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SABER Study for Selected Early Stage Breast Cancer (SABER)

Primary Purpose

Breast Cancer, Early-stage Breast Cancer

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Stereotactic Ablative Breast Radiotherapy
Sponsored by
University of Miami
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring Breast Cancer, Early-stage Breast Cancer

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • University of MiamiRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Preoperative SABER

Arm Description

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.

Outcomes

Primary Outcome Measures

Recommended Phase 2 Dose (RP2D) of Pre-Operative SABER
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

Number of Participants Experiencing Treatment-Related Toxicity
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.
Percentage of participants with Complete Pathological Response (pCR)
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.
Cosmesis Evaluation
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).
Participant-Reported Health-Related Quality of Life (HR-QoL)
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.

Full Information

First Posted
April 6, 2020
Last Updated
July 28, 2023
Sponsor
University of Miami
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1. Study Identification

Unique Protocol Identification Number
NCT04360330
Brief Title
SABER Study for Selected Early Stage Breast Cancer
Acronym
SABER
Official Title
Phase I Study to Evaluate the Safety and Feasibility of Preoperative Ablative Breast Radiotherapy (SABER) for Selected Early Stage Breast Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 5, 2020 (Actual)
Primary Completion Date
May 2024 (Anticipated)
Study Completion Date
May 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Miami

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Early-stage Breast Cancer
Keywords
Breast Cancer, Early-stage Breast Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
18 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Preoperative SABER
Arm Type
Experimental
Arm Description
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.
Intervention Type
Radiation
Intervention Name(s)
Stereotactic Ablative Breast Radiotherapy
Other Intervention Name(s)
SABER
Intervention Description
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)
Primary Outcome Measure Information:
Title
Recommended Phase 2 Dose (RP2D) of Pre-Operative SABER
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
Time Frame
Up to 13 Weeks
Secondary Outcome Measure Information:
Title
Number of Participants Experiencing Treatment-Related Toxicity
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.
Time Frame
Up to 13 weeks
Title
Percentage of participants with Complete Pathological Response (pCR)
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.
Time Frame
Up to 9 weeks
Title
Cosmesis Evaluation
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).
Time Frame
1, 6 ,12 and 24 months post-therapy, up to 2.5 years
Title
Participant-Reported Health-Related Quality of Life (HR-QoL)
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.
Time Frame
1, 6 ,12 and 24 months post-therapy, up to 2.5 years

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Female, ≥ 50 years of age. Oncotype or MammaPrint diagnosis results are required prior to the start of treatment Histologically confirmed invasive breast cancer. Clinical stage T1N0M0. Receptor status: Estrogen-Receptor (ER)/Progesterone-Receptor (PR) positive and Human Epidermal Growth Factor Receptor 2 (HER2) negative. Unifocal breast cancer. Eastern Cooperative Oncology Group (ECOG) 0, 1. Ability to undergo MRI. 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. 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: Patients without histologically confirmed invasive breast cancer. Patients without Oncotype or MammaPrint diagnosis results at the start of treatment. Patients with metastatic disease. ECOG 2, 3, 4. Patients that are unable to undergo MRI. Prior history of radiation to the chest. History of collagenous disease (systemic lupus erythematosus, scleroderma, dermatomyositis). Any serious medical or psychiatric illness/condition likely in the judgment of the Investigator(s) to interfere or limit compliance with study requirements/treatment. Diagnosis of another primary malignancy within the last 5 years with the exception of non-melanoma skin cancer. Patients unable to consent, who are pregnant or nursing, or are prisoners.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zuzel Rodriguez
Phone
305-243-0124
Email
z.rodriguez1@med.miami.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cristiane Takita, MD, MBA
Organizational Affiliation
University of Miami
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zuzel Rodriguez
Phone
305-243-0124
Email
z.rodriguez1@med.miami.edu
First Name & Middle Initial & Last Name & Degree
Cristiane Takita, MD, MBA

12. IPD Sharing Statement

Plan to Share IPD
No

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SABER Study for Selected Early Stage Breast Cancer

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