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N/A

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 after completion of radiation therapy
Awards & highlights

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.Check my eligibility
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.See study design
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 weeks
Treatment ~ Varies
Follow Up ~up to 5 years after completion of radiation therapy
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years after completion of radiation therapy for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Invasive breast cancer recurrence-free interval (IBC-RFI)
Secondary outcome measures
Ipsilateral/local/regional invasive breast cancer recurrence (ILR-REC)
Overall survival
Other outcome measures
Adequacy of radiation fields, dose delivered to supraclavicular and axillary nodes
Breast lymphedema (in BCT patients)
Development of arm lymphedema if there is a 10% increase in the volume of the ipsilateral arm from its pre-surgery volume
+1 more

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.

Find a Location

Who is running the clinical trial?

Alliance for Clinical Trials in OncologyLead Sponsor
512 Previous Clinical Trials
215,614 Total Patients Enrolled
75 Trials studying Breast Cancer
40,143 Patients Enrolled for Breast Cancer
National Cancer Institute (NCI)NIH
13,748 Previous Clinical Trials
40,957,389 Total Patients Enrolled
944 Trials studying Breast Cancer
1,544,008 Patients Enrolled for Breast Cancer
Canadian Cancer Trials GroupNETWORK
127 Previous Clinical Trials
66,292 Total Patients Enrolled
9 Trials studying Breast Cancer
8,724 Patients Enrolled for Breast Cancer

Media Library

Axillary Lymph Node Dissection (ALND) (N/A) Clinical Trial Eligibility Overview. Trial Name: NCT01901094 — Phase 3
Breast Cancer Research Study Groups: Arm 1: ALND + nodal radiation therapy, Arm 2: Axillary radiation and nodal radiation therapy
Breast Cancer Clinical Trial 2023: Axillary Lymph Node Dissection (ALND) Highlights & Side Effects. Trial Name: NCT01901094 — Phase 3
Axillary Lymph Node Dissection (ALND) (N/A) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01901094 — Phase 3
~77 spots leftby Jan 2025