Precision Medicine in Action: Phase II Trial of Response Adaptive Ablative Pre-operative SPBI (RAPS) and Non-operative Sentinel Lymph Node Biopsy in Patients With Early-stage ER+ Breast Cancer: RAPS Trial

Launched by UNIVERSITY OF TEXAS SOUTHWESTERN MEDICAL CENTER · May 30, 2024

Keywords

ClinConnect Summary

The RAPS Trial is a clinical study looking at new ways to treat early-stage breast cancer, specifically for women with tumors that are 3 centimeters or smaller. The trial is exploring the effectiveness of a special type of preoperative radiation therapy called PULSAR, and it's also evaluating a new imaging technique using microbubbles to see if it can replace a traditional method of checking lymph nodes before surgery. This research aims to help doctors understand how well the radiation works on the tumor and if the new imaging technique can be a good alternative.

To participate in this trial, women must be at least 18 years old, have a specific type of breast cancer that is hormone receptor-positive and Her2-negative, and have a tumor that is visible on imaging tests. They should not have had previous surgeries or treatments for their current breast cancer. Participants will receive the preoperative radiation treatment and undergo various imaging tests to monitor their tumor's response. It's important for potential participants to discuss any concerns with their doctor, especially regarding the use of contraception during the study, as the radiation therapy could affect pregnancy.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • 1. Invasive epithelial (ductal, medullary, lobular, papillary, mucinous (colloid), or tubular) histologies of the breast 3 cm or less(T1-T2cN0) in women who have not undergone surgery or neoadjuvant endocrine or chemotherapy for current breast cancer diagnosis. For cohort 1, it is highly recommended those tumors are at least 1 cm.
• • 2. Tumor must not involve the overlying skin based on imaging evaluation and/or clinical exam 3. Age \>/= 18 years old and female 4. Greatest Tumor dimension is 3cm or less based on US. MRI measurements can be included only if performed BEFORE the biopsy 5. Tumor must be unifocal 6. The tumor must be visible on CT scan and/or preferably marked with clip(s) in tumor if not visible. At least one clip should be placed in or around tumor prior to enrollment 7. Patients must undergo an MRI for work up to aid in tumor delineation and to rule out additional foci of disease. If additional foci of disease are present, they need to have a negative biopsy to proceed with treatment.
• • 8. Clinically and radiographically node negative on ultrasound of the axilla or MRI on on initial workup prior to microbubble contrast assessment 9. Estrogen receptor positive or Progesterone receptor positive and Her2neu negative 10. Ability to understand and the willingness to sign a written informed consent.
• • 11. Women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control) prior to the start of study and for the duration of radiation therapy. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately
• A female of child-bearing potential is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:
• • Has not undergone a hysterectomy or bilateral oophorectomy; or
• • Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months
• • 12. If patient has had a prior biopsy clip placed in the lymph node deemed the sentinel lymph node at time of microbubble CEUS, it is up to investigator if additional biopsy and clip placement will be obtained.
• Exclusion Criteria:
• • - 1. Multi-centric disease 2. Prior Radiation to the involved breast 3. Tumor Size \>3cm 4. Patients who are pregnant or lactating due to the potential exposure to the fetus to radiation therapy and unknown effects of radiation therapy to lactating females 5. Prior ipsilateral breast cancer 6. Patients with active lupus or scleroderma 7. History of allergic reactions attributed to compounds of similar chemical or biologic composition to Gadolinium or other agents used in study.
• • 8. If patient has a positive lymph node at time of microbubble contrast enhanced ultrasound, they will be removed from the study. Only N0 patients to be treated on this study.

Trial Officials