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Radiation Therapy
Hypofractionated Radiation Therapy for Breast Cancer
Phase 3
Waitlist Available
Research Sponsored by Alliance for Clinical Trials in Oncology
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
No prior therapeutic radiation therapy to the chest, neck or axilla; prior radioactive oral iodine is permitted
Negative inked histologic margins from mastectomy pathology (no invasive cells at margin). Patients with DCIS at margin are eligible
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Pivotal Trial
No Placebo-Only Group
Summary
This trial is testing how well higher doses of radiation therapy over a shorter period of time works to prevent cancer recurrence in patients who have undergone mastectomy.
Who is the study for?
This trial is for women with stage IIa-IIIa breast cancer who've had a mastectomy. They must not be pregnant, have no history of certain other cancers or severe diseases, and agree to birth control if of childbearing potential. Participants should not have received prior chest radiation and must plan to start treatment within specific timeframes.
What is being tested?
The study tests hypofractionated radiation therapy, which uses higher doses over a shorter period than traditional radiation, after mastectomy to prevent cancer recurrence. It includes lab biomarker analysis and quality-of-life assessments.
What are the potential side effects?
Potential side effects may include skin irritation, fatigue, swelling in the treated area, changes in breast appearance or sensation, and rare risks like heart problems or secondary cancers due to increased radiation exposure.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I haven't had radiation therapy to my chest, neck, or armpit area; but I may have had radioactive iodine treatment.
Select...
My mastectomy showed no cancer cells at the edges of the removed tissue.
Select...
I do not have any active collagen vascular diseases like lupus.
Select...
My breast cancer is confirmed and not metaplastic.
Select...
I have never had breast cancer or DCIS in the same breast before, but benign conditions are okay.
Select...
My tissue expander is filled with fluid, not air, if I'm undergoing radiation therapy.
Select...
I am fully active or restricted in physically strenuous activity but can do light work.
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My radiation treatment does not include a boost to the chest wall or scar.
Select...
My breast cancer is at an early stage and has not spread to distant parts of my body.
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I do not have any health conditions that could shorten my life to under 5 years.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Rate of breast reconstruction complications
Secondary study objectives
Economic analyses
Incidence of acute and late radiation complications based on Common Terminology Criteria for Adverse Events 4.0 toxicity
Incidence of arm lymphedema as measured by percent change in ipsilateral arm volume post-radiation from its pre-radiation volume
+7 moreSide effects data
From 2023 Phase 3 trial • 107 Patients • NCT0332480280%
Dermatitis radiation
54%
Skin hyperpigmentation
48%
Pain
35%
Lymphedema
22%
Superficial soft tissue fibrosis
7%
Skin hypopigmentation
6%
Edema limbs
2%
Device related infection
100%
80%
60%
40%
20%
0%
Study treatment Arm
Arm 1 (Radiation Therapy, 15 Fractions)
Arm 2 (Hypofractionated Radiation Therapy, 5 Fractions)
Awards & Highlights
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Group II (hypofractionated radiation therapy)Experimental Treatment4 Interventions
Patients undergo hypofractionated radiation therapy daily on Monday-Friday for 3-4 weeks.
Group II: Group I (radiation therapy)Active Control4 Interventions
Patients undergo radiation therapy daily on Monday-Friday for 5-6 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Hypofractionated Radiation Therapy
2016
Completed Phase 3
~130
Find a Location
Who is running the clinical trial?
Alliance for Clinical Trials in OncologyLead Sponsor
516 Previous Clinical Trials
220,024 Total Patients Enrolled
5 Trials studying Breast Carcinoma
4,018 Patients Enrolled for Breast Carcinoma
National Cancer Institute (NCI)NIH
13,906 Previous Clinical Trials
41,011,135 Total Patients Enrolled
104 Trials studying Breast Carcinoma
46,525 Patients Enrolled for Breast Carcinoma
Canadian Cancer Trials GroupNETWORK
131 Previous Clinical Trials
68,650 Total Patients Enrolled
1 Trials studying Breast Carcinoma
3,177 Patients Enrolled for Breast Carcinoma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't had radiation therapy to my chest, neck, or armpit area; but I may have had radioactive iodine treatment.My mastectomy showed no cancer cells at the edges of the removed tissue.I have never had invasive breast cancer in my other breast.I do not have any active collagen vascular diseases like lupus.Women who could become pregnant must have a negative pregnancy test within 7 days before joining the study, even if they have had their tubes tied. This applies to women who are capable of having children and have not gone through menopause for at least a year.My breast cancer is confirmed and not metaplastic.I have never had breast cancer or DCIS in the same breast before, but benign conditions are okay.I haven't had major complications after breast removal that needed unexpected surgery or IV antibiotics.My radiation treatment is planned to target all cancer areas while protecting healthy tissues.My doctor and I plan to start radiation treatment soon, as outlined.My tissue expander is filled with fluid, not air, if I'm undergoing radiation therapy.My last hemoglobin A1C test was within the last 3 months.I agree to use birth control or abstain from sex during radiation therapy.I am fully active or restricted in physically strenuous activity but can do light work.I haven't had any cancer except for skin cancer or cervical pre-cancer in the last 5 years.My radiation treatment does not include a boost to the chest wall or scar.I had or plan to have breast reconstruction within 18 months after radiation.My cancer's stage has been determined using the TNM system.My breast cancer is at an early stage and has not spread to distant parts of my body.My breast cancer has not spread to specific areas like the internal mammary nodes.I do not have any health conditions that could shorten my life to under 5 years.I had chemo before surgery for breast cancer and my cancer was at an early stage after surgery.My treatment plan includes radiation to the lymph nodes and chest area.
Research Study Groups:
This trial has the following groups:- Group 1: Group II (hypofractionated radiation therapy)
- Group 2: Group I (radiation therapy)
Awards:
This trial has 2 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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