Finding the best radiation dose for early-stage breast cancer before surgery

Phase I Study to Evaluate the Safety and Feasibility of Preoperative Ablative Breast Radiotherapy (SABER) for Selected Early Stage Breast Cancer

This study is testing a shorter and potentially more effective radiation treatment for early-stage breast cancer in women aged 50 and older before they have surgery.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 18 (estimated)
• Ages: 50 Years and up
• Sex: Female
• Sponsor: University of Miami (Academic / other)
• Drugs / interventions: radiation
• Locations: 1 site (Miami, Florida)
• Trial ID: NCT04360330 on ClinicalTrials.gov

What this trial studies

This study aims to determine the most effective dose of stereotactic ablative breast radiotherapy for treating early-stage breast cancer prior to standard partial mastectomy or axillary surgery. It focuses on women aged 50 and older with specific cancer characteristics, including receptor status and clinical staging. Participants will receive radiation therapy in a shorter timeframe, potentially improving treatment efficiency and outcomes. The study will assess the safety and effectiveness of this approach compared to traditional methods.

Who should consider this trial

Good fit: Ideal candidates are women aged 50 and older with histologically confirmed invasive breast cancer that is unifocal and meets specific receptor status criteria.

Not a fit: Patients with advanced breast cancer, those who are not eligible based on receptor status, or those unable to undergo MRI may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to more effective and efficient radiation treatment for early-stage breast cancer, improving patient outcomes.

How similar studies have performed: Other studies have shown promising results with similar approaches to radiation therapy in breast cancer, indicating potential for success in this trial.

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.

Where this trial is running

Miami, Florida

• University of Miami — Miami, Florida, United States (Recruiting)

Study contacts

• Principal investigator: Cristiane Takita, MD, MBA — University of Miami
• Study coordinator: Zuzel Rodriguez

Conditions Breast Cancer; Early-stage Breast Cancer