Trial Title:
Hypofractionated Radiotherapy Before or After Breast Surgery for Treatment of Patients With Non-Metastatic Breast Cancer
NCT ID:
NCT06635980
Condition:
Anatomic Stage I Breast Cancer AJCC v8
Anatomic Stage II Breast Cancer AJCC v8
Anatomic Stage III Breast Cancer AJCC v8
Breast Carcinoma
Triple-Negative Breast Carcinoma
Conditions: Official terms:
Carcinoma
Breast Neoplasms
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
Biopsy of Breast
Description:
Undergo breast biopsy
Arm group label:
Arm I (Preoperative radiation therapy + surgery)
Arm group label:
Arm II (Surgery + postoperative radiation therapy)
Other name:
Breast Biopsy
Intervention type:
Procedure
Intervention name:
Biospecimen Collection
Description:
Undergo blood sample collection
Arm group label:
Arm I (Preoperative radiation therapy + surgery)
Arm group label:
Arm II (Surgery + postoperative radiation therapy)
Other name:
Biological Sample Collection
Other name:
Biospecimen Collected
Other name:
Specimen Collection
Intervention type:
Procedure
Intervention name:
Breast Surgery
Description:
Undergo breast surgery
Arm group label:
Arm I (Preoperative radiation therapy + surgery)
Arm group label:
Arm II (Surgery + postoperative radiation therapy)
Intervention type:
Drug
Intervention name:
Chemotherapy
Description:
Receive SOC chemotherapy
Arm group label:
Arm I (Preoperative radiation therapy + surgery)
Arm group label:
Arm II (Surgery + postoperative radiation therapy)
Other name:
Chemo
Other name:
Chemotherapy (NOS)
Other name:
Chemotherapy, Cancer, General
Intervention type:
Procedure
Intervention name:
Computed Tomography
Description:
Undergo CT
Arm group label:
Arm I (Preoperative radiation therapy + surgery)
Arm group label:
Arm II (Surgery + postoperative radiation therapy)
Other name:
CAT
Other name:
CAT Scan
Other name:
Computed Axial Tomography
Other name:
Computerized Axial Tomography
Other name:
Computerized axial tomography (procedure)
Other name:
Computerized Tomography
Other name:
Computerized Tomography (CT) scan
Other name:
CT
Other name:
CT Scan
Other name:
tomography
Intervention type:
Procedure
Intervention name:
Contrast Enhanced Digital Mammography
Description:
Undergo CEDM
Arm group label:
Arm I (Preoperative radiation therapy + surgery)
Arm group label:
Arm II (Surgery + postoperative radiation therapy)
Other name:
CEDM
Other name:
Contrast Enhanced Spectral Mammography
Other name:
Contrast-Enhanced Digital Mammography
Intervention type:
Radiation
Intervention name:
Hypofractionated Radiation Therapy
Description:
Undergo hypofractionated radiotherapy
Arm group label:
Arm I (Preoperative radiation therapy + surgery)
Arm group label:
Arm II (Surgery + postoperative radiation therapy)
Other name:
Hypofractionated
Other name:
Hypofractionated Radiotherapy
Other name:
hypofractionation
Other name:
Radiation, Hypofractionated
Intervention type:
Procedure
Intervention name:
Magnetic Resonance Imaging
Description:
Undergo MRI
Arm group label:
Arm I (Preoperative radiation therapy + surgery)
Arm group label:
Arm II (Surgery + postoperative radiation therapy)
Other name:
Magnetic Resonance
Other name:
Magnetic Resonance Imaging (MRI)
Other name:
Magnetic resonance imaging (procedure)
Other name:
Magnetic Resonance Imaging Scan
Other name:
Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance
Other name:
MR
Other name:
MR Imaging
Other name:
MRI
Other name:
MRI Scan
Other name:
MRIs
Other name:
NMR Imaging
Other name:
NMRI
Other name:
Nuclear Magnetic Resonance Imaging
Other name:
sMRI
Other name:
Structural MRI
Intervention type:
Procedure
Intervention name:
Positron Emission Tomography
Description:
Undergo PET
Arm group label:
Arm I (Preoperative radiation therapy + surgery)
Arm group label:
Arm II (Surgery + postoperative radiation therapy)
Other name:
Medical Imaging, Positron Emission Tomography
Other name:
PET
Other name:
PET Scan
Other name:
Positron emission tomography (procedure)
Other name:
Positron Emission Tomography Scan
Other name:
Positron-Emission Tomography
Other name:
proton magnetic resonance spectroscopic imaging
Other name:
PT
Intervention type:
Other
Intervention name:
Survey Administration
Description:
Ancillary studies
Arm group label:
Arm I (Preoperative radiation therapy + surgery)
Arm group label:
Arm II (Surgery + postoperative radiation therapy)
Intervention type:
Procedure
Intervention name:
Tissue Collection
Description:
Undergo tissue collection
Arm group label:
Arm I (Preoperative radiation therapy + surgery)
Arm group label:
Arm II (Surgery + postoperative radiation therapy)
Other name:
Tissue Bank
Other name:
Tissue Repository
Other name:
Tissue/Specimen Collection
Intervention type:
Procedure
Intervention name:
Ultrasound Imaging
Description:
Undergo ultrasound
Arm group label:
Arm I (Preoperative radiation therapy + surgery)
Arm group label:
Arm II (Surgery + postoperative radiation therapy)
Other name:
2-Dimensional Grayscale Ultrasound Imaging
Other name:
2-Dimensional Ultrasound Imaging
Other name:
2D-US
Other name:
Ultrasonography
Other name:
Ultrasound
Other name:
Ultrasound Test
Other name:
Ultrasound, Medical
Other name:
US
Summary:
This phase II trial studies how well hypofractionated radiotherapy before (preoperative)
or after (postoperative) breast surgery works in treating patients with different types
of non-metastatic (has not spread from original tumor site) breast cancer and to
determine the outcomes and side effects of this treatment. Radiation therapy is
considered an integral part of breast conserving therapy. Hypofractionated radiation
therapy is a radiation treatment in which the total dose of radiation is divided into
large doses and treatments are given less than once a day. This has been shown to be an
effective treatment for breast cancer while reducing treatment time and decreasing side
effects. Preoperative radiotherapy alone or concurrently with chemotherapy has also been
tested with excellent results and with minimal toxicity. Preoperative radiation of the
intact tumor with a hypofractionated regimen can potentially decrease toxicity by
allowing the delivery of treatment to intact breast tissue. The potential advantages of
preoperative radiation therapy include the delivery of radiation in the intact breast
when radiation can be more effective as more oxygen can be available in the tissue.
Furthermore, complications and cosmetic results are expected to be lower in pre-operative
radiotherapy before surgery, as there have been no changes in blood supply to the breast.
This lends to the possibility of using lower doses of radiotherapy to patients, and
potentially better cancer associated clinical outcomes for our breast cancer patients.
Undergoing hypofractionated radiation therapy before or after breast surgery may be safe
and effective in treating patients with different types of non-metastatic breast cancer.
Detailed description:
PRIMARY OBJECTIVE:
I. Compare grade (G)3 or higher radiation treatment related adverse events with the use
of preoperative and postoperative radiation within the first 2-years.
CORRELATIVE AND EXPLORATORY OBJECTIVES:
I. Grade 3 wound complications and seroma infection between preop and postoperative
radiation.
II. Locoregional control with or without surgery at 2-years in group D (Her2+). III. To
evaluate radiographic complete response and near complete response. IV. To estimate the
5-year locoregional control, distant recurrence, invasive disease-free survival,
cause-specific survival, and overall survival.
V. To evaluate patient-reported outcomes. VI. To evaluate clinical features, treatment
technique, dose-volume parameters, histologic and genetic variants associated with
adverse events, and fair and poor cosmetic outcomes or unplanned surgical intervention.
VII. Evaluate tumor mutation signatures before and after chemotherapy, radiation, and
surgery, correlate tumor mutation signatures before and after radiation with pathologic
information at the time of surgery.
VIII. To describe the pathologic changes seen in breast cancer patients with preoperative
radiation.
IX. Evaluate circulating tumor deoxyribonucleic acid (DNA), tumor infiltrating
lymphocytes, neo-epitopes, and peripheral blood mononuclear before and after
chemotherapy, radiation, and surgery; correlate tumor mutation signatures before and
after radiation with pathologic information at the time of surgery.
X. Group A-D: Determine the rate of implant/tissue expander failure after preop and
postop radiation.
XI. Group A-C: To determine the pathologic complete response (pCR) rate and near
pathologic rate with cellularity <10% after neoadjuvant chemotherapy and hypofractionated
radiotherapy to the whole breast with nodal irradiation if indicated, based on the
postsurgical specimen.
XII. Group D: Determine locoregional control with the use of preoperative radiation
conformal radiation. It will be determined based on the number of patients with
controlled locoregional disease at 6-months.
XIII. Group A-C: To determine true radiographic complete response based on post treatment
positron emission tomography (PET) standardized uptake value (SUV) <2.5 or uptake <
mediastinum.
XIV. Group A-C: To determine the pathologic complete response (pCR) rate and near
pathologic rate with cellularity <10% after neoadjuvant chemotherapy and hypofractionated
radiotherapy to the whole breast with nodal irradiation if indicated, based on the
postsurgical specimen.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients undergo standard of care (SOC) chemotherapy followed by breast
hypofractionated radiotherapy once daily (QD) for a total of 5 fractions. Patients then
undergo SOC breast surgery 10 weeks after radiation treatment. Patients also undergo
computed tomography (CT), magnetic resonance imaging (MRI), positron emission tomography
(PET), contrast-enhanced digital mammography (CEDM), and/or breast ultrasound (US)
throughout the study. Additionally, patients undergo a biopsy and may undergo optional
blood sample collection and tissue collection on study.
ARM II: Patients undergo SOC chemotherapy and SOC breast surgery followed by breast
hypofractionated radiotherapy QD for a total of 5 fractions. Patients also undergo CT,
MRI, PET, CEDM, and/or breast US throughout the study. Additionally, patients undergo a
biopsy and may undergo optional blood sample collection and tissue collection on study.
After completion of study treatment, patients are followed up at 16 weeks, 6 months, 12
months, 24 months, 36 months, and at 5 years.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Age >= 18 years
- Histological confirmation of breast cancer
- Clinical stage T1-T4 N0-3 M0
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 to 2
- Able to and provides Institutional Review Board (IRB)-approved study specific
written informed consent
- Able to complete all mandatory tests listed in the trial
- Willing to return to enrolling institution for follow-up (during the active
monitoring phase of the study)
- Indications for radiotherapy for breast cancer
Exclusion Criteria:
- Medical contraindication to receipt of radiotherapy
- Severe active co-morbid systemic illnesses or other severe concurrent disease which,
in the judgment of the investigator, would make the patient inappropriate for entry
into this study or interfere significantly with the proper assessment of safety and
toxicity of the prescribed regimens
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active
infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
arrhythmia, or psychiatric illness/social situations that would limit compliance
with study requirements or providing informed consent in the judgment of the
principal investigator
- Active systemic lupus or scleroderma
- Pregnancy
- Women of childbearing potential who are unwilling to employ adequate contraception
- Prior receipt of ipsilateral breast or chest wall radiation
- Recurrent breast cancer
Gender:
Female
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Mayo Clinic in Arizona
Address:
City:
Scottsdale
Zip:
85259
Country:
United States
Contact:
Last name:
Clinical Trials Referral Office
Phone:
855-776-0015
Email:
mayocliniccancerstudies@mayo.edu
Investigator:
Last name:
Carlos E. Vargas, MD
Email:
Principal Investigator
Start date:
November 3, 2024
Completion date:
October 21, 2034
Lead sponsor:
Agency:
Mayo Clinic
Agency class:
Other
Source:
Mayo Clinic
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06635980
