Trial Outcomes & Findings for TACTIC - TAA Specific Cytotoxic T Lymphocytes in Patients With Breast Cancer (NCT NCT03093350)

Last Updated: 2025-08-29

Results Overview

To determine the clinical efficacy associated with the administration of multiTAA-specific T cells in breast cancer patients with metastatic or locally recurrent unresectable disease as measured by clinical benefit rate (defined as overall response plus stable disease for 10 weeks or longer). Per the Response Evaluation Criteria in Solid Tumors (RECIST v1.1) criteria and assessed by CT or MRI: Complete Response (CR), disappearance of all target lesions; Partial Response (PR), at least a 30% decrease in the sum of the longest diameter (LD) of target lesions; Progressive Disease (PD), At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; Stable Disease (SD), Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started; Overall Response (OR) = CR + PR.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

12 participants

Primary outcome timeframe

12 weeks

Results posted on

2025-08-29

Participant Flow

Participant milestones

Participant milestones
Measure	TAA-Specific CTLs Patients receiving TAA-specific CTLs as therapy for breast cancer. TAA-specific CTLs: Each patient will receive 2 injections at a fixed dose, 28 days apart, according to the following dose schedule: The expected volume of infusion will be 1 to 10 cc. Dose schedule: Day 0: 2 x 10\^7 cells/m2 Day 28: 2 x 10\^7 cells/m2 If patients have stable disease or a partial response by the Response Evaluation Criteria in Solid Tumors (RECIST) criteria at their 6 week evaluation after the 2nd cell dose, they will be eligible to receive up to 6 additional doses of CTLs, At least one month should have passed before each additional dose.. Each additional infusion will consist of the same cell number or less (if there is not enough product available for the subject's original dose) than their second infusion. Patients will not be able to receive additional doses until the initial safety profile is completed at 6 weeks following the second infusion.
Overall Study STARTED	12
Overall Study Started Treatment	10
Overall Study COMPLETED	10
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Reasons for withdrawal
Measure	TAA-Specific CTLs Patients receiving TAA-specific CTLs as therapy for breast cancer. TAA-specific CTLs: Each patient will receive 2 injections at a fixed dose, 28 days apart, according to the following dose schedule: The expected volume of infusion will be 1 to 10 cc. Dose schedule: Day 0: 2 x 10\^7 cells/m2 Day 28: 2 x 10\^7 cells/m2 If patients have stable disease or a partial response by the Response Evaluation Criteria in Solid Tumors (RECIST) criteria at their 6 week evaluation after the 2nd cell dose, they will be eligible to receive up to 6 additional doses of CTLs, At least one month should have passed before each additional dose.. Each additional infusion will consist of the same cell number or less (if there is not enough product available for the subject's original dose) than their second infusion. Patients will not be able to receive additional doses until the initial safety profile is completed at 6 weeks following the second infusion.
Overall Study Death	1
Overall Study Signed consent, never began treartment	1

Baseline Characteristics

TACTIC - TAA Specific Cytotoxic T Lymphocytes in Patients With Breast Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	TAA-Specific CTLs n=10 Participants Patients receiving TAA-specific CTLs as therapy for breast cancer. TAA-specific CTLs: Each patient will receive 2 injections at a fixed dose, 28 days apart, according to the following dose schedule: The expected volume of infusion will be 1 to 10 cc. Dose schedule: Day 0: 2 x 10\^7 cells/m2 Day 28: 2 x 10\^7 cells/m2 If patients have stable disease or a partial response by the Response Evaluation Criteria in Solid Tumors (RECIST) criteria at their 6 week evaluation after the 2nd cell dose, they will be eligible to receive up to 6 additional doses of CTLs, At least one month should have passed before each additional dose.. Each additional infusion will consist of the same cell number or less (if there is not enough product available for the subject's original dose) than their second infusion. Patients will not be able to receive additional doses until the initial safety profile is completed at 6 weeks following the second infusion.
Age, Continuous	58.80 years STANDARD_DEVIATION 11.91 • n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	9 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	0 Participants n=5 Participants
Race (NIH/OMB) White	10 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: 12 weeks

Population: 12 patients were enrolled, but 10 were assigned to treatment. 1 patient signed consent but never began treatment, and 1 patient died before treatment began. 9 patients completed treatment; 1 patient progressed prior to 2nd infusion and was considered inevaluable.

Outcome measures

Outcome measures
Measure	TAA-Specific CTLs n=9 Participants Patients receiving TAA-specific CTLs as therapy for breast cancer. TAA-specific CTLs: Each patient will receive 2 injections at a fixed dose, 28 days apart, according to the following dose schedule: The expected volume of infusion will be 1 to 10 cc. Dose schedule: Day 0: 2 x 10\^7 cells/m2 Day 28: 2 x 10\^7 cells/m2 If patients have stable disease or a partial response by the Response Evaluation Criteria in Solid Tumors (RECIST) criteria at their 6 week evaluation after the 2nd cell dose, they will be eligible to receive up to 6 additional doses of CTLs, At least one month should have passed before each additional dose.. Each additional infusion will consist of the same cell number or less (if there is not enough product available for the subject's original dose) than their second infusion. Patients will not be able to receive additional doses until the initial safety profile is completed at 6 weeks following the second infusion.
The Number of Evaluable Patients With Complete Response or Partial Response or Stable Disease for ≥10 Weeks From the First Infusion (6 Weeks After the Second Infusion) According to the RECIST Criteria	1 Participants

SECONDARY outcome

Timeframe: 1 year

Population: 12 patients were enrolled, but 10 were assigned to, and began, treatment. 1 patient signed consent but never began treatment, and 1 patient died before treatment began.

To evaluate the progression-free survival of patients after multiTAA-specific T cell infusion. Progression is defined, according to the Response Evaluation Criteria in Solid Tumors (RECIST v1.1) Criteria, as at least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.

Outcome measures

Outcome measures
Measure	TAA-Specific CTLs n=10 Participants Patients receiving TAA-specific CTLs as therapy for breast cancer. TAA-specific CTLs: Each patient will receive 2 injections at a fixed dose, 28 days apart, according to the following dose schedule: The expected volume of infusion will be 1 to 10 cc. Dose schedule: Day 0: 2 x 10\^7 cells/m2 Day 28: 2 x 10\^7 cells/m2 If patients have stable disease or a partial response by the Response Evaluation Criteria in Solid Tumors (RECIST) criteria at their 6 week evaluation after the 2nd cell dose, they will be eligible to receive up to 6 additional doses of CTLs, At least one month should have passed before each additional dose.. Each additional infusion will consist of the same cell number or less (if there is not enough product available for the subject's original dose) than their second infusion. Patients will not be able to receive additional doses until the initial safety profile is completed at 6 weeks following the second infusion.
Median Progression-free Survival	69.5 days Interval 13.0 to 72.0

SECONDARY outcome

Timeframe: 1 year

Population: 12 patients were enrolled, but 10 were assigned to, and began, treatment. 1 patient signed consent but never began treatment, and 1 patient died before treatment began.

To evaluate the overall survival of patients after multiTAA-specific T cell infusion

Outcome measures

Outcome measures
Measure	TAA-Specific CTLs n=10 Participants Patients receiving TAA-specific CTLs as therapy for breast cancer. TAA-specific CTLs: Each patient will receive 2 injections at a fixed dose, 28 days apart, according to the following dose schedule: The expected volume of infusion will be 1 to 10 cc. Dose schedule: Day 0: 2 x 10\^7 cells/m2 Day 28: 2 x 10\^7 cells/m2 If patients have stable disease or a partial response by the Response Evaluation Criteria in Solid Tumors (RECIST) criteria at their 6 week evaluation after the 2nd cell dose, they will be eligible to receive up to 6 additional doses of CTLs, At least one month should have passed before each additional dose.. Each additional infusion will consist of the same cell number or less (if there is not enough product available for the subject's original dose) than their second infusion. Patients will not be able to receive additional doses until the initial safety profile is completed at 6 weeks following the second infusion.
Median Overall Survival	116 days Interval 37.0 to Not enough participants had event to calculate upper 95% CI.

Adverse Events

TAA-Specific CTLs

Serious events: 1 serious events

Other events: 7 other events

Deaths: 5 deaths

Serious adverse events

Serious adverse events
Measure	TAA-Specific CTLs n=10 participants at risk Patients receiving TAA-specific CTLs as therapy for breast cancer. TAA-specific CTLs: Each patient will receive 2 injections at a fixed dose, 28 days apart, according to the following dose schedule: The expected volume of infusion will be 1 to 10 cc. Dose schedule: Day 0: 2 x 10\^7 cells/m2 Day 28: 2 x 10\^7 cells/m2 If patients have stable disease or a partial response by the Response Evaluation Criteria in Solid Tumors (RECIST) criteria at their 6 week evaluation after the 2nd cell dose, they will be eligible to receive up to 6 additional doses of CTLs, At least one month should have passed before each additional dose.. Each additional infusion will consist of the same cell number or less (if there is not enough product available for the subject's original dose) than their second infusion. Patients will not be able to receive additional doses until the initial safety profile is completed at 6 weeks following the second infusion.
General disorders Fever	10.0% 1/10 • Number of events 1 • 10 weeks (from date of 1st injection up to 6 weeks after date of 2nd injection) for adverse events, and 1 year (from date of 1st injection) for all-cause mortality. Adverse events were assessed starting at the date of 1st injection, then at 1 week after 1st injection, 2 weeks after 1st injection, date of 2nd injection (4 weeks after 1st injection), 1 week after 2nd injection, 2 weeks after 2nd injection, 4 weeks after 2nd injection, and 6 weeks after 2nd injection using descriptions and grading scales found in CTCAE v4.0. All-cause mortality was assessed for 1 year from the date of 1st injection.
Metabolism and nutrition disorders Dehydration	10.0% 1/10 • Number of events 1 • 10 weeks (from date of 1st injection up to 6 weeks after date of 2nd injection) for adverse events, and 1 year (from date of 1st injection) for all-cause mortality. Adverse events were assessed starting at the date of 1st injection, then at 1 week after 1st injection, 2 weeks after 1st injection, date of 2nd injection (4 weeks after 1st injection), 1 week after 2nd injection, 2 weeks after 2nd injection, 4 weeks after 2nd injection, and 6 weeks after 2nd injection using descriptions and grading scales found in CTCAE v4.0. All-cause mortality was assessed for 1 year from the date of 1st injection.
Skin and subcutaneous tissue disorders Pruritus	10.0% 1/10 • Number of events 1 • 10 weeks (from date of 1st injection up to 6 weeks after date of 2nd injection) for adverse events, and 1 year (from date of 1st injection) for all-cause mortality. Adverse events were assessed starting at the date of 1st injection, then at 1 week after 1st injection, 2 weeks after 1st injection, date of 2nd injection (4 weeks after 1st injection), 1 week after 2nd injection, 2 weeks after 2nd injection, 4 weeks after 2nd injection, and 6 weeks after 2nd injection using descriptions and grading scales found in CTCAE v4.0. All-cause mortality was assessed for 1 year from the date of 1st injection.

Other adverse events

Other adverse events
Measure	TAA-Specific CTLs n=10 participants at risk Patients receiving TAA-specific CTLs as therapy for breast cancer. TAA-specific CTLs: Each patient will receive 2 injections at a fixed dose, 28 days apart, according to the following dose schedule: The expected volume of infusion will be 1 to 10 cc. Dose schedule: Day 0: 2 x 10\^7 cells/m2 Day 28: 2 x 10\^7 cells/m2 If patients have stable disease or a partial response by the Response Evaluation Criteria in Solid Tumors (RECIST) criteria at their 6 week evaluation after the 2nd cell dose, they will be eligible to receive up to 6 additional doses of CTLs, At least one month should have passed before each additional dose.. Each additional infusion will consist of the same cell number or less (if there is not enough product available for the subject's original dose) than their second infusion. Patients will not be able to receive additional doses until the initial safety profile is completed at 6 weeks following the second infusion.
Blood and lymphatic system disorders Anemia	10.0% 1/10 • Number of events 1 • 10 weeks (from date of 1st injection up to 6 weeks after date of 2nd injection) for adverse events, and 1 year (from date of 1st injection) for all-cause mortality. Adverse events were assessed starting at the date of 1st injection, then at 1 week after 1st injection, 2 weeks after 1st injection, date of 2nd injection (4 weeks after 1st injection), 1 week after 2nd injection, 2 weeks after 2nd injection, 4 weeks after 2nd injection, and 6 weeks after 2nd injection using descriptions and grading scales found in CTCAE v4.0. All-cause mortality was assessed for 1 year from the date of 1st injection.
Ear and labyrinth disorders Vertigo	10.0% 1/10 • Number of events 1 • 10 weeks (from date of 1st injection up to 6 weeks after date of 2nd injection) for adverse events, and 1 year (from date of 1st injection) for all-cause mortality. Adverse events were assessed starting at the date of 1st injection, then at 1 week after 1st injection, 2 weeks after 1st injection, date of 2nd injection (4 weeks after 1st injection), 1 week after 2nd injection, 2 weeks after 2nd injection, 4 weeks after 2nd injection, and 6 weeks after 2nd injection using descriptions and grading scales found in CTCAE v4.0. All-cause mortality was assessed for 1 year from the date of 1st injection.
Gastrointestinal disorders Nausea	10.0% 1/10 • Number of events 1 • 10 weeks (from date of 1st injection up to 6 weeks after date of 2nd injection) for adverse events, and 1 year (from date of 1st injection) for all-cause mortality. Adverse events were assessed starting at the date of 1st injection, then at 1 week after 1st injection, 2 weeks after 1st injection, date of 2nd injection (4 weeks after 1st injection), 1 week after 2nd injection, 2 weeks after 2nd injection, 4 weeks after 2nd injection, and 6 weeks after 2nd injection using descriptions and grading scales found in CTCAE v4.0. All-cause mortality was assessed for 1 year from the date of 1st injection.
General disorders Fatigue	10.0% 1/10 • Number of events 1 • 10 weeks (from date of 1st injection up to 6 weeks after date of 2nd injection) for adverse events, and 1 year (from date of 1st injection) for all-cause mortality. Adverse events were assessed starting at the date of 1st injection, then at 1 week after 1st injection, 2 weeks after 1st injection, date of 2nd injection (4 weeks after 1st injection), 1 week after 2nd injection, 2 weeks after 2nd injection, 4 weeks after 2nd injection, and 6 weeks after 2nd injection using descriptions and grading scales found in CTCAE v4.0. All-cause mortality was assessed for 1 year from the date of 1st injection.
General disorders Pain	10.0% 1/10 • Number of events 1 • 10 weeks (from date of 1st injection up to 6 weeks after date of 2nd injection) for adverse events, and 1 year (from date of 1st injection) for all-cause mortality. Adverse events were assessed starting at the date of 1st injection, then at 1 week after 1st injection, 2 weeks after 1st injection, date of 2nd injection (4 weeks after 1st injection), 1 week after 2nd injection, 2 weeks after 2nd injection, 4 weeks after 2nd injection, and 6 weeks after 2nd injection using descriptions and grading scales found in CTCAE v4.0. All-cause mortality was assessed for 1 year from the date of 1st injection.
Investigations Alanine aminotransferase increased	30.0% 3/10 • Number of events 5 • 10 weeks (from date of 1st injection up to 6 weeks after date of 2nd injection) for adverse events, and 1 year (from date of 1st injection) for all-cause mortality. Adverse events were assessed starting at the date of 1st injection, then at 1 week after 1st injection, 2 weeks after 1st injection, date of 2nd injection (4 weeks after 1st injection), 1 week after 2nd injection, 2 weeks after 2nd injection, 4 weeks after 2nd injection, and 6 weeks after 2nd injection using descriptions and grading scales found in CTCAE v4.0. All-cause mortality was assessed for 1 year from the date of 1st injection.
Investigations Aspartate aminotransferase increased	30.0% 3/10 • Number of events 5 • 10 weeks (from date of 1st injection up to 6 weeks after date of 2nd injection) for adverse events, and 1 year (from date of 1st injection) for all-cause mortality. Adverse events were assessed starting at the date of 1st injection, then at 1 week after 1st injection, 2 weeks after 1st injection, date of 2nd injection (4 weeks after 1st injection), 1 week after 2nd injection, 2 weeks after 2nd injection, 4 weeks after 2nd injection, and 6 weeks after 2nd injection using descriptions and grading scales found in CTCAE v4.0. All-cause mortality was assessed for 1 year from the date of 1st injection.
Investigations Blood bilirubin increased	10.0% 1/10 • Number of events 2 • 10 weeks (from date of 1st injection up to 6 weeks after date of 2nd injection) for adverse events, and 1 year (from date of 1st injection) for all-cause mortality. Adverse events were assessed starting at the date of 1st injection, then at 1 week after 1st injection, 2 weeks after 1st injection, date of 2nd injection (4 weeks after 1st injection), 1 week after 2nd injection, 2 weeks after 2nd injection, 4 weeks after 2nd injection, and 6 weeks after 2nd injection using descriptions and grading scales found in CTCAE v4.0. All-cause mortality was assessed for 1 year from the date of 1st injection.
Metabolism and nutrition disorders Hypoalbuminemia	10.0% 1/10 • Number of events 1 • 10 weeks (from date of 1st injection up to 6 weeks after date of 2nd injection) for adverse events, and 1 year (from date of 1st injection) for all-cause mortality. Adverse events were assessed starting at the date of 1st injection, then at 1 week after 1st injection, 2 weeks after 1st injection, date of 2nd injection (4 weeks after 1st injection), 1 week after 2nd injection, 2 weeks after 2nd injection, 4 weeks after 2nd injection, and 6 weeks after 2nd injection using descriptions and grading scales found in CTCAE v4.0. All-cause mortality was assessed for 1 year from the date of 1st injection.
Musculoskeletal and connective tissue disorders Back pain	10.0% 1/10 • Number of events 1 • 10 weeks (from date of 1st injection up to 6 weeks after date of 2nd injection) for adverse events, and 1 year (from date of 1st injection) for all-cause mortality. Adverse events were assessed starting at the date of 1st injection, then at 1 week after 1st injection, 2 weeks after 1st injection, date of 2nd injection (4 weeks after 1st injection), 1 week after 2nd injection, 2 weeks after 2nd injection, 4 weeks after 2nd injection, and 6 weeks after 2nd injection using descriptions and grading scales found in CTCAE v4.0. All-cause mortality was assessed for 1 year from the date of 1st injection.
Musculoskeletal and connective tissue disorders Pain in extremity	10.0% 1/10 • Number of events 1 • 10 weeks (from date of 1st injection up to 6 weeks after date of 2nd injection) for adverse events, and 1 year (from date of 1st injection) for all-cause mortality. Adverse events were assessed starting at the date of 1st injection, then at 1 week after 1st injection, 2 weeks after 1st injection, date of 2nd injection (4 weeks after 1st injection), 1 week after 2nd injection, 2 weeks after 2nd injection, 4 weeks after 2nd injection, and 6 weeks after 2nd injection using descriptions and grading scales found in CTCAE v4.0. All-cause mortality was assessed for 1 year from the date of 1st injection.
Nervous system disorders Headache	10.0% 1/10 • Number of events 1 • 10 weeks (from date of 1st injection up to 6 weeks after date of 2nd injection) for adverse events, and 1 year (from date of 1st injection) for all-cause mortality. Adverse events were assessed starting at the date of 1st injection, then at 1 week after 1st injection, 2 weeks after 1st injection, date of 2nd injection (4 weeks after 1st injection), 1 week after 2nd injection, 2 weeks after 2nd injection, 4 weeks after 2nd injection, and 6 weeks after 2nd injection using descriptions and grading scales found in CTCAE v4.0. All-cause mortality was assessed for 1 year from the date of 1st injection.

Additional Information

Shaun Bulsara

Baylor College of Medicine

Phone: 713-798-8014

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place