SABER Study for Selected Early Stage Breast Cancer

Breast Cancer Clinical Trial

— SABER  

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 Details — Status: Recruiting

Administrative data

• NCT number: NCT04360330
• Other study ID #: 20190283
• Status: Recruiting
• Phase: N/A
• Start date: August 5, 2020
• Est. completion date: May 2027

Study information

• Verified date: May 2024
• Source: University of Miami
• Contact: Zuzel Rodriguez
• Phone: 305-243-0124
• Email: z.rodriguez1[@]med.miami.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 18
• Est. completion date: May 2027
• Est. primary completion date: May 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 50 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Early-stage Breast Cancer

Intervention

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 fractions of 8 Gy) Dose Level III: 45 Gy (5 fractions of 9 Gy) Dose Level IV: 50 Gy (5 fractions of 10 Gy)

Locations

Country	Name	City	State
United States	University of Miami	Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Miami

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Up to 13 Weeks
Secondary	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.	Up to 13 weeks
Secondary	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.	Up to 9 weeks
Secondary	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).	1, 6 ,12 and 24 months post-therapy, up to 2.5 years
Secondary	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.	1, 6 ,12 and 24 months post-therapy, up to 2.5 years