Clinical Trials Logo

Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT03137693
Other study ID # MCC-18596
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
Start date November 29, 2017
Est. completion date January 27, 2020

Study information

Verified date February 2023
Source H. Lee Moffitt Cancer Center and Research Institute
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Terminated
Enrollment 20
Est. completion date January 27, 2020
Est. primary completion date November 1, 2019
Accepts healthy volunteers No
Gender Female
Age group 50 Years and older
Eligibility Inclusion Criteria: - Understand and voluntarily sign an informed consent document prior to conducting any study related assessments or procedures. - Histologically proven invasive adenocarcinoma of breast. - Must have marker clip indicating location of target tumor in breast. - Unifocal tumor less than or equal to 2 cm based on contrast-enhanced prone-breast MRI. - Must be clinically and radiographically node negative (N0) to participate on this protocol. Clinically suspicious regional nodes by imaging or physical exam require biopsy evaluation to exclude disease involvement. - Appropriate candidate for breast-conserving surgery based on multi-disciplinary assessment. - Females age = 50 years. - Able to tolerate prone body positioning during radiation therapy. - No prior ipsilateral-breast or thoracic radiotherapy. - As defined on MRI, target lesion must be at least 10 mm distance from skin (defined as volume encompassing first 3 mm from breast surface). - Must be estrogen receptor (ER) positive. - Must be negative for Her-2 amplification. (Either 1+ on semi-quantitative evaluation of immunostain or negative by fluorescent in-situ hybridization). - No implanted hardware or other material that would prohibit appropriate treatment planning or treatment delivery in the investigator's opinion. - No history of an invasive malignancy (other than this breast cancer, or non-metastatic basal or squamous skin cancers) in the last 5 years. - Must not have received nor be planned for neoadjuvant chemotherapy prior to SABR or surgery. - ECOG performance status less than 2. - Females of childbearing potential must have a negative urine pregnancy test prior to simulation and within seven days of SABR start. Exclusion Criteria: - Have invasive lobular carcinoma. - Have a Tumor > 2 cm as measured on prone contrast-enhanced breast MRI. - Have presence of histologically proven lymph node disease. - Are not a candidate for breast conserving surgery. - Have had prior ipsilateral-breast or thoracic radiotherapy. - History of scleroderma or lupus erythematosus with either cutaneous manifestation or requiring active treatment. - An MRI defined target tumor that is within 10 mm of skin (defined as volume encompassing first 3 mm from skin surface). - Have amplification of Her-2 (Either 3+ by semi-quantitative immunostain or positive by Fluorescent in-situ hybridization (FISH)). - Have implanted hardware or other material that would prohibit appropriate treatment planning or treatment delivery in the investigator's opinion. - History of an invasive malignancy (other than this breast cancer, or non-metastatic basal or squamous skin cancers) in the last 5 years. - Have received or plan to receive neoadjuvant chemotherapy either before radiotherapy or before surgery. - A known carrier of BRCA1 or BRCA2 gene mutation. - Pregnant or unwilling to undergo pregnancy screening.

Study Design


Intervention

Other:
Standard of Care Schedule Variation: SABR
SABR will be delivered over 3 days, prior to surgery.
Procedure:
Breast-conserving Surgery
Breast-conserving surgery will be scheduled for 6-8 weeks after SABR and will be conducted by a Moffitt breast surgeon.

Locations

Country Name City State
United States H. Lee Moffitt Cancer Center and Research Institute Tampa Florida

Sponsors (1)

Lead Sponsor Collaborator
H. Lee Moffitt Cancer Center and Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Rate of Pathologic Complete Response (pCR) 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. 6 weeks post SABR
See also
  Status Clinical Trial Phase
Recruiting NCT04681911 - Inetetamab Combined With Pyrotinib and Chemotherapy in the Treatment of HER2 Positive Metastatic Breast Cancer Phase 2
Terminated NCT04066790 - Pyrotinib or Trastuzumab Plus Nab-paclitaxel as Neoadjuvant Therapy in HER2-positive Breast Cancer Phase 2
Completed NCT04890327 - Web-based Family History Tool N/A
Completed NCT03591848 - Pilot Study of a Web-based Decision Aid for Young Women With Breast Cancer, During the Proposal for Preservation of Fertility N/A
Recruiting NCT03954197 - Evaluation of Priming Before in Vitro Maturation for Fertility Preservation in Breast Cancer Patients N/A
Terminated NCT02202746 - A Study to Assess the Safety and Efficacy of the VEGFR-FGFR-PDGFR Inhibitor, Lucitanib, Given to Patients With Metastatic Breast Cancer Phase 2
Active, not recruiting NCT01472094 - The Hurria Older PatiEnts (HOPE) With Breast Cancer Study
Completed NCT06049446 - Combining CEM and Magnetic Seed Localization of Non-Palpable Breast Tumors
Withdrawn NCT06057636 - Hypnosis for Pain in Black Women With Advanced Breast Cancer: A Feasibility Study N/A
Recruiting NCT05560334 - A Single-Arm, Open, Exploratory Clinical Study of Pemigatinib in the Treatment of HER2-negative Advanced Breast Cancer Patients With FGFR Alterations Phase 2
Active, not recruiting NCT05501769 - ARV-471 in Combination With Everolimus for the Treatment of Advanced or Metastatic ER+, HER2- Breast Cancer Phase 1
Recruiting NCT04631835 - Phase I Study of the HS-10352 in Patients With Advanced Breast Cancer Phase 1
Completed NCT04307407 - Exercise in Breast Cancer Survivors N/A
Recruiting NCT03544762 - Correlation of 16α-[18F]Fluoro-17β-estradiol PET Imaging With ESR1 Mutation Phase 3
Terminated NCT02482389 - Study of Preoperative Boost Radiotherapy N/A
Enrolling by invitation NCT00068003 - Harvesting Cells for Experimental Cancer Treatments
Completed NCT00226967 - Stress, Diurnal Cortisol, and Breast Cancer Survival
Recruiting NCT06019325 - Rhomboid Intercostal Plane Block on Chronic Pain Incidence and Acute Pain Scores After Mastectomy N/A
Recruiting NCT06006390 - CEA Targeting Chimeric Antigen Receptor T Lymphocytes (CAR-T) in the Treatment of CEA Positive Advanced Solid Tumors Phase 1/Phase 2
Recruiting NCT06037954 - A Study of Mental Health Care in People With Cancer N/A