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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
Patients must have had axillary ultrasound with fine needle aspiration (FNA) or core needle biopsy of axillary lymph nodes documenting axillary metastasis at the time of diagnosis, prior to or at most 14 days after starting neoadjuvant chemotherapy
Patients must have had estrogen receptor, progesterone receptor and HER2 status (by immunohistochemistry [IHC] and/or in situ hybridization [ISH]) evaluated on diagnostic core biopsy prior to start of neoadjuvant chemotherapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years after completion of radiation therapy
Awards & highlights

Study 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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I had a biopsy confirming cancer in my underarm lymph nodes before or shortly after starting chemotherapy.
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My cancer's hormone and HER2 status were tested before starting chemotherapy.
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I have finished all my chemotherapy before surgery, without breaks.
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I have received specific treatment for my HER-2 positive cancer.
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I completed my breast and sentinel lymph node surgeries within 8 weeks after my last chemotherapy dose.
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I am fully active or can carry out light work.
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My breast cancer was stage 1 to 3 with lymph node involvement but no distant spread when first diagnosed.
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My lymph nodes were found to have cancer larger than 0.2 mm after surgery, without complete lymph node removal.
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I had breast and lymph node surgery within 56 days after my last chemo, with all cancer removed.
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I have a lymph node with cancer larger than 0.2 mm.
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My underarm lymph nodes are not enlarged after my chemotherapy.
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Between 1 and 8 lymph nodes were removed during my surgery.
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Between 1 and 8 of my lymph nodes were removed during my surgery.
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I had a lymph node removed that was found to have cancer larger than 0.2 mm.

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
215,622 Total Patients Enrolled
75 Trials studying Breast Cancer
40,143 Patients Enrolled for Breast Cancer
National Cancer Institute (NCI)NIH
13,609 Previous Clinical Trials
40,913,634 Total Patients Enrolled
939 Trials studying Breast Cancer
1,543,333 Patients Enrolled for Breast Cancer
Canadian Cancer Trials GroupNETWORK
122 Previous Clinical Trials
65,140 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are we able to enroll patients in this trial at this time?

"The clinical trial mentioned is no longer recruiting patients, as indicated by the information found on clinicaltrials.gov. This specific trial was posted on 2/7/2014 and updated for the last time on 8/2/2022; however, there are 2369 other trials that are actively seeking patients."

Answered by AI

Where are patients able to participate in this trial?

"If you wish to enroll in this trial, know that there are 10 sites currently recruiting patients. The locations of these sites include Sherman, Bremerton and Willow Grove among others. To cut down on travel costs and time, make sure to choose the location nearest you."

Answered by AI

Has this procedure received government sanctioning?

"There is prior clinical evidence backing the safety of this treatment, which is why it received a score of 3."

Answered by AI
~139 spots leftby Jan 2025