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.
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
Name | Type | Description | Interventions |
---|
Preoperative SABER | Experimental | 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. | |
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.
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
July 9, 2021