Trial Outcomes & Findings for Trial of Ra-223 Dichloride in Combination With Hormonal Therapy and Denosumab in the Treatment of Patients With Hormone-Positive Bone-Dominant Metastatic Breast Cancer (NCT NCT02366130)
NCT ID: NCT02366130
Last Updated: 2021-10-07
Results Overview
Disease control rate is defined as the rate of the patients at that time with clinically complete or partial response or stable disease.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
45 participants
Primary outcome timeframe
9 months from receiving the first dose of Radium-223
Results posted on
2021-10-07
Participant Flow
The participating subjects must sign the consent document pertaining to the study and meet all the eligibility criteria as mentioned in the protocol, before initiating on the study treatment. This study was conducted at the University of Texas MD Anderson Cancer Center. All patients received at least one dose of Radium-223 and thus were evaluable for toxicity and disease control rate at 9 months.
Participant milestones
| Measure |
Ra-223 Dichloride + Denosumab
Ra-223 dichloride 55 kBq/kg administered as a bolus intravenous (IV) injection (over 1 minute) through a secure in-dwelling catheter on day 1 of the study and then every four weeks thereafter for 6 cycles.
Denosumab 120 mg by subcutaneous (SC) injections on Day 1 of Cycles 2-5.
A single hormonal agent (ie, Tamoxifen or Aromatase Inhibitor or Fulvestrant) administered daily while on study. Physician to decide what type of hormone therapy participant will receive.
Ra-223 dichloride: 55 kBq/kg by vein on Day 1 of each 28 day cycle, and then every four weeks thereafter for 6 cycles.
Denosumab: 120 mg by subcutaneous (SC) injections on Day 1 of Cycles 2-5.
Hormone Therapy: A single hormonal agent administered daily while on study. Physician to decide what type of hormone therapy participant will receive.
|
|---|---|
|
Overall Study
STARTED
|
45
|
|
Overall Study
COMPLETED
|
36
|
|
Overall Study
NOT COMPLETED
|
9
|
Reasons for withdrawal
| Measure |
Ra-223 Dichloride + Denosumab
Ra-223 dichloride 55 kBq/kg administered as a bolus intravenous (IV) injection (over 1 minute) through a secure in-dwelling catheter on day 1 of the study and then every four weeks thereafter for 6 cycles.
Denosumab 120 mg by subcutaneous (SC) injections on Day 1 of Cycles 2-5.
A single hormonal agent (ie, Tamoxifen or Aromatase Inhibitor or Fulvestrant) administered daily while on study. Physician to decide what type of hormone therapy participant will receive.
Ra-223 dichloride: 55 kBq/kg by vein on Day 1 of each 28 day cycle, and then every four weeks thereafter for 6 cycles.
Denosumab: 120 mg by subcutaneous (SC) injections on Day 1 of Cycles 2-5.
Hormone Therapy: A single hormonal agent administered daily while on study. Physician to decide what type of hormone therapy participant will receive.
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
3
|
|
Overall Study
Ineligible
|
6
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Ra-223 Dichloride + Denosumab
n=36 Participants
Ra-223 dichloride 55 kBq/kg administered as a bolus intravenous (IV) injection (over 1 minute) through a secure in-dwelling catheter on day 1 of the study and then every four weeks thereafter for 6 cycles.
Denosumab 120 mg by subcutaneous (SC) injections on Day 1 of Cycles 2-5.
A single hormonal agent (ie, Tamoxifen or Aromatase Inhibitor or Fulvestrant) administered daily while on study. Physician to decide what type of hormone therapy participant will receive.
Ra-223 dichloride: 55 kBq/kg by vein on Day 1 of each 28 day cycle, and then every four weeks thereafter for 6 cycles.
Denosumab: 120 mg by subcutaneous (SC) injections on Day 1 of Cycles 2-5.
Hormone Therapy: A single hormonal agent administered daily while on study. Physician to decide what type of hormone therapy participant will receive.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=36 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
28 Participants
n=36 Participants
|
|
Age, Categorical
>=65 years
|
8 Participants
n=36 Participants
|
|
Age, Continuous
|
58 years
n=36 Participants
|
|
Sex: Female, Male
Female
|
36 Participants
n=36 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=36 Participants
|
|
Region of Enrollment
United States
|
36 participants
n=36 Participants
|
PRIMARY outcome
Timeframe: 9 months from receiving the first dose of Radium-223Population: 1 patient was lost to FU between 6 and 9 months from first dose of Radium -223
Disease control rate is defined as the rate of the patients at that time with clinically complete or partial response or stable disease.
Outcome measures
| Measure |
Ra-223 Dichloride + Denosumab
n=35 Participants
Ra-223 dichloride 55 kBq/kg administered as a bolus intravenous (IV) injection (over 1 minute) through a secure in-dwelling catheter on day 1 of the study and then every four weeks thereafter for 6 cycles.
Denosumab 120 mg by subcutaneous (SC) injections on Day 1 of Cycles 2-5.
A single hormonal agent (ie, Tamoxifen or Aromatase Inhibitor or Fulvestrant) administered daily while on study. Physician to decide what type of hormone therapy participant will receive.
Ra-223 dichloride: 55 kBq/kg by vein on Day 1 of each 28 day cycle, and then every four weeks thereafter for 6 cycles.
Denosumab: 120 mg by subcutaneous (SC) injections on Day 1 of Cycles 2-5.
Hormone Therapy: A single hormonal agent administered daily while on study. Physician to decide what type of hormone therapy participant will receive.
|
|---|---|
|
Number of Participants With Disease Control Rate at 9 Months
|
35 Participants
|
PRIMARY outcome
Timeframe: 6 months from receiving the first dose of Radium-223Disease control rate is defined as the rate of the patients at that time with clinically complete or partial response or stable disease.
Outcome measures
| Measure |
Ra-223 Dichloride + Denosumab
n=36 Participants
Ra-223 dichloride 55 kBq/kg administered as a bolus intravenous (IV) injection (over 1 minute) through a secure in-dwelling catheter on day 1 of the study and then every four weeks thereafter for 6 cycles.
Denosumab 120 mg by subcutaneous (SC) injections on Day 1 of Cycles 2-5.
A single hormonal agent (ie, Tamoxifen or Aromatase Inhibitor or Fulvestrant) administered daily while on study. Physician to decide what type of hormone therapy participant will receive.
Ra-223 dichloride: 55 kBq/kg by vein on Day 1 of each 28 day cycle, and then every four weeks thereafter for 6 cycles.
Denosumab: 120 mg by subcutaneous (SC) injections on Day 1 of Cycles 2-5.
Hormone Therapy: A single hormonal agent administered daily while on study. Physician to decide what type of hormone therapy participant will receive.
|
|---|---|
|
The Number of Participants With Disease Control Rate at 6 Months
|
21 Participants
|
Adverse Events
Ra-223 Dichloride + Denosumab
Serious events: 28 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Ra-223 Dichloride + Denosumab
n=36 participants at risk
Ra-223 dichloride 55 kBq/kg administered as a bolus intravenous (IV) injection (over 1 minute) through a secure in-dwelling catheter on day 1 of the study and then every four weeks thereafter for 6 cycles.
Denosumab 120 mg by subcutaneous (SC) injections on Day 1 of Cycles 2-5.
A single hormonal agent (ie, Tamoxifen or Aromatase Inhibitor or Fulvestrant) administered daily while on study. Physician to decide what type of hormone therapy participant will receive.
Ra-223 dichloride: 55 kBq/kg by vein on Day 1 of each 28 day cycle, and then every four weeks thereafter for 6 cycles.
Denosumab: 120 mg by subcutaneous (SC) injections on Day 1 of Cycles 2-5.
Hormone Therapy: A single hormonal agent administered daily while on study. Physician to decide what type of hormone therapy participant will receive.
|
|---|---|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
77.8%
28/36 • Number of events 28 • adverse events were collected from First dose of Ra-223 up to 9 months
|
|
General disorders
Fatigue
|
41.7%
15/36 • Number of events 15 • adverse events were collected from First dose of Ra-223 up to 9 months
|
|
Gastrointestinal disorders
Nausea
|
36.1%
13/36 • Number of events 13 • adverse events were collected from First dose of Ra-223 up to 9 months
|
|
Hepatobiliary disorders
AST/ALT elevation
|
30.6%
11/36 • Number of events 11 • adverse events were collected from First dose of Ra-223 up to 9 months
|
|
Gastrointestinal disorders
Diarrhea
|
30.6%
11/36 • Number of events 11 • adverse events were collected from First dose of Ra-223 up to 9 months
|
|
Nervous system disorders
Headache
|
19.4%
7/36 • Number of events 7 • adverse events were collected from First dose of Ra-223 up to 9 months
|
|
Endocrine disorders
Hyperglycemia
|
19.4%
7/36 • Number of events 7 • adverse events were collected from First dose of Ra-223 up to 9 months
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
16.7%
6/36 • Number of events 6 • adverse events were collected from First dose of Ra-223 up to 9 months
|
|
General disorders
Flu-like symptoms
|
16.7%
6/36 • Number of events 6 • adverse events were collected from First dose of Ra-223 up to 9 months
|
|
General disorders
Hot Flashes
|
13.9%
5/36 • Number of events 5 • adverse events were collected from First dose of Ra-223 up to 9 months
|
|
Infections and infestations
Arthralgia
|
11.1%
4/36 • Number of events 4 • adverse events were collected from First dose of Ra-223 up to 9 months
|
|
Psychiatric disorders
Insomnia
|
11.1%
4/36 • Number of events 4 • adverse events were collected from First dose of Ra-223 up to 9 months
|
|
Blood and lymphatic system disorders
Lymphocytopenia
|
27.8%
10/36 • Number of events 10 • adverse events were collected from First dose of Ra-223 up to 9 months
|
|
Blood and lymphatic system disorders
Neutropenia
|
25.0%
9/36 • Number of events 9 • adverse events were collected from First dose of Ra-223 up to 9 months
|
|
Blood and lymphatic system disorders
Anemia
|
16.7%
6/36 • Number of events 6 • adverse events were collected from First dose of Ra-223 up to 9 months
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
11.1%
4/36 • Number of events 4 • adverse events were collected from First dose of Ra-223 up to 9 months
|
Other adverse events
Adverse event data not reported
Additional Information
Dr. Naoto T Ueno, Professor, Breast Medical Oncology
UT MD Anderson Cancer Center
Phone: (713) 792-8754
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place