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Hormone Therapy

Radiation Therapy + Palbociclib + Hormone Therapy for Breast Cancer (ASPIRE Trial)

Phase 2
Waitlist Available
Led By Mylin Torres, MD
Research Sponsored by Emory University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Tamoxifen (20 mg PO daily)
Exemestane (25 mg PO daily) -or-
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 3 months post-radiation
Awards & highlights

ASPIRE Trial Summary

This trialstudies how radiation, palbociclib, and hormone therapy work to treat breast cancer spread to the bones.

Eligible Conditions
  • Metastatic Breast Cancer
  • No change needed.
  • Breast Cancer
  • Progesterone Receptor Positive
  • Bone Metastasis

ASPIRE Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
You are taking tamoxifen, a medication that is given orally (by mouth) at a dose of 20 milligrams per day.
Select...
You are required to take exemestane (a medication) once a day orally.

ASPIRE Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 3 months post-radiation
This trial's timeline: 3 weeks for screening, Varies for treatment, and at 3 months post-radiation for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Response rate
Secondary outcome measures
Adherence as measured by drug diary
Depression as measured by Hospital Anxiety and Depression Scale (HADS)
Fatigue as measured by The Multidimensional Fatigue Inventory (MFI)
+7 more

Side effects data

From 2012 Phase 3 trial • 514 Patients • NCT00256698
12%
Arthralgia
11%
Fatigue
9%
Nausea
8%
Hot flush
6%
Diarrhoea
6%
Constipation
5%
Urinary tract infection
5%
Dyspnoea
5%
Vomiting
4%
Cough
4%
Back pain
3%
Musculoskeletal pain
1%
Pleural Effusion
1%
Pulmonary Embolism
1%
Renal Failure
1%
Cardiac Failure
1%
Femur Fracture
1%
Pneumonia
1%
Sepsis
1%
Back Pain
1%
Dizziness
1%
Syncope
1%
Infection
100%
80%
60%
40%
20%
0%
Study treatment Arm
Fulvestrant + Anastrozole
Anastrozole

ASPIRE Trial Design

1Treatment groups
Experimental Treatment
Group I: Radiation, palbociclib, hormone therapyExperimental Treatment7 Interventions
Patients undergo radiation therapy over 5-10 days and receive palbociclib PO QD on days 1-21. At the discretion of treating physician, patients also receive letrozole, anastrozole, exemestane, or tamoxifen PO QD on days 1-28, or fulvestrant IM on days 1 and 15 of cycle 1 and on day 1 of subsequent cycles. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tamoxifen
FDA approved
Fulvestrant
FDA approved
Anastrozole
FDA approved
Exemestane
FDA approved
Palbociclib
FDA approved
Radiation Therapy
2017
Completed Phase 3
~7250
Letrozole
FDA approved

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH
13,609 Previous Clinical Trials
40,915,608 Total Patients Enrolled
939 Trials studying Breast Cancer
1,543,333 Patients Enrolled for Breast Cancer
National Institutes of Health (NIH)NIH
2,679 Previous Clinical Trials
6,910,644 Total Patients Enrolled
50 Trials studying Breast Cancer
110,785 Patients Enrolled for Breast Cancer
Emory UniversityLead Sponsor
1,627 Previous Clinical Trials
2,560,727 Total Patients Enrolled
28 Trials studying Breast Cancer
3,028 Patients Enrolled for Breast Cancer

Media Library

Anastrozole (Hormone Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT03691493 — Phase 2
Breast Cancer Research Study Groups: Radiation, palbociclib, hormone therapy
Breast Cancer Clinical Trial 2023: Anastrozole Highlights & Side Effects. Trial Name: NCT03691493 — Phase 2
Anastrozole (Hormone Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03691493 — Phase 2

Frequently Asked Questions

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

Is it dangerous to take Fulvestrant long-term?

"Fulvestrant currently sits at a 2 on our safety scale because, while there is evidence suggesting it is safe, there is no data affirming that it works as intended."

Answered by AI

How many different hospitals are participating in this trial?

"To lessen the burden of travel for potential participants, this study is enrolling patients at 10 sites located near major cities. The trial locations include Columbus, Savannah and Portland among other locations."

Answered by AI

Are new participants being signed up for this trial at this time?

"According to the latest information on clinicaltrials.gov, this study is not currently enrolling patients. This particular research project was first posted on February 8th, 2019 and updated as recently as October 12th, 2020. Although this study isn't looking for volunteers right now, there are approximately 5099 other studies that are presently recruiting participants."

Answered by AI

How many research participants are needed for this clinical trial?

"Unfortunately, this particular study is not accepting new patients at the moment. The trial was initially posted on February 8th, 2019 and was last updated on October 12th, 2022. If you are looking for other trials, there are 4695 clinical trials actively recruiting participants with breast cancer and 404 trials for Fulvestrant that are currently searching for participants."

Answered by AI

Could you please list other Fulvestrant-based research projects?

"Fulvestrant is being studied in 404 different clinical trials, 91 of which are currently ongoing. The many studies for Fulvestrant are based in Shanghai but the treatment is being trialed at 22144 locations globally."

Answered by AI

For which medical condition is Fulvestrant commonly prescribed?

"Fulvestrant is commonly used to treat progression, disease. However, it can also be effective against other conditions like malignant neoplasms, ovarian cancer, and tamoxifen."

Answered by AI
~6 spots leftby Mar 2025