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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.
Adequate organ function:
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2.5 years
Awards & highlights

Study 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.Check my eligibility
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.See study design
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 organs are working well.
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I am 18 or older with HER2-negative breast cancer that has spread or come back.
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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 am a woman who can have children, have a recent negative pregnancy test, and will use birth control during and after the study.
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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.
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I am using medications like bisphosphonates or RANKL antibodies, or undergoing ovarian suppression.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Maximum tolerated volume
Number of patients with treatment-related toxicities by maximum observed grade
Secondary outcome measures
Overall response rate (ORR)
Response duration

Side effects data

From 2014 Phase 3 trial • 31 Patients • NCT01368276
67%
Cough
67%
Fatigue
33%
Influenza like illness
33%
Dyspnoea
33%
Injection site mass
33%
Flushing
33%
Chills
33%
Ecchymosis
33%
Urticaria
33%
Diarrhoea
33%
Nausea
33%
Vomiting
33%
Oedema peripheral
33%
Pyrexia
33%
Folliculitis
33%
Oral herpes
33%
Pneumonia
33%
Upper respiratory tract infection
33%
Lipoma
33%
Haemoptysis
33%
Hypopnoea
33%
Oropharyngeal pain
33%
Blood blister
33%
Hyperhidrosis
33%
Night sweats
33%
Pruritus
100%
80%
60%
40%
20%
0%
Study treatment Arm
GM-CSF
Talimogene Laherparepvec

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
~2070
Nab paclitaxel
2014
Completed Phase 2
~70
Carboplatin
2014
Completed Phase 3
~6670
Anastrozole
2019
Completed Phase 4
~10090
Exemestane
2003
Completed Phase 4
~7880
Fulvestrant
2011
Completed Phase 3
~3700
Letrozole
2002
Completed Phase 4
~3240
Paclitaxel
2011
Completed Phase 4
~5380
Talimogene Laherparepvec
2008
Completed Phase 3
~640
Tamoxifen
2005
Completed Phase 4
~29860

Find a Location

Who is running the clinical trial?

University of California, San FranciscoLead Sponsor
2,493 Previous Clinical Trials
11,931,778 Total Patients Enrolled
46 Trials studying Breast Cancer
3,828,435 Patients Enrolled for Breast Cancer
AmgenIndustry Sponsor
1,355 Previous Clinical Trials
1,384,051 Total Patients Enrolled
45 Trials studying Breast Cancer
79,146 Patients Enrolled for Breast Cancer
Amy J Chien, MDPrincipal InvestigatorUniversity of California, San Francisco

Media Library

Anastrozole (Anti-estrogen) Clinical Trial Eligibility Overview. Trial Name: NCT03554044 — Phase 1
Breast Cancer Research Study Groups: Cohort II (talimogene laherparepvec, endocrine therapy), Cohort I (talimogene laherparepvec, chemotherapy)
Breast Cancer Clinical Trial 2023: Anastrozole Highlights & Side Effects. Trial Name: NCT03554044 — Phase 1
Anastrozole (Anti-estrogen) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03554044 — Phase 1

Frequently Asked Questions

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

For what illnesses is Talimogene Laherparepvec commonly prescribed?

"Talimogene Laherparepvec is regularly employed for treating non-Hodgkin's lymphoma. It can also be efficacious in the management of other diseases like advanced stage non-small cell lung cancer, bladder cancer metastasis, and early treatment of malignancies."

Answered by AI

To what extent may patients be imperiled by Talimogene Laherparepvec?

"Because of the limited evidence to support Talimogene Laherparepvec's safety and efficacy, our team at Power assessed its risk as a 1 on their scale."

Answered by AI

How many participants comprise this clinical trial?

"Correct. According to the information listed on clinicaltrials.gov, this experiment is currently recruiting participants with an initial listing date of February 5th 2020 and a most recent update of December 22nd 2021. The research team are looking for 25 volunteers from one location."

Answered by AI

Are participants currently being accepted for this clinical research?

"Affirmative. Clinicaltrials.gov verifies that this medical trial, posted on February 5th 2020, is actively recruiting patients. The study requires 25 subjects from a single site to complete the trial."

Answered by AI
~4 spots leftby Apr 2025