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Anti-metabolites

Oncolytic Virus + Chemotherapy for Breast Cancer

Q: What is the sample size of this research endeavor?

This trial is presently not enrolling any participants, as the last update to its information was on November 10th 2022. It was initially posted 5 months prior in May 2nd 2017. Nonetheless, there are 4912 clinical studies actively seeking patients with <a href="https://www.withpower.com/clinical-trials/breast-cancer">breast cancer</a> and 852 independent trials for Talimogene laherparepvec recruiting now.

Q: Is enrollment available for this experiment currently?

According to clinicaltrials.gov, this trial does not presently have any open recruitment slots; its first posting was on May 2nd 2017 and the last modification was made November 10th 2022. However, 5764 other medical tests are seeking participants as of now.

Q: Is the age range for this experimentation limited to those aged 70 or below?

To meet the criteria for this medical experiment, applicants must be between 18 and 70 years old. Additionally, there are 166 clinical trials specifically targeting minors while 5633 studies focus on geriatric patients.

Q: What is the eligibility criteria for participating in this study?

A sample size of 50 individuals between the ages 18 to 70 who have recently been diagnosed with <a href="https://www.withpower.com/clinical-trials/breast-cancer">breast cancer</a> are required for this medical trial. Candidates also must not possess a history of invasive breast cancers, need to demonstrate an Eastern Cooperative <a href="https://www.withpower.com/clinical-trials/oncology">Oncology</a> Group (ECOG) performance status 0-1 and meet certain normal organ/marrow function criteria as described in the protocol.

Q: In what medical conditions has Talimogene laherparepvec been found to be effective?

Talimogene laherparepvec is used to reduct the symptoms of non-small cell lung carcinoma (<a href="https://www.withpower.com/clinical-trials/nsclc">nsclc</a>), recurrent <a href="https://www.withpower.com/clinical-trials/melanoma">melanoma</a>, and neoplasm metastasis.

Q: What kind of research has been conducted regarding Talimogene laherparepvec's efficacy?

Currently, there are 852 clinical trials that focus on Talimogene laherparepvec with a majority of them in Phase 3. In Woolloongabba, Queensland alone, 227 studies have been launched; across the globe 45921 centres are conducting research for this drug.

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.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years follow-up

Awards & highlights

Study 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.Check my eligibility

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.See study design

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

Select...

My organs and bone marrow are functioning normally.

Select...

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

Select...

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

Select...

I have never had invasive breast cancer before.

Select...

I am between 18 and 70 years old.

Select...

I am fully active or can carry out light work.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

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

Other outcome measures

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

Back pain

Abdominal 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

Gastrointestinal haemorrhage

Intestinal obstruction

Rib fracture

Metastases to central nervous system

Deep vein thrombosis

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

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

~5380

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

H. Lee Moffitt Cancer Center and Research InstituteLead Sponsor

542 Previous Clinical Trials

135,442 Total Patients Enrolled

40 Trials studying Breast Cancer

5,730 Patients Enrolled for Breast Cancer

AmgenIndustry Sponsor

1,370 Previous Clinical Trials

1,377,638 Total Patients Enrolled

44 Trials studying Breast Cancer

79,096 Patients Enrolled for Breast Cancer

Hatem Soliman, M.D.Principal InvestigatorH. Lee Moffitt Cancer Center and Research Institute

2 Previous Clinical Trials

15 Total Patients Enrolled

2 Trials studying Breast Cancer

15 Patients Enrolled for Breast Cancer

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the sample size of this research endeavor?

"This trial is presently not enrolling any participants, as the last update to its information was on November 10th 2022. It was initially posted 5 months prior in May 2nd 2017. Nonetheless, there are 4912 clinical studies actively seeking patients with breast cancer and 852 independent trials for Talimogene laherparepvec recruiting now."

Answered by AI

Is enrollment available for this experiment currently?

"According to clinicaltrials.gov, this trial does not presently have any open recruitment slots; its first posting was on May 2nd 2017 and the last modification was made November 10th 2022. However, 5764 other medical tests are seeking participants as of now."

Answered by AI

Is the age range for this experimentation limited to those aged 70 or below?

"To meet the criteria for this medical experiment, applicants must be between 18 and 70 years old. Additionally, there are 166 clinical trials specifically targeting minors while 5633 studies focus on geriatric patients."

Answered by AI

What is the eligibility criteria for participating in this study?

"A sample size of 50 individuals between the ages 18 to 70 who have recently been diagnosed with breast cancer are required for this medical trial. Candidates also must not possess a history of invasive breast cancers, need to demonstrate an Eastern Cooperative Oncology Group (ECOG) performance status 0-1 and meet certain normal organ/marrow function criteria as described in the protocol."

Answered by AI

In what medical conditions has Talimogene laherparepvec been found to be effective?

"Talimogene laherparepvec is used to reduct the symptoms of non-small cell lung carcinoma (nsclc), recurrent melanoma, and neoplasm metastasis."

Answered by AI

What kind of research has been conducted regarding Talimogene laherparepvec's efficacy?

"Currently, there are 852 clinical trials that focus on Talimogene laherparepvec with a majority of them in Phase 3. In Woolloongabba, Queensland alone, 227 studies have been launched; across the globe 45921 centres are conducting research for this drug."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2017. "Talimogene Laherparepvec in Combination With Neoadjuvant Chemotherapy in Triple Negative Breast Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02779855.

All > Metastatic Triple Negative Breast Cancer > Triple Negative Breast Cancer