FASN Inhibitor TVB-2640 for Breast Cancer

Mayo Clinic in Rochester, Rochester, MN
Breast Cancer+7 More ConditionsFASN Inhibitor TVB-2640 - Drug
All Sexes
What conditions do you have?

Study Summary

This trial is studying how well FASN inhibitor TVB-2640, paclitaxel, and trastuzumab work in treating patients with HER2 positive breast cancer that has spread to other places in the body (metastatic).

Eligible Conditions
  • HER2-positive Breast Cancer
  • Stage III Breast Cancer
  • Stage IIIB Breast Cancer
  • Stage IIIA Breast Cancer
  • Breast Cancer
  • Stage IV Breast Cancer

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3
Phase 2

Study Objectives

1 Primary · 3 Secondary · Reporting Duration: Up to 3 years

Day 28
Changes in biomarker expression
Up to 3 years
Clinical benefit rate
Duration of response
Overall response rate
Progression free survival

Trial Safety

Phase-Based Safety

2 of 3
This is further along than 68% of similar trials

Awards & Highlights

No Placebo Group
All patients enrolled in this trial will receive the new treatment.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 10 Other Conditions
This treatment demonstrated efficacy for 10 other conditions.

Trial Design

2 Treatment Groups

Cohort A (FASN inhibitor TVB-2640, paclitaxel, trastuzumab)
1 of 2
Cohort B (TVB-2640, trastuzumab, endocrine therapy)
1 of 2

Experimental Treatment

80 Total Participants · 2 Treatment Groups

Primary Treatment: FASN Inhibitor TVB-2640 · No Placebo Group · Phase 2

Cohort A (FASN inhibitor TVB-2640, paclitaxel, trastuzumab)Experimental Group · 5 Interventions: Denifanstat, Laboratory Biomarker Analysis, FASN Inhibitor TVB-2640, Paclitaxel, Trastuzumab · Intervention Types: Drug, Other, Drug, Drug, Biological
Cohort B (TVB-2640, trastuzumab, endocrine therapy)Experimental Group · 8 Interventions: Denifanstat, Laboratory Biomarker Analysis, Fulvestrant, Anastrozole, Letrozole, FASN Inhibitor TVB-2640, Exemestane, Trastuzumab · Intervention Types: Drug, Other, Drug, Drug, Drug, Drug, Drug, Biological
First Studied
Drug Approval Stage
How many patients have taken this drug
FDA approved
FDA approved
FDA approved
FDA approved
FDA approved
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 3 years

Who is running the clinical trial?

Mayo ClinicLead Sponsor
3,007 Previous Clinical Trials
3,512,800 Total Patients Enrolled
85 Trials studying Breast Cancer
17,187 Patients Enrolled for Breast Cancer
National Cancer Institute (NCI)NIH
13,275 Previous Clinical Trials
41,234,732 Total Patients Enrolled
932 Trials studying Breast Cancer
1,541,946 Patients Enrolled for Breast Cancer
Tufia C HaddadPrincipal InvestigatorMayo Clinic in Rochester
2 Previous Clinical Trials
93 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 0 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:

Frequently Asked Questions

Are there any precedent studies regarding the effectiveness of FASN Inhibitor TVB-2640?

"Currently, there are 1219 clinical trials actively researching FASN Inhibitor TVB-2640. Of these live studies, 322 have reached Phase 3. Primarily based in Seattle, Washington, the expansive research on this inhibitor is being conducted across a staggering 69515 sites around the world." - Anonymous Online Contributor

Unverified Answer

Is recruitment for this investigation still open to participants?

"Affirmative. Clinicaltrials.gov attests to this medical research's current recruitment status, which began on September 25th 2017 and was recently updated on May 31st 2022. The investigation requires 80 participants across 3 sites of study." - Anonymous Online Contributor

Unverified Answer

To what extent has enrollment in this experiment grown?

"Affirmative. The information available on clinicaltrials.gov demonstrates that the study, which was initially advertised on September 25th 2017 is actively recruiting patients. A total of 80 participants are required to be recruited from 3 separate medical facilities." - Anonymous Online Contributor

Unverified Answer

In what circumstances is TVB-2640, a FASN inhibitor, usually administered?

"FASN Inhibitor TVB-2640 is an effective treatment option for those with metastatic bladder cancer, inflammatory breast cancer (ibc), or acquired immunodeficiency syndrome." - Anonymous Online Contributor

Unverified Answer

What potential risks are associated with FASN Inhibitor TVB-2640?

"Due to the lack of efficacy-confirming data, FASN Inhibitor TVB-2640 was given a safety rating of 2 on our team's scale. This is because it has only been tested in Phase 2 trials thus far." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.