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Immunotherapy + Radiation for Hormone-Sensitive Breast Cancer (CBCV Trial)

Phase 2

Recruiting

Led By Silvia Formenti, M.D.

Research Sponsored by Weill Medical College of Cornell University

Eligibility Criteria Checklist

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

Must have

Biopsy proven diagnosis of ER+ PR+ or PR- HER2- breast cancer

Clinical stage I(>1.5cm, if N0) - III breast cancer, as per AJCC staging 8th edition

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 4 years

Awards & highlights

CBCV Trial Summary

This trial is for post-menopausal women who have been newly diagnosed with stage II-III breast cancer that is HR+ and HER2-. Patients will receive 4 months of standard neoadjuvant hormonal therapy with letrozole and will be randomly assigned to one of four arms of the trial. Two of the arms will be testing focal hypo-fractionated RT alone, and the other two arms will be testing immunotherapy combinations.

Who is the study for?

Post-menopausal women over 18 with stage I-III HR+HER2- breast cancer, who can sign consent and have good performance status (ECOG 0-1). They must have adequate organ function and no prior treatments with certain immune drugs, severe allergies to pembrolizumab, or immunosuppressive therapies. Excluded are those with active infections, certain viral diseases like HIV or hepatitis B/C, recent live vaccines, autoimmune diseases requiring treatment in the past 2 years, other cancers within 3 years.Check my eligibility

What is being tested?

The trial is testing focal radiation therapy alone or combined with immunotherapy drugs Pembrolizumab and CDX-301 on patients already receiving standard hormonal therapy. Participants are randomly assigned to one of four groups at five US academic institutions.See study design

What are the potential side effects?

Possible side effects include allergic reactions to pembrolizumab's ingredients, immune system complications such as inflammation in various organs including lungs (pneumonitis), fatigue from radiation therapy and potential blood disorders due to bone marrow suppression.

CBCV Trial Eligibility Criteria

Inclusion Criteria

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

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My breast cancer is ER positive, may or may not be PR positive, and is HER2 negative.

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My breast cancer is between stage I (larger than 1.5cm if no lymph node involvement) and III.

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My blood, liver, and kidney functions meet the required levels for the trial.

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I am fully active or can carry out light work.

CBCV Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 4 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~4 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 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

Clinical response rate to tumor radiation +/-immunotherapy during standard endocrine therapy for HR+ breast cancer will be measured.

Pathological response rate to tumor radiation +/-immunotherapy during standard endocrine therapy for HR+ breast cancer will be measured.

Tolerability will be demonstrated if no grade 3 or higher toxicities are observed in the first 8 patients, of each arm.

Secondary outcome measures

Local immune response will be measured by assessing tumor specimens for T-cell infiltration at baseline and and during treatment.

Systemic immune response will be measured by collecting serial blood samples for serum and peripheral blood mononuclear cells (PBMCs) at multiple time points.

CBCV Trial Design

4Treatment groups

Active Control

Group I: ARM 4Active Control3 Interventions

Ftl-3 ligand, self administered subcutaneous injections at day 1 for 5 consecutive days+ Focal hypo-fractionated Radiation therapy starting day 8, - 8 Gy x 3 fractions, every other day (M/W/F or W/F/M or F/M/W). + Pembrolizumab, on day 12 (last day of radiotherapy), 200mg IV infused over 30 minutes then repeated every 3 weeks until disease progression or unacceptable toxicity.

Group II: ARM 3Active Control2 Interventions

Ftl-3 ligand, self-administered by subcutaneous injections at week 1, daily, for 5 consecutive days + Focal hypo-fractionated radiation therapy - 8 Gy x 3 fractions starting day 8, (every other day (M/W/F or W/F/M or F/M/W).

Group III: ARM 1Active Control1 Intervention

Focal hypo-fractionated radiation therapy 8 Gy x 3 fractions, starting day 8, every other day (M/W/F or W/F/M or F/M/W).

Group IV: ARM 2Active Control2 Interventions

Focal hypo-fractionated radiation therapy - 8 Gy x 3 fractions starting day 8, every other day (M/W/F or W/F/M or F/M/W). + Pembrolizumab, on day 12 (last day of radiotherapy), infused over 200mg IV over 30 minutes and then repeated every 3 weeks until disease progression or unacceptable toxicity.

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Weill Medical College of Cornell UniversityLead Sponsor

1,055 Previous Clinical Trials

1,316,194 Total Patients Enrolled

29 Trials studying Breast Cancer

27,082 Patients Enrolled for Breast Cancer

Merck Sharp & Dohme LLCIndustry Sponsor

3,888 Previous Clinical Trials

5,059,835 Total Patients Enrolled

58 Trials studying Breast Cancer

7,434 Patients Enrolled for Breast Cancer

Celldex TherapeuticsIndustry Sponsor

61 Previous Clinical Trials

3,850 Total Patients Enrolled

5 Trials studying Breast Cancer

363 Patients Enrolled for Breast Cancer

Media Library

Focal Radiation therapy Clinical Trial Eligibility Overview. Trial Name: NCT03804944 — Phase 2

Breast Cancer Research Study Groups: ARM 4, ARM 3, ARM 1, ARM 2

Breast Cancer Clinical Trial 2023: Focal Radiation therapy Highlights & Side Effects. Trial Name: NCT03804944 — Phase 2

Focal Radiation therapy 2023 Treatment Timeline for Medical Study. Trial Name: NCT03804944 — Phase 2

Frequently Asked Questions

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

Is there an upper age limit for participation in the research?

"Eligible participants for this research must be over 18 years of age and not exceed 90 years."

Answered by AI

Has recruitment for this trial commenced?

"Yes, this investigation is currently in the process of enrolling volunteers. As per clinicaltrials.gov it was first made available for recruitment on March 17th 2020 and has been recently adjusted on April 29th 2022."

Answered by AI

How many participants are currently included in this research project?

"A total of 100 participants, meeting the specific criteria set out by this trial, are necessary for its completion. Those interested can find locations in Pittsburgh at Weill Cornell Medicine New york Presbyterian Hospital and Houston's UPMC Hillman Cancer Center."

Answered by AI

Am I eligible to participate in this experimental research?

"This medical trial is seeking 100 individuals between 18 and 90 years old who present with breast cancer. Additionally, patients must meet the criteria of having an Eastern Cooperative Oncology Group (ECOG) performance status 0-1 as well as a biopsy proven diagnosis of ER+HER2- breast cancer."

Answered by AI

To what degree does ARM 1 pose a risk to people?

"The safety of ARM 1 has been assessed as a 2 on our scale, indicating that there is clinical evidence to support its safety but no data yet confirming efficacy."

Answered by AI

In what medical scenarios is ARM 1 commonly prescribed as a treatment?

"ARM 1 is a viable treatment option for malignant neoplasms, unresectable melanomas, and microsatellite instability high cases."

Answered by AI

Have any other research studies included ARM 1 as a factor?

"Currently, there are 961 active clinical trials for ARM 1 with 122 at the Phase 3 stage. Despite most of these taking place in Houston, Texas, 35727 sites across the US offer studies concerning this particular arm."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Converting HR+ Breast Cancer Into an Individualized Vaccine

2020. "Converting HR+ Breast Cancer Into an Individualized Vaccine". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03804944.

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