Anatomic Stage III Breast Cancer AJCC v8 Clinical Trial
Official title:
A Phase III Trial of Hypofractionated Radiotherapy to the Whole Breast or Post-Mastectomy Chest Wall Including Regional Nodal Irradiation
Verified date | January 2024 |
Source | Mayo Clinic |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This phase III trial compares the rate of complications of x-ray therapy versus proton beam radiation therapy after breast conserving surgery or mastectomy in treating patients with breast cancer. X-ray therapy is a form of radiation therapy that uses high-energy radiation from x-rays to kill tumor cells and shrink tumors. Proton beam radiation therapy is a type of radiation therapy that uses high-energy beams to treat tumors. It is not yet known what level of complications x-ray therapy or proton beam radiation therapy have in treating patients with breast cancer.
Status | Recruiting |
Enrollment | 146 |
Est. completion date | June 1, 2025 |
Est. primary completion date | June 1, 2025 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Age >= 18 years - Histological confirmation of breast cancer - Breast conserving surgery or mastectomy (reconstruction is allowed) - Clinical or pathologic T1-T4c, N0-3, M0 disease - 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 - Indications for breast or post mastectomy radiation with regional nodal radiotherapy per the discretion of the treating physician - If uncertain of eligibility please consult the principal investigator (PI) 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 or PI, 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 - Active systemic lupus or scleroderma - Prior receipt of ipsilateral breast or chest wall radiation - Persistent positive margins on ink after definitive surgery either for ductal carcinoma in situ (DCIS) or invasive cancer - No active metastatic disease from other origin - Recurrent breast cancer - Patient requires bilateral breast radiation treatment - cT4d patients (inflammatory breast cancer) - Patients that may not be compliant or fit for the study at the discretion of the PI - Male patients |
Country | Name | City | State |
---|---|---|---|
United States | Mayo Clinic in Florida | Jacksonville | Florida |
United States | Mayo Clinic in Rochester | Rochester | Minnesota |
United States | Mayo Clinic in Arizona | Scottsdale | Arizona |
Lead Sponsor | Collaborator |
---|---|
Mayo Clinic |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Cosmetic outcome | Will compare cosmetic outcome with patient self-reported and panel-assessed cosmetic outcome measures to include elements from the Mayo Breast Patient Survey, blinded photograph assessment, the modified Harvard/National Surgical Adjuvant Breast and Bowel Project/Radiation Therapy Oncology Group Cosmesis Scale, and the Breast Cancer Treatment Outcome Scale. Will be summarized with the frequencies and confidence intervals of fair or poor cosmesis events at baseline, 2 years, and 5 years by treatment arm. Comparisons between arms will employ chi-squared tests. | Up to 5 years post-radiation therapy | |
Primary | Complication rate | Will be defined as the percentage of women evaluable at 24 months who develop one or more of these events: grade 3 or higher late adverse event or unplanned surgeries for cosmetic or treatment related events, including surgeries to remove implant. | At 24 months | |
Secondary | Incidence of acute adverse events | The maximum grade for each type of acute adverse event will be recorded for each patient. Data will be summarized as frequencies and relative frequencies by treatment arm. Additionally, the relationship of the adverse event(s) to the study treatment will be taken into consideration. Rates will be compared between arms using chi-squared tests. | Up to 12 months post-radiation therapy | |
Secondary | Incidence of late toxicity | Will be defined as any adverse event that occurred or persisted after the first 12 months post-radiation therapy and up to 5 years post-radiation therapy. The maximum grade for each type of late adverse event will be recorded for each patient. Data will be summarized as frequencies and relative frequencies by treatment arm. Additionally, the relationship of the adverse event(s) to the study treatment will be taken into consideration. Rates will be compared between arms using chi-squared tests. | Up to 5 years post-radiation therapy | |
Secondary | Locoregional control | The cumulative incidence of locoregional recurrence will be estimated using a competing risks method by treatment arm. The competing risks will be distant breast cancer recurrence and death. Comparison between arms will employ Fine-Gray regression. | Up to 5 years post-radiation therapy | |
Secondary | Invasive disease-free survival | Invasive disease recurrence is defined by ipsilateral breast tumor recurrence (IBTR), regional recurrence, or distant recurrence. Will be estimated with a Kaplan-Meier estimator and curve by treatment arm. Estimates will be given for specific time points along with 95% confidence intervals. Comparison between arms will employ a log-rank test. | From study registration until the time of invasive disease recurrence (not including ductal carcinoma in situ) or death due to any cause, assessed up to 5 years post-radiation therapy | |
Secondary | Disease-free survival | Defined as the time from registration until the time of disease recurrence or death due to any cause. Will be estimated with a Kaplan-Meier estimator and curve by treatment arm. Estimates will be given for specific time points along with 95% confidence intervals. Comparison between arms will employ a log-rank test. | Up to 5 years post-radiation therapy | |
Secondary | Cause-specific survival | Will be estimated with a Kaplan-Meier estimator and curve by treatment arm. Estimates will be given for specific time points along with 95% confidence intervals. Comparison between arms will employ a log-rank test. | Up to 5 years post-radiation therapy | |
Secondary | Overall survival | Defined as the time from registration to death due to any cause. Will be estimated with a Kaplan-Meier estimator and curve by treatment arm. Estimates will be given for specific time points along with 95% confidence intervals. Comparison between arms will employ a log-rank test. | Up to 5 years post-radiation therapy |
Status | Clinical Trial | Phase | |
---|---|---|---|
Not yet recruiting |
NCT06113016 -
Prevention of Frailty With Fisetin and Exercise (PROFFi) in Breast Cancer Survivors
|
Phase 2 | |
Recruiting |
NCT05673200 -
Testing the Addition of an Anti-cancer Drug, ASTX727 (Cedazuridine, Decitabine), to Chemotherapy (Paclitaxel) and Immunotherapy (Pembrolizumab) for Metastatic Triple-Negative Breast Cancer
|
Phase 1 | |
Active, not recruiting |
NCT03218826 -
PI3Kbeta Inhibitor AZD8186 and Docetaxel in Treating Patients Advanced Solid Tumors With PTEN or PIK3CB Mutations That Are Metastatic or Cannot Be Removed by Surgery
|
Phase 1 | |
Completed |
NCT04535323 -
Platelet Rich Plasma for the Treatment of Genitourinary Syndrome of Menopause in Patients With Stage 0-III Breast Cancer
|
Phase 1 | |
Recruiting |
NCT05464810 -
Letrozole With and Without Simvastatin for the Treatment of Stage I-III Hormone Receptor Positive, HER2 Negative Breast Cancer
|
Early Phase 1 | |
Active, not recruiting |
NCT04249622 -
Rifaximin for the Treatment of Gastrointestinal Toxicities Related to Pertuzumab-Based Therapy in Patients With Stage I-III HER2 Positive Breast Cancer
|
Phase 2 | |
Withdrawn |
NCT03666819 -
Carbon Dioxide Fractional Laser in Treating Participants With Stage 0-III Hormone Receptor-Positive Breast Cancer With Vulvovaginal Atrophy
|
Phase 2 | |
Recruiting |
NCT04862585 -
Safely Stopping Pre-medications in Patients With Breast Cancer Who Are Receiving Paclitaxel
|
Phase 2/Phase 3 | |
Withdrawn |
NCT05967286 -
Olaparib and Alpelisib for Treatment of Metastatic Breast Cancer, A ComboMATCH Treatment Trial
|
Phase 2 | |
Recruiting |
NCT04593277 -
Interactive Survivorship Program for the Improvement of Healthcare Resources in Adolescent and Young Adult Cancer Survivors, INSPIRE-AYA Study
|
N/A | |
Active, not recruiting |
NCT05086731 -
Mobile Health to Improve Oral Chemotherapy Adherence Among Women With Breast Cancer
|
N/A | |
Recruiting |
NCT05368428 -
Transcutaneous Electrical Nerve Stimulation in Chemotherapy Induced Peripheral Neuropathy in Patients With Stage I-III Early Stage Breast Cancer
|
N/A | |
Recruiting |
NCT04673448 -
Niraparib and TSR-042 for the Treatment of BRCA-Mutated Unresectable or Metastatic Breast, Pancreas, Ovary, Fallopian Tube, or Primary Peritoneal Cancer
|
Phase 1 | |
Not yet recruiting |
NCT05539365 -
Dendritic Cell-Based Treatment Plus Immunotherapy for the Treatment of Metastatic or Unresectable Triple Negative Breast Cancer
|
Phase 2 | |
Active, not recruiting |
NCT04086875 -
A Text-based Intervention in Improving Adherence to Hormone Therapy in Patients With Stage I-III Hormone Receptor Positive Breast Cancer
|
N/A | |
Completed |
NCT00507923 -
Tibetan Yoga in Improving Fatigue and Sleep in Participants With Stage I-III Breast Cancer
|
N/A | |
Recruiting |
NCT06058377 -
Adding an Immunotherapy Drug, MEDI4736 (Durvalumab), to the Usual Chemotherapy Treatment (Paclitaxel, Cyclophosphamide, and Doxorubicin) for Stage II-III Breast Cancer
|
Phase 3 | |
Active, not recruiting |
NCT04514484 -
Testing the Combination of the Anti-cancer Drugs XL184 (Cabozantinib) and Nivolumab in Patients With Advanced Cancer and HIV
|
Phase 1 | |
Recruiting |
NCT05455658 -
STEMVAC in Patients With Early Stage Triple Negative Breast Cancer
|
Phase 2 | |
Recruiting |
NCT05674578 -
Health Coaching-Based Navigation at the Conclusion of Treatment for the Support of Black Breast Cancer Survivors
|
N/A |