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Anti-estrogen

T-VEC + Chemotherapy/Endocrine Therapy for Breast Cancer

Phase 1

Waitlist Available

Led By Amy J Chien, MD

Research Sponsored by University of California, San Francisco

Eligibility Criteria Checklist

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

Must have

Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1.

Histologic or cytologic confirmation of invasive breast cancer that is HER2-negative by standard clinical criteria.

Must not have

Patients on therapeutic anticoagulation that cannot be held around injections.

History of symptomatic autoimmune disease or active autoimmune disease that has required systemic treatment in the 2 weeks prior to enrollment. Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2.5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing the combination of talimogene laherparepvec, a biological therapy, with chemotherapy or endocrine therapy in treating patients with HER2-negative breast cancer.

Who is the study for?

Adults with HER2-negative breast cancer that's spread, can't be surgically removed, or has returned. Participants must not be naturally postmenopausal for at least a year, have no severe immune conditions or recent major treatments, and agree to use effective birth control. Suitable candidates have at least one tumor that can be injected and are in good health as per ECOG standards.

What is being tested?

The trial is testing the effectiveness of talimogene laherparepvec (a biological therapy) combined with either chemotherapy drugs like nab-paclitaxel, gemcitabine, carboplatin or endocrine therapies such as letrozole and tamoxifen in treating advanced HER2-negative breast cancer.

What are the potential side effects?

Potential side effects include reactions at the injection site, flu-like symptoms from talimogene laherparepvec; nausea, hair loss from chemotherapy; and hot flashes or joint pain from endocrine therapy. The severity of side effects varies among individuals.

Eligibility Criteria

Inclusion Criteria

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

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I am fully active or can carry out light work.

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My breast cancer is confirmed and does not have the HER2 protein.

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My breast cancer is ER+ with at least 1% of cells showing ER presence.

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I have a tumor or lymph node that is at least 1cm big and can be injected with medicine.

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I have not had my uterus or both ovaries removed.

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I have had a menstrual period in the last 12 months.

Exclusion Criteria

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

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I am on blood thinners that cannot be stopped for injections.

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I have an autoimmune disease but haven't needed strong medication for it in the last 2 weeks.

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I have severe nerve pain or tingling.

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My cancer has spread to the lining of my brain and spinal cord.

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My lesions are not infected or causing significant bleeding.

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I have been treated with a cancer-killing virus before.

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I am not pregnant or breast-feeding.

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I have previously received a cancer vaccine.

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I have a history of heart disease, heart failure, or irregular heartbeats.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2.5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2.5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2.5 years for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Maximum tolerated volume

Number of patients with treatment-related toxicities by maximum observed grade

Secondary study objectives

Overall response rate (ORR)

Response duration

Side effects data

From 2014 Phase 3 trial • 31 Patients • NCT01368276

18%

Pyrexia

18%

Chills

14%

Diarrhoea

14%

Back pain

11%

Dizziness

11%

Vomiting

11%

Oedema peripheral

11%

Vitiligo

11%

Upper respiratory tract infection

11%

Abdominal pain

11%

Fatigue

11%

Skin irritation

Myalgia

Headache

Injection site pain

Oropharyngeal pain

Tumour pain

Nausea

Ear pain

Abdominal discomfort

Pruritus

Cough

Lipoma

Disease progression

Vasculitis

Pneumonia

Hypovolaemic shock

Clavicle fracture

Influenza like illness

Lung neoplasm malignant

Cardiac arrest

Dyspnoea

Renal failure

Haemangioma of liver

Respiratory failure

Restrictive cardiomyopathy

Metastatic malignant melanoma

Pleural effusion

Ecchymosis

Hyperhidrosis

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

2Treatment groups

Experimental Treatment

Group I: Cohort II (talimogene laherparepvec, endocrine therapy)Experimental Treatment6 Interventions

Patients receive talimogene laherparepvec intra-tumorally (IT) every 2 weeks for the first 10 weeks and every 3 weeks thereafter along with letrozole PO, anastrazole PO, exemestane PO, tamoxifen PO on days 1-21 or fulvestrant IM every 2 weeks for 3 doses then every 4 weeks for the subsequent courses. Cycles repeat every 28 days until disease progression or unacceptable toxicity

Group II: Cohort I (talimogene laherparepvec, chemotherapy)Experimental Treatment5 Interventions

Patients receive talimogene laherparepvec intra-tumorally (IT) every 2 weeks for the first 10 weeks and every 3 weeks thereafter along with one of the following chemotherapies: paclitaxel (IV), nab-paclitaxel IV, or gemcitabine / carboplatin IV. Cycles repeat every 21 days until disease progression or unacceptable toxicity

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Gemcitabine

2017

Completed Phase 3

~1920

Carboplatin

2014

Completed Phase 3

~6120