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Anti-mitotic Agent

Radium Therapy + Chemotherapy for Metastatic Breast Cancer

Phase 2

Waitlist Available

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

Must not have

Prior hemibody external radiotherapy

Patients must not have an active infection requiring systemic treatment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from randomization to death due to any cause, assessed up to 2 years

Awards & highlights

No Placebo-Only Group

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.

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.

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 below

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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had radiation treatment on half of my body.

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I do not have an infection that needs treatment with medication.

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I have previously been treated with radionuclide therapy.

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I have had treatment for spinal cord compression or bone issues related to my cancer.

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My nerve damage does not severely affect my daily activities.

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I am not taking any medications that affect my heart's electrical cycle.

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I haven't had chemotherapy, immunotherapy, radiation, or hormone therapy within the specified times before starting the new treatment.

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I am not pregnant or breastfeeding.

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My heart's electrical cycle is longer than normal.

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and from randomization to death due to any cause, assessed up to 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Progression-free survival (PFS)

Secondary study objectives

Incidence of adverse events (AEs)

Objective response rate

Overall survival (OS)

+2 more

Other study objectives

Molecular profiling assays on malignant and normal tissues

Side effects data

From 2014 Phase 4 trial • 32 Patients • NCT01301729

59%

Leukopenia

56%

Neutropenia

34%

Hypoaesthesia

31%

Agranulocytosis

22%

Alopecia

22%

Asthenia

19%

Pyrexia

16%

Nail disorder

16%

Oedema peripheral

16%

Diarrhoea

16%

Hypophagia

13%

Alanine aminotransferase increased

13%

Neurotoxicity

13%

Cough

13%

Vomting

Musculoskeletal pain

Headache

Aspartate aminotransferase increased

Chest discomfort

Rash

Pigmentation disorder

Nausea

Bone marrow failure

Anaemia

Transaminases increased

Insomnia

Constipation

Mouth ulceration

Nasopharyngitis

Paronychia

Flushing

Face oedema

Thrombocytopenia

Infection

Upper respiratory tract infection

Completed suicide

Cataract

100%

80%

60%

40%

20%

Study treatment Arm

Trastuzumab

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

~5450

Bone Scan

2015

Completed Phase 2

~50