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Radiation vs. Radiation + Lymph Node Dissection 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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group
Pivotal Trial
Summary
This trial is comparing radiation therapy alone to radiation therapy with lymph node dissection in treating breast cancer patients who have already had chemotherapy and surgery.
Who is the study for?
This trial is for breast cancer patients who've finished chemotherapy and surgery, with certain hormone receptor statuses checked. They should have a performance status of 0-1, indicating they're fully active or restricted in physically strenuous activity but ambulatory. Participants must not be pregnant, have no history of invasive cancer in the opposite breast within 5 years (except certain skin cancers or cervical carcinoma in situ), and no prior radiation therapy.
What is being tested?
The study compares two approaches after chemotherapy and surgery: one group undergoes axillary lymph node dissection (ALND) where lymph nodes are surgically removed; another receives only axillary radiation therapy to destroy any remaining cancer cells. The goal is to determine which method is more effective for treating breast cancer that has spread to nearby lymph nodes.
What are the potential side effects?
Potential side effects from ALND may include pain, swelling, limited arm movement, nerve injury causing numbness or weakness, and risk of lymphedema (arm swelling due to fluid buildup). Radiation therapy might cause skin changes like redness and irritation, fatigue, arm swelling as well as a slight risk of secondary cancers.
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
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
2Treatment groups
Experimental Treatment
Group I: Arm 2: Axillary radiation and nodal radiation therapyExperimental Treatment2 Interventions
Radiation Therapy: Radiation is delivered to the breast/chest wall, full axilla including Levels I, II, III, supraclavicular nodes and internal mammary nodes in the first 3 intercostal spaces. Treatment will be given 5 days a week over 5-6 weeks.
Group II: Arm 1: ALND + nodal radiation therapyExperimental Treatment2 Interventions
Surgery: For patients randomized to axillary lymph node dissection (ALND), it is recommended that a complete level I and II dissection with resection of minimum of a total of 8 lymph nodes (SLN and ALND together) be done. Level III dissection is not required, but may be performed at the discretion of the surgeon. If fewer than 8 lymph nodes (SLN and ALND together) are resected, then the patient will discontinue protocol treatment.
Radiation Therapy: Radiation is delivered to the breast/chest wall, undissected axilla, supraclavicular nodes and internal mammary nodes in the first 3 intercostal spaces. Treatment will be given 5 days a week over 5-6 weeks.
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Who is running the clinical trial?
Alliance for Clinical Trials in OncologyLead Sponsor
516 Previous Clinical Trials
218,909 Total Patients Enrolled
75 Trials studying Breast Cancer
40,143 Patients Enrolled for Breast Cancer
National Cancer Institute (NCI)NIH
13,906 Previous Clinical Trials
41,010,037 Total Patients Enrolled
942 Trials studying Breast Cancer
1,443,183 Patients Enrolled for Breast Cancer
Canadian Cancer Trials GroupNETWORK
131 Previous Clinical Trials
67,535 Total Patients Enrolled
9 Trials studying Breast Cancer
8,724 Patients Enrolled for Breast Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't had surgery to check lymph nodes in my armpit before or during my chemotherapy.I had a biopsy confirming cancer in my underarm lymph nodes before or shortly after starting chemotherapy.I have never had invasive breast cancer in my other breast.I am not eligible if cancer is found in my other breast during surgery.My cancer's hormone and HER2 status were tested before starting chemotherapy.I have finished all my chemotherapy before surgery, without breaks.I have received specific treatment for my HER-2 positive cancer.I haven't had any cancer except skin cancer or cervical pre-cancer in the last 5 years.I have never had breast cancer or DCIS in the same breast before.I have not had surgery on the lymph nodes under my arm.I completed my breast and sentinel lymph node surgeries within 8 weeks after my last chemotherapy dose.I am fully active or can carry out light work.I have had less than 8 weeks of hormone therapy before starting chemotherapy.My breast cancer was stage 1 to 3 with lymph node involvement but no distant spread when first diagnosed.My lymph nodes were found to have cancer larger than 0.2 mm after surgery, without complete lymph node removal.I had breast and lymph node surgery within 56 days after my last chemo, with all cancer removed.I have a lymph node with cancer larger than 0.2 mm.My underarm lymph nodes are not enlarged after my chemotherapy.Between 1 and 8 lymph nodes were removed during my surgery.I have not had radiation therapy before surgery.Between 1 and 8 of my lymph nodes were removed during my surgery.I had a lymph node removed that was found to have cancer larger than 0.2 mm.I do not have inflammatory breast cancer.
Research Study Groups:
This trial has the following groups:- Group 1: Arm 1: ALND + nodal radiation therapy
- Group 2: Arm 2: Axillary radiation and nodal radiation therapy
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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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