Trial Outcomes & Findings for Targeted T Cells After Neoadjuvant Chemotherapy in Treating Women With Stage II or III Breast Cancer Undergoing Surgery (NCT NCT01147016)

Last Updated: 2023-04-27

Results Overview

Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesion

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

8 participants

Primary outcome timeframe

From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 7 years..

Results posted on

2023-04-27

Participant Flow

Participant milestones

Participant milestones
Measure	Treated Single group study
Overall Study STARTED	8
Overall Study COMPLETED	8
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Targeted T Cells After Neoadjuvant Chemotherapy in Treating Women With Stage II or III Breast Cancer Undergoing Surgery

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treated n=8 Participants Single group study
Age, Continuous	44.5 years n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	8 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	0 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	4 Participants n=5 Participants
Race (NIH/OMB) White	4 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
Region of Enrollment United States	8 participants n=5 Participants
enrollment	8 Participants n=5 Participants

PRIMARY outcome

Timeframe: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 7 years..

Population: Women with stage II-III, HER2/neu (0-2+) negative breast cancer treated with anti-CD3 x anti-HER2neu (Her2BI) armed, activated T cells after neoadjuvant chemotherapy

Outcome measures

Outcome measures
Measure	Activated T Cells n=8 Participants All participants enrolled
Progression-free Survival	43 months Interval 2.0 to The sample size is very small and there are too few events to estimate the upper 95% CI.

SECONDARY outcome

Timeframe: From date of randomization until date of death from any cause or end of study, whichever came first, assessed up to 7 years

Population: The participant who died had the longest follow-up time.

Total number of deaths

Outcome measures

Outcome measures
Measure	Activated T Cells n=8 Participants All participants enrolled
Overall Deaths	1 Participants

Adverse Events

Treated

Serious events: 0 serious events

Other events: 8 other events

Deaths: 1 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Treated n=8 participants at risk All 8 participants enrolled
Cardiac disorders Hypertension	100.0% 1/1 • Number of events 1 • Up to 7 years.
General disorders chills/rigors	87.5% 7/8 • Number of events 7 • Up to 7 years.
Gastrointestinal disorders Nausea	87.5% 7/8 • Number of events 7 • Up to 7 years.
Gastrointestinal disorders Vomiting	50.0% 4/8 • Number of events 4 • Up to 7 years.
General disorders fatigue	87.5% 7/8 • Number of events 7 • Up to 7 years.
General disorders Rash	37.5% 3/8 • Number of events 3 • Up to 7 years.
General disorders edema	25.0% 2/8 • Number of events 2 • Up to 7 years.
Nervous system disorders neuroppathy	37.5% 3/8 • Number of events 3 • Up to 7 years.
General disorders hypotension	62.5% 5/8 • Number of events 5 • Up to 7 years.
General disorders fever	75.0% 6/8 • Number of events 6 • Up to 7 years.
General disorders hyponatremia	12.5% 1/8 • Number of events 1 • Up to 7 years.
Endocrine disorders hypoglycemia	25.0% 2/8 • Number of events 2 • Up to 7 years.
General disorders neutropenia	50.0% 4/8 • Number of events 4 • Up to 7 years.
General disorders AST elevation	12.5% 1/8 • Number of events 1 • Up to 7 years.
General disorders ALT elevation	12.5% 1/8 • Number of events 1 • Up to 7 years.
Blood and lymphatic system disorders Anemia	62.5% 5/8 • Number of events 5 • Up to 7 years.
Cardiac disorders Afibrillation	12.5% 1/8 • Number of events 1 • Up to 7 years.
Gastrointestinal disorders Diarrhea	12.5% 1/8 • Number of events 1 • Up to 7 years.
Infections and infestations Infection	37.5% 3/8 • Number of events 3 • Up to 7 years.
Blood and lymphatic system disorders Low platelets	62.5% 5/8 • Number of events 5 • Up to 7 years.
Blood and lymphatic system disorders hypoalbuminemia	25.0% 2/8 • Number of events 2 • Up to 7 years.
Blood and lymphatic system disorders Alkaline Phosphatase	25.0% 2/8 • Number of events 2 • Up to 7 years.
Blood and lymphatic system disorders Hypercalcemia	25.0% 2/8 • Number of events 2 • Up to 7 years.
Blood and lymphatic system disorders Hypocalcemia	100.0% 1/1 • Number of events 1 • Up to 7 years.
Blood and lymphatic system disorders hypokalemia	12.5% 1/8 • Number of events 1 • Up to 7 years.

Additional Information

Dr. Amy Weise

Barbara Ann Karmanos Cancer Institute

Phone: 248-344-6688

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place