Trial Summary
What is the purpose of this trial?This clinical trial studies eliminating surgery and how well radiation therapy after systemic therapy works in treating patients with HER2 positive or triple negative breast cancer when image-guided biopsy shows no residual cancer. Patients then receive standard breast radiotherapy.
What data supports the idea that Radiation Therapy After Systemic Therapy for Breast Cancer is an effective treatment?The available research does not provide specific data on the effectiveness of Radiation Therapy After Systemic Therapy for Breast Cancer. Instead, it discusses the use of external beam radiation therapy (EBRT) for other conditions like prostate cancer and bone metastases. For breast cancer, the research mentions that shorter radiation regimens might lead to fewer patients not completing their treatment, which could imply better adherence and potentially better outcomes. However, there is no direct data comparing the effectiveness of EBRT for breast cancer to other treatments in the provided information.5671113
Do I need to stop my current medications for this trial?The trial protocol does not specify if you need to stop taking your current medications. However, if you are taking anti-estrogen therapy, you are required to continue it if you are in Cohort B1 or B2.
Is radiation therapy a promising treatment after systemic therapy for breast cancer?Radiation therapy can be a promising treatment for breast cancer after systemic therapy because it may help reduce the chance of cancer coming back and improve overall treatment success.1271213
What safety data exists for radiation therapy in breast cancer treatment?The safety data for external beam radiation therapy (EBRT) includes information on toxicities and side effects. Studies have compared toxicities between brachytherapy and EBRT in breast cancer patients, highlighting the contemporary toxicity profile. Additionally, EBRT is associated with pain flare in patients with bone metastases, occurring in 16-41% of steroid-naïve patients. Other studies have investigated gastrointestinal toxicities in gynecologic malignancies and bladder and bowel symptoms in prostate cancer, which may provide insights into potential side effects in breast cancer treatment.348910
Eligibility Criteria
This trial is for women aged 40+ with HER2 positive or triple negative breast cancer, stages T1-T2 and N0-N1, who want to avoid surgery. It's also open to those with specific types of hormone receptor-positive breast cancer meeting Oncotype criteria. Participants must not have had prior invasive breast treatments or show signs of advanced disease.Exclusion Criteria
My breast cancer is at stage T2-T3 or clinically at stage T4.
Treatment Details
The study tests if radiation therapy can replace surgery after systemic therapy in patients showing no residual cancer on biopsy. It includes external beam radiation, biomarker analysis, quality-of-life assessments, and questionnaires to evaluate the effectiveness of this approach.
4Treatment groups
Experimental Treatment
Group I: Cohort DExperimental Treatment1 Intervention
* Optional biopsy for nanomechanical biomarker assessment
* Chart review every year after surgery for 5 years
* Eligible patients who have undergone the optional biopsy may later move to Cohort A or C if they meet all eligibility requirements and desire radiation omission.
Group II: Cohort CExperimental Treatment5 Interventions
* Optional biopsy for nanomechanical biomarker assessment
* Neoadjuvant chemotherapy therapy
* Surgery (\& optional biopsy nanomechanical biomarker assessment): if no disease remaining - stay on the study and skip radiation
* H\&P and Imaging every 6 months
Group III: Cohort BExperimental Treatment5 Interventions
* Neoadjuvant endocrine therapy for 6 months
* Radiation if there is less than 25% tumor increase
* Biopsy: if negative - additional endocrine therapy under the guidance of medical oncologist (skip breast surgery)
* H\&P and Imaging every 6 months
Cohort B Radiation:
Treatment (Stereotactic ablative radiotherapy -SABR) Following 3-6 months of endocrine therapy, if less than 25% tumor increase, patients undergo SABR irradiation over 10 fractions every other business day.
Group IV: Cohort AExperimental Treatment5 Interventions
* Neoadjuvant chemotherapy therapy
* Biopsy: if no disease remaining - stay on the study and receive radiation (skip breast surgery)
* H\&P and Imaging every 6 months
Treatment (whole breast irradiation, EBRT) Within 12 weeks of completing neoadjuvant systemic therapy, patients undergo whole breast irradiation over 15-25 fractions on consecutive days. Patients then undergo EBRT boost over 7 fractions on consecutive days beginning the day following completion of whole breast irradiation.
Find a clinic near you
Research locations nearbySelect from list below to view details:
M D Anderson Cancer CenterHouston, TX
MD Anderson Cancer Center at Cooper-VoorheesVoorhees, NJ
Baptist MD Anderson Cancer CenterJacksonville, FL
Banner Health/Banner ResearchPhoenix, AZ
More Trial Locations
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Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
ArtidisIndustry Sponsor
National Cancer Institute (NCI)Collaborator
References
External beam radiation therapy for bronchial stump recurrence of non-small-cell lung cancer after complete resection. [2019]External beam radiation therapy (EBRT) is occasionally used in the treatment of bronchial stump recurrences after complete surgical resection in patients with non-small-cell lung cancer (NSCLC), but no prospective study exists, so far. The objective of this review is to determine effectiveness of high-dose EBRT in this disease.
Effectiveness of adjuvant intermittent endocrine therapy following neoadjuvant endocrine therapy and external beam radiation therapy in men with locally advanced prostate cancer. [2013]To clarify the optimal duration and methods for adjuvant endocrine therapy after external beam radiation therapy (EBRT) in patients with locally advanced prostate cancer.
Predictors of severe gastrointestinal toxicity after external beam radiotherapy and interstitial brachytherapy for advanced or recurrent gynecologic malignancies. [2022]The aim of this retrospective review of patients with gynecologic malignancies treated with external beam radiotherapy (EBRT) and interstitial brachytherapy was to determine the rate of Grade > or =2 rectovaginal fistula and Grade > or =4 small bowel obstruction as defined by the National Cancer Institute Common Toxicity Criteria for Adverse Events, version 3.0.
Five-year prospective patient evaluation of bladder and bowel symptoms after dose-escalated radiotherapy for prostate cancer with the BeamCath technique. [2019]Late side effects were prospectively evaluated up to 5 years after dose-escalated external beam radiotherapy (EBRT) and were compared with a previously treated series with conventional conformal technique.
20 Gy versus 44 Gy of supplemental external beam radiotherapy with palladium-103 for patients with greater risk disease: results of a prospective randomized trial. [2013]The necessity of external beam radiotherapy (EBRT) as a supplement to prostate brachytherapy remains unknown. We report brachytherapy outcomes for patients with higher risk features randomized to substantially different supplemental EBRT regimens.
Single fraction radiotherapy versus multiple fraction radiotherapy for bone metastases in prostate cancer patients: comparative effectiveness. [2020]External beam radiotherapy (EBRT) is an effective treatment for symptomatic bone metastases from a variety of primary malignancies. Previous meta-analyses and systematic reviews have reported on the efficacy of EBRT on bone metastases from multiple primaries. This review is focused on the comparative effectiveness of single fraction radiotherapy versus multiple fraction radiotherapy for bone metastases in prostate cancer patients.
Salvage radical prostatectomy after external beam radiation therapy: a systematic review of current approaches. [2022]Radical external beam radiotherapy (EBRT) is a standard treatment for prostate cancer patients. Despite this, the rate of intraprostatic relapses after primary EBRT is still not negligible. There is no consensus on the most appropriate management of these patients after EBRT failure. For these patients, local salvage therapy such as radical prostatectomy, cryotherapy, and brachytherapy may be indicated.
Contemporary Toxicity Profile of Breast Brachytherapy Versus External Beam Radiation After Lumpectomy for Breast Cancer. [2022]We compared toxicities after brachytherapy versus external beam radiation therapy (EBRT) in contemporary breast cancer patients.
An investigation into the incidence of pain flare in patients undergoing radiotherapy for symptomatic bone metastases. [2018]External Beam Radiotherapy (EBRT) is a recognised intervention for symptomatic pain relief from bone metastases. Pain flare is a reported EBRT toxicity, described in 16-41% of steroid-naïve patients. This study aimed to determine incidence and duration of pain flare amongst patients within one Oncology Centre.
External beam radiation therapy (EBRT) for asymptomatic bone metastases in patients with solid tumors reduces the risk of skeletal-related events (SREs). [2020]The potential benefit of administering external beam radiation therapy (EBRT) to patients with asymptomatic bone metastases has rarely been addressed in clinical investigations. The aim of this study was to determine if cancer patients who were treated with EBRT for asymptomatic bone metastases experienced later onset of pain and skeletal-related events (SREs) than those who were untreated.
Learning in 360 Degrees: A Pilot Study on the Use of Virtual Reality for Radiation Therapy Patient Education. [2021]Patient education for external beam radiation therapy (EBRT) is traditionally delivered in verbal and/or written form, which may not provide a full picture of the complex, technical aspects of treatment. The purpose of this pilot study was to create and evaluate a prototype 360-degree virtual reality (VR) video outlining the technical aspects of EBRT to the pelvis as a supplement to traditional education methods.
Long-term biopsy outcomes in prostate cancer patients treated with external beam radiotherapy: a systematic review and meta-analysis. [2023]Biopsy after external beam radiotherapy (EBRT) for localised prostate cancer (PCa) is an infrequently used but potentially valuable technique to evaluate local recurrence and predict long-term outcomes.
Shorter Radiation Regimens and Treatment Noncompletion Among Patients With Breast and Prostate Cancer in the United States: An Analysis of Racial Disparities in Access and Quality. [2023]Compared with conventional external-beam radiation therapy (cEBRT) for patients with breast cancer (BC) and prostate cancer (PC), shorter radiation regimens may be associated with lower treatment noncompletion rates. We assess disparities in receipt of shorter radiation regimens and treatment noncompletion for BC and PC.