What side effects are associated with this type of intervention?

Common treatments for breast cancer, such as focal hypo-fractionated radiotherapy and immunotherapy, have specific side effects. Focal hypo-fractionated radiotherapy, which involves targeted radiation to shrink tumors, can cause acute skin reactions, fatigue, and, in some cases, long-term effects like fibrosis and changes in breast appearance. Immunotherapy, which enhances the immune response, may lead to side effects such as fatigue, skin rashes, diarrhea, and, less commonly, more severe immune-related adverse events like pneumonitis and colitis. These treatments aim to minimize damage to surrounding tissues while effectively targeting cancer cells.

What prior FDA approvals exist?

The FDA has approved several treatments for breast cancer that involve targeted radiation and immunotherapy. One notable example is the use of pembrolizumab (Keytruda), an immune checkpoint inhibitor, which has been approved for use in combination with chemotherapy for triple-negative breast cancer. Additionally, targeted radiation therapies, such as stereotactic body radiotherapy (SBRT), have been used to precisely target and shrink tumors. These treatments aim to enhance the immune response and improve outcomes for breast cancer patients, similar to the approach being studied in the trial involving focal hypo-fractionated radiotherapy and immunotherapy.

What other types of research exist?

Promising novel alternatives for breast cancer treatment in 2024 include: 1) Personalized cancer vaccines, which are designed to target specific tumor antigens unique to an individual's cancer. 2) CAR-T cell therapy, which involves modifying a patient's T cells to better recognize and attack cancer cells. 3) PARP inhibitors, particularly for patients with BRCA mutations, which block DNA repair mechanisms in cancer cells. 4) Antibody-drug conjugates (ADCs), which deliver cytotoxic drugs directly to cancer cells, minimizing damage to healthy tissue. These therapies are being actively researched and have shown potential in improving outcomes for breast cancer patients.

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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

Must not have

Known history of active TB (Bacillus Tuberculosis)

History of (non-infectious) pneumonitis that required steroids or has current pneumonitis

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 4 years

Awards & highlights

No Placebo-Only Group

Summary

This trial tests different treatments in post-menopausal women with a specific type of breast cancer. The goal is to find the best way to lower hormones, kill cancer cells, or boost the immune system to fight the disease. One of the treatments being tested is a medication used for treating postmenopausal women with hormone-sensitive advanced breast cancer.

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.

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.

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.

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.

Exclusion Criteria

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

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I have an active tuberculosis infection.

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I have had pneumonitis treated with steroids or have it now.

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I am currently on medication for an infection.

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I have a history of Hepatitis B or active Hepatitis C.

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I have been diagnosed with HIV.

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I have an active connective tissue disorder like lupus or scleroderma needing treatment for flares.

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I have had radiation therapy on the same breast before.

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I have been treated with specific immune therapy drugs before.

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I have an immune system disorder or have been on high-dose steroids or other immune-weakening medicines recently.

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I have had surgery to remove breast cancer.

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I am currently on chemotherapy, hormone therapy, or HER2-targeted therapy.

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

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

Primary study objectives

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 study objectives

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.

Awards & Highlights

No Placebo-Only Group

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

Trial Design

4Treatment groups

Active Control

Group I: 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 II: 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.

Group III: 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 IV: 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).

0 / 15Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for breast cancer include hormonal therapy, radiotherapy, and immunotherapy. Hormonal therapy, like letrozole, reduces estrogen levels or blocks estrogen receptors, which is essential for treating hormone receptor-positive breast cancer. Radiotherapy uses high-energy rays to target and destroy cancer cells, helping to shrink tumors and prevent recurrence. Immunotherapy enhances the immune system's ability to recognize and attack cancer cells. These treatments, especially when combined, provide a multifaceted approach to effectively manage and treat breast cancer, improving patient outcomes.

Treatment Minimization in Older Patients With Early-Stage Breast Cancer.