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SABER Study for Selected Early Stage Breast Cancer (SABER)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04360330
Recruitment Status : Recruiting
First Posted : April 24, 2020
Last Update Posted : August 6, 2020
Sponsor:
Information provided by (Responsible Party):
Cristiane Takita, University of Miami

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 Intervention/treatment Phase
Breast Cancer Early-stage Breast Cancer Radiation: Stereotactic Ablative Breast Radiotherapy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 18 participants
Intervention Model: Sequential Assignment
Masking: None (Open Label)
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 : August 5, 2020
Estimated Primary Completion Date : August 2023
Estimated Study Completion Date : August 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: 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.
Radiation: 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 Name: SABER




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Number of Participants Experiencing Treatment-Related Toxicity [ Time Frame: Up to 13 weeks ]
    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.

  2. Percentage of participants with Complete Pathological Response (pCR) [ Time Frame: Up to 9 weeks ]
    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.

  3. Cosmesis Evaluation [ Time Frame: 1, 6 ,12 and 24 months post-therapy, up to 2.5 years ]
    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).

  4. Participant-Reported Health-Related Quality of Life (HR-QoL) [ Time Frame: 1, 6 ,12 and 24 months post-therapy, up to 2.5 years ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04360330


Contacts
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Contact: Cristiane Takita, MD, MBA 305-243-4337 ctakita@med.miami.edu

Locations
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United States, Florida
University of Miami Recruiting
Miami, Florida, United States, 33136
Contact: Cristiane Takita, MD, MBA    305-243-4337    ctakita@med.maimi.edu   
Principal Investigator: Cristiane Takita, MD, MBA         
Sponsors and Collaborators
University of Miami
Investigators
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Principal Investigator: Cristiane Takita, MD, MBA University of Miami
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Responsible Party: Cristiane Takita, Professor of Clinical, University of Miami
ClinicalTrials.gov Identifier: NCT04360330    
Other Study ID Numbers: 20190283
First Posted: April 24, 2020    Key Record Dates
Last Update Posted: August 6, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by Cristiane Takita, University of Miami:
Breast Cancer
Early-stage Breast Cancer
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases