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Anti-metabolites

Oncolytic Virus + Chemotherapy for Breast Cancer

Phase 1 & 2

Waitlist Available

Led By Hatem Soliman, M.D.

Research Sponsored by H. Lee Moffitt Cancer Center and Research Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Must have normal organ and marrow function as outlined in protocol

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 not have

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

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years follow-up

Awards & highlights

No Placebo-Only Group

Summary

This trial will test whether an oncolytic virus can help destroy triple negative breast cancer tumors when used in combination with chemotherapy.

Who is the study for?

This trial is for adults aged 18-70 with a specific breast cancer type (triple negative, stages T2-3 N0-2). Participants must have no prior invasive breast cancer history, normal organ/marrow function, and measurable disease. They should not be pregnant/nursing or have certain other cancers, uncontrolled illnesses, known active hepatitis B/C infection, or a history of severe herpes simplex virus complications.

What is being tested?

The study tests Talimogene Laherparepvec (a modified herpes virus targeting cancer cells) combined with chemotherapy before surgery in triple negative breast cancer patients. The goal is to see if this oncolytic virus can boost the immune system's response to destroy tumor tissue more effectively than chemotherapy alone.

What are the potential side effects?

Potential side effects may include reactions similar to herpes infections since the treatment uses a modified herpes virus but designed not to harm normal tissue. Chemotherapy side effects typically include fatigue, nausea, hair loss, increased risk of infection and blood disorders.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My organs and bone marrow are functioning normally.

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My breast cancer is triple negative and not spread beyond nearby lymph nodes.

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I have a tumor that can be seen and measured on scans, and it can be reached for direct injection.

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I have never had invasive breast cancer before.

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I am between 18 and 70 years old.

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I am fully active or can carry out light work.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My breast cancer is advanced, has spread, or I have cancer in both breasts.

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I am not on experimental drugs and can be treated with doxorubicin, cyclophosphamide, and paclitaxel.

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I have had herpes infections or complications like encephalitis, or need antiviral drugs now.

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I do not have any serious illnesses that could interfere with the study.

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I am not pregnant or nursing.

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I do not have HIV, an autoimmune disease, or take high doses of immunosuppressants.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years follow-up

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years follow-up

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years follow-up for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Phase II: Percentage of Participants With Pathologic Complete Response Rate (pCR)

Other study objectives

Overall Survival (OS) Rate

Recurrence Free Survival Rate

Side effects data

From 2014 Phase 3 trial • 437 Patients • NCT00769704

50%

Fatigue

48%

Chills

41%

Pyrexia

36%

Nausea

30%

Influenza like illness

28%

Injection site pain

21%

Vomiting

19%

Diarrhoea

19%

Headache

17%

Arthralgia

17%

Myalgia

16%

Pain

16%

Pain in extremity

12%

Constipation

12%

Oedema peripheral

11%

Cough

10%

Upper respiratory tract infection

10%

Decreased appetite

10%

Dizziness

10%

Pruritus

Abdominal pain

Back pain

Rash

Hyperhidrosis

Erythema

Tumour pain

Anxiety

Insomnia

Oropharyngeal pain

Weight decreased

Dyspepsia

Injection site erythema

Musculoskeletal pain

Neck pain

Depression

Anaemia

Vitiligo

Muscle spasms

Dyspnoea

Injection site reaction

Injection site swelling

Disease progression

Injection site pruritus

Cellulitis

Deep vein thrombosis

Rib fracture

Metastases to central nervous system

Intestinal obstruction

Gastrointestinal haemorrhage

Pleural effusion

Dehydration

Infected neoplasm

Metastatic malignant melanoma

Cerebral haemorrhage

Convulsion

Mental status changes

Pulmonary embolism

Atrial fibrillation

100%

80%

60%

40%

20%

Study treatment Arm

Talimogene Laherparepvec

GM-CSF

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Talimogene laherparepvec + ChemotherapyExperimental Treatment2 Interventions

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Talimogene laherparepvec

2014

Completed Phase 3

~810

Paclitaxel

2011

Completed Phase 4

~5370