Trial Outcomes & Findings for Neoadjuvant Study of Palbociclib in Combination With Letrozole and Trastuzumab in Stage II-III ER+ HER2+ Breast Cancer (NCT NCT02907918)
NCT ID: NCT02907918
Last Updated: 2021-09-29
Results Overview
A pathologic complete response (pCR) is defined as no histology evidence of invasive tumor cells in the surgical breast specimen and sentinel or axillary lymph nodes.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
26 participants
Primary outcome timeframe
Completion of 4 cycles of treatment (approximately 16 weeks)
Results posted on
2021-09-29
Participant Flow
Participant milestones
| Measure |
Palbociclib + Letrozole + Trastuzumab +/- Goserelin
* Neoadjuvant palbociclib + letrozole (plus goserelin if premenopausal) + trastuzumab for a total of 16 weeks, consisting of (4) 28-day cycles
* Definitive surgery will be performed preferably within 6 weeks after the end of Cycle 4. Letrozole and trastuzumab will continue until the day of surgery. Letrozole will continue to be taken daily and trastuzumab will be given every 3 weeks per standard of care guidelines. Adjuvant therapy following definitive surgery will be at the discretion of the treating physician
|
|---|---|
|
Overall Study
STARTED
|
26
|
|
Overall Study
COMPLETED
|
26
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Neoadjuvant Study of Palbociclib in Combination With Letrozole and Trastuzumab in Stage II-III ER+ HER2+ Breast Cancer
Baseline characteristics by cohort
| Measure |
Palbociclib + Letrozole + Trastuzumab +/- Goserelin
n=26 Participants
* Neoadjuvant palbociclib + letrozole (plus goserelin if premenopausal) + trastuzumab for a total of 16 weeks, consisting of (4) 28-day cycles
* Definitive surgery will be performed preferably within 6 weeks after the end of Cycle 4. Letrozole and trastuzumab will continue until the day of surgery. Letrozole will continue to be taken daily and trastuzumab will be given every 3 weeks per standard of care guidelines. Adjuvant therapy following definitive surgery will be at the discretion of the treating physician
|
|---|---|
|
Age, Continuous
|
59 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
26 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
26 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
24 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
26 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Completion of 4 cycles of treatment (approximately 16 weeks)Population: One participant is not evaluable for this outcome measure because the participant experienced progressive disease after completion of treatment but prior to surgery.
A pathologic complete response (pCR) is defined as no histology evidence of invasive tumor cells in the surgical breast specimen and sentinel or axillary lymph nodes.
Outcome measures
| Measure |
Palbociclib + Letrozole + Trastuzumab +/- Goserelin
n=25 Participants
* Neoadjuvant palbociclib + letrozole (plus goserelin if premenopausal) + trastuzumab for a total of 16 weeks, consisting of (4) 28-day cycles
* Definitive surgery will be performed preferably within 6 weeks after the end of Cycle 4. Letrozole and trastuzumab will continue until the day of surgery. Letrozole will continue to be taken daily and trastuzumab will be given every 3 weeks per standard of care guidelines. Adjuvant therapy following definitive surgery will be at the discretion of the treating physician
|
Cycle 2 Day 1: Palbociclib + Letrozole + Trastuzumab +/- Goserelin
* Neoadjuvant palbociclib + letrozole (plus goserelin if premenopausal) + trastuzumab for a total of 16 weeks, consisting of (4) 28-day cycles
* Definitive surgery will be performed preferably within 6 weeks after the end of Cycle 4. Letrozole and trastuzumab will continue until the day of surgery. Letrozole will continue to be taken daily and trastuzumab will be given every 3 weeks per standard of care guidelines. Adjuvant therapy following definitive surgery will be at the discretion of the treating physician
|
End of Cycle 4: Palbociclib + Letrozole + Trastuzumab +/- Goserelin
* Neoadjuvant palbociclib + letrozole (plus goserelin if premenopausal) + trastuzumab for a total of 16 weeks, consisting of (4) 28-day cycles
* Definitive surgery will be performed preferably within 6 weeks after the end of Cycle 4. Letrozole and trastuzumab will continue until the day of surgery. Letrozole will continue to be taken daily and trastuzumab will be given every 3 weeks per standard of care guidelines. Adjuvant therapy following definitive surgery will be at the discretion of the treating physician
|
|---|---|---|---|
|
Number of Participants With Pathologic Complete Response (pCR)
|
2 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: 30 days after completion of neoadjuvant therapy (approximately 21 weeks)-The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for all toxicity reporting.
Outcome measures
| Measure |
Palbociclib + Letrozole + Trastuzumab +/- Goserelin
n=26 Participants
* Neoadjuvant palbociclib + letrozole (plus goserelin if premenopausal) + trastuzumab for a total of 16 weeks, consisting of (4) 28-day cycles
* Definitive surgery will be performed preferably within 6 weeks after the end of Cycle 4. Letrozole and trastuzumab will continue until the day of surgery. Letrozole will continue to be taken daily and trastuzumab will be given every 3 weeks per standard of care guidelines. Adjuvant therapy following definitive surgery will be at the discretion of the treating physician
|
Cycle 2 Day 1: Palbociclib + Letrozole + Trastuzumab +/- Goserelin
* Neoadjuvant palbociclib + letrozole (plus goserelin if premenopausal) + trastuzumab for a total of 16 weeks, consisting of (4) 28-day cycles
* Definitive surgery will be performed preferably within 6 weeks after the end of Cycle 4. Letrozole and trastuzumab will continue until the day of surgery. Letrozole will continue to be taken daily and trastuzumab will be given every 3 weeks per standard of care guidelines. Adjuvant therapy following definitive surgery will be at the discretion of the treating physician
|
End of Cycle 4: Palbociclib + Letrozole + Trastuzumab +/- Goserelin
* Neoadjuvant palbociclib + letrozole (plus goserelin if premenopausal) + trastuzumab for a total of 16 weeks, consisting of (4) 28-day cycles
* Definitive surgery will be performed preferably within 6 weeks after the end of Cycle 4. Letrozole and trastuzumab will continue until the day of surgery. Letrozole will continue to be taken daily and trastuzumab will be given every 3 weeks per standard of care guidelines. Adjuvant therapy following definitive surgery will be at the discretion of the treating physician
|
|---|---|---|---|
|
Safety and Tolerability of Palbociclib in Combination With Neoadjuvant Letrozole and Trastuzumab (or FDA Approved Biosimilar) as Measured by Number of Participants With Grade 3 & 4 Adverse Events
Neutrophil count decreased
|
13 Participants
|
—
|
—
|
|
Safety and Tolerability of Palbociclib in Combination With Neoadjuvant Letrozole and Trastuzumab (or FDA Approved Biosimilar) as Measured by Number of Participants With Grade 3 & 4 Adverse Events
Lymphocyte count decreased
|
1 Participants
|
—
|
—
|
|
Safety and Tolerability of Palbociclib in Combination With Neoadjuvant Letrozole and Trastuzumab (or FDA Approved Biosimilar) as Measured by Number of Participants With Grade 3 & 4 Adverse Events
Hypertension
|
8 Participants
|
—
|
—
|
|
Safety and Tolerability of Palbociclib in Combination With Neoadjuvant Letrozole and Trastuzumab (or FDA Approved Biosimilar) as Measured by Number of Participants With Grade 3 & 4 Adverse Events
White blood cell decreased
|
2 Participants
|
—
|
—
|
|
Safety and Tolerability of Palbociclib in Combination With Neoadjuvant Letrozole and Trastuzumab (or FDA Approved Biosimilar) as Measured by Number of Participants With Grade 3 & 4 Adverse Events
Colitis
|
1 Participants
|
—
|
—
|
|
Safety and Tolerability of Palbociclib in Combination With Neoadjuvant Letrozole and Trastuzumab (or FDA Approved Biosimilar) as Measured by Number of Participants With Grade 3 & 4 Adverse Events
Hypokalemia
|
1 Participants
|
—
|
—
|
|
Safety and Tolerability of Palbociclib in Combination With Neoadjuvant Letrozole and Trastuzumab (or FDA Approved Biosimilar) as Measured by Number of Participants With Grade 3 & 4 Adverse Events
Pulmonary edema
|
1 Participants
|
—
|
—
|
|
Safety and Tolerability of Palbociclib in Combination With Neoadjuvant Letrozole and Trastuzumab (or FDA Approved Biosimilar) as Measured by Number of Participants With Grade 3 & 4 Adverse Events
Ventricular tachycardia
|
1 Participants
|
—
|
—
|
|
Safety and Tolerability of Palbociclib in Combination With Neoadjuvant Letrozole and Trastuzumab (or FDA Approved Biosimilar) as Measured by Number of Participants With Grade 3 & 4 Adverse Events
Alanine aminotransferase increased
|
1 Participants
|
—
|
—
|
|
Safety and Tolerability of Palbociclib in Combination With Neoadjuvant Letrozole and Trastuzumab (or FDA Approved Biosimilar) as Measured by Number of Participants With Grade 3 & 4 Adverse Events
Aspartate aminotransferase increased
|
1 Participants
|
—
|
—
|
|
Safety and Tolerability of Palbociclib in Combination With Neoadjuvant Letrozole and Trastuzumab (or FDA Approved Biosimilar) as Measured by Number of Participants With Grade 3 & 4 Adverse Events
Colonic obstruction
|
1 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, cycle 2 day 1 (approximately 29 days), and end of cycle 4 (approximately 16 weeks)Population: 3 participants at the end of cycle 4 did not complete the questionnaire.
* Answers ranging from None to Very Severe (none=0 to very severe=4); Not at All to Very Much (not at all=0 to very much=4), Never to Almost Constantly (0=never to almost constantly=4) * PRO-CTCAE responses are scored from 0 to 4, and there are no standardized scoring rules yet established for how to combine attributes into a single score or how best to analyze PRO-CTCAE data longitudinally. * PRO-CTCAE scores for each attribute (frequency, severity and/or interference) will be presented descriptively
Outcome measures
| Measure |
Palbociclib + Letrozole + Trastuzumab +/- Goserelin
n=26 Participants
* Neoadjuvant palbociclib + letrozole (plus goserelin if premenopausal) + trastuzumab for a total of 16 weeks, consisting of (4) 28-day cycles
* Definitive surgery will be performed preferably within 6 weeks after the end of Cycle 4. Letrozole and trastuzumab will continue until the day of surgery. Letrozole will continue to be taken daily and trastuzumab will be given every 3 weeks per standard of care guidelines. Adjuvant therapy following definitive surgery will be at the discretion of the treating physician
|
Cycle 2 Day 1: Palbociclib + Letrozole + Trastuzumab +/- Goserelin
n=26 Participants
* Neoadjuvant palbociclib + letrozole (plus goserelin if premenopausal) + trastuzumab for a total of 16 weeks, consisting of (4) 28-day cycles
* Definitive surgery will be performed preferably within 6 weeks after the end of Cycle 4. Letrozole and trastuzumab will continue until the day of surgery. Letrozole will continue to be taken daily and trastuzumab will be given every 3 weeks per standard of care guidelines. Adjuvant therapy following definitive surgery will be at the discretion of the treating physician
|
End of Cycle 4: Palbociclib + Letrozole + Trastuzumab +/- Goserelin
n=23 Participants
* Neoadjuvant palbociclib + letrozole (plus goserelin if premenopausal) + trastuzumab for a total of 16 weeks, consisting of (4) 28-day cycles
* Definitive surgery will be performed preferably within 6 weeks after the end of Cycle 4. Letrozole and trastuzumab will continue until the day of surgery. Letrozole will continue to be taken daily and trastuzumab will be given every 3 weeks per standard of care guidelines. Adjuvant therapy following definitive surgery will be at the discretion of the treating physician
|
|---|---|---|---|
|
Change in Patient Reported Outcomes as Measured by NCI PRO-CTCAE
In the last 7 days, what was the severity of your dry skin at its worst?
|
1.3076923 score on a scale
Standard Deviation 0.5491252
|
1.6923077 score on a scale
Standard Deviation 0.8375789
|
1.5652174 score on a scale
Standard Deviation 0.7277666
|
|
Change in Patient Reported Outcomes as Measured by NCI PRO-CTCAE
In the last 7 days, what was the severity of your decreased appetite at its worst?
|
1.3461538 score on a scale
Standard Deviation 0.8918434
|
1.3461538 score on a scale
Standard Deviation 0.6894814
|
1.3043478 score on a scale
Standard Deviation 0.8756703
|
|
Change in Patient Reported Outcomes as Measured by NCI PRO-CTCAE
In the last 7 days, how much did decreased appetite interfere with your usual or daily activities?
|
1.0769231 score on a scale
Standard Deviation 0.8448942
|
0.9615385 score on a scale
Standard Deviation 0.3441824
|
1.0434783 score on a scale
Standard Deviation 0.3665888
|
|
Change in Patient Reported Outcomes as Measured by NCI PRO-CTCAE
In the last 7 days, how often did you have nausea?
|
1.2307692 score on a scale
Standard Deviation 0.5870395
|
1.5000000 score on a scale
Standard Deviation 0.9899495
|
1.2608696 score on a scale
Standard Deviation 0.5408236
|
|
Change in Patient Reported Outcomes as Measured by NCI PRO-CTCAE
In the last 7 days, what was the severity of your nausea at its worst?
|
1.1923077 score on a scale
Standard Deviation 0.800961
|
1.4230769 score on a scale
Standard Deviation 0.8566482
|
1.2173913 score on a scale
Standard Deviation 0.6712622
|
|
Change in Patient Reported Outcomes as Measured by NCI PRO-CTCAE
In the last 7 days, what was the severity of your shortness of breath (SOB) at its worst?
|
1.1923077 score on a scale
Standard Deviation 0.5670436
|
1.1153846 score on a scale
Standard Deviation 0.515901
|
1.4347826 score on a scale
Standard Deviation 0.8957519
|
|
Change in Patient Reported Outcomes as Measured by NCI PRO-CTCAE
In the last 7 days, how much did your SOB interfere with your usual or daily activities?
|
0.9615385 score on a scale
Standard Deviation 0.4454902
|
1.0384615 score on a scale
Standard Deviation 0.4454902
|
1.173913 score on a scale
Standard Deviation 0.6503268
|
|
Change in Patient Reported Outcomes as Measured by NCI PRO-CTCAE
In the last 7 days, what was the severity of your cough at its worst?
|
1.1923077 score on a scale
Standard Deviation 0.4019185
|
1.2307692 score on a scale
Standard Deviation 0.5870395
|
1.5217391 score on a scale
Standard Deviation 1.0816471
|
|
Change in Patient Reported Outcomes as Measured by NCI PRO-CTCAE
In the last 7 days, how much did your cough interfere with your usual and daily activities?
|
1.0000000 score on a scale
Standard Deviation 0.2828427
|
1.0384615 score on a scale
Standard Deviation 0.5276946
|
1.3043478 score on a scale
Standard Deviation 0.9739695
|
|
Change in Patient Reported Outcomes as Measured by NCI PRO-CTCAE
In the last 7 days, how often did you have arm or leg swelling?
|
1.0000000 score on a scale
Standard Deviation 0.0000000
|
1.0384615 score on a scale
Standard Deviation 0.3441824
|
1.2608696 score on a scale
Standard Deviation 0.9153832
|
|
Change in Patient Reported Outcomes as Measured by NCI PRO-CTCAE
In the last 7 days, what was the severity of your arm or leg swelling at its worst?
|
0.8846154 score on a scale
Standard Deviation 0.3258126
|
1.0384615 score on a scale
Standard Deviation 0.5276946
|
1.1304348 score on a scale
Standard Deviation 0.4576966
|
|
Change in Patient Reported Outcomes as Measured by NCI PRO-CTCAE
In the last 7 days, how much did arm or leg swelling interfere with your usual or daily activities?
|
0.9230769 score on a scale
Standard Deviation 0.2717465
|
0.8846154 score on a scale
Standard Deviation 0.3258126
|
1.0434783 score on a scale
Standard Deviation 0.474654
|
|
Change in Patient Reported Outcomes as Measured by NCI PRO-CTCAE
In the last 7 days, how often did you feel a pounding or racing heartbeat (palpitations)?
|
1.1538462 score on a scale
Standard Deviation 0.4640955
|
1.1923077 score on a scale
Standard Deviation 0.5670436
|
1.173913 score on a scale
Standard Deviation 0.4910262
|
|
Change in Patient Reported Outcomes as Measured by NCI PRO-CTCAE
In the last 7 days, what was the severity of your pounding or racing heartbeat at its worst?
|
1.0384615 score on a scale
Standard Deviation 0.4454902
|
1.1923077 score on a scale
Standard Deviation 0.6939297
|
1.1304348 score on a scale
Standard Deviation 0.5480833
|
|
Change in Patient Reported Outcomes as Measured by NCI PRO-CTCAE
In the last 7 days, did you have any rash?
|
1.8461538 score on a scale
Standard Deviation 0.3679465
|
1.6153846 score on a scale
Standard Deviation 0.5710988
|
1.826087 score on a scale
Standard Deviation 0.3875534
|
|
Change in Patient Reported Outcomes as Measured by NCI PRO-CTCAE
In the last 7 days, did you have any hair loss?
|
1.0769231 score on a scale
Standard Deviation 0.2717465
|
1.1153846 score on a scale
Standard Deviation 0.4314555
|
1.6086957 score on a scale
Standard Deviation 0.8913284
|
|
Change in Patient Reported Outcomes as Measured by NCI PRO-CTCAE
In the last 7 days, what was the severity of your problems with concentration at their worst?
|
1.1923077 score on a scale
Standard Deviation 0.4914656
|
1.5000000 score on a scale
Standard Deviation 0.8602325
|
1.4782609 score on a scale
Standard Deviation 0.7902569
|
|
Change in Patient Reported Outcomes as Measured by NCI PRO-CTCAE
In the past 7 days, how much did problems with concentration interfere with usual/daily activities?
|
1.1538462 score on a scale
Standard Deviation 0.543493
|
1.3076923 score on a scale
Standard Deviation 0.6793662
|
1.3478261 score on a scale
Standard Deviation 0.9820524
|
Adverse Events
Palbociclib + Letrozole + Trastuzumab +/- Goserelin
Serious events: 2 serious events
Other events: 26 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Palbociclib + Letrozole + Trastuzumab +/- Goserelin
n=26 participants at risk
* Neoadjuvant palbociclib + letrozole (plus goserelin if premenopausal) + trastuzumab for a total of 16 weeks, consisting of (4) 28-day cycles
* Definitive surgery will be performed preferably within 6 weeks after the end of Cycle 4. Letrozole and trastuzumab will continue until the day of surgery. Letrozole will continue to be taken daily and trastuzumab will be given every 3 weeks per standard of care guidelines. Adjuvant therapy following definitive surgery will be at the discretion of the treating physician
|
|---|---|
|
Gastrointestinal disorders
Colonic obstruction
|
3.8%
1/26 • Adverse events were followed from start of treatment through 30 days after last dose of palbociclib.
|
|
Injury, poisoning and procedural complications
Fracture
|
3.8%
1/26 • Adverse events were followed from start of treatment through 30 days after last dose of palbociclib.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary edema
|
3.8%
1/26 • Adverse events were followed from start of treatment through 30 days after last dose of palbociclib.
|
|
Vascular disorders
Hypertension
|
3.8%
1/26 • Adverse events were followed from start of treatment through 30 days after last dose of palbociclib.
|
Other adverse events
| Measure |
Palbociclib + Letrozole + Trastuzumab +/- Goserelin
n=26 participants at risk
* Neoadjuvant palbociclib + letrozole (plus goserelin if premenopausal) + trastuzumab for a total of 16 weeks, consisting of (4) 28-day cycles
* Definitive surgery will be performed preferably within 6 weeks after the end of Cycle 4. Letrozole and trastuzumab will continue until the day of surgery. Letrozole will continue to be taken daily and trastuzumab will be given every 3 weeks per standard of care guidelines. Adjuvant therapy following definitive surgery will be at the discretion of the treating physician
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
76.9%
20/26 • Adverse events were followed from start of treatment through 30 days after last dose of palbociclib.
|
|
Blood and lymphatic system disorders
Intravenous antibiotics for positive blood cultures
|
3.8%
1/26 • Adverse events were followed from start of treatment through 30 days after last dose of palbociclib.
|
|
Blood and lymphatic system disorders
Lymph node pain
|
3.8%
1/26 • Adverse events were followed from start of treatment through 30 days after last dose of palbociclib.
|
|
Cardiac disorders
Palpitations
|
7.7%
2/26 • Adverse events were followed from start of treatment through 30 days after last dose of palbociclib.
|
|
Cardiac disorders
Ventricular tachycardia
|
3.8%
1/26 • Adverse events were followed from start of treatment through 30 days after last dose of palbociclib.
|
|
Eye disorders
Blurred vision
|
11.5%
3/26 • Adverse events were followed from start of treatment through 30 days after last dose of palbociclib.
|
|
Eye disorders
Depth perception change
|
3.8%
1/26 • Adverse events were followed from start of treatment through 30 days after last dose of palbociclib.
|
|
Eye disorders
Dry eye
|
11.5%
3/26 • Adverse events were followed from start of treatment through 30 days after last dose of palbociclib.
|
|
Eye disorders
Stye - left eye
|
3.8%
1/26 • Adverse events were followed from start of treatment through 30 days after last dose of palbociclib.
|
|
Eye disorders
Watering eyes
|
3.8%
1/26 • Adverse events were followed from start of treatment through 30 days after last dose of palbociclib.
|
|
Gastrointestinal disorders
Colitis
|
3.8%
1/26 • Adverse events were followed from start of treatment through 30 days after last dose of palbociclib.
|
|
Gastrointestinal disorders
Constipation
|
11.5%
3/26 • Adverse events were followed from start of treatment through 30 days after last dose of palbociclib.
|
|
Gastrointestinal disorders
Diarrhea
|
26.9%
7/26 • Adverse events were followed from start of treatment through 30 days after last dose of palbociclib.
|
|
Gastrointestinal disorders
Dry mouth
|
3.8%
1/26 • Adverse events were followed from start of treatment through 30 days after last dose of palbociclib.
|
|
Gastrointestinal disorders
Dyspepsia
|
11.5%
3/26 • Adverse events were followed from start of treatment through 30 days after last dose of palbociclib.
|
|
Gastrointestinal disorders
Hemorrhoids
|
3.8%
1/26 • Adverse events were followed from start of treatment through 30 days after last dose of palbociclib.
|
|
Gastrointestinal disorders
Mucositis oral
|
19.2%
5/26 • Adverse events were followed from start of treatment through 30 days after last dose of palbociclib.
|
|
Gastrointestinal disorders
Nausea
|
30.8%
8/26 • Adverse events were followed from start of treatment through 30 days after last dose of palbociclib.
|
|
Gastrointestinal disorders
Oral pain
|
3.8%
1/26 • Adverse events were followed from start of treatment through 30 days after last dose of palbociclib.
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
3.8%
1/26 • Adverse events were followed from start of treatment through 30 days after last dose of palbociclib.
|
|
Gastrointestinal disorders
Stomach ache
|
3.8%
1/26 • Adverse events were followed from start of treatment through 30 days after last dose of palbociclib.
|
|
Gastrointestinal disorders
Vomiting
|
11.5%
3/26 • Adverse events were followed from start of treatment through 30 days after last dose of palbociclib.
|
|
General disorders
Chills
|
11.5%
3/26 • Adverse events were followed from start of treatment through 30 days after last dose of palbociclib.
|
|
General disorders
Edema limbs
|
3.8%
1/26 • Adverse events were followed from start of treatment through 30 days after last dose of palbociclib.
|
|
General disorders
Fatigue
|
69.2%
18/26 • Adverse events were followed from start of treatment through 30 days after last dose of palbociclib.
|
|
General disorders
Fever
|
3.8%
1/26 • Adverse events were followed from start of treatment through 30 days after last dose of palbociclib.
|
|
General disorders
Hypertension
|
61.5%
16/26 • Adverse events were followed from start of treatment through 30 days after last dose of palbociclib.
|
|
General disorders
Left armpit pain
|
3.8%
1/26 • Adverse events were followed from start of treatment through 30 days after last dose of palbociclib.
|
|
General disorders
Pain
|
7.7%
2/26 • Adverse events were followed from start of treatment through 30 days after last dose of palbociclib.
|
|
General disorders
Right hip pain
|
3.8%
1/26 • Adverse events were followed from start of treatment through 30 days after last dose of palbociclib.
|
|
General disorders
Right underarm edema
|
3.8%
1/26 • Adverse events were followed from start of treatment through 30 days after last dose of palbociclib.
|
|
Immune system disorders
Allergic reaction
|
3.8%
1/26 • Adverse events were followed from start of treatment through 30 days after last dose of palbociclib.
|
|
Immune system disorders
Seasonal allergies
|
3.8%
1/26 • Adverse events were followed from start of treatment through 30 days after last dose of palbociclib.
|
|
Infections and infestations
Bronchial infection
|
3.8%
1/26 • Adverse events were followed from start of treatment through 30 days after last dose of palbociclib.
|
|
Infections and infestations
Cold sores
|
3.8%
1/26 • Adverse events were followed from start of treatment through 30 days after last dose of palbociclib.
|
|
Infections and infestations
Papulopustular rash
|
3.8%
1/26 • Adverse events were followed from start of treatment through 30 days after last dose of palbociclib.
|
|
Infections and infestations
Prophylactic herpes
|
3.8%
1/26 • Adverse events were followed from start of treatment through 30 days after last dose of palbociclib.
|
|
Infections and infestations
Redness of nail bed - right
|
3.8%
1/26 • Adverse events were followed from start of treatment through 30 days after last dose of palbociclib.
|
|
Infections and infestations
Sinusitis
|
3.8%
1/26 • Adverse events were followed from start of treatment through 30 days after last dose of palbociclib.
|
|
Infections and infestations
Upper respiratory infection
|
3.8%
1/26 • Adverse events were followed from start of treatment through 30 days after last dose of palbociclib.
|
|
Infections and infestations
Urinary tract infection
|
3.8%
1/26 • Adverse events were followed from start of treatment through 30 days after last dose of palbociclib.
|
|
Infections and infestations
Wound infection
|
3.8%
1/26 • Adverse events were followed from start of treatment through 30 days after last dose of palbociclib.
|
|
Injury, poisoning and procedural complications
Breast pain - surgery
|
3.8%
1/26 • Adverse events were followed from start of treatment through 30 days after last dose of palbociclib.
|
|
Injury, poisoning and procedural complications
Pain related to surgery
|
3.8%
1/26 • Adverse events were followed from start of treatment through 30 days after last dose of palbociclib.
|
|
Investigations
Alanine aminotransferase increased
|
26.9%
7/26 • Adverse events were followed from start of treatment through 30 days after last dose of palbociclib.
|
|
Investigations
Aspartate aminotransferase increased
|
23.1%
6/26 • Adverse events were followed from start of treatment through 30 days after last dose of palbociclib.
|
|
Investigations
Creatinine increased
|
7.7%
2/26 • Adverse events were followed from start of treatment through 30 days after last dose of palbociclib.
|
|
Investigations
Ejection fraction decreased
|
3.8%
1/26 • Adverse events were followed from start of treatment through 30 days after last dose of palbociclib.
|
|
Investigations
Electrocardiogram QT corrected
|
3.8%
1/26 • Adverse events were followed from start of treatment through 30 days after last dose of palbociclib.
|
|
Investigations
Lymphocyte count decreased
|
34.6%
9/26 • Adverse events were followed from start of treatment through 30 days after last dose of palbociclib.
|
|
Investigations
Neutrophil count decreased
|
88.5%
23/26 • Adverse events were followed from start of treatment through 30 days after last dose of palbociclib.
|
|
Investigations
Platelet count decreased
|
57.7%
15/26 • Adverse events were followed from start of treatment through 30 days after last dose of palbociclib.
|
|
Investigations
White blood cell decreased
|
100.0%
26/26 • Adverse events were followed from start of treatment through 30 days after last dose of palbociclib.
|
|
Metabolism and nutrition disorders
Anorexia
|
3.8%
1/26 • Adverse events were followed from start of treatment through 30 days after last dose of palbociclib.
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
11.5%
3/26 • Adverse events were followed from start of treatment through 30 days after last dose of palbociclib.
|
|
Metabolism and nutrition disorders
Hypernatremia
|
3.8%
1/26 • Adverse events were followed from start of treatment through 30 days after last dose of palbociclib.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
3.8%
1/26 • Adverse events were followed from start of treatment through 30 days after last dose of palbociclib.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
7.7%
2/26 • Adverse events were followed from start of treatment through 30 days after last dose of palbociclib.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
7.7%
2/26 • Adverse events were followed from start of treatment through 30 days after last dose of palbociclib.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
11.5%
3/26 • Adverse events were followed from start of treatment through 30 days after last dose of palbociclib.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
11.5%
3/26 • Adverse events were followed from start of treatment through 30 days after last dose of palbociclib.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia - knees
|
3.8%
1/26 • Adverse events were followed from start of treatment through 30 days after last dose of palbociclib.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
3.8%
1/26 • Adverse events were followed from start of treatment through 30 days after last dose of palbociclib.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
3.8%
1/26 • Adverse events were followed from start of treatment through 30 days after last dose of palbociclib.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
3.8%
1/26 • Adverse events were followed from start of treatment through 30 days after last dose of palbociclib.
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
3.8%
1/26 • Adverse events were followed from start of treatment through 30 days after last dose of palbociclib.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
3.8%
1/26 • Adverse events were followed from start of treatment through 30 days after last dose of palbociclib.
|
|
Nervous system disorders
Concentration impairment
|
7.7%
2/26 • Adverse events were followed from start of treatment through 30 days after last dose of palbociclib.
|
|
Nervous system disorders
Dizziness
|
15.4%
4/26 • Adverse events were followed from start of treatment through 30 days after last dose of palbociclib.
|
|
Nervous system disorders
Dysgeusia
|
15.4%
4/26 • Adverse events were followed from start of treatment through 30 days after last dose of palbociclib.
|
|
Nervous system disorders
Headache
|
42.3%
11/26 • Adverse events were followed from start of treatment through 30 days after last dose of palbociclib.
|
|
Nervous system disorders
Migraine
|
3.8%
1/26 • Adverse events were followed from start of treatment through 30 days after last dose of palbociclib.
|
|
Nervous system disorders
Paresthesia
|
3.8%
1/26 • Adverse events were followed from start of treatment through 30 days after last dose of palbociclib.
|
|
Nervous system disorders
Peripheral motor neuropathy
|
3.8%
1/26 • Adverse events were followed from start of treatment through 30 days after last dose of palbociclib.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
7.7%
2/26 • Adverse events were followed from start of treatment through 30 days after last dose of palbociclib.
|
|
Nervous system disorders
Peripheral sensory neuropathy - fingers
|
3.8%
1/26 • Adverse events were followed from start of treatment through 30 days after last dose of palbociclib.
|
|
Psychiatric disorders
Anxiety
|
3.8%
1/26 • Adverse events were followed from start of treatment through 30 days after last dose of palbociclib.
|
|
Psychiatric disorders
Insomnia
|
7.7%
2/26 • Adverse events were followed from start of treatment through 30 days after last dose of palbociclib.
|
|
Reproductive system and breast disorders
Bilateral breast pain
|
3.8%
1/26 • Adverse events were followed from start of treatment through 30 days after last dose of palbociclib.
|
|
Reproductive system and breast disorders
Breast pain
|
3.8%
1/26 • Adverse events were followed from start of treatment through 30 days after last dose of palbociclib.
|
|
Reproductive system and breast disorders
Vaginal pruritus
|
3.8%
1/26 • Adverse events were followed from start of treatment through 30 days after last dose of palbociclib.
|
|
Respiratory, thoracic and mediastinal disorders
Cold/sore throat
|
3.8%
1/26 • Adverse events were followed from start of treatment through 30 days after last dose of palbociclib.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
23.1%
6/26 • Adverse events were followed from start of treatment through 30 days after last dose of palbociclib.
|
|
Respiratory, thoracic and mediastinal disorders
Dry nose
|
3.8%
1/26 • Adverse events were followed from start of treatment through 30 days after last dose of palbociclib.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
19.2%
5/26 • Adverse events were followed from start of treatment through 30 days after last dose of palbociclib.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
34.6%
9/26 • Adverse events were followed from start of treatment through 30 days after last dose of palbociclib.
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
3.8%
1/26 • Adverse events were followed from start of treatment through 30 days after last dose of palbociclib.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
7.7%
2/26 • Adverse events were followed from start of treatment through 30 days after last dose of palbociclib.
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal drip
|
11.5%
3/26 • Adverse events were followed from start of treatment through 30 days after last dose of palbociclib.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary edema
|
3.8%
1/26 • Adverse events were followed from start of treatment through 30 days after last dose of palbociclib.
|
|
Respiratory, thoracic and mediastinal disorders
Runny nose
|
3.8%
1/26 • Adverse events were followed from start of treatment through 30 days after last dose of palbociclib.
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
7.7%
2/26 • Adverse events were followed from start of treatment through 30 days after last dose of palbociclib.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
3.8%
1/26 • Adverse events were followed from start of treatment through 30 days after last dose of palbociclib.
|
|
Skin and subcutaneous tissue disorders
Acne on nose
|
3.8%
1/26 • Adverse events were followed from start of treatment through 30 days after last dose of palbociclib.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
11.5%
3/26 • Adverse events were followed from start of treatment through 30 days after last dose of palbociclib.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
11.5%
3/26 • Adverse events were followed from start of treatment through 30 days after last dose of palbociclib.
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
3.8%
1/26 • Adverse events were followed from start of treatment through 30 days after last dose of palbociclib.
|
|
Skin and subcutaneous tissue disorders
Facial rash
|
3.8%
1/26 • Adverse events were followed from start of treatment through 30 days after last dose of palbociclib.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
3.8%
1/26 • Adverse events were followed from start of treatment through 30 days after last dose of palbociclib.
|
|
Skin and subcutaneous tissue disorders
Itchy rash bilateral arms
|
3.8%
1/26 • Adverse events were followed from start of treatment through 30 days after last dose of palbociclib.
|
|
Skin and subcutaneous tissue disorders
Mild rash face/chin
|
3.8%
1/26 • Adverse events were followed from start of treatment through 30 days after last dose of palbociclib.
|
|
Skin and subcutaneous tissue disorders
Papular urticaria
|
3.8%
1/26 • Adverse events were followed from start of treatment through 30 days after last dose of palbociclib.
|
|
Skin and subcutaneous tissue disorders
Peeling fingers
|
3.8%
1/26 • Adverse events were followed from start of treatment through 30 days after last dose of palbociclib.
|
|
Skin and subcutaneous tissue disorders
Pruritis
|
7.7%
2/26 • Adverse events were followed from start of treatment through 30 days after last dose of palbociclib.
|
|
Skin and subcutaneous tissue disorders
Rash
|
7.7%
2/26 • Adverse events were followed from start of treatment through 30 days after last dose of palbociclib.
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
3.8%
1/26 • Adverse events were followed from start of treatment through 30 days after last dose of palbociclib.
|
|
Skin and subcutaneous tissue disorders
Rash maculopapular
|
11.5%
3/26 • Adverse events were followed from start of treatment through 30 days after last dose of palbociclib.
|
|
Skin and subcutaneous tissue disorders
Rash near port site
|
3.8%
1/26 • Adverse events were followed from start of treatment through 30 days after last dose of palbociclib.
|
|
Skin and subcutaneous tissue disorders
Sensitive skin
|
3.8%
1/26 • Adverse events were followed from start of treatment through 30 days after last dose of palbociclib.
|
|
Skin and subcutaneous tissue disorders
Skin pain
|
3.8%
1/26 • Adverse events were followed from start of treatment through 30 days after last dose of palbociclib.
|
|
Skin and subcutaneous tissue disorders
Stye
|
3.8%
1/26 • Adverse events were followed from start of treatment through 30 days after last dose of palbociclib.
|
|
Vascular disorders
Hot flashes
|
19.2%
5/26 • Adverse events were followed from start of treatment through 30 days after last dose of palbociclib.
|
|
Vascular disorders
Hypertension
|
57.7%
15/26 • Adverse events were followed from start of treatment through 30 days after last dose of palbociclib.
|
Additional Information
Foluso O. Ademuyiwa, M.D., MPH
Washington University School of Medicine
Phone: 314-454-8313
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place