SABER Study for Selected Early Stage Breast Cancer (SABER)
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|ClinicalTrials.gov Identifier: NCT04360330|
Recruitment Status : Recruiting
First Posted : April 24, 2020
Last Update Posted : August 6, 2020
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer Early-stage Breast Cancer||Radiation: Stereotactic Ablative Breast Radiotherapy||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||18 participants|
|Intervention Model:||Sequential Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I Study to Evaluate the Safety and Feasibility of Preoperative Ablative Breast Radiotherapy (SABER) for Selected Early Stage Breast Cancer|
|Actual Study Start Date :||August 5, 2020|
|Estimated Primary Completion Date :||August 2023|
|Estimated Study Completion Date :||August 2025|
Experimental: Preoperative SABER
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:
Other Name: SABER
- Recommended Phase 2 Dose (RP2D) of Pre-Operative SABER [ Time Frame: Up to 13 Weeks ]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
- Number of Participants Experiencing Treatment-Related Toxicity [ Time Frame: Up to 13 weeks ]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.
- Percentage of participants with Complete Pathological Response (pCR) [ Time Frame: Up to 9 weeks ]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.
- Cosmesis Evaluation [ Time Frame: 1, 6 ,12 and 24 months post-therapy, up to 2.5 years ]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).
- Participant-Reported Health-Related Quality of Life (HR-QoL) [ Time Frame: 1, 6 ,12 and 24 months post-therapy, up to 2.5 years ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04360330
|Contact: Cristiane Takita, MD, MBAemail@example.com|
|United States, Florida|
|University of Miami||Recruiting|
|Miami, Florida, United States, 33136|
|Contact: Cristiane Takita, MD, MBA 305-243-4337 firstname.lastname@example.org|
|Principal Investigator: Cristiane Takita, MD, MBA|
|Principal Investigator:||Cristiane Takita, MD, MBA||University of Miami|