Clinical trial NCT04360330: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Breast Cancer
Early-stage Breast Cancer
Keywords: Breast Cancer
Early-stage Breast Cancer
Lead sponsor: University of Miami
Sponsor class: OTHER
First posted: 2020-04-24
Enrollment: 18
Sex: FEMALE
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Recommended Phase 2 Dose (RP2D) of Pre-Operative SABER
timeFrame: Up to 13 Weeks
Secondary outcomes:
measure: Number of Participants Experiencing Treatment-Related Toxicity
timeFrame: Up to 13 weeks
measure: Percentage of participants with Complete Pathological Response (pCR)
timeFrame: Up to 9 weeks
measure: Cosmesis Evaluation
timeFrame: 1, 6 ,12 and 24 months post-therapy, up to 2.5 years
measure: Participant-Reported Health-Related Quality of Life (HR-QoL)
timeFrame: 1, 6 ,12 and 24 months post-therapy, up to 2.5 years
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami
state: Florida
Study officials:
affiliation: University of Miami
name: Cristiane Takita, MD, MBA
role: PRINCIPAL_INVESTIGATOR
References: