Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Adenocarcinoma

Breast Diseases

Skin Diseases

Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

All Drugs and Chemicals

Estrogens

Progesterone

Pre-Surgery SABR: Treatment with Stereotactic Ablative Body Radiation Therapy (SABR) followed by breast-conserving surgery. The usual treatment for patients with early-stage breast cancer who have breast-conserving treatment (BCT) is to receive radiotherapy AFTER surgery, targeting either the whole breast or part of the breast.

SABR will be delivered over 3 days, prior to surgery.

Standard of Care Schedule Variation: SABR

Breast-conserving surgery will be scheduled for 6-8 weeks after SABR and will be conducted by a Moffitt breast surgeon.

Breast-conserving Surgery

Michael Montejo

This study involves a course of radiation to the tumor that is delivered BEFORE surgery. The type of radiation is called stereotactic ablative body radiation therapy (SABR). The purpose of this study is to evaluate the effects, good and/or bad, of pre-operative SABR specifically focusing on its ability to reduce the chances that additional breast surgery will be needed, reducing the amount of breast/heart/lung tissue that is irradiated, and to study the tumor-tissue effects of SABR. The usual treatment for patients with early-stage breast cancer who have breast-conserving treatment (BCT) is to receive radiotherapy AFTER surgery, targeting either the whole breast or part of the breast.

Preoperative Stereotactic Ablative Body Radiotherapy (SABR) for Early-Stage Breast Cancer

A Phase II Study of Preoperative Stereotactic Ablative Body Radiotherapy (SABR) for Early-Stage Breast Cancer: Introduction of a Novel Form of Accelerated Partial Breast Radiotherapy

Rate of pathologic complete response following pre-operative SABR for early-stage breast carcinoma. pCR: The absence of residual invasive disease in the breast and in the axillary lymph nodes at the completion of the neoadjuvant treatment.

H. Lee Moffitt Cancer Center and Research Institute

All participants who received Stereotactic Ablative Body Radiotherapy (SABR) prior to breast surgery

All Participants

Age, Categorical

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Michael Montejo, MD

Rate of Pathologic Complete Response (pCR)

Overall Study

Anti-Infective Agents

Formaldehyde

The Breast Cancer Index (BCI) is a novel gene expression-based prognostic predictor for ER positive cancers and is provided through a CLIA certified commercial laboratory. It is an RT-PCR assay that can be performed on formalin fixed paraffin embedded sections of archived tissues. Participants will work in concert with a physician to determine future treatment options based on BCI results.

The nature of the intervention is to utilize the BCI results in the decision making process for ER-positive breast cancer patients and their physicians.

BCI Assay Results

Tara Sanft, MD

Investigators will examine the impact of the Breast Cancer Index (BCI) result on patients' anxiety / fear of recurrence and satisfaction with decisions regarding endocrine therapy.

The investigators' objective is to assess patient decision-making, anxiety and patient satisfaction with recommendations made by an oncologist before and after the BCI test results are known. In addition, a chart review will be performed annually for five years to assess disease status and medications. Specifically, if extended endocrine therapy was recommended the chart review will record if participants are taking the medication and, if not, why the treatment was discontinued.

Assessment of the Decision-making Impact of the Breast Cancer Index in Recommending Extended Adjuvant Endocrine Therapy for Patients With Early Stage ER-positive Breast Cancer

These questionnaires are aimed at gathering the patient's perceived risk of recurrence, preference for continuing endocrine therapy after 5 years, concerns surrounding taking additional medication including concerns of cost, side effects, safety and benefit, as well as the level of comfort with the choice made both before and after the BCI test results are known.

Anxiety will be measured using the 20-item State-Trait Anxiety Index. This test differentiates between transient anxiety ('state anxiety') and more long-standing anxiety ('trait anxiety'). Participants will be asked to complete only the state anxiety (STAI-Y1) as trait anxiety is not expected to be modifiable based on the knowledge of the BCI results.

The Decisional Conflict Scale (DCS) will be used to measure the uncertainty of the patient in making a health-related decision (in this case, making the decision to take or not to take extended endocrine therapy), the factors contributing to the uncertainty and the perceived effective decision making.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Preoperative Stereotactic Ablative Body Radiotherapy (SABR) for Early-Stage Breast Cancer	NCT03137693	Breast Cancer Breast Cancer F... Breast Adenocar...	Standard of Car... Breast-conservi...	50 Years -	H. Lee Moffitt Cancer Center and Research Institute
Assessment of the Decision-making Impact of the Breast Cancer Index in Recommending Extended Adjuvant Endocrine Therapy for Patients With Early Stage ER-positive Breast Cancer	NCT02057029	Breast Cancer Early Stage Est...	BCI Assay Resul...	-	Yale University
Assessment of the Decision-making Impact of the Breast Cancer Index in Recommending Extended Adjuvant Endocrine Therapy for Patients With Early Stage ER-positive Breast Cancer	NCT02057029	Breast Cancer Early Stage Est...	BCI Assay Resul...	-	Yale University
Preoperative Stereotactic Ablative Body Radiotherapy (SABR) for Early-Stage Breast Cancer	NCT03137693	Breast Cancer Breast Cancer F... Breast Adenocar...	Standard of Car... Breast-conservi...	50 Years -	H. Lee Moffitt Cancer Center and Research Institute

Spots Global Cancer Trial Database for estrogen receptor (er) positive