Axillary Lymph Node Dissection for Stage III Breast Cancer

Phase-Based Progress Estimates
MD Anderson West Houston, Houston, TXStage III Breast Cancer+15 MoreAxillary Lymph Node Dissection - Procedure
All Sexes
What conditions do you have?

Study Summary

This trial is studying a combination of drugs given before surgery to see how well it works in treating patients with triple-negative breast cancer.

Eligible Conditions
  • Stage III Breast Cancer
  • Stage IA Breast Cancer
  • Stage IIA Breast Cancer
  • Stage IIIA Breast Cancer
  • Progesterone Receptor Negative Breast Cancer
  • HER2/Neu Negative Breast Cancer
  • Androgen Receptor Positive
  • Estrogen Receptor Negative Breast Cancer
  • Stage IIIB Breast Cancer
  • Stage IB Breast Cancer
  • Triple Negative Breast Cancer
  • Stage I Breast Cancer
  • Stage II Breast Cancer
  • Breast Cancer
  • Stage IIB Breast Cancer

Treatment Effectiveness

Study Objectives

2 Primary · 1 Secondary · Reporting Duration: Up to 30 days after surgery

Day 30
Progression-free survival distribution
Day 30
Incidence of pathologic complete response (residual cancer burden-zero) and residual cancer burden-index
Incidence of residual cancer burden-index
Levels of biomarkers of response

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Trial Design

1 Treatment Group

Treatment (enzalutamide, paclitaxel)
1 of 1

Experimental Treatment

37 Total Participants · 1 Treatment Group

Primary Treatment: Axillary Lymph Node Dissection · No Placebo Group · Phase 2

Treatment (enzalutamide, paclitaxel)Experimental Group · 6 Interventions: Laboratory Biomarker Analysis, Axillary Lymph Node Dissection, Paclitaxel, Therapeutic Conventional Surgery, Lymph Node Biopsy, Enzalutamide · Intervention Types: Other, Procedure, Drug, Procedure, Procedure, Drug
First Studied
Drug Approval Stage
How many patients have taken this drug
Axillary Lymph Node Dissection
Completed Phase 4
FDA approved
Therapeutic Conventional Surgery
Completed Phase 3
Lymph Node Biopsy
Completed Phase 1
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 30 days after surgery

Who is running the clinical trial?

National Cancer Institute (NCI)NIH
13,153 Previous Clinical Trials
41,163,062 Total Patients Enrolled
M.D. Anderson Cancer CenterLead Sponsor
2,825 Previous Clinical Trials
1,792,534 Total Patients Enrolled
Naoto T UenoPrincipal InvestigatorM.D. Anderson Cancer Center
8 Previous Clinical Trials
2,631 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 15 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have breast cancer that is classified as stage I-III according to the American Joint Committee on Cancer (AJCC) 7th edition.

Frequently Asked Questions

How many people are participating in this clinical trial?

"That is correct. The information available on supports that this trial is ongoing and seeking new participants. According to the site, the study was established on September 22nd, 2016 and was updated on September 22nd, 2020. They are looking for a total of 37 patients from 2 different locations." - Anonymous Online Contributor

Unverified Answer

Is recruitment still underway for this research project?

"The listing on shows that this study is still looking for patients to enroll. The trial was originally posted on September 22nd, 2016 and has since been updated multiple times, with the most recent edit being on September 22nd, 2020. Currently, 37 people are needed between 2 different sites." - Anonymous Online Contributor

Unverified Answer

Are there other ongoing research studies that focus on Axillary Lymph Node Dissection?

"At present, there are 973 clinical trials studying axillary lymph node dissection (ALND), with 264 of those trials in Phase 3. Most of the ALND clinical trials are located in Germantown, Tennessee, but there are 51812 locations worldwide conducting studies on this topic." - Anonymous Online Contributor

Unverified Answer

What is the standard medical procedure for Axillary Lymph Node Dissection?

"Axillary Lymph Node Dissection is a viable treatment option for patients struggling with neoplasm metastasis, kaposi sarcoma, and advance directives." - Anonymous Online Contributor

Unverified Answer

What is the most common side effect for patients who undergo Axillary Lymph Node Dissection?

"Phase 2 trials are limited to safety data, so our team has given Axillary Lymph Node Dissection a score of 2." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.