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Antiandrogen

Enzalutamide + Paclitaxel for Breast Cancer

Phase 2
Waitlist Available
Led By Clinton Yam
Research Sponsored by M.D. Anderson Cancer Center
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 30 days after surgery
Awards & highlights

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
  • Breast Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from enrollment to progression of disease or death whichever comes first, up to 30 days after surgery
This trial's timeline: 3 weeks for screening, Varies for treatment, and from enrollment to progression of disease or death whichever comes first, up to 30 days after surgery for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of pathologic complete response (residual cancer burden-zero) and residual cancer burden-index
Incidence of residual cancer burden-index
Secondary outcome measures
Progression-free survival distribution
Other outcome measures
Levels of biomarkers of response

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (enzalutamide, paclitaxel)Experimental Treatment6 Interventions
Patients receive enzalutamide PO daily on days 1-7 and paclitaxel IV over 2 hours on day 1. Treatments repeat every 7 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. SURGERY: After 12 cycles of therapy, patients undergo surgical resection of primary tumor with or without lymph node biopsy or complete axillary dissection.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Axillary Lymph Node Dissection
2004
Completed Phase 4
~530
Lymph Node Biopsy
2014
Completed Phase 2
~50
Paclitaxel
2011
Completed Phase 4
~5380
Therapeutic Conventional Surgery
2005
Completed Phase 3
~9850
Enzalutamide
2014
Completed Phase 4
~2760

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
2,967 Previous Clinical Trials
1,804,778 Total Patients Enrolled
148 Trials studying Breast Cancer
63,286 Patients Enrolled for Breast Cancer
National Cancer Institute (NCI)NIH
13,657 Previous Clinical Trials
40,933,643 Total Patients Enrolled
940 Trials studying Breast Cancer
1,543,360 Patients Enrolled for Breast Cancer
Clinton YamPrincipal InvestigatorM.D. Anderson Cancer Center
6 Previous Clinical Trials
1,206 Total Patients Enrolled

Media Library

Enzalutamide (Antiandrogen) Clinical Trial Eligibility Overview. Trial Name: NCT02689427 — Phase 2
Breast Cancer Research Study Groups: Treatment (enzalutamide, paclitaxel)
Breast Cancer Clinical Trial 2023: Enzalutamide Highlights & Side Effects. Trial Name: NCT02689427 — Phase 2
Enzalutamide (Antiandrogen) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02689427 — Phase 2

Frequently Asked Questions

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

How many people are participating in this clinical trial?

"That is correct. The information available on clinicaltrials.gov 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."

Answered by AI

Is recruitment still underway for this research project?

"The listing on clinicaltrials.gov 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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Enzalutamide and Paclitaxel Before Surgery in Treating Patients With Stage I-III Androgen Receptor-Positive Triple-Negative Breast Cancer
2016. "Enzalutamide and Paclitaxel Before Surgery in Treating Patients With Stage I-III Androgen Receptor-Positive Triple-Negative Breast Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02689427.
~3 spots leftby Apr 2025
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