Testing the Addition of Radium Therapy (Radium-223 Dichloride) to the Usual Chemotherapy Treatmen… (NCT04090398) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Testing the Addition of Radium Therapy (Radium-223 Dichloride) to the Usual Chemotherapy Treatment (Paclitaxel) for Advanced Breast Cancer That Has Spread to the Bones
United States70 participantsStarted 2020-08-04
Plain-language summary
This phase II trial studies how well radium-223 dichloride and paclitaxel work in treating patients with advanced breast cancer that has spread to the bones. Radium-223 dichloride is a radioactive drug that behaves in a similar way to calcium and collects in cancer that has spread to the bones (bone metastases). The radioactive particles in radium-223 dichloride act on bone metastases, killing the tumor cells and reducing the pain that they can cause. Drugs used in chemotherapy, such as paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving radium-223 dichloride and paclitaxel may work better in treating patients with metastatic breast cancer compared to paclitaxel alone.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Women or men with metastatic breast cancer with two or more bone metastases identified by technetium Tc-99m (99mTc) bone scintigraphy and/or CT, at least one of these bone lesions must not have been treated with prior radiation therapy
* A diagnosis of breast cancer must have been histologically or cytologically confirmed at any time point
* Patients with non-bone metastases (in addition to bone metastases) are permitted if:
* Five or less visceral metastasis (=\< 4 cm in size) and asymptomatic (not including lymph nodes)
* Enlarged lymph nodes =\< 4 cm
* Patients with HER2 negative disease (HER2 negativity by immunohistochemistry \[IHC\] or fluorescent in situ hybridization \[FISH\] ratio according to the American Society of Clinical Oncology-College of American Pathologists guideline criteria) (Hammond et al., 2010; Wolff et al., 2013). Hormone-receptor positive (estrogen receptor \[ER\]-positive and/or progesterone receptor \[PR\]-positive) as well as triple-negative (ER-negative, PR-negative and no overexpression of HER2) breast cancer may be enrolled. Hormone receptor status will be determined at the local institution. ER and PR negativity will be defined as \< 1% tumor staining by IHC
* Patient must be eligible to receive therapy with paclitaxel for the treatment of their breast cancer. Patients with hormone-receptor positive disease should have progressed on at least one prior line of hormone therapy and a CDK4/6 inhibitor in the metastatic …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is combining radium-223 — a radiation therapy usually used for prostate cancer — with paclitaxel chemotherapy for breast cancer that has spread to the bones; can you help me understand why this combination is being tested, and what is currently known about its safety profile in breast cancer patients specifically?
2Since this is a Phase 2 trial, it's still in an earlier stage of testing — what does that mean for how much we know about whether this approach is actually better than paclitaxel alone, and should I consider sticking with standard chemotherapy options first?
3The trial is active but no longer enrolling new patients, so it sounds like I may not be able to join — but could the results from this trial, once published, still influence what treatment options might be available to me in the future?
4The main thing this trial is measuring is progression-free survival, meaning how long the cancer stays controlled — how does that compare to what current standard treatments for HER2-negative breast cancer with bone metastases typically achieve?
5Given that radium-223 works by targeting bone specifically, does my particular pattern of metastases — how many bone lesions I have, whether I also have spread elsewhere — affect whether this kind of approach would even make sense for my situation?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Progression-free survival (PFS)
Timeframe: From randomization to the first documented tumor progression or death due to any cause, whichever occurred first, assessed up to 2 years