2020-08-05
Estimated Primary Completion Date : 2026-05
Estimated Study Completion Date : 2028-05

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 50 Years
Sexes Eligible for Study: FEMALE
Accepts Healthy Volunteers:
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.
SABER Study for Selected Early Stage Breast Cancer

Location Details

NCT04360330

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, Florida

University of Miami

Miami, Florida, United States, 33136