Recruiting NCT04360330
SABER Study for Selected Early Stage Breast Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Stereotactic Ablative Breast Radiotherapy.
- Who it may be relevant to
- Registry conditions: Breast Cancer, Early-stage Breast Cancer. Basic parameters: from 50 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Phase I Study to Evaluate the Safety and Feasibility of Preoperative Ablative Breast Radiotherapy (SABER) for Selected Early Stage Breast Cancer
Overview
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.
Interventions
- 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 frac
Primary outcome measures
- Recommended Phase 2 Dose (RP2D) of Pre-Operative SABER [Time frame: Up to 13 Weeks]
Secondary outcome measures (4)
- Number of Participants Experiencing Treatment-Related Toxicity [Time frame: Up to 13 weeks]
- Percentage of participants with Complete Pathological Response (pCR) [Time frame: Up to 9 weeks]
- Cosmesis Evaluation [Time frame: 1, 6 ,12 and 24 months post-therapy, up to 2.5 years]
- Participant-Reported Health-Related Quality of Life (HR-QoL) [Time frame: 1, 6 ,12 and 24 months post-therapy, up to 2.5 years]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Sequential
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- University of Miami — Miami
Identifiers
NCT: NCT04360330 · 20190283