Talimogene Laherparepvec in Combination With Neoadjuvant Chemotherapy in Triple Negative Breast Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02779855|
Recruitment Status : Recruiting
First Posted : May 20, 2016
Last Update Posted : September 9, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer Ductal Carcinoma Invasive Breast Carcinoma Invasive Ductal Breast Carcinoma||Biological: Talimogene laherparepvec Drug: Paclitaxel||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||46 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 1/2 Study of Talimogene Laherparepvec in Combination With Neoadjuvant Chemotherapy in Triple Negative Breast Cancer|
|Actual Study Start Date :||March 22, 2017|
|Estimated Primary Completion Date :||August 31, 2021|
|Estimated Study Completion Date :||August 31, 2022|
Experimental: Talimogene laherparepvec + Chemotherapy
Talimogene laherparepvec with Neoadjuvant Paclitaxel Chemotherapy treatment administration on an outpatient basis. Phase I: Dose Escalation to Determine Maximum Tolerated Dose (MTD). Phase II: Treatment at MTD.
Biological: Talimogene laherparepvec
Talimogene laherparepvec injection. Phase I: Dose escalation. Phase II: Treatment at Maximum Tolerated Dose (MTD) from Phase I. The MTD dose level is defined as the highest dose level with ≤1 out of 6 patients experiencing a dose limiting toxicity (DLT).
Paclitaxel chemotherapy infusion. The paclitaxel weekly dose is fixed at 80 mg/m^2.
Other Name: Taxol®
- Phase I: Maximum Tolerated Dose (MTD) / Recommended Phase II Dose (RP2D) [ Time Frame: Up to 6 months ]MTD/RP2D of talimogene laherparepvec administered with neoadjuvant paclitaxel- doxorubicin/cyclophosphamide chemotherapy.
- Phase II: Pathologic Complete Response Rate (pCR) [ Time Frame: Up to 36 months ]pCR following study treatment, defined as: Disappearance of histopathologic evidence of malignant cells in breast and axillary lymph nodes.
- Recurrence Free Survival Rate [ Time Frame: Up to 5 years follow-up ]Percentage of participants who are disease recurrence free at 5 year follow-up.
- Overall Survival (OS) Rate [ Time Frame: Up to 5 years follow-up ]Percentage of participants who are alive at 5 year follow-up.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02779855
|United States, Florida|
|H. Lee Moffitt Cancer Center and Research Institute||Recruiting|
|Tampa, Florida, United States, 33612|
|Contact: Deanna Hogue 813-745-8304 firstname.lastname@example.org|
|Contact: Hatem Soliman, M.D. 813-745-4933 email@example.com|
|Principal Investigator: Hatem Soliman, M.D.|
|Principal Investigator:||Hatem Soliman, M.D.||H. Lee Moffitt Cancer Center and Research Institute|