Trial Outcomes & Findings for Enzalutamide and Paclitaxel Before Surgery in Treating Patients With Stage I-III Androgen Receptor-Positive Triple-Negative Breast Cancer (NCT NCT02689427)

Last Updated: 2024-09-19

Results Overview

The RCB (Residual Cancer Burden) is a continuous variable derived from the primary tumor dimensions, cellularity of the tumor bed, and axillary nodal burden. RCB can be divided into four classes (RCB-0 to RCB-III) and will be collected as part of the study. RCB-0 (pCR), Minimal RCB (RCB-I), Moderate RCB (RCB-II), and Extensive RCB (RCB-III)

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

24 participants

Primary outcome timeframe

4 years

Results posted on

2024-09-19

Participant Flow

Participant milestones

Participant milestones
Measure	Enzalutamide + Paclitaxel Patients receive 120mg 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
Overall Study STARTED	24
Overall Study COMPLETED	24
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Enzalutamide and Paclitaxel Before Surgery in Treating Patients With Stage I-III Androgen Receptor-Positive Triple-Negative Breast Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Enzalutamide + Paclitaxel n=24 Participants Patients receive 120mg 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
Age, Continuous	57.5 Years n=5 Participants
Sex: Female, Male Female	24 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	21 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants
Race (NIH/OMB) White	19 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: 4 years

Outcome measures

Outcome measures
Measure	Enzalutamide + Paclitaxel n=24 Participants Patients receive 120mg 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
RCB Status pcR	4 Participants
RCB Status RCB-I	6 Participants
RCB Status RCB-II	8 Participants
RCB Status RCB-III	6 Participants

PRIMARY outcome

Timeframe: Up to 30 days after surgery

Using a Simon optimal two-stage design with alpha = beta = 10%, and then setting the threshold for an acceptable pathologic complete response or residual cancer burden-index rate at 20%. Will be estimated by the proportion of patients with pathologic complete response (residual cancer burden-zero) or residual cancer burden-index as the response rate along with an appropriate 95% confidence interval.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From enrollment to progression of disease or death whichever comes first, up to 30 days after surgery

Estimated using Kaplan-Meier method. Progression of disease defined as \> 20% increase in tumor.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 30 days after surgery

Correlated with pathologic response to treatment using appropriate statistical analyses for the biomarker of interest.

Outcome measures

Outcome data not reported

Adverse Events

Enzalutamide + Paclitaxel

Serious events: 3 serious events

Other events: 10 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Enzalutamide + Paclitaxel n=24 participants at risk Patients receive 120mg 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
General disorders Cholecystitis	4.2% 1/24 • 4 years
Metabolism and nutrition disorders Dehydration	8.3% 2/24 • Number of events 2 • 4 years

Other adverse events

Other adverse events
Measure	Enzalutamide + Paclitaxel n=24 participants at risk Patients receive 120mg 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
Nervous system disorders Dizziness	4.2% 1/24 • Number of events 1 • 4 years
Nervous system disorders Syncope	4.2% 1/24 • Number of events 1 • 4 years
Investigations Neutrophil Count decreased	37.5% 9/24 • Number of events 12 • 4 years
Blood and lymphatic system disorders Anemia	33.3% 8/24 • Number of events 15 • 4 years
Nervous system disorders Peripheral Sensory Neuropathy	33.3% 8/24 • Number of events 10 • 4 years
Respiratory, thoracic and mediastinal disorders Dyspnea	8.3% 2/24 • Number of events 3 • 4 years
General disorders Fatigue	25.0% 6/24 • Number of events 7 • 4 years
Gastrointestinal disorders Nausea	4.2% 1/24 • Number of events 1 • 4 years
Metabolism and nutrition disorders Anorexia	4.2% 1/24 • Number of events 1 • 4 years
Gastrointestinal disorders Vomiting	4.2% 1/24 • Number of events 1 • 4 years
Gastrointestinal disorders Diarrhea	4.2% 1/24 • Number of events 1 • 4 years
Gastrointestinal disorders Abdominal Pain	4.2% 1/24 • Number of events 1 • 4 years
Investigations White blood cell count decreased	8.3% 2/24 • Number of events 3 • 4 years

Additional Information

Clinton Yam, MD

The University of Texas MD Anderson Cancer Center

Phone: (832) 589-8343

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place