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Radiation Therapy + Palbociclib + Hormone Therapy for Breast Cancer (ASPIRE Trial)
ASPIRE Trial Summary
This trialstudies how radiation, palbociclib, and hormone therapy work to treat breast cancer spread to the bones.
- 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 belowASPIRE Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2012 Phase 3 trial • 514 Patients • NCT00256698ASPIRE Trial Design
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Who is running the clinical trial?
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- You are taking tamoxifen, a medication that is given orally (by mouth) at a dose of 20 milligrams per day.You are currently taking hormone replacement therapy.You have cancer that has spread to an area within 2 cm of a spot that was previously treated with radiation.You have a history of mental health or drug abuse problems.The healthcare team knows the status of the hormones estrogen, progesterone, and human epidermal growth factor receptor 2 (Her2) in either the original cancer or its spread.You will need to receive an injection of Fulvestrant twice during the first month of the study and then once a month for the rest of the study.You have an ongoing autoimmune disease that has required treatment in the past 2 years.You cannot have symptoms of spinal cord compression, but if you have evidence of it on medical images, you may still be eligible to participate.You have already received chemotherapy treatment once for your advanced disease.You had cancer in the past, except for skin cancer that is not melanoma. You must have been free of cancer for at least 3 years.You have already received radiation treatment for the condition being studied in this clinical trial.You have severe and active health problems in addition to the one being studied.You have been diagnosed with breast cancer that has spread to other parts of your body.You must be mentally and physically healthy enough to participate in the study and complete all requirements and follow-up appointments.You have received chemotherapy or radiation therapy within the last 2 weeks and have not yet fully recovered from any related side effects.You have a type of breast cancer that has spread to your bones and is positive for estrogen and/or progesterone receptors, but negative for Her2/neu. Imaging tests have confirmed the bone metastasis within the past 60 days before radiation simulation.You will need to take 2.5 mg of Letrozole orally every day.You are taking anastrozole medication daily.Women who could become pregnant and are sexually active must use birth control methods that are considered safe and effective during the study.You are required to take exemestane (a medication) once a day orally.You can receive up to 4 radiation treatments for bone metastases to help relieve pain.
- Group 1: Radiation, palbociclib, hormone therapy
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Approved for 10 Other Conditions - This treatment demonstrated efficacy for 10 other conditions.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
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."
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."
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."
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."
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."
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."
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