Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

ACTIVE NOT RECRUITING Phase 3

Comparison of Axillary Lymph Node Dissection with Axillary Radiation for Patients with Node-Positive Breast Cancer Treated with Chemotherapy

NCT01901094 · View on ClinicalTrials.gov ↗

Study Summary

This randomized phase III trial studies lymph node dissection and radiation therapy to see how well it works compared to radiation therapy alone in treating patients with breast cancer previously treated with chemotherapy and surgery. Lymph node dissection may remove cancer cells that have spread to nearby lymph nodes in patients with breast cancer. Radiation therapy uses high-energy x rays or protons to kill tumor cells. It is not yet known if radiation therapy works better alone or with lymph node dissection in treating patients with breast cancer previously treated with chemotherapy and surgery.

Interventions

  • PROCEDURE Axillary Lymph Node Dissection (ALND)
  • RADIATION Nodal Radiation Therapy
  • RADIATION Axillary Radiation Therapy

Study Locations (20)

Alaska

  • Anchorage Associates in Radiation Medicine — Anchorage
  • Anchorage Radiation Therapy Center — Anchorage
  • Alaska Breast Care and Surgery LLC — Anchorage
  • Alaska Oncology and Hematology LLC — Anchorage
  • Alaska Regional Hospital — Anchorage
  • Alaska Women's Cancer Care — Anchorage
  • Anchorage Oncology Centre — Anchorage
  • Katmai Oncology Group — Anchorage
  • Providence Alaska Medical Center — Anchorage
  • Fairbanks Memorial Hospital — Fairbanks

Alabama

  • Southern Cancer Center PC-Daphne — Daphne
  • Mobile Infirmary Medical Center — Mobile
  • Southern Cancer Center PC-Mobile — Mobile
  • Southern Cancer Center PC-Providence — Mobile
  • Southern Cancer Center PC-Springhill — Mobile
  • University of South Alabama Mitchell Cancer Institute — Mobile

Arizona

  • Arizona Breast Cancer Specialists-Gilbert — Gilbert
  • Virginia G Piper Cancer Care-Glendale — Glendale
  • Arizona Center for Cancer Care-Peoria — Peoria
  • Cancer Center at Saint Joseph's — Phoenix

Trial Details

FieldValue
Enrollment Target 2,012 participants
Start Date 2014-02-24
Est. Completion 2026-01-01
Phase Phase 3

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT01901094

The ClinicalTrials.gov registry entry for NCT01901094 describes a study currently listed as active not recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 2,012 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Alliance for Clinical Trials in Oncology, which has 147 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 2 conditions, with Stage II Breast Cancer appearing as the primary indexed condition, and to 3 interventions — of which Axillary Lymph Node Dissection (ALND) is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT01901094 reports 20 study locations spanning 3 distinct geographic areas — top geographies include Alaska, Alabama, Arizona. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT01901094 about?

NCT01901094 is a clinical study titled "Comparison of Axillary Lymph Node Dissection with Axillary Radiation for Patients with Node-Positive Breast Cancer Treated with Chemotherapy". This randomized phase III trial studies lymph node dissection and radiation therapy to see how well it works compared to radiation therapy alone in treating patients with breast cancer previously treated with chemotherapy and surgery. Lymph node dissection may remove cancer cells that have spread to...

What is the current status of trial NCT01901094?

This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 2,012 participants. The study started on 2014-02-24. Estimated completion is 2026-01-01.

What conditions does trial NCT01901094 study?

This clinical trial studies the following conditions: Stage II Breast Cancer, Stage IIIA Breast Cancer. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT01901094?

The interventions under investigation include: Axillary Lymph Node Dissection (ALND) (PROCEDURE), Nodal Radiation Therapy (RADIATION), Axillary Radiation Therapy (RADIATION). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT01901094?

This trial is sponsored by Alliance for Clinical Trials in Oncology, which has 147 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT01901094 being conducted?

This trial has 20 study locations across Alabama, Alaska, Arizona. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial