Clinical Trials Logo
  1. Home
  2. Stage II Breast Cancer
  3. NCT03345420

Hypofractionated Radiation Therapy in Treating Patients With Stage 0-IIB Breast Cancer — NOVEMBER  

Stage II Breast Cancer Clinical Trial

Official title:
NOVEMBER (Novem- (9), BrEast Radiation), A Phase II Trial of a 9 Day Course of Whole Breast Radiotherapy for Early Stage Breast Cancer

Clinical Trial Summary

This phase II trial studies how well hypofractionated radiation therapy works in treating patients with stage 0-IIB breast cancer. Hypofractionated radiation therapy delivers higher doses of radiation therapy over a shorter period of time and may kill more tumor cells and have fewer side effects.

Clinical Trial Description

PRIMARY OBJECTIVES: I. To evaluate 24 month breast photographic cosmetic scores with 9 fraction radiation compared to standard hypofractionation. SECONDARY OBJECTIVES: I. To evaluate Breast-Q patient reported outcomes (PROs) compared to historical control in breast conservation. II. To evaluate the incidence of acute and late radiation complications, based on Common Terminology Criteria for Adverse Events (CTCAE) 4.0 toxicity. III. To evaluate the local and local regional recurrence rate. IV. To compare the direct and indirect patient costs for radiation therapy compared to historical controls as well as quality adjusted life years, utilizing the Breast-Q Patient Reported Outcomes (PROs) and the EQ-5D. OUTLINE: Within 12 weeks after breast conserving surgery, patients undergo hypofractionated radiation therapy for 9 fractions over 2 weeks. After completion of study treatment, patients are followed up at 2-8 weeks, 6 months, and annually for 3 years. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03345420
Study type Interventional
Source University of Utah
Contact
Status Active, not recruiting
Phase Phase 2
Start date December 12, 2017
Completion date September 3, 2025
View Details
See also
  Status Clinical Trial Phase
Completed NCT03233555 - Extended Cancer Education for Longer-Term Survivors in Primary Care for Patients With Stage I-II Breast or Prostate Cancer or Stage I-III Colorectal Cancer N/A
Completed NCT03061175 - Web-Based Decision Aid in Improving Informed Decisions in Patients With Stage 0-IIIA Breast Cancer Considering Contralateral Prophylactic Mastectomy N/A
Completed NCT01959490 - Trastuzumab and Pertuzumab or Bevacizumab With Combination Chemotherapy in Treating Patients With Stage II-III Breast Cancer Phase 2
Recruiting NCT03156309 - Vaccine Therapy in Preventing Cancer Recurrence in Patients With Non-Metastatic, Node Positive, HER2 Negative Breast Cancer That is in Remission Phase 1
Active, not recruiting NCT02240836 - Energy Balance and Breast Cancer Aspects-II N/A
Terminated NCT01368263 - Goserelin and Letrozole or Anastrozole in Premenopausal Patients With Stage II-III Estrogen Receptor-Positive Breast Cancer Phase 2
Terminated NCT01222377 - Endoscopic Breast Surgery in Treating Patients With Breast Cancer N/A
Terminated NCT00148720 - Capecitabine in Women With Operable Breast Cancer Phase 2
Active, not recruiting NCT02780401 - Vaccine Therapy in Preventing Cancer Recurrence in Patients With Non-Metastatic, Node Positive, HER2 Negative Breast Cancer That is in Remission Phase 1
Recruiting NCT06087120 - Investigate the Prognostic and Predictive Value of ctDNA During Neoadjuvant Chemotherapy for Breast Cancer.
Recruiting NCT04553770 - Trastuzumab Deruxtecan Alone or in Combination With Anastrozole for the Treatment of Early Stage HER2 Low, Hormone Receptor Positive Breast Cancer Phase 2
Completed NCT01478477 - Omega-3 Fatty Acids in Preventing Joint Symptoms in Patients With Stage I-III Breast Cancer Receiving Anastrozole, Exemestane, or Letrozole N/A
Withdrawn NCT01695057 - Vorinostat Before Surgery in Treating Patients With Triple-Negative Breast Cancer N/A
Completed NCT01672684 - Phase I: At-Home Support for Rural Women Using Group Video Calling Phase 1
Terminated NCT01233505 - Veliparib, Oxaliplatin, and Capecitabine in Treating Patients With Advanced Solid Tumors Phase 1
Terminated NCT01234532 - Entinostat and Anastrozole in Treating Postmenopausal Women With TNBC That Can Be Removed by Surgery Phase 2
Completed NCT00416715 - Vitamin D Deficiency, Muscle Pain, Joint Pain, and Joint Stiffness in Postmenopausal Women Receiving Letrozole For Stage I-III Breast Cancer Phase 2
Completed NCT00119262 - Bevacizumab and Combination Chemotherapy in Patients With Lymph Node Positive Breast Cancer Phase 2
Completed NCT00262834 - Vorinostat in Treating Women Who Are Undergoing Surgery For Newly Diagnosed Stage I -III Breast Cancer Phase 2
Completed NCT00194779 - Combination Chemotherapy and Filgrastim Before Surgery in Treating Patients With HER2-Positive Breast Cancer That Can Be Removed By Surgery Phase 2