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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up end of study, up to 36 months.
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Progression free survival (PFS) will be measured
Secondary outcome measures
Change in Number of Subjects with Adverse events
Circulating tumor DNA (ctDNA) levels
Objective response rate (ORR) will be assessed.
+2 more

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.

Find a Location

Who is running the clinical trial?

Weill Medical College of Cornell UniversityLead Sponsor
1,054 Previous Clinical Trials
1,316,207 Total Patients Enrolled
29 Trials studying Breast Cancer
27,114 Patients Enrolled for Breast Cancer
Silvia Formenti, M.D.Principal InvestigatorWeill Medical College of Cornell University
13 Previous Clinical Trials
1,217 Total Patients Enrolled
6 Trials studying Breast Cancer
1,040 Patients Enrolled for Breast Cancer

Media Library

Letrozole (Aromatase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04563507 — Phase 2
Breast Cancer Research Study Groups: ARM 2 - Letrozole and Palbociclib + I-SBRT, ARM 1 - Letrozole and Palbociclib
Breast Cancer Clinical Trial 2023: Letrozole Highlights & Side Effects. Trial Name: NCT04563507 — Phase 2
Letrozole (Aromatase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04563507 — Phase 2

Frequently Asked Questions

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

Are any individuals aged 60 or over participating in the trial?

"This clinical trial stipulates that participants must be at least 18 years old, with the upper age limit set to 90."

Answered by AI

What is the current cohort size participating in this research?

"Affirmative. According to clinicaltrials.gov, this medical investigation is still enrolling participants since its post on November 12th 2020 and the latest edit of June 29th 2022. The research team needs 102 individuals from 5 distinct sites for data collection purposes."

Answered by AI

To what maladies is the combination of ARM 2 - Letrozole and Palbociclib + I-SBRT typically prescribed?

"ARM 2 - Letrozole and Palbociclib + I-SBRT is frequently prescribed to treat a variety of malignant neoplasms, including advanced hr+ her2 - breast cancer, prior endocrine therapy, and anovulatory cycles."

Answered by AI

For which demographic is enrollment in this research endeavor available?

"This research initiative is searching for 102 participants affected by breast cancer, aged 18 to 90. Eligibility requirements must be met for admission into the trial."

Answered by AI

What potential risks are associated with the combination of Letrozole, Palbociclib and I-SBRT?

"The combination therapy of Letrozole and Palbociclib + I-SBRT was given a rating of 2 due to its Phase 2 status, meaning that there is anecdotal evidence for safety but no clinical trials have been conducted yet to determine efficacy."

Answered by AI

Is this trial currently enrolling participants?

"Affirmative. Clinicaltrials.gov records demonstrate that this clinical trial, first posted on November 12th 2020, is actively seeking participants. As many as 102 patients need to be recruited across five separate medical centers."

Answered by AI

Are there other studies that have explored the impact of combining Letrozole and Palbociclib with I-SBRT for ARM 2 patients?

"Currently, 253 trials are live that investigate ARM 2 - Letrozole and Palbociclib + I-SBRT with 48 studies in the third phase. Most of these experiments take place in Burgas, New jersey but there is a total of 15066 medical centres conducting clinical trials for this therapy regimen."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Combined Immunotherapies in Metastatic ER+ Breast Cancer
2020. "Combined Immunotherapies in Metastatic ER+ Breast Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04563507.
~13 spots leftby Oct 2024
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