Trial Outcomes & Findings for TVB-2640 and Trastuzumab With Paclitaxel or Endocrine Therapy for Treatment of HER2 Positive Metastatic Breast Cancer (NCT NCT03179904)

Last Updated: 2026-05-05

Results Overview

Will be defined as the number of patients whose disease meets the Response Evaluation Criteria in Solid Tumors criteria for a partial or complete response on two consecutive evaluations at least 8 weeks apart divided by the total number of patients in that cohort who started protocol treatment.

Recruitment status

ACTIVE_NOT_RECRUITING

Study phase

PHASE2

Target enrollment

17 participants

Primary outcome timeframe

14 months

Results posted on

2026-05-05

Participant Flow

Participant milestones

Participant milestones
Measure	Cohort A (FASN Inhibitor TVB-2640, Paclitaxel, Trastuzumab) Patients receive FASN inhibitor TVB-2640 PO QD on days 1-28, paclitaxel IV over 1-96 hours on days 1, 8, and 15, and trastuzumab IV over 30-90 minutes on days 1, 8, 15, and 22 and optionally every 21 days after 3 cycles and paclitaxel is discontinued. Cycles repeat every 28 days in the absence of disease progression or unexpected toxicity. Patients also undergo ECHO and CT or MRI at screening and on study and undergo collection of blood samples and biopsy on study.	Cohort B (TVB-2640, Trastuzumab, Endocrine Therapy) Patients receive FASN inhibitor TVB-2640 PO QD on days 1-28 and trastuzumab IV over 30-90 minutes on days 1, 8, 15, and 22 and optionally every 21 days after 3 cycles and paclitaxel is discontinued. Patients also continue endocrine therapy of either anastrozole PO QD, exemestane PO QD, fulvestrant IM on days 1 and 14 of cycle 1 and day 1 of subsequent cycles, or letrozole PO QD. Cycles repeat every 28 days in the absence of disease progression or unexpected toxicity. Patients also undergo ECHO and CT or MRI at screening and on study and undergo collection of blood samples and biopsy on study.
Overall Study STARTED	16	1
Overall Study COMPLETED	15	1
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Cohort A (FASN Inhibitor TVB-2640, Paclitaxel, Trastuzumab) Patients receive FASN inhibitor TVB-2640 PO QD on days 1-28, paclitaxel IV over 1-96 hours on days 1, 8, and 15, and trastuzumab IV over 30-90 minutes on days 1, 8, 15, and 22 and optionally every 21 days after 3 cycles and paclitaxel is discontinued. Cycles repeat every 28 days in the absence of disease progression or unexpected toxicity. Patients also undergo ECHO and CT or MRI at screening and on study and undergo collection of blood samples and biopsy on study.	Cohort B (TVB-2640, Trastuzumab, Endocrine Therapy) Patients receive FASN inhibitor TVB-2640 PO QD on days 1-28 and trastuzumab IV over 30-90 minutes on days 1, 8, 15, and 22 and optionally every 21 days after 3 cycles and paclitaxel is discontinued. Patients also continue endocrine therapy of either anastrozole PO QD, exemestane PO QD, fulvestrant IM on days 1 and 14 of cycle 1 and day 1 of subsequent cycles, or letrozole PO QD. Cycles repeat every 28 days in the absence of disease progression or unexpected toxicity. Patients also undergo ECHO and CT or MRI at screening and on study and undergo collection of blood samples and biopsy on study.
Overall Study Progression prior to treatment	1	0

Baseline Characteristics

TVB-2640 and Trastuzumab With Paclitaxel or Endocrine Therapy for Treatment of HER2 Positive Metastatic Breast Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cohort A (FASN Inhibitor TVB-2640, Paclitaxel, Trastuzumab) n=15 Participants Patients receive FASN inhibitor TVB-2640 PO QD on days 1-28, paclitaxel IV over 1-96 hours on days 1, 8, and 15, and trastuzumab IV over 30-90 minutes on days 1, 8, 15, and 22 and optionally every 21 days after 3 cycles and paclitaxel is discontinued. Cycles repeat every 28 days in the absence of disease progression or unexpected toxicity. Patients also undergo ECHO and CT or MRI at screening and on study and undergo collection of blood samples and biopsy on study.	Cohort B (TVB-2640, Trastuzumab, Endocrine Therapy) n=1 Participants Patients receive FASN inhibitor TVB-2640 PO QD on days 1-28 and trastuzumab IV over 30-90 minutes on days 1, 8, 15, and 22 and optionally every 21 days after 3 cycles and paclitaxel is discontinued. Patients also continue endocrine therapy of either anastrozole PO QD, exemestane PO QD, fulvestrant IM on days 1 and 14 of cycle 1 and day 1 of subsequent cycles, or letrozole PO QD. Cycles repeat every 28 days in the absence of disease progression or unexpected toxicity. Patients also undergo ECHO and CT or MRI at screening and on study and undergo collection of blood samples and biopsy on study.	Total n=16 Participants Total of all reporting groups
Age, Continuous	57.3 Years STANDARD_DEVIATION 11.9 • n=54 Participants	41 Years STANDARD_DEVIATION NA • n=60 Participants	56.3 Years STANDARD_DEVIATION 12.1 • n=114 Participants
Sex: Female, Male Female	15 Participants n=54 Participants	1 Participants n=60 Participants	16 Participants n=114 Participants
Sex: Female, Male Male	0 Participants n=54 Participants	0 Participants n=60 Participants	0 Participants n=114 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=54 Participants	0 Participants n=60 Participants	0 Participants n=114 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	15 Participants n=54 Participants	1 Participants n=60 Participants	16 Participants n=114 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=54 Participants	0 Participants n=60 Participants	0 Participants n=114 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=54 Participants	0 Participants n=60 Participants	0 Participants n=114 Participants
Race (NIH/OMB) Asian	2 Participants n=54 Participants	0 Participants n=60 Participants	2 Participants n=114 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=54 Participants	0 Participants n=60 Participants	0 Participants n=114 Participants
Race (NIH/OMB) Black or African American	1 Participants n=54 Participants	0 Participants n=60 Participants	1 Participants n=114 Participants
Race (NIH/OMB) White	12 Participants n=54 Participants	1 Participants n=60 Participants	13 Participants n=114 Participants
Race (NIH/OMB) More than one race	0 Participants n=54 Participants	0 Participants n=60 Participants	0 Participants n=114 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=54 Participants	0 Participants n=60 Participants	0 Participants n=114 Participants

PRIMARY outcome

Timeframe: 14 months

Population: Cohorts were combined to maintain patient privacy and deidentification.

Outcome measures

Outcome measures
Measure	Cohort A n=15 Participants Cohort A patients receive FASN inhibitor TVB-2640 PO QD on days 1-28, paclitaxel IV over 1-96 hours on days 1, 8, and 15, and trastuzumab IV over 30-90 minutes on days 1, 8, 15, and 22 and optionally every 21 days after 3 cycles and paclitaxel is discontinued. Cycles repeat every 28 days in the absence of disease progression or unexpected toxicity. Patients also undergo ECHO and CT or MRI at screening and on study and undergo collection of blood samples and biopsy on study.	Cohort B n=1 Participants Patients receive FASN inhibitor TVB-2640 PO QD on days 1-28 and trastuzumab IV over 30-90 minutes on days 1, 8, 15, and 22 and optionally every 21 days after 3 cycles and paclitaxel is discontinued. Patients also continue endocrine therapy of either anastrozole PO QD, exemestane PO QD, fulvestrant IM on days 1 and 14 of cycle 1 and day 1 of subsequent cycles, or letrozole PO QD. Cycles repeat every 28 days in the absence of disease progression or unexpected toxicity. Patients also undergo ECHO and CT or MRI at screening and on study and undergo collection of blood samples and biopsy on study.
Overall Response Rate	0.333 proportion of patients Interval 0.142 to 0.577	NA proportion of patients Not reported in order to maintain patient privacy.

SECONDARY outcome

Timeframe: 14 months

Will be defined as the time from the first radiologic finding of a partial response or complete response to disease progression among those patients whose disease meets the Response Evaluation Criteria in Solid Tumors criteria for complete response or partial response on 2 consecutive evaluations approximately 8 weeks apart. A point and interval estimate of the response rate as well as the clinical benefit rate will be constructed using the Duffy-Santner approach to take into account the sequential nature of the study design. The distribution of response times and progression-free survival times will be estimated using the Kaplan-Meier approach.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 41 months

Will be defined as the proportion of patients who have completed 6 cycles of treatment without disease progression (that is, their objective disease status is a complete response, partial response, or stable for 6 cycles or more). A point and interval estimate of the response rate as well as the clinical benefit rate will be constructed using the Duffy-Santner approach to take into account the sequential nature of the study design. The distribution of response times and progression-free survival times will be estimated using the Kaplan-Meier approach.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 41 months

Population: Cohorts were combined to maintain patient privacy and deidentification.

Will be defined as time from randomization to the first of these disease events: local/regional or distant breast recurrence, ductal breast carcinoma in situ or invasive breast disease in contralateral breast, non-breast second primary, or death due to any cause. A point and interval estimate of the response rate as well as the clinical benefit rate will be constructed using the Duffy-Santner approach to take into account the sequential nature of the study design. The distribution of response times and progression-free survival times will be estimated using the Kaplan-Meier approach.

Outcome measures

Outcome measures
Measure	Cohort A n=15 Participants Cohort A patients receive FASN inhibitor TVB-2640 PO QD on days 1-28, paclitaxel IV over 1-96 hours on days 1, 8, and 15, and trastuzumab IV over 30-90 minutes on days 1, 8, 15, and 22 and optionally every 21 days after 3 cycles and paclitaxel is discontinued. Cycles repeat every 28 days in the absence of disease progression or unexpected toxicity. Patients also undergo ECHO and CT or MRI at screening and on study and undergo collection of blood samples and biopsy on study.	Cohort B n=1 Participants Patients receive FASN inhibitor TVB-2640 PO QD on days 1-28 and trastuzumab IV over 30-90 minutes on days 1, 8, 15, and 22 and optionally every 21 days after 3 cycles and paclitaxel is discontinued. Patients also continue endocrine therapy of either anastrozole PO QD, exemestane PO QD, fulvestrant IM on days 1 and 14 of cycle 1 and day 1 of subsequent cycles, or letrozole PO QD. Cycles repeat every 28 days in the absence of disease progression or unexpected toxicity. Patients also undergo ECHO and CT or MRI at screening and on study and undergo collection of blood samples and biopsy on study.
Progression Free Survival	7 months Interval 3.7 to 11.3	NA months Not reported in order to maintain patient privacy.

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline up to 28 days

The changes in H score FASN, pAKT, and pS6 expression and levels of cellular apoptosis in tumor tissue will be examined graphically by plotting the difference in pre and post levels against pre-levels of the biomarker, with patients who derived clinical benefit represented by dashed line and those who did not by solid line. For each patient cohort, Wilcoxon signed rank tests will be used to assess the changes in serum FASN.

Outcome measures

Outcome data not reported

Adverse Events

Cohort A

Serious events: 7 serious events

Other events: 15 other events

Deaths: 0 deaths

Cohort B

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Cohort A n=15 participants at risk Cohort A patients receive FASN inhibitor TVB-2640 PO QD on days 1-28, paclitaxel IV over 1-96 hours on days 1, 8, and 15, and trastuzumab IV over 30-90 minutes on days 1, 8, 15, and 22 and optionally every 21 days after 3 cycles and paclitaxel is discontinued. Cycles repeat every 28 days in the absence of disease progression or unexpected toxicity. Patients also undergo ECHO and CT or MRI at screening and on study and undergo collection of blood samples and biopsy on study.	Cohort B Cohort B patients receive FASN inhibitor TVB-2640 PO QD on days 1-28 and trastuzumab IV over 30-90 minutes on days 1, 8, 15, and 22 and optionally every 21 days after 3 cycles and paclitaxel is discontinued. Patients also continue endocrine therapy of either anastrozole PO QD, exemestane PO QD, fulvestrant IM on days 1 and 14 of cycle 1 and day 1 of subsequent cycles, or letrozole PO QD. Cycles repeat every 28 days in the absence of disease progression or unexpected toxicity. Patients also undergo ECHO and CT or MRI at screening and on study and undergo collection of blood samples and biopsy on study.
Gastrointestinal disorders Abdominal pain	0.00% 0/15 • Adverse events were followed for 15 months and mortality was followed for 41 months The Cohort B patient is not reported in order to maintain patient privacy.	— 0/0 • Adverse events were followed for 15 months and mortality was followed for 41 months The Cohort B patient is not reported in order to maintain patient privacy.
Infections and infestations Skin infection	6.7% 1/15 • Number of events 1 • Adverse events were followed for 15 months and mortality was followed for 41 months The Cohort B patient is not reported in order to maintain patient privacy.	— 0/0 • Adverse events were followed for 15 months and mortality was followed for 41 months The Cohort B patient is not reported in order to maintain patient privacy.
Investigations Blood bilirubin increased	0.00% 0/15 • Adverse events were followed for 15 months and mortality was followed for 41 months The Cohort B patient is not reported in order to maintain patient privacy.	— 0/0 • Adverse events were followed for 15 months and mortality was followed for 41 months The Cohort B patient is not reported in order to maintain patient privacy.
Respiratory, thoracic and mediastinal disorders Dyspnea	6.7% 1/15 • Number of events 1 • Adverse events were followed for 15 months and mortality was followed for 41 months The Cohort B patient is not reported in order to maintain patient privacy.	— 0/0 • Adverse events were followed for 15 months and mortality was followed for 41 months The Cohort B patient is not reported in order to maintain patient privacy.
Respiratory, thoracic and mediastinal disorders Pleural effusion	13.3% 2/15 • Number of events 2 • Adverse events were followed for 15 months and mortality was followed for 41 months The Cohort B patient is not reported in order to maintain patient privacy.	— 0/0 • Adverse events were followed for 15 months and mortality was followed for 41 months The Cohort B patient is not reported in order to maintain patient privacy.
Respiratory, thoracic and mediastinal disorders Pneumonitis	20.0% 3/15 • Number of events 4 • Adverse events were followed for 15 months and mortality was followed for 41 months The Cohort B patient is not reported in order to maintain patient privacy.	— 0/0 • Adverse events were followed for 15 months and mortality was followed for 41 months The Cohort B patient is not reported in order to maintain patient privacy.
Respiratory, thoracic and mediastinal disorders Resp, thoracic, mediastinal - Oth spec	6.7% 1/15 • Number of events 1 • Adverse events were followed for 15 months and mortality was followed for 41 months The Cohort B patient is not reported in order to maintain patient privacy.	— 0/0 • Adverse events were followed for 15 months and mortality was followed for 41 months The Cohort B patient is not reported in order to maintain patient privacy.

Other adverse events

Additional Information

Tufia Haddad

Mayo Clinic

Phone: 507-293-0526

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place