CLINICAL TRIAL

Stereotactic Radiosurgery (SRS) for Breast Cancer

Recruiting · 18+ · All Sexes · Tampa, FL

This study is evaluating whether a drug called abemaciclib can be used to treat brain metastases in people with breast cancer.

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About the trial for Breast Cancer

Eligible Conditions
Tumors Metastatic to Brain · HR+ Metastatic Breast Cancer · Neoplasm Metastasis · Breast Neoplasms · Brain Neoplasms

Treatment Groups

This trial involves 2 different treatments. Stereotactic Radiosurgery (SRS) is the primary treatment being studied. Participants will be divided into 2 treatment groups. There is no placebo group. The treatments being tested are in Phase 1 & 2 and have already been tested with other people.

Experimental Group 1
Stereotactic Radiosurgery (SRS)
RADIATION
+
Abemaciclib
DRUG
+
Endocrine therapy
DRUG
Experimental Group 2
Stereotactic Radiosurgery (SRS)
RADIATION
+
Abemaciclib
DRUG
+
Endocrine therapy
DRUG

About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Stereotactic Radiosurgery (SRS)
2012
Completed Phase 2
~70
Abemaciclib
FDA approved
Endocrine therapy
2019
Completed Phase 1
~35010

Eligibility

This trial is for patients born any sex aged 18 and older. There are 10 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
HR+ breast cancer to fulfill the requirement of HR+ disease, a breast cancer must express (≥ 1%), by immunohistochemistry (IHC), at least 1 of the hormone receptors (estrogen receptor [ER] or progesterone receptor [PR]) as defined in the American Society of Clinical Oncology (ASCO) / College of American Pathologists (CAP) Guidelines
Able to swallow oral medications
You have measurable brain metastases per RANO-BM criteria that can be measured in at least one dimension as ≥ 0.5 cm for both intact brain metastases and post-operative cavities. show original
You are eligible for SRS to brain metastases or to the post-operative bed following surgical resection. show original
Maximum diameter of the largest intact brain metastases ≤ 4 cm
Eastern Cooperative Oncology Group performance status 0 to 2
You have a maximum of 15 brain metastases eligible for stereotactic radiation. show original
HER2+ disease is defined as a breast cancer that demonstrates overexpression of HER2 by either IHC or in-situ hybridization as defined by the ASCO / CAP Guidelines. show original
You are willing to comply with all study procedures and available for the duration of the study. show original
This study is evaluating whether certain biomarkers can help predict the effectiveness of treatment in patients with brain cancer. show original
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: Up to 12 months
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Up to 12 months.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Stereotactic Radiosurgery (SRS) will improve 1 primary outcome and 4 secondary outcomes in patients with Breast Cancer. Measurement will happen over the course of Up to 12 months.

Intracranial Progression Free Survival (PFS)
UP TO 12 MONTHS
Intracranial Progression Free Survival: defined as the time from the date of start of treatment to investigator-determined date of progression or death due to any cause, whichever comes first. Progression will be determined by Response Assessment in Neuro-Oncology Brain Metastases (RANO-BM) Criteria.
Intracranial local brain tumor control
UP TO 12 MONTHS
Intracranial local brain tumor control following SRS and abemaciclib will be determined from irradiated lesions according to RANO-BM criteria.
Overall Survival
UP TO 12 MONTHS
Overall Survival is defined as the time from the start of treatment to death due to any cause.
Extracranial Progression Free Survival
UP TO 12 MONTHS
Extracranial Progression Free Survival: Time from the date of start of treatment to the investigator determined date of progression (determined by RECIST) or death due to any cause, whichever occurs first.
Intracranial distant brain tumor control
UP TO 12 MONTHS
Intracranial distant brain tumor control following SRS and abemaciclib will determined by the development of new lesions outside of the irradiated area.

Patient Q & A Section

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

What is the survival rate for breast cancer?

The survival rates of breast cancer patients are improving over the last decade, with an overall five-year survival rate of 72% for newly diagnosed cases in 2009 compared with 62% in 1998. This change is mainly driven by reductions in mortality among women younger than 50 years old.

Anonymous Patient Answer

What is the primary cause of breast cancer?

In a recent study, the data suggests that hormonal factors play the major role in development of breast cancers. It seems that both genetic and environmental factors contribute to development of breast cancers. Results from a recent clinical trial also show that the causative factors of breast cancers are changing due to modern environment and lifestyle changes. We believe that our work will help to develop new treatments of breast cancers.

Anonymous Patient Answer

How quickly does breast cancer spread?

Results from a recent paper give a more complete picture of how fast breast cancer spreads compared with what was found using only the data on distant metastases. For patients with localized disease, there is considerable variation in the rate of tumor progression between individuals.

Anonymous Patient Answer

What are the chances of developing breast cancer?

Results from a recent clinical trial suggests that among women born in Australia, the lifetime risk of developing breast cancer is 5.9%. There were no differences between men and women in terms of breast cancer risk.

Anonymous Patient Answer

Have there been any new discoveries for treating breast cancer?

There are numerous research findings that may pave the way for additional advances in the treatment of breast cancer. This article focuses solely on new advancements in the field of radiation therapy and chemotherapy.

Anonymous Patient Answer
See if you qualify for this trial
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