Trial Outcomes & Findings for Treatment of Metastatic Breast Cancer With Fulvestrant Plus Palbociclib or Tamoxifen Plus Palbociclib (NCT NCT02913430)
NCT ID: NCT02913430
Last Updated: 2024-09-23
Results Overview
The duration of time from time of randomization to time of progression or death, whichever occurs first. Disease progression (PD) as defined by RECIST v1.1: At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The progression of non-target lesions or the appearance of one or more new lesions is also considered progression. PFS for a subject without an event will be censored on the date of last tumor assessment. If an interval of 6 months passes without a tumor assessment, PFS will be censored at the time of the earlier tumor assessment, even if an event (progressive disease or death) is later observed.
COMPLETED
EARLY_PHASE1
7 participants
Up to 3 years and 351 days
2024-09-23
Participant Flow
All patients
Participant milestones
| Measure |
Fulvestrant + Palbociclib
Fulvestrant: 500mg IM Q28 days
Palbociclib: 125mg/day PO on a 21 days on/7 days off schedule
|
Tamoxifen + Palbociclib
Tamoxifen: 20mg PO Q-daily
Palbociclib: 125mg/day PO on a 21 days on/7 days off schedule
|
|---|---|---|
|
Overall Study
STARTED
|
5
|
2
|
|
Overall Study
COMPLETED
|
5
|
2
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Treatment of Metastatic Breast Cancer With Fulvestrant Plus Palbociclib or Tamoxifen Plus Palbociclib
Baseline characteristics by cohort
| Measure |
Fulvestrant + Palbociclib
n=5 Participants
Fulvestrant: 500mg IM Q28 days
Palbociclib: 125mg/day PO on a 21 days on/7 days off schedule
|
Tamoxifen + Palbociclib
n=2 Participants
Tamoxifen: 20mg PO Q-daily
Palbociclib: 125mg/day PO on a 21 days on/7 days off schedule
|
Total
n=7 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
65.00 years
STANDARD_DEVIATION 14.32 • n=5 Participants
|
69.50 years
STANDARD_DEVIATION 4.95 • n=7 Participants
|
66.29 years
STANDARD_DEVIATION 12.07 • n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
ECOG Performance Status (at study entry)
ECOG = 0
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
ECOG Performance Status (at study entry)
ECOG = 1
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
ECOG Performance Status (at study entry)
ECOG = 2
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
ECOG Performance Status (at study entry)
ECOG = 3
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
ECOG Performance Status (at study entry)
ECOG = 4
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
ECOG Performance Status (at study entry)
ECOG = 5
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 3 years and 351 daysPopulation: Treated patients that were radiologically evaluable.
The duration of time from time of randomization to time of progression or death, whichever occurs first. Disease progression (PD) as defined by RECIST v1.1: At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The progression of non-target lesions or the appearance of one or more new lesions is also considered progression. PFS for a subject without an event will be censored on the date of last tumor assessment. If an interval of 6 months passes without a tumor assessment, PFS will be censored at the time of the earlier tumor assessment, even if an event (progressive disease or death) is later observed.
Outcome measures
| Measure |
Fulvestrant + Palbociclib
n=5 Participants
Fulvestrant: 500mg IM Q28 days
Palbociclib: 125mg/day PO on a 21 days on/7 days off schedule
|
Tamoxifen + Palbociclib
n=2 Participants
Tamoxifen: 20mg PO Q-daily
Palbociclib: 125mg/day PO on a 21 days on/7 days off schedule
|
|---|---|---|
|
Progression-free Survival (PFS)
|
4.131147 months
Interval 1.672131 to
Upper bound of confidence interval not reached. Insufficient number of participants with events.
|
NA months
Confidence interval NOT determined. Insufficient number of participants with events.
|
SECONDARY outcome
Timeframe: Up to 5 yearsPopulation: Treated patients that were radiologically evaluable.
The number of patients experiencing Complete Response (CR), Partial Response (PR), Stable Disease (SD) or Progressive Disease (PD) per RECIST v1.1; Per Response Evaluation Criteria in Solid Tumors (RECIST v1.1): (CR) is disappearance of all target and nontarget lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm; (PR) is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters; (SD) is neither sufficient decrease (target lesions) to qualify as a PR or sufficient increase to qualify as PD. Incomplete Response/Stable Disease (SD) is the persistence of one or more non-target lesions. (PD) is defined as at least a 20% increase in the sum of the diameters of target lesions compared to baseline sum of target lesions, or any new lesions. It also includes the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions.
Outcome measures
| Measure |
Fulvestrant + Palbociclib
n=5 Participants
Fulvestrant: 500mg IM Q28 days
Palbociclib: 125mg/day PO on a 21 days on/7 days off schedule
|
Tamoxifen + Palbociclib
n=2 Participants
Tamoxifen: 20mg PO Q-daily
Palbociclib: 125mg/day PO on a 21 days on/7 days off schedule
|
|---|---|---|
|
Best Overall Response (BOR)
Progressive Disease (PD)
|
2 Participants
|
0 Participants
|
|
Best Overall Response (BOR)
Complete Response (CR)
|
0 Participants
|
0 Participants
|
|
Best Overall Response (BOR)
Partial Response (PR)
|
0 Participants
|
0 Participants
|
|
Best Overall Response (BOR)
Stable Disease (SD)
|
3 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Up to 6 monthsPopulation: Treated patients that were radiologically evaluable.
The number of patients experiencing Complete Response (CR), Partial Response (PR), or Stable Disease (SD) per RECIST v1.1; Per Response Evaluation Criteria in Solid Tumors (RECIST v1.1): (CR) is disappearance of all target and nontarget lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm; (PR) is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters; (SD) is neither sufficient decrease (target lesions) to qualify as a PR or sufficient increase to qualify as PD. Incomplete Response/Stable Disease (SD) is the persistence of one or more non-target lesions.
Outcome measures
| Measure |
Fulvestrant + Palbociclib
n=5 Participants
Fulvestrant: 500mg IM Q28 days
Palbociclib: 125mg/day PO on a 21 days on/7 days off schedule
|
Tamoxifen + Palbociclib
n=2 Participants
Tamoxifen: 20mg PO Q-daily
Palbociclib: 125mg/day PO on a 21 days on/7 days off schedule
|
|---|---|---|
|
6-Month Clinical Benefit Rate (CBR)
|
2 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Up to 5 yearsPopulation: Treated patients that were radiologically evaluable.
The number of patients experiencing Complete Response (CR), Partial Response (PR), or Stable Disease (SD) per RECIST v1.1; Per Response Evaluation Criteria in Solid Tumors (RECIST v1.1): (CR) is disappearance of all target and nontarget lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm; (PR) is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters; (SD) is neither sufficient decrease (target lesions) to qualify as a PR or sufficient increase to qualify as PD. Incomplete Response/Stable Disease (SD) is the persistence of one or more non-target lesions.
Outcome measures
| Measure |
Fulvestrant + Palbociclib
n=5 Participants
Fulvestrant: 500mg IM Q28 days
Palbociclib: 125mg/day PO on a 21 days on/7 days off schedule
|
Tamoxifen + Palbociclib
n=2 Participants
Tamoxifen: 20mg PO Q-daily
Palbociclib: 125mg/day PO on a 21 days on/7 days off schedule
|
|---|---|---|
|
Clinical Benefit Rate (CBR)
|
3 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Up to 5 yearsPopulation: All enrolled patients.
The median length of time from the start of treatment that patients remain alive.
Outcome measures
| Measure |
Fulvestrant + Palbociclib
n=5 Participants
Fulvestrant: 500mg IM Q28 days
Palbociclib: 125mg/day PO on a 21 days on/7 days off schedule
|
Tamoxifen + Palbociclib
n=2 Participants
Tamoxifen: 20mg PO Q-daily
Palbociclib: 125mg/day PO on a 21 days on/7 days off schedule
|
|---|---|---|
|
Overall Survival (OS)
|
NA months
Interval 11.77049 to
Insufficient number of participants with event.
|
18.75410 months
Interval 18.7541 to
Insufficient number of participants with event.
|
Adverse Events
Fulvestrant + Palbociclib
Tamoxifen + Palbociclib
Serious adverse events
| Measure |
Fulvestrant + Palbociclib
n=5 participants at risk
Fulvestrant: 500mg IM Q28 days
Palbociclib: 125mg/day PO on a 21 days on/7 days off schedule
|
Tamoxifen + Palbociclib
n=2 participants at risk
Tamoxifen: 20mg PO Q-daily
Palbociclib: 125mg/day PO on a 21 days on/7 days off schedule
|
|---|---|---|
|
Blood and lymphatic system disorders
Neutrophil count decreased
|
40.0%
2/5 • Up to 5 years
Common Terminology Criteria for Adverse Events (CTCAE) v4.0
|
0.00%
0/2 • Up to 5 years
Common Terminology Criteria for Adverse Events (CTCAE) v4.0
|
|
Blood and lymphatic system disorders
White blood cell decreased
|
20.0%
1/5 • Up to 5 years
Common Terminology Criteria for Adverse Events (CTCAE) v4.0
|
0.00%
0/2 • Up to 5 years
Common Terminology Criteria for Adverse Events (CTCAE) v4.0
|
Other adverse events
| Measure |
Fulvestrant + Palbociclib
n=5 participants at risk
Fulvestrant: 500mg IM Q28 days
Palbociclib: 125mg/day PO on a 21 days on/7 days off schedule
|
Tamoxifen + Palbociclib
n=2 participants at risk
Tamoxifen: 20mg PO Q-daily
Palbociclib: 125mg/day PO on a 21 days on/7 days off schedule
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
60.0%
3/5 • Up to 5 years
Common Terminology Criteria for Adverse Events (CTCAE) v4.0
|
0.00%
0/2 • Up to 5 years
Common Terminology Criteria for Adverse Events (CTCAE) v4.0
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other
|
60.0%
3/5 • Up to 5 years
Common Terminology Criteria for Adverse Events (CTCAE) v4.0
|
0.00%
0/2 • Up to 5 years
Common Terminology Criteria for Adverse Events (CTCAE) v4.0
|
|
Blood and lymphatic system disorders
Anemia
|
40.0%
2/5 • Up to 5 years
Common Terminology Criteria for Adverse Events (CTCAE) v4.0
|
0.00%
0/2 • Up to 5 years
Common Terminology Criteria for Adverse Events (CTCAE) v4.0
|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders - Other
|
20.0%
1/5 • Up to 5 years
Common Terminology Criteria for Adverse Events (CTCAE) v4.0
|
50.0%
1/2 • Up to 5 years
Common Terminology Criteria for Adverse Events (CTCAE) v4.0
|
|
General disorders
General disorders and administration site conditions
|
40.0%
2/5 • Up to 5 years
Common Terminology Criteria for Adverse Events (CTCAE) v4.0
|
0.00%
0/2 • Up to 5 years
Common Terminology Criteria for Adverse Events (CTCAE) v4.0
|
|
Metabolism and nutrition disorders
Hyponatremia
|
40.0%
2/5 • Up to 5 years
Common Terminology Criteria for Adverse Events (CTCAE) v4.0
|
0.00%
0/2 • Up to 5 years
Common Terminology Criteria for Adverse Events (CTCAE) v4.0
|
|
Investigations
Lymphocyte count decreased
|
40.0%
2/5 • Up to 5 years
Common Terminology Criteria for Adverse Events (CTCAE) v4.0
|
0.00%
0/2 • Up to 5 years
Common Terminology Criteria for Adverse Events (CTCAE) v4.0
|
|
General disorders
Pain
|
40.0%
2/5 • Up to 5 years
Common Terminology Criteria for Adverse Events (CTCAE) v4.0
|
0.00%
0/2 • Up to 5 years
Common Terminology Criteria for Adverse Events (CTCAE) v4.0
|
|
Renal and urinary disorders
Renal and urinary disorders - Other
|
20.0%
1/5 • Up to 5 years
Common Terminology Criteria for Adverse Events (CTCAE) v4.0
|
50.0%
1/2 • Up to 5 years
Common Terminology Criteria for Adverse Events (CTCAE) v4.0
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
20.0%
1/5 • Up to 5 years
Common Terminology Criteria for Adverse Events (CTCAE) v4.0
|
0.00%
0/2 • Up to 5 years
Common Terminology Criteria for Adverse Events (CTCAE) v4.0
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
20.0%
1/5 • Up to 5 years
Common Terminology Criteria for Adverse Events (CTCAE) v4.0
|
0.00%
0/2 • Up to 5 years
Common Terminology Criteria for Adverse Events (CTCAE) v4.0
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
20.0%
1/5 • Up to 5 years
Common Terminology Criteria for Adverse Events (CTCAE) v4.0
|
0.00%
0/2 • Up to 5 years
Common Terminology Criteria for Adverse Events (CTCAE) v4.0
|
|
Injury, poisoning and procedural complications
Bruising
|
20.0%
1/5 • Up to 5 years
Common Terminology Criteria for Adverse Events (CTCAE) v4.0
|
0.00%
0/2 • Up to 5 years
Common Terminology Criteria for Adverse Events (CTCAE) v4.0
|
|
Gastrointestinal disorders
Constipation
|
20.0%
1/5 • Up to 5 years
Common Terminology Criteria for Adverse Events (CTCAE) v4.0
|
0.00%
0/2 • Up to 5 years
Common Terminology Criteria for Adverse Events (CTCAE) v4.0
|
|
Eye disorders
Eye pain
|
20.0%
1/5 • Up to 5 years
Common Terminology Criteria for Adverse Events (CTCAE) v4.0
|
0.00%
0/2 • Up to 5 years
Common Terminology Criteria for Adverse Events (CTCAE) v4.0
|
|
Injury, poisoning and procedural complications
Fall
|
20.0%
1/5 • Up to 5 years
Common Terminology Criteria for Adverse Events (CTCAE) v4.0
|
0.00%
0/2 • Up to 5 years
Common Terminology Criteria for Adverse Events (CTCAE) v4.0
|
|
General disorders
Fatigue
|
20.0%
1/5 • Up to 5 years
Common Terminology Criteria for Adverse Events (CTCAE) v4.0
|
0.00%
0/2 • Up to 5 years
Common Terminology Criteria for Adverse Events (CTCAE) v4.0
|
|
General disorders
Flu like symptoms
|
20.0%
1/5 • Up to 5 years
Common Terminology Criteria for Adverse Events (CTCAE) v4.0
|
0.00%
0/2 • Up to 5 years
Common Terminology Criteria for Adverse Events (CTCAE) v4.0
|
|
Injury, poisoning and procedural complications
Fracture
|
20.0%
1/5 • Up to 5 years
Common Terminology Criteria for Adverse Events (CTCAE) v4.0
|
0.00%
0/2 • Up to 5 years
Common Terminology Criteria for Adverse Events (CTCAE) v4.0
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
20.0%
1/5 • Up to 5 years
Common Terminology Criteria for Adverse Events (CTCAE) v4.0
|
0.00%
0/2 • Up to 5 years
Common Terminology Criteria for Adverse Events (CTCAE) v4.0
|
|
Cardiac disorders
Heart failure
|
20.0%
1/5 • Up to 5 years
Common Terminology Criteria for Adverse Events (CTCAE) v4.0
|
0.00%
0/2 • Up to 5 years
Common Terminology Criteria for Adverse Events (CTCAE) v4.0
|
|
Vascular disorders
Hypertension
|
0.00%
0/5 • Up to 5 years
Common Terminology Criteria for Adverse Events (CTCAE) v4.0
|
50.0%
1/2 • Up to 5 years
Common Terminology Criteria for Adverse Events (CTCAE) v4.0
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
20.0%
1/5 • Up to 5 years
Common Terminology Criteria for Adverse Events (CTCAE) v4.0
|
0.00%
0/2 • Up to 5 years
Common Terminology Criteria for Adverse Events (CTCAE) v4.0
|
|
Metabolism and nutrition disorders
Hypokalemia
|
20.0%
1/5 • Up to 5 years
Common Terminology Criteria for Adverse Events (CTCAE) v4.0
|
0.00%
0/2 • Up to 5 years
Common Terminology Criteria for Adverse Events (CTCAE) v4.0
|
|
Vascular disorders
Hypotension
|
20.0%
1/5 • Up to 5 years
Common Terminology Criteria for Adverse Events (CTCAE) v4.0
|
0.00%
0/2 • Up to 5 years
Common Terminology Criteria for Adverse Events (CTCAE) v4.0
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
20.0%
1/5 • Up to 5 years
Common Terminology Criteria for Adverse Events (CTCAE) v4.0
|
0.00%
0/2 • Up to 5 years
Common Terminology Criteria for Adverse Events (CTCAE) v4.0
|
|
Nervous system disorders
Nervous system disorders - Other
|
20.0%
1/5 • Up to 5 years
Common Terminology Criteria for Adverse Events (CTCAE) v4.0
|
0.00%
0/2 • Up to 5 years
Common Terminology Criteria for Adverse Events (CTCAE) v4.0
|
|
Investigations
Platelet count decreased
|
20.0%
1/5 • Up to 5 years
Common Terminology Criteria for Adverse Events (CTCAE) v4.0
|
0.00%
0/2 • Up to 5 years
Common Terminology Criteria for Adverse Events (CTCAE) v4.0
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/5 • Up to 5 years
Common Terminology Criteria for Adverse Events (CTCAE) v4.0
|
50.0%
1/2 • Up to 5 years
Common Terminology Criteria for Adverse Events (CTCAE) v4.0
|
|
Psychiatric disorders
Psychiatric disorders - Other
|
20.0%
1/5 • Up to 5 years
Common Terminology Criteria for Adverse Events (CTCAE) v4.0
|
0.00%
0/2 • Up to 5 years
Common Terminology Criteria for Adverse Events (CTCAE) v4.0
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other
|
20.0%
1/5 • Up to 5 years
Common Terminology Criteria for Adverse Events (CTCAE) v4.0
|
0.00%
0/2 • Up to 5 years
Common Terminology Criteria for Adverse Events (CTCAE) v4.0
|
|
Investigations
Neutrophil count decreased
|
60.0%
3/5 • Up to 5 years
Common Terminology Criteria for Adverse Events (CTCAE) v4.0
|
50.0%
1/2 • Up to 5 years
Common Terminology Criteria for Adverse Events (CTCAE) v4.0
|
|
Investigations
White blood cell decreased
|
60.0%
3/5 • Up to 5 years
Common Terminology Criteria for Adverse Events (CTCAE) v4.0
|
50.0%
1/2 • Up to 5 years
Common Terminology Criteria for Adverse Events (CTCAE) v4.0
|
Additional Information
Barbara Stadterman, MPH, MSCR
UPMC Hillman Cancer Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place