Clinical Trials /

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

NCT02779855

Description:

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.

Related Conditions:
  • Breast Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 1/Phase 2

Trial Eligibility

Document

<span class="go-doc-concept go-doc-intervention">Talimogene Laherparepvec</span> in Combination With <span class="go-doc-concept go-doc-intervention">Neoadjuvant Chemotherapy</span> in <span class="go-doc-concept go-doc-alteration">Triple Negative Breast Cancer</span>

Title

  • Brief Title: Talimogene Laherparepvec in Combination With Neoadjuvant Chemotherapy in Triple Negative Breast Cancer
  • Official Title: A Phase 1/2 Study of Talimogene Laherparepvec in Combination With Neoadjuvant Chemotherapy in Triple Negative Breast Cancer
  • Clinical Trial IDs

    NCT ID: NCT02779855

    ORG ID: MCC-18621

    Trial Conditions

    Breast Cancer

    Ductal Carcinoma

    Invasive Breast Carcinoma

    Invasive Ductal Breast Carcinoma

    Trial Interventions

    Drug Synonyms Arms
    Paclitaxel Taxol Talimogene laherparepvec + Chemotherapy

    Trial Purpose

    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.

    Detailed Description

    Trial Arms

    Name Type Description Interventions
    Talimogene laherparepvec + Chemotherapy Experimental 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. Paclitaxel

    Eligibility Criteria

    Inclusion Criteria:

    - Must have histologically or cytologically confirmed clinical stage T2-3 N0-2 triple
    negative (estrogen receptor/progesterone receptor <1% human epidermal growth factor
    receptor 2 (HER2) 0-1 by ImmunoHistoChemistry (IHC) or unamplified by fluorescence in
    situ hybridization (FISH)) invasive ductal carcinoma.

    - Must have measurable disease, defined as at least one lesion that can be accurately
    measured in at least one dimension (longest diameter to be recorded) as >20 mm with
    conventional techniques or as >10 mm with spiral CT scan. As well, participants must
    have primary tumor able to be visualized on ultrasound and amenable to direct
    injection.

    - No prior history of an invasive breast cancer

    - Adults ages 18-70

    - Eastern Cooperative Oncology Group (ECOG) performance status 0-1

    - Must have normal organ and marrow function as outlined in protocol

    - Sexually active women of child-bearing potential and men must agree to use adequate
    contraception prior to study entry and for the duration of study participation.

    - Ability to understand and the willingness to sign a written informed consent document

    Exclusion Criteria:

    - T4 tumors, known metastatic disease, recurrent disease, inflammatory breast cancer,
    multicentric disease, and/or synchronous bilateral breast cancer

    - A second active malignancy, exceptions are localized non-melanoma skin cancers or
    prior in situ carcinoma

    - Receiving any other investigational agents or are unable to be treated with
    doxorubicin, cyclophosphamide, and paclitaxel.

    - History of allergic reactions attributed to compounds of similar chemical or biologic
    composition to talimogene laherparepvec or other agents used in the study

    - Known active or prior herpes simplex virus infections (HSV), prior complications from
    HSV infections such as encephalitis, or require systemic antiviral therapy at the
    time of study enrollment

    - Uncontrolled intercurrent illness including, but not limited to, ongoing or active
    infection, known active hepatitis B/C infection, symptomatic congestive heart
    failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social
    situations that would limit compliance with study requirements.

    - Women who are pregnant or nursing

    - Immunocompromised patients may be at increased risk of herpetic infections when
    treated with talimogene laherparepvec. Therefore, HIV-positive patients, patients
    with acquired or congenital immunodeficiency conditions, those on chronic systemic
    immunosuppressants (requiring > 10 mg of prednisone or equivalent/day), Those with
    active autoimmune disease are excluded from the study.

    Minimum Eligible Age: 18 Years

    Maximum Eligible Age: 70 Years

    Eligible Gender: Both

    Primary Outcome Measures

    Phase I: Maximum Tolerated Dose (MTD) / Recommended Phase II Dose (RP2D)

    Phase II: Pathologic Complete Response Rate (pCR)

    Secondary Outcome Measures

    Trial Keywords

    triple negative breast cancer (TNBC)

    estrogen receptor

    progesterone receptor

    invasive ductal carcinoma

    breast cancer tumors