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Aromatase Inhibitor

Immunotherapy + SBRT for Metastatic Breast Cancer

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

Metastatic disease (≤ 5 sites of measurable disease)

Eligible for treatment with CDK4/6 + aromatase inhibitors

Must not have

Uncontrolled brain metastases

Any lesion >5 cm in greatest diameter

Timeline

Screening 3 weeks

Treatment Varies

Follow Up end of study, up to 36 months.

Awards & highlights

No Placebo-Only Group

Summary

This trial is for women with hormone receptor and human epidermal growth factor receptor negative metastatic breast cancer. Patients will be receiving standard first line therapy and will be randomly assigned to also receive stereotactic body radiation therapy.

Who is the study for?

This trial is for women over 18 with HR+ HER2- metastatic breast cancer, who can receive CDK4/6 inhibitors and aromatase inhibitors. They must have adequate organ function, no more than five measurable disease sites, and not be on certain therapies or have active infections or autoimmune diseases.

What is being tested?

The study tests if adding Stereotactic Body Radiation Therapy (SBRT) to standard first-line treatment (letrozole and palbociclib) improves outcomes in metastatic breast cancer. Participants are randomly assigned to either the combined treatment group or the standard therapy group.

What are the potential side effects?

Possible side effects include fatigue, nausea, skin reactions from radiation, low blood counts leading to increased infection risk or bleeding problems. Letrozole may cause hot flashes and joint pain; Palbociclib can cause neutropenia which increases infection risk.

Eligibility Criteria

Inclusion Criteria

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

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My cancer has spread to 5 or fewer places in my body.

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I am eligible for treatment with CDK4/6 inhibitors and aromatase inhibitors.

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I am fully active or can carry out light work.

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My breast cancer is hormone-receptor positive and HER2-negative with ER expression over 10%.

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My kidney function, measured by creatinine or GFR, is within the required range.

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I have had both of my ovaries surgically removed.

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I am a woman aged 18 or older, regardless of my menopausal status.

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My liver function tests are within the required range.

Exclusion Criteria

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

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I have brain metastases that are not under control.

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I have a tumor larger than 5 cm.

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I have been diagnosed with HIV.

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I have not taken high-dose steroids or immunosuppressants in the last week.

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I am a male diagnosed with breast cancer.

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I am currently on medication for an infection.

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

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ end of study, up to 36 months.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~end of study, up to 36 months.

This trial's timeline: 3 weeks for screening, Varies for treatment, and end of study, up to 36 months. for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Progression free survival (PFS) will be measured

Secondary study objectives

Change in Number of Subjects with Adverse events

Circulating tumor DNA (ctDNA) levels

Objective response rate (ORR) will be assessed.

+2 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

2Treatment groups

Active Control

Group I: ARM 2 - Letrozole and Palbociclib + I-SBRTActive Control3 Interventions

Patients randomized to arm 2 will start letrozole alone, and add palbociclib on day 21, after completion of I-SBRT. Treatment may be given daily (to keep the total I-SBRT treatment time to ≤ 12 days) and lesions targeted with I-SBRT will thus be alternated each day to accommodate for the 48 hour interval between fractions.

Group II: ARM 1 - Letrozole and PalbociclibActive Control2 Interventions

Patients randomized to arm 1 will start standard Letrozole followed by Palbociclib at day 21.

0 / 16Eligibility criteria met