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NCT02779855 · ClinicalTrials.gov registry record · Phase 1

Talimogene Laherparepvec in Combination With Neoadjuvant Chemotherapy in Triple Negative Breast Cancer

A Phase 1 study, sponsored by H. Lee Moffitt Cancer Center and Research Institute.

Completed
Registry status
Phase 1
Development phase
50
Enrollment target

NCT02779855: Completed Phase 1 study, sponsored by H. Lee Moffitt Cancer Center and Research Institute.

NCT02779855 is a Phase 1 study that has completed, run by H. Lee Moffitt Cancer Center and Research Institute. The registered enrollment target is 50 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (17% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02779855, a Phase 1 study, has completed, sponsored by H. Lee Moffitt Cancer Center and Research Institute.

COMPLETED
Registry status
Phase 1
Development phase
50 participants
Enrollment target

Study Summary

The purpose of this study is to determine if an oncolytic virus called Talimogene laherparepvec (a modified herpes simplex 1 virus that can specifically destroy cancer cells while leaving normal cells alone) injected directly into the tumor during chemotherapy prior to surgery can enhance the elimination of triple negative breast cancer tumors. The natural herpes simplex 1 virus typically causes cold sores around the mouth, but the talimogene laherparepvec version of the herpes virus has been changed to prevent it from reproducing in normal tissue. However, it can still attack and break open cancer tissue which is why it is used as a treatment for cancer. It is thought that this virus can also help recruit the participant's immune system to attack the cancer cells during their treatment and possibly destroy the tumor tissue more effectively than chemotherapy alone. This virus is already FDA approved to treat melanoma skin tumors, so investigators want to determine if this virus can achieve a similar benefit in women with triple negative breast tumors.

Primary Outcome

MTD/RP2D of talimogene laherparepvec administered with neoadjuvant paclitaxel- doxorubicin/cyclophosphamide chemotherapy.

Interventions

  • DRUG Paclitaxel
  • BIOLOGICAL Talimogene laherparepvec

Trial Details

FieldValue
Enrollment Target 50 participants
Start Date 2017-05-02
Est. Completion 2025-08-26
Phase Phase 1

What the finished NCT02779855 record still lists

NCT02779855 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (17% lower).

The record links to 0 conditions, and to 2 interventions - of which Paclitaxel is the first listed.

NCT02779855 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02779855 about?

NCT02779855 is a clinical study titled "Talimogene Laherparepvec in Combination With Neoadjuvant Chemotherapy in Triple Negative Breast Cancer". The purpose of this study is to determine if an oncolytic virus called Talimogene laherparepvec (a modified herpes simplex 1 virus that can specifically destroy cancer cells while leaving normal cells alone) injected directly into the tumor during chemotherapy prior to surgery can enhance the elimin...

What is the current status of trial NCT02779855?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 50 participants. The study started on 2017-05-02. Estimated completion is 2025-08-26.

What interventions are being tested in trial NCT02779855?

The interventions under investigation include: Paclitaxel (DRUG), Talimogene laherparepvec (BIOLOGICAL).

Who is sponsoring clinical trial NCT02779855?

This trial is sponsored by H. Lee Moffitt Cancer Center and Research Institute, which has 502 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT02779855's enrollment target sits among peer trials

50 973rd of 2000 higher than 984 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT02779855, the US trial registry maintained by the National Library of Medicine. NCT02779855 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.