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Anti-mitotic Agent
Radium Therapy + Chemotherapy for Metastatic Breast Cancer
Phase 2
Recruiting
Led By Jyoti Malhotra
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Creatinine =< 1.5 x institutional ULN OR glomerular filtration rate (GFR) >= 40 mL/min/1.73 m^2
A diagnosis of breast cancer must have been histologically or cytologically confirmed at any time point
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from randomization to death due to any cause, assessed up to 2 years
Awards & highlights
Study Summary
This trial is testing radium-223 dichloride (a radioactive drug) + paclitaxel (a chemotherapy drug) to see if it's more effective than paclitaxel alone in treating patients with metastatic breast cancer.
Who is the study for?
This trial is for adults with advanced breast cancer that has spread to the bones. Participants must have good performance status, confirmed diagnosis, specific blood and organ function levels, and at least one untreated bone lesion. They should not have had certain treatments recently and must agree to contraception if of childbearing potential.Check my eligibility
What is being tested?
The study is testing whether adding Radium-223 Dichloride (a radioactive drug targeting bone metastases) to Paclitaxel (a chemotherapy drug) provides better outcomes than Paclitaxel alone in treating patients with breast cancer that has spread to the bones.See study design
What are the potential side effects?
Potential side effects include pain reduction from tumor cells in bones but also risks associated with radiation such as nausea, diarrhea, low blood counts leading to increased infection risk or bleeding problems, and possible damage to surrounding healthy tissue.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My kidney function, measured by creatinine or GFR, is within the required range.
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My breast cancer diagnosis was confirmed through testing.
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I am 18 years old or older.
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I can take care of myself but might not be able to do heavy physical work.
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My hepatitis B virus load is undetectable with treatment.
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I have breast cancer that has spread to my bones, with at least one untreated bone lesion.
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I haven't had paclitaxel for cancer that has spread in the last 2 years or as part of initial treatment in the last 6 months.
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I had hepatitis C but am cured, or I'm being treated with no detectable virus.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from randomization to death due to any cause, assessed up to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from randomization to death due to any cause, assessed up to 2 years
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)
Secondary outcome measures
Incidence of adverse events (AEs)
Objective response rate
Overall survival (OS)
+2 moreOther outcome measures
Molecular profiling assays on malignant and normal tissues
Side effects data
From 2014 Phase 4 trial • 32 Patients • NCT0130172959%
Leukopenia
56%
Neutropenia
34%
Hypoaesthesia
31%
Agranulocytosis
22%
Alopecia
22%
Asthenia
19%
Pyrexia
16%
Nail disorder
16%
Oedema peripheral
16%
Diarrhoea
16%
Hypophagia
13%
Neurotoxicity
13%
Alanine aminotransferase increased
13%
Cough
13%
Vomting
9%
Headache
9%
Musculoskeletal pain
9%
Aspartate aminotransferase increased
9%
Chest discomfort
9%
Rash
9%
Pigmentation disorder
9%
Nausea
9%
Bone marrow failure
9%
Anaemia
6%
Transaminases increased
6%
Insomnia
6%
Constipation
6%
Mouth ulceration
6%
Nasopharyngitis
6%
Paronychia
6%
Flushing
6%
Face oedema
6%
Thrombocytopenia
3%
Infection
3%
Upper respiratory tract infection
3%
Completed suicide
3%
Cataract
100%
80%
60%
40%
20%
0%
Study treatment Arm
Trastuzumab
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Arm I (paclitaxel, radium Ra 223 dichloride)Experimental Treatment8 Interventions
Patients receive paclitaxel IV over 1 hour on days 1, 8, and 15 and radium Ra 223 dichloride IV over 1 minute on day 1 of each cycle. Treatment with radium Ra 223 dichloride repeats every 28 days for 6 cycles and treatment with paclitaxel repeats every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT scan, bone scan and/or MRI, as well as collection of blood samples throughout trial. Patients may optionally undergo SPECT on trial.
Group II: Arm II (paclitaxel)Active Control7 Interventions
Patients receive paclitaxel IV over 1 hour on days 1, 8, and 15 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT scan, bone scan, and/or MRI, as well as collection of blood samples throughout trial. Patients may optionally undergo SPECT on trial.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Paclitaxel
2011
Completed Phase 4
~5380
Biospecimen Collection
2004
Completed Phase 2
~1730
Magnetic Resonance Imaging
2017
Completed Phase 3
~1190
Computed Tomography
2017
Completed Phase 2
~2720
Single Photon Emission Computed Tomography
2008
Completed Phase 4
~310
Radium Ra 223 Dichloride
2017
Completed Phase 2
~90
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,658 Previous Clinical Trials
40,924,571 Total Patients Enrolled
Jyoti MalhotraPrincipal InvestigatorCity of Hope Comprehensive Cancer Center LAO
5 Previous Clinical Trials
176 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My kidney function, measured by creatinine or GFR, is within the required range.My breast cancer diagnosis was confirmed through testing.I haven't taken strong immune-suppressing drugs in the last week, except for low-dose or topical steroids, or if I have Crohn's or ulcerative colitis.I have had radiation treatment on half of my body.I do not have an infection that needs treatment with medication.I can be treated with paclitaxel for my breast cancer and have tried other treatments if my cancer is hormone-receptor positive.I am 18 years old or older.I can take care of myself but might not be able to do heavy physical work.Your total bilirubin level is within a certain range, unless you have Gilbert's disease.You have had allergic reactions to drugs similar to radium-223 dichloride.I am HIV positive, on treatment, and my viral load is undetectable.My hepatitis B virus load is undetectable with treatment.My brain cancer has been treated, is not currently causing symptoms, and hasn't worsened in the last 4 weeks.I have recovered from side effects of previous cancer treatments, except for hair loss.My breast cancer has spread but not severely, and it's either hormone-receptor positive or triple-negative.I agree to use effective birth control during and 6 months after the study.I have breast cancer that has spread to my bones, with at least one untreated bone lesion.You are not expected to live for more than 6 months.I have previously been treated with radionuclide therapy.I have had cancer before, but it won't affect this treatment's safety or results.I have had treatment for spinal cord compression or bone issues related to my cancer.I haven't had paclitaxel for cancer that has spread in the last 2 years or as part of initial treatment in the last 6 months.My nerve damage does not severely affect my daily activities.I am not on any experimental drugs, but I am vaccinated for COVID-19.I can understand and am willing to sign the consent form, or I have someone who can do it for me.I have risk factors for a specific heart rhythm problem (like heart failure or low potassium).I am not taking any medications that affect my heart's electrical cycle.Your hemoglobin level is higher than 10 grams per deciliter.I haven't had chemotherapy, immunotherapy, radiation, or hormone therapy within the specified times before starting the new treatment.I had hepatitis C but am cured, or I'm being treated with no detectable virus.I am not pregnant or breastfeeding.My heart's electrical cycle is longer than normal.You have enough infection-fighting white blood cells in your body.Your platelet count is at least 100,000 per microliter.Your liver function tests should not be more than three times the normal limit, or five times the normal limit if you have cancer that has spread to the liver.I am using, or will start using, bone-strengthening drugs before the study begins.My heart is healthy enough for this study, even with my history of heart issues or treatments.
Research Study Groups:
This trial has the following groups:- Group 1: Arm I (paclitaxel, radium Ra 223 dichloride)
- Group 2: Arm II (paclitaxel)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- 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
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What are the primary applications of Paclitaxel as a therapeutic?
"Paclitaxel can be employed to combat the spread of tumors and malignancies, such as Kaposi's sarcoma, ovarian cancer, and metastatic directives."
Answered by AI
Is the recruitment phase of this clinical trial still open to participants?
"As detailed through clinicaltrials.gov, this experiment is actively seeking participants. First reported on December 27th 2019 and recently amended on November 26th 2022, the trial is open for recruitment."
Answered by AI
How many US-based medical facilities are running this experiment?
"Currently, 24 different sites are recruiting participants for this clinical trial. Prominent locations include Farmington Hills, Lee's Summit and Topeka as well as several other places nearby. It is advised that patients select the closest site to mitigate any travel requirements associated with participation in this study."
Answered by AI
What is the maximal enrolment capacity of this clinical trial?
"Affirmative. Data hosted on clinicaltrials.gov attests to the fact that this research study is actively seeking volunteers; it was initial posted on December 27th 2019, and updated lastly in November 26th 2022. Currently, 70 individuals are sought from 24 distinct sites."
Answered by AI
Can you elaborate on previous investigations regarding Paclitaxel?
"Paclitaxel is the subject of 832 ongoing studies, 227 of which are currently in Phase 3. Of these research sites, most are found in Westmead, New South Wales; however there is a total of 45639 locations researching Paclitaxel across the globe."
Answered by AI
In what ways can Paclitaxel be a health risk for individuals?
"With some evidence of safe use, Paclitaxel was assigned a rating of 2 out of 3. As it is still in the second phase of clinical trials, there are no reports confirming its efficacy as yet."
Answered by AI
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