RecruitingPhase 2

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
Female only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests PULSAR radiation before surgery for women with early-stage breast cancer that responds to hormones and is HER2-negative. It also tests whether ultrasound with tiny bubbles can replace surgery to check a nearby lymph node, and whether a method called OA can measure the tumor’s response. Healthy women may also join as volunteers.

1\. Efficacy of PULSAR preoperative radiation 2. Evaluate potential of microbubble CEUS as an alternative to operative SLNBx 3. Evaluate potential of OA to evaluate treatment response of pre-operative radiation on the tumor

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Patients must be women age 18 or older with invasive breast cancer, meaning cancer that has grown into nearby breast tissue.
  • The tumor must be 3 cm or smaller and must not involve the skin over it. Multiple nearby tumors may qualify if their total span is 3 cm or less and the study doctor approves.
  • The cancer must be estrogen receptor-positive or progesterone receptor-positive, meaning hormones help it grow, and HER2-negative.
  • Patients must not have had surgery, hormone treatment, or chemotherapy for their current breast cancer.
  • The tumor must be seen on CT or MRI, or preferably marked with clips if it cannot be seen. Patients must have a breast MRI or mammogram with contrast dye. Suspicious areas elsewhere in the breast may need a biopsy showing no cancer.
  • For group 1, an exam and ultrasound or MRI must show no cancer in nearby lymph nodes before the microbubble test.
  • Participants must understand and agree to sign a consent form. Patients who could become pregnant must use birth control before the study and during radiation and hormone treatment, and report any possible pregnancy right away.
  • Healthy volunteers must be women age 18 or older, have no current breast cancer diagnosis, and understand and agree to sign a consent form.

Who can't join

  • Cancer in separate areas of the breast, or one tumor or a combined tumor span larger than 3 cm.
  • Past radiation treatment to the breast being treated.
  • Past cancer in the same breast.
  • Pregnancy or breastfeeding for patients; pregnancy for healthy volunteers.
  • Active lupus or scleroderma, diseases in which the immune system attacks the body.
  • Patients who cannot have breast MRI or a mammogram with contrast dye, as judged by their doctor.
  • For group 1, cancer found in a lymph node during the microbubble ultrasound test means the patient must leave the study.
  • Healthy volunteers who cannot safely have an MRI.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria * 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. It is recommended that these tumors are at least 1 cm for cohort 1 and less than 1 cm for cohort 2, however this is not required. * Tumor must not involve the overlying skin based on imaging evaluation and/or clinical exam * Age \>/= 18 years old and female * If the tumor is unifocal, greatest tumor dimension is 3cm or less based on imaging. Multifocal disease may be included if the aggregate span of disease is 3 cm or less, subject to investigator evaluation and approval. * The tumor must be visible on CTor MRI scan or preferably marked with clip(s) in tumor if not visible. * Patients must have undergone standard of care breast MRI or contrast-enhanced mammography for work up to aid in tumor delineation and to rule out multicentric disease. If areas suspicious of multicentric disease are seen which are beyond the scope of SBRT, they need to have a negative biopsy to proceed with treatment. * Clinically and radiographically node negative on ultrasound of the axilla or MRI on initial workup prior to microbubble contrast assessment (for cohort 1). * Estrogen receptor positive or Progesterone receptor positive and Her2neu negative Ability to understand and the willingness to sign a written informed consent. 10. 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 as well as the endocrine 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 * For Cohort 1: 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 * Multi-centric disease * Prior Radiation to the involved breast * Aggregate or single tumor Size \>3cm * 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 * Prior ipsilateral breast cancer * Patients with active lupus or scleroderma * Patients unable to have MRI or contrast-enhanced mammography per physician assessment. * For Cohort 1: If patient has a positive lymph node at time of microbubble contrast enhanced ultrasound, they will be removed from the study. Only cN0 patients to be treated on this study. Healthy Volunteer Inclusion Criteria * Ability to understand and the willingness to sign a written informed consent. * Age \>/= 18 years old and female * Without current diagnosis of breast cancer Healthy Volunteer Exclusion Criteria * Contraindication ot MRI * Volunteers who are pregnant

Study sites (1)

TX