Trial Outcomes & Findings for Ribociclib and Aromatase Inhibitor in Treating Older Participants With Hormone Receptor Positive Metastatic Breast Cancer (NCT NCT03477396)
NCT ID: NCT03477396
Last Updated: 2024-02-20
Results Overview
Number of participants with grade 2 and above toxicities attributed (possible, probable or definite) to ribociclib
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
2 participants
Primary outcome timeframe
Up to 30 days of last study drug, about 3 years and 3 months
Results posted on
2024-02-20
Participant Flow
Participant milestones
| Measure |
Treatment (Ribociclib, Aromatase Inhibitor)
Participants receive ribociclib orally PO QD on days 1-21 and aromatase inhibitor per treating investigator's discretion. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Aromatase Inhibitor: Aromatase inhibitor per treating investigator's discretion
Laboratory Biomarker Analysis: Correlative studies
Pharmacokinetic Study: Correlative studies
Questionnaire Administration: Ancillary studies
Ribociclib: Given PO
|
|---|---|
|
Overall Study
STARTED
|
2
|
|
Overall Study
COMPLETED
|
2
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Ribociclib and Aromatase Inhibitor in Treating Older Participants With Hormone Receptor Positive Metastatic Breast Cancer
Baseline characteristics by cohort
| Measure |
Treatment (Ribociclib, Aromatase Inhibitor)
n=2 Participants
Participants receive ribociclib orally PO QD on days 1-21 and aromatase inhibitor per treating investigator's discretion. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Aromatase Inhibitor: Aromatase inhibitor per treating investigator's discretion
Laboratory Biomarker Analysis: Correlative studies
Pharmacokinetic Study: Correlative studies
Questionnaire Administration: Ancillary studies
Ribociclib: Given PO
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=99 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
2 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
2 participants
n=99 Participants
|
|
Karnofsky Status
100 - Normal no complaints; no evidence of disease
|
1 Participants
n=99 Participants
|
|
Karnofsky Status
90 - Able to carry on normal activity; minor signs or symptoms of disease
|
1 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Up to 30 days of last study drug, about 3 years and 3 monthsNumber of participants with grade 2 and above toxicities attributed (possible, probable or definite) to ribociclib
Outcome measures
| Measure |
Treatment (Ribociclib, Aromatase Inhibitor)
n=2 Participants
Participants receive ribociclib orally PO QD on days 1-21 and aromatase inhibitor per treating investigator's discretion. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Aromatase Inhibitor: Aromatase inhibitor per treating investigator's discretion
Laboratory Biomarker Analysis: Correlative studies
Pharmacokinetic Study: Correlative studies
Questionnaire Administration: Ancillary studies
Ribociclib: Given PO
|
|---|---|
|
Number of Participants With Grade 2 and Above Toxicities Attributed to Ribociclib
|
2 Participants
|
SECONDARY outcome
Timeframe: Up to 3.5 yearsOutcome measures
| Measure |
Treatment (Ribociclib, Aromatase Inhibitor)
n=2 Participants
Participants receive ribociclib orally PO QD on days 1-21 and aromatase inhibitor per treating investigator's discretion. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Aromatase Inhibitor: Aromatase inhibitor per treating investigator's discretion
Laboratory Biomarker Analysis: Correlative studies
Pharmacokinetic Study: Correlative studies
Questionnaire Administration: Ancillary studies
Ribociclib: Given PO
|
|---|---|
|
Number of Participants With Dose Reductions
|
2 Participants
|
SECONDARY outcome
Timeframe: Up to 3.5 yearsOutcome measures
| Measure |
Treatment (Ribociclib, Aromatase Inhibitor)
n=2 Participants
Participants receive ribociclib orally PO QD on days 1-21 and aromatase inhibitor per treating investigator's discretion. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Aromatase Inhibitor: Aromatase inhibitor per treating investigator's discretion
Laboratory Biomarker Analysis: Correlative studies
Pharmacokinetic Study: Correlative studies
Questionnaire Administration: Ancillary studies
Ribociclib: Given PO
|
|---|---|
|
Number of Participants With Dose Delays
|
2 Participants
|
SECONDARY outcome
Timeframe: Up to 3.5 yearsOutcome measures
| Measure |
Treatment (Ribociclib, Aromatase Inhibitor)
n=2 Participants
Participants receive ribociclib orally PO QD on days 1-21 and aromatase inhibitor per treating investigator's discretion. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Aromatase Inhibitor: Aromatase inhibitor per treating investigator's discretion
Laboratory Biomarker Analysis: Correlative studies
Pharmacokinetic Study: Correlative studies
Questionnaire Administration: Ancillary studies
Ribociclib: Given PO
|
|---|---|
|
Number of Participants With Dose Discontinuations
|
2 Participants
|
SECONDARY outcome
Timeframe: Up to 3.5 yearsObjective response rate (defined as complete response \[CR\] + partial response \[PR\]) as determined by RECIST criteria Complete Response (CR): Disappearance of all target lesions. Lymph node CR is when the lymph node has decreased to less than 10mm in the short axis. Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD.
Outcome measures
| Measure |
Treatment (Ribociclib, Aromatase Inhibitor)
n=2 Participants
Participants receive ribociclib orally PO QD on days 1-21 and aromatase inhibitor per treating investigator's discretion. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Aromatase Inhibitor: Aromatase inhibitor per treating investigator's discretion
Laboratory Biomarker Analysis: Correlative studies
Pharmacokinetic Study: Correlative studies
Questionnaire Administration: Ancillary studies
Ribociclib: Given PO
|
|---|---|
|
Objective Response Rate by Response Evaluation Criteria in Solid Tumors (RECIST) Criteria
|
1 Participants
|
SECONDARY outcome
Timeframe: Up to 3.5 yearsClinical benefit rate (defined as CR+PR+ stable disease) as determined by RECIST Complete Response (CR): Disappearance of all target lesions. Lymph node CR is when the lymph node has decreased to less than 10mm in the short axis. Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.
Outcome measures
| Measure |
Treatment (Ribociclib, Aromatase Inhibitor)
n=2 Participants
Participants receive ribociclib orally PO QD on days 1-21 and aromatase inhibitor per treating investigator's discretion. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Aromatase Inhibitor: Aromatase inhibitor per treating investigator's discretion
Laboratory Biomarker Analysis: Correlative studies
Pharmacokinetic Study: Correlative studies
Questionnaire Administration: Ancillary studies
Ribociclib: Given PO
|
|---|---|
|
Clinical Benefit Rate as Determined by RECIST
|
2 Participants
|
Adverse Events
Treatment (Ribociclib, Aromatase Inhibitor)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 1 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Treatment (Ribociclib, Aromatase Inhibitor)
n=2 participants at risk
Participants receive ribociclib orally PO QD on days 1-21 and aromatase inhibitor per treating investigator's discretion. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Aromatase Inhibitor: Aromatase inhibitor per treating investigator's discretion
Laboratory Biomarker Analysis: Correlative studies
Pharmacokinetic Study: Correlative studies
Questionnaire Administration: Ancillary studies
Ribociclib: Given PO
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
50.0%
1/2 • Up to 30 days post cycle, up to 3.5 years total
All serious adverse events are reported regardless of attribution and grade. Count of participants experiencing other adverse events are reported (after removing serious adverse from the toxicity dataset).
|
|
Eye disorders
left upper eyelid droop
|
50.0%
1/2 • Up to 30 days post cycle, up to 3.5 years total
All serious adverse events are reported regardless of attribution and grade. Count of participants experiencing other adverse events are reported (after removing serious adverse from the toxicity dataset).
|
|
Gastrointestinal disorders
Constipation
|
50.0%
1/2 • Up to 30 days post cycle, up to 3.5 years total
All serious adverse events are reported regardless of attribution and grade. Count of participants experiencing other adverse events are reported (after removing serious adverse from the toxicity dataset).
|
|
Gastrointestinal disorders
Diarrhea
|
50.0%
1/2 • Up to 30 days post cycle, up to 3.5 years total
All serious adverse events are reported regardless of attribution and grade. Count of participants experiencing other adverse events are reported (after removing serious adverse from the toxicity dataset).
|
|
Gastrointestinal disorders
Dyspepsia
|
50.0%
1/2 • Up to 30 days post cycle, up to 3.5 years total
All serious adverse events are reported regardless of attribution and grade. Count of participants experiencing other adverse events are reported (after removing serious adverse from the toxicity dataset).
|
|
Gastrointestinal disorders
Nausea
|
100.0%
2/2 • Up to 30 days post cycle, up to 3.5 years total
All serious adverse events are reported regardless of attribution and grade. Count of participants experiencing other adverse events are reported (after removing serious adverse from the toxicity dataset).
|
|
Gastrointestinal disorders
Vomiting
|
50.0%
1/2 • Up to 30 days post cycle, up to 3.5 years total
All serious adverse events are reported regardless of attribution and grade. Count of participants experiencing other adverse events are reported (after removing serious adverse from the toxicity dataset).
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
50.0%
1/2 • Up to 30 days post cycle, up to 3.5 years total
All serious adverse events are reported regardless of attribution and grade. Count of participants experiencing other adverse events are reported (after removing serious adverse from the toxicity dataset).
|
|
General disorders
Chills
|
50.0%
1/2 • Up to 30 days post cycle, up to 3.5 years total
All serious adverse events are reported regardless of attribution and grade. Count of participants experiencing other adverse events are reported (after removing serious adverse from the toxicity dataset).
|
|
General disorders
Fatigue
|
100.0%
2/2 • Up to 30 days post cycle, up to 3.5 years total
All serious adverse events are reported regardless of attribution and grade. Count of participants experiencing other adverse events are reported (after removing serious adverse from the toxicity dataset).
|
|
General disorders
Pain
|
50.0%
1/2 • Up to 30 days post cycle, up to 3.5 years total
All serious adverse events are reported regardless of attribution and grade. Count of participants experiencing other adverse events are reported (after removing serious adverse from the toxicity dataset).
|
|
General disorders
Edema limbs
|
50.0%
1/2 • Up to 30 days post cycle, up to 3.5 years total
All serious adverse events are reported regardless of attribution and grade. Count of participants experiencing other adverse events are reported (after removing serious adverse from the toxicity dataset).
|
|
General disorders
blood in stool
|
50.0%
1/2 • Up to 30 days post cycle, up to 3.5 years total
All serious adverse events are reported regardless of attribution and grade. Count of participants experiencing other adverse events are reported (after removing serious adverse from the toxicity dataset).
|
|
Infections and infestations
Upper respiratory infection
|
50.0%
1/2 • Up to 30 days post cycle, up to 3.5 years total
All serious adverse events are reported regardless of attribution and grade. Count of participants experiencing other adverse events are reported (after removing serious adverse from the toxicity dataset).
|
|
Investigations
Alanine aminotransferase increased
|
100.0%
2/2 • Up to 30 days post cycle, up to 3.5 years total
All serious adverse events are reported regardless of attribution and grade. Count of participants experiencing other adverse events are reported (after removing serious adverse from the toxicity dataset).
|
|
Investigations
Alkaline phosphatase increased
|
100.0%
2/2 • Up to 30 days post cycle, up to 3.5 years total
All serious adverse events are reported regardless of attribution and grade. Count of participants experiencing other adverse events are reported (after removing serious adverse from the toxicity dataset).
|
|
Investigations
Aspartate aminotransferase increased
|
100.0%
2/2 • Up to 30 days post cycle, up to 3.5 years total
All serious adverse events are reported regardless of attribution and grade. Count of participants experiencing other adverse events are reported (after removing serious adverse from the toxicity dataset).
|
|
Investigations
Cholesterol high
|
50.0%
1/2 • Up to 30 days post cycle, up to 3.5 years total
All serious adverse events are reported regardless of attribution and grade. Count of participants experiencing other adverse events are reported (after removing serious adverse from the toxicity dataset).
|
|
Investigations
Creatinine increased
|
50.0%
1/2 • Up to 30 days post cycle, up to 3.5 years total
All serious adverse events are reported regardless of attribution and grade. Count of participants experiencing other adverse events are reported (after removing serious adverse from the toxicity dataset).
|
|
Investigations
Lymphocyte count decreased
|
50.0%
1/2 • Up to 30 days post cycle, up to 3.5 years total
All serious adverse events are reported regardless of attribution and grade. Count of participants experiencing other adverse events are reported (after removing serious adverse from the toxicity dataset).
|
|
Investigations
Neutrophil count decreased
|
100.0%
2/2 • Up to 30 days post cycle, up to 3.5 years total
All serious adverse events are reported regardless of attribution and grade. Count of participants experiencing other adverse events are reported (after removing serious adverse from the toxicity dataset).
|
|
Investigations
Platelet count decreased
|
50.0%
1/2 • Up to 30 days post cycle, up to 3.5 years total
All serious adverse events are reported regardless of attribution and grade. Count of participants experiencing other adverse events are reported (after removing serious adverse from the toxicity dataset).
|
|
Investigations
White blood cell decreased
|
100.0%
2/2 • Up to 30 days post cycle, up to 3.5 years total
All serious adverse events are reported regardless of attribution and grade. Count of participants experiencing other adverse events are reported (after removing serious adverse from the toxicity dataset).
|
|
Metabolism and nutrition disorders
Anorexia
|
50.0%
1/2 • Up to 30 days post cycle, up to 3.5 years total
All serious adverse events are reported regardless of attribution and grade. Count of participants experiencing other adverse events are reported (after removing serious adverse from the toxicity dataset).
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
50.0%
1/2 • Up to 30 days post cycle, up to 3.5 years total
All serious adverse events are reported regardless of attribution and grade. Count of participants experiencing other adverse events are reported (after removing serious adverse from the toxicity dataset).
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
50.0%
1/2 • Up to 30 days post cycle, up to 3.5 years total
All serious adverse events are reported regardless of attribution and grade. Count of participants experiencing other adverse events are reported (after removing serious adverse from the toxicity dataset).
|
|
Metabolism and nutrition disorders
Hypertriglyceridemia
|
50.0%
1/2 • Up to 30 days post cycle, up to 3.5 years total
All serious adverse events are reported regardless of attribution and grade. Count of participants experiencing other adverse events are reported (after removing serious adverse from the toxicity dataset).
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
50.0%
1/2 • Up to 30 days post cycle, up to 3.5 years total
All serious adverse events are reported regardless of attribution and grade. Count of participants experiencing other adverse events are reported (after removing serious adverse from the toxicity dataset).
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
50.0%
1/2 • Up to 30 days post cycle, up to 3.5 years total
All serious adverse events are reported regardless of attribution and grade. Count of participants experiencing other adverse events are reported (after removing serious adverse from the toxicity dataset).
|
|
Metabolism and nutrition disorders
Hyponatremia
|
100.0%
2/2 • Up to 30 days post cycle, up to 3.5 years total
All serious adverse events are reported regardless of attribution and grade. Count of participants experiencing other adverse events are reported (after removing serious adverse from the toxicity dataset).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
50.0%
1/2 • Up to 30 days post cycle, up to 3.5 years total
All serious adverse events are reported regardless of attribution and grade. Count of participants experiencing other adverse events are reported (after removing serious adverse from the toxicity dataset).
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
50.0%
1/2 • Up to 30 days post cycle, up to 3.5 years total
All serious adverse events are reported regardless of attribution and grade. Count of participants experiencing other adverse events are reported (after removing serious adverse from the toxicity dataset).
|
|
Nervous system disorders
Headache
|
50.0%
1/2 • Up to 30 days post cycle, up to 3.5 years total
All serious adverse events are reported regardless of attribution and grade. Count of participants experiencing other adverse events are reported (after removing serious adverse from the toxicity dataset).
|
|
Nervous system disorders
Memory impairment
|
50.0%
1/2 • Up to 30 days post cycle, up to 3.5 years total
All serious adverse events are reported regardless of attribution and grade. Count of participants experiencing other adverse events are reported (after removing serious adverse from the toxicity dataset).
|
|
Psychiatric disorders
Anxiety
|
50.0%
1/2 • Up to 30 days post cycle, up to 3.5 years total
All serious adverse events are reported regardless of attribution and grade. Count of participants experiencing other adverse events are reported (after removing serious adverse from the toxicity dataset).
|
|
Psychiatric disorders
Depression
|
50.0%
1/2 • Up to 30 days post cycle, up to 3.5 years total
All serious adverse events are reported regardless of attribution and grade. Count of participants experiencing other adverse events are reported (after removing serious adverse from the toxicity dataset).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
100.0%
2/2 • Up to 30 days post cycle, up to 3.5 years total
All serious adverse events are reported regardless of attribution and grade. Count of participants experiencing other adverse events are reported (after removing serious adverse from the toxicity dataset).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
50.0%
1/2 • Up to 30 days post cycle, up to 3.5 years total
All serious adverse events are reported regardless of attribution and grade. Count of participants experiencing other adverse events are reported (after removing serious adverse from the toxicity dataset).
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
50.0%
1/2 • Up to 30 days post cycle, up to 3.5 years total
All serious adverse events are reported regardless of attribution and grade. Count of participants experiencing other adverse events are reported (after removing serious adverse from the toxicity dataset).
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
50.0%
1/2 • Up to 30 days post cycle, up to 3.5 years total
All serious adverse events are reported regardless of attribution and grade. Count of participants experiencing other adverse events are reported (after removing serious adverse from the toxicity dataset).
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
50.0%
1/2 • Up to 30 days post cycle, up to 3.5 years total
All serious adverse events are reported regardless of attribution and grade. Count of participants experiencing other adverse events are reported (after removing serious adverse from the toxicity dataset).
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
50.0%
1/2 • Up to 30 days post cycle, up to 3.5 years total
All serious adverse events are reported regardless of attribution and grade. Count of participants experiencing other adverse events are reported (after removing serious adverse from the toxicity dataset).
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
50.0%
1/2 • Up to 30 days post cycle, up to 3.5 years total
All serious adverse events are reported regardless of attribution and grade. Count of participants experiencing other adverse events are reported (after removing serious adverse from the toxicity dataset).
|
|
Vascular disorders
Hot flashes
|
50.0%
1/2 • Up to 30 days post cycle, up to 3.5 years total
All serious adverse events are reported regardless of attribution and grade. Count of participants experiencing other adverse events are reported (after removing serious adverse from the toxicity dataset).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place