Trial Outcomes & Findings for Women's MoonShot: Neoadjuvant Treatment With PaCT for Patients With Locally Advanced TNBC (NCT NCT02593175)

NCT ID: NCT02593175

Last Updated: 2025-11-06

Results Overview

Residual Disease at the time of surgery, which can help predict disease recurrence and survival across all breast cancer subtypes.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 43 participants
• Primary outcome timeframe: At the time of surgery
• Results posted on: 2025-11-06

Participant Flow

Recruitment and enrollment took place in the Breast Medical Oncology clinics of MD Anderson Cancer Center locations from November of 2016 through August of 2021

Participant milestones

Measure	Panitumumab Plus Carboplatin and Paclitaxel Patients receive panitumumab 2.5mg/kg IV and paclitaxel 80mg/kg IV weekly x 12 weeks, and carboplatin AUC4 IV q3w x 4 cycles
Overall Study STARTED	43
Overall Study COMPLETED	34
Overall Study NOT COMPLETED	9

Reasons for withdrawal

Measure	Panitumumab Plus Carboplatin and Paclitaxel Patients receive panitumumab 2.5mg/kg IV and paclitaxel 80mg/kg IV weekly x 12 weeks, and carboplatin AUC4 IV q3w x 4 cycles
Overall Study Adverse Event	5
Overall Study Disease progression	4

Baseline Characteristics

Women's MoonShot: Neoadjuvant Treatment With PaCT for Patients With Locally Advanced TNBC

Baseline characteristics by cohort

Measure	Panitumumab Plus Carboplatin and Paclitaxel n=43 Participants Patients receive panitumumab 2.5mg/kg IV and paclitaxel 80mg/kg IV weekly x 12 weeks, and carboplatin AUC4 IV q3w x 4 cycles
Age, Categorical <=18 years	0 Participants n=49 Participants
Age, Categorical Between 18 and 65 years	37 Participants n=49 Participants
Age, Categorical >=65 years	6 Participants n=49 Participants
Age, Continuous	48.6 years n=49 Participants
Sex: Female, Male Female	43 Participants n=49 Participants
Sex: Female, Male Male	0 Participants n=49 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	6 Participants n=49 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	37 Participants n=49 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=49 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=49 Participants
Race (NIH/OMB) Asian	8 Participants n=49 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=49 Participants
Race (NIH/OMB) Black or African American	6 Participants n=49 Participants
Race (NIH/OMB) White	25 Participants n=49 Participants
Race (NIH/OMB) More than one race	4 Participants n=49 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=49 Participants
Region of Enrollment United States	43 participants n=49 Participants

PRIMARY outcome

Timeframe: At the time of surgery

Population: All patients were evaluable for data analysis

Residual Disease at the time of surgery, which can help predict disease recurrence and survival across all breast cancer subtypes.

Outcome measures

Measure	Panitumumab Plus Carboplatin and Paclitaxel n=24 Participants Patients receive panitumumab 2.5mg/kg IV and paclitaxel 80mg/kg IV weekly x 12 weeks, and carboplatin AUC4 IV q3w x 4 cycles
Number of Participants With Residual Disease	24 Participants

Adverse Events

Panitumumab Plus Carboplatin and Paclitaxel

Serious events: 2 serious events

Other events: 40 other events

Deaths: 0 deaths

Serious adverse events

Measure	Panitumumab Plus Carboplatin and Paclitaxel n=43 participants at risk Patients receive panitumumab 2.5mg/kg IV and paclitaxel 80mg/kg IV weekly x 12 weeks, and carboplatin AUC4 IV q3w x 4 cycles
Renal and urinary disorders Cystitis	2.3% 1/43 • Number of events 2 • 5 years
Nervous system disorders Vertigo	2.3% 1/43 • Number of events 1 • 5 years

Other adverse events

Measure	Panitumumab Plus Carboplatin and Paclitaxel n=43 participants at risk Patients receive panitumumab 2.5mg/kg IV and paclitaxel 80mg/kg IV weekly x 12 weeks, and carboplatin AUC4 IV q3w x 4 cycles
Investigations Neutrophil Count decreased	51.2% 22/43 • Number of events 31 • 5 years
Nervous system disorders Peripheral sensory neuropathy	41.9% 18/43 • Number of events 21 • 5 years
General disorders Fatigue	51.2% 22/43 • Number of events 22 • 5 years
Blood and lymphatic system disorders Anemia	39.5% 17/43 • Number of events 26 • 5 years
Skin and subcutaneous tissue disorders Rash Maculopapular	46.5% 20/43 • Number of events 20 • 5 years
Gastrointestinal disorders Mucositis Oral	62.8% 27/43 • Number of events 27 • 5 years
Skin and subcutaneous tissue disorders Dry Skin	74.4% 32/43 • Number of events 32 • 5 years

Additional Information

Clinton Yam

MD Anderson Cancer Center

Phone: 832-589-8343

Email: cyam@mdanderson.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place