Clinical Trials /

SABER Study for Selected Early Stage Breast Cancer

NCT04360330

Description:

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.

Related Conditions:
  • Invasive Breast Carcinoma
Recruiting Status:

Recruiting

Phase:

N/A

Trial Eligibility

Document

Title

  • Brief Title: SABER Study for Selected Early Stage Breast Cancer
  • Official Title: Phase I Study to Evaluate the Safety and Feasibility of Preoperative Ablative Breast Radiotherapy (SABER) for Selected Early Stage Breast Cancer

Clinical Trial IDs

  • ORG STUDY ID: 20190283
  • NCT ID: NCT04360330

Conditions

  • Breast Cancer
  • Early-stage Breast Cancer

Purpose

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.

Trial Arms

NameTypeDescriptionInterventions
Preoperative SABERExperimentalExperimental: 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.

    Eligibility Criteria

            Inclusion Criteria:
    
              1. Female, ≥ 50 years of age.
    
              2. Histologically confirmed invasive breast cancer.
    
              3. Clinical stage T1N0M0.
    
              4. Receptor status: Estrogen-Receptor (ER)/Progesterone-Receptor (PR) positive and Human
                 Epidermal Growth Factor Receptor 2 (HER2) negative.
    
              5. Unifocal breast cancer.
    
              6. Eastern Cooperative Oncology Group (ECOG) 0, 1.
    
              7. Ability to undergo MRI.
    
              8. 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.
    
              9. 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 with metastatic disease.
    
              3. ECOG 2, 3, 4.
    
              4. Patients that are unable to undergo MRI.
    
              5. Prior history of radiation to the chest.
    
              6. History of collagenous disease (systemic lupus erythematosus, scleroderma,
                 dermatomyositis).
    
              7. Any serious medical or psychiatric illness/condition likely in the judgment of the
                 Investigator(s) to interfere or limit compliance with study requirements/treatment.
    
              8. Diagnosis of another primary malignancy within the last 5 years with the exception of
                 non-melanoma skin cancer.
    
              9. Patients unable to consent, who are pregnant or nursing, or are prisoners.
          
    Maximum Eligible Age:N/A
    Minimum Eligible Age:50 Years
    Eligible Gender:Female
    Healthy Volunteers:No

    Primary Outcome Measures

    Measure:Recommended Phase 2 Dose (RP2D) of Pre-Operative SABER
    Time Frame:Up to 13 Weeks
    Safety Issue:
    Description: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

    Secondary Outcome Measures

    Measure:Number of Participants Experiencing Treatment-Related Toxicity
    Time Frame:Up to 13 weeks
    Safety Issue:
    Description: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.
    Measure:Percentage of participants with Complete Pathological Response (pCR)
    Time Frame:Up to 9 weeks
    Safety Issue:
    Description: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.
    Measure:Cosmesis Evaluation
    Time Frame:1, 6 ,12 and 24 months post-therapy, up to 2.5 years
    Safety Issue:
    Description: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).
    Measure:Participant-Reported Health-Related Quality of Life (HR-QoL)
    Time Frame:1, 6 ,12 and 24 months post-therapy, up to 2.5 years
    Safety Issue:
    Description: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.

    Details

    Phase:N/A
    Primary Purpose:Interventional
    Overall Status:Recruiting
    Lead Sponsor:University of Miami

    Trial Keywords

    • Breast Cancer
    • Early-stage Breast Cancer

    Last Updated

    May 19, 2020