Trial Outcomes & Findings for Alternative Dosing Schedule of Palbociclib in Metastatic Hormone Receptor Positive Breast Cancer (NCT NCT03007979)
NCT ID: NCT03007979
Last Updated: 2024-03-20
Results Overview
* 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. * Grade 3 neutropenia: \<1000-500/mm\^3; \<1.0-0.5 x 10e9/L * Grade 4 neutropenia: \<500/mm\^3; \<0.5 x 10e9/L
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
55 participants
Primary outcome timeframe
Through the first 29 days of treatment
Results posted on
2024-03-20
Participant Flow
Participant milestones
| Measure |
Palbociclib + Letrozole or + Fulvestrant
* Palbociclib should be taken by mouth with food on a 5 days on/2 days off schedule (meaning: on Days 1-5, 8-12, 15-19, and 22-26 of each 28-day cycle).
* Patients who are receiving letrozole will take it daily by mouth, every day of each 28-day cycle.
* Patients who are receiving fulvestrant will receive it as two intramuscular injections (one into each buttock) on Days 1 and 15 of Cycle 1 and then on Day 1 of each cycle thereafter.
* Goserelin is given as a subcutaneous injection every 28 days. It is preferred to be given on Day 1 of each cycle, but it may be administered on any day of the treatment cycle to accommodate its specific Q28-day cycle. It will be given to pre- or peri-menopausal women only.
* Optional research biopsy at baseline and progression
* Blood for research at baseline, cycle 1 day 15, cycle 2 day 1, every 2-3 months (to coincide with imaging studies), and time of progression
|
|---|---|
|
Overall Study
STARTED
|
55
|
|
Overall Study
COMPLETED
|
54
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Palbociclib + Letrozole or + Fulvestrant
* Palbociclib should be taken by mouth with food on a 5 days on/2 days off schedule (meaning: on Days 1-5, 8-12, 15-19, and 22-26 of each 28-day cycle).
* Patients who are receiving letrozole will take it daily by mouth, every day of each 28-day cycle.
* Patients who are receiving fulvestrant will receive it as two intramuscular injections (one into each buttock) on Days 1 and 15 of Cycle 1 and then on Day 1 of each cycle thereafter.
* Goserelin is given as a subcutaneous injection every 28 days. It is preferred to be given on Day 1 of each cycle, but it may be administered on any day of the treatment cycle to accommodate its specific Q28-day cycle. It will be given to pre- or peri-menopausal women only.
* Optional research biopsy at baseline and progression
* Blood for research at baseline, cycle 1 day 15, cycle 2 day 1, every 2-3 months (to coincide with imaging studies), and time of progression
|
|---|---|
|
Overall Study
Deemed not eligible prior to starting palbociclib
|
1
|
Baseline Characteristics
Alternative Dosing Schedule of Palbociclib in Metastatic Hormone Receptor Positive Breast Cancer
Baseline characteristics by cohort
| Measure |
Palbociclib + Letrozole or + Fulvestrant
n=55 Participants
* Palbociclib should be taken by mouth with food on a 5 days on/2 days off schedule (meaning: on Days 1-5, 8-12, 15-19, and 22-26 of each 28-day cycle).
* Patients who are receiving letrozole will take it daily by mouth, every day of each 28-day cycle.
* Patients who are receiving fulvestrant will receive it as two intramuscular injections (one into each buttock) on Days 1 and 15 of Cycle 1 and then on Day 1 of each cycle thereafter.
* Goserelin is given as a subcutaneous injection every 28 days. It is preferred to be given on Day 1 of each cycle, but it may be administered on any day of the treatment cycle to accommodate its specific Q28-day cycle. It will be given to pre- or peri-menopausal women only.
* Optional research biopsy at baseline and progression
* Blood for research at baseline, cycle 1 day 15, cycle 2 day 1, every 2-3 months (to coincide with imaging studies), and time of progression
|
|---|---|
|
Age, Continuous
|
61 years
n=93 Participants
|
|
Sex: Female, Male
Female
|
55 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
55 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Black or African American
|
10 Participants
n=93 Participants
|
|
Race (NIH/OMB)
White
|
45 Participants
n=93 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
|
Region of Enrollment
United States
|
55 participants
n=93 Participants
|
PRIMARY outcome
Timeframe: Through the first 29 days of treatmentPopulation: The following participants were not evaluable for this outcome measure: 4 participants did not take palbociclib dose as per protocol and were without dose-limiting toxicity; 2 participants withdrew in cycle 1, and 1 participant went off treatment in cycle 1 due to adverse events unrelated to the study.
* 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. * Grade 3 neutropenia: \<1000-500/mm\^3; \<1.0-0.5 x 10e9/L * Grade 4 neutropenia: \<500/mm\^3; \<0.5 x 10e9/L
Outcome measures
| Measure |
Palbociclib + Letrozole or + Fulvestrant
n=47 Participants
* Palbociclib should be taken by mouth with food on a 5 days on/2 days off schedule (meaning: on Days 1-5, 8-12, 15-19, and 22-26 of each 28-day cycle).
* Patients who are receiving letrozole will take it daily by mouth, every day of each 28-day cycle.
* Patients who are receiving fulvestrant will receive it as two intramuscular injections (one into each buttock) on Days 1 and 15 of Cycle 1 and then on Day 1 of each cycle thereafter.
* Goserelin is given as a subcutaneous injection every 28 days. It is preferred to be given on Day 1 of each cycle, but it may be administered on any day of the treatment cycle to accommodate its specific Q28-day cycle. It will be given to pre- or peri-menopausal women only.
* Optional research biopsy at baseline and progression
* Blood for research at baseline, cycle 1 day 15, cycle 2 day 1, every 2-3 months (to coincide with imaging studies), and time of progression
|
|---|---|
|
Rate of Grade 3 or Higher Neutropenia
|
10 Participants
|
SECONDARY outcome
Timeframe: Through 30 day follow-up (estimated to be 25 months)Population: The following participants were not evaluable for this outcome measure: 4 participants did not take palbociclib dose as per protocol and were without dose-limiting toxicity; 2 participants withdrew in cycle 1, and 1 participant went off treatment in cycle 1 due to adverse events unrelated to the study.
* 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. * Grade 3 neutropenia: \<1000-500/mm\^3; \<1.0-0.5 x 10e9/L * Grade 4 neutropenia: \<500/mm\^3; \<0.5 x 10e9/L
Outcome measures
| Measure |
Palbociclib + Letrozole or + Fulvestrant
n=47 Participants
* Palbociclib should be taken by mouth with food on a 5 days on/2 days off schedule (meaning: on Days 1-5, 8-12, 15-19, and 22-26 of each 28-day cycle).
* Patients who are receiving letrozole will take it daily by mouth, every day of each 28-day cycle.
* Patients who are receiving fulvestrant will receive it as two intramuscular injections (one into each buttock) on Days 1 and 15 of Cycle 1 and then on Day 1 of each cycle thereafter.
* Goserelin is given as a subcutaneous injection every 28 days. It is preferred to be given on Day 1 of each cycle, but it may be administered on any day of the treatment cycle to accommodate its specific Q28-day cycle. It will be given to pre- or peri-menopausal women only.
* Optional research biopsy at baseline and progression
* Blood for research at baseline, cycle 1 day 15, cycle 2 day 1, every 2-3 months (to coincide with imaging studies), and time of progression
|
|---|---|
|
Rate of Grade 3 or Higher Neutropenia
|
23 Participants
|
SECONDARY outcome
Timeframe: Through the completion of treatment (estimated to be 24 months)-Percentage of participants who have a palbociclib dose reduction during treatment
Outcome measures
| Measure |
Palbociclib + Letrozole or + Fulvestrant
n=54 Participants
* Palbociclib should be taken by mouth with food on a 5 days on/2 days off schedule (meaning: on Days 1-5, 8-12, 15-19, and 22-26 of each 28-day cycle).
* Patients who are receiving letrozole will take it daily by mouth, every day of each 28-day cycle.
* Patients who are receiving fulvestrant will receive it as two intramuscular injections (one into each buttock) on Days 1 and 15 of Cycle 1 and then on Day 1 of each cycle thereafter.
* Goserelin is given as a subcutaneous injection every 28 days. It is preferred to be given on Day 1 of each cycle, but it may be administered on any day of the treatment cycle to accommodate its specific Q28-day cycle. It will be given to pre- or peri-menopausal women only.
* Optional research biopsy at baseline and progression
* Blood for research at baseline, cycle 1 day 15, cycle 2 day 1, every 2-3 months (to coincide with imaging studies), and time of progression
|
|---|---|
|
Rate of Palbociclib Dose Reduction
|
13 Participants
|
SECONDARY outcome
Timeframe: Through the completion of treatment (estimated to be 24 months)-Percentage of participants who have a palbociclib dose interruption during treatment
Outcome measures
| Measure |
Palbociclib + Letrozole or + Fulvestrant
n=54 Participants
* Palbociclib should be taken by mouth with food on a 5 days on/2 days off schedule (meaning: on Days 1-5, 8-12, 15-19, and 22-26 of each 28-day cycle).
* Patients who are receiving letrozole will take it daily by mouth, every day of each 28-day cycle.
* Patients who are receiving fulvestrant will receive it as two intramuscular injections (one into each buttock) on Days 1 and 15 of Cycle 1 and then on Day 1 of each cycle thereafter.
* Goserelin is given as a subcutaneous injection every 28 days. It is preferred to be given on Day 1 of each cycle, but it may be administered on any day of the treatment cycle to accommodate its specific Q28-day cycle. It will be given to pre- or peri-menopausal women only.
* Optional research biopsy at baseline and progression
* Blood for research at baseline, cycle 1 day 15, cycle 2 day 1, every 2-3 months (to coincide with imaging studies), and time of progression
|
|---|---|
|
Rate of Palbociclib Dose Interruption
|
39 Participants
|
SECONDARY outcome
Timeframe: Through the completion of treatment (estimated to be 24 months)-Percentage of participants who discontinue palbociclib due to adverse event
Outcome measures
| Measure |
Palbociclib + Letrozole or + Fulvestrant
n=54 Participants
* Palbociclib should be taken by mouth with food on a 5 days on/2 days off schedule (meaning: on Days 1-5, 8-12, 15-19, and 22-26 of each 28-day cycle).
* Patients who are receiving letrozole will take it daily by mouth, every day of each 28-day cycle.
* Patients who are receiving fulvestrant will receive it as two intramuscular injections (one into each buttock) on Days 1 and 15 of Cycle 1 and then on Day 1 of each cycle thereafter.
* Goserelin is given as a subcutaneous injection every 28 days. It is preferred to be given on Day 1 of each cycle, but it may be administered on any day of the treatment cycle to accommodate its specific Q28-day cycle. It will be given to pre- or peri-menopausal women only.
* Optional research biopsy at baseline and progression
* Blood for research at baseline, cycle 1 day 15, cycle 2 day 1, every 2-3 months (to coincide with imaging studies), and time of progression
|
|---|---|
|
Rate of Palbociclib Discontinuation
|
2 Participants
|
SECONDARY outcome
Timeframe: Through the 30 day follow-up (estimated to be 25 months)* 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. * Relationship of possible, probably, or definitely related.
Outcome measures
| Measure |
Palbociclib + Letrozole or + Fulvestrant
n=54 Participants
* Palbociclib should be taken by mouth with food on a 5 days on/2 days off schedule (meaning: on Days 1-5, 8-12, 15-19, and 22-26 of each 28-day cycle).
* Patients who are receiving letrozole will take it daily by mouth, every day of each 28-day cycle.
* Patients who are receiving fulvestrant will receive it as two intramuscular injections (one into each buttock) on Days 1 and 15 of Cycle 1 and then on Day 1 of each cycle thereafter.
* Goserelin is given as a subcutaneous injection every 28 days. It is preferred to be given on Day 1 of each cycle, but it may be administered on any day of the treatment cycle to accommodate its specific Q28-day cycle. It will be given to pre- or peri-menopausal women only.
* Optional research biopsy at baseline and progression
* Blood for research at baseline, cycle 1 day 15, cycle 2 day 1, every 2-3 months (to coincide with imaging studies), and time of progression
|
|---|---|
|
Adverse Event Profile of Palbociclib
Grade 1-2 anemia
|
31 Participants
|
|
Adverse Event Profile of Palbociclib
Grade 3-4 anemia
|
4 Participants
|
|
Adverse Event Profile of Palbociclib
Grade 1-2 blurred vision
|
1 Participants
|
|
Adverse Event Profile of Palbociclib
Grade 1/2 constipation
|
5 Participants
|
|
Adverse Event Profile of Palbociclib
Grade 1-2 diarrhea
|
8 Participants
|
|
Adverse Event Profile of Palbociclib
Grade 1-2 dyspepsia
|
1 Participants
|
|
Adverse Event Profile of Palbociclib
Grade 1-2 gastric ulcer
|
1 Participants
|
|
Adverse Event Profile of Palbociclib
Grade 1-2 mucositis oral
|
11 Participants
|
|
Adverse Event Profile of Palbociclib
Grade 1-2 nausea
|
16 Participants
|
|
Adverse Event Profile of Palbociclib
Grade 1-2 oral dysesthesia
|
1 Participants
|
|
Adverse Event Profile of Palbociclib
Grade 1-2 vomiting
|
7 Participants
|
|
Adverse Event Profile of Palbociclib
Grade 1-2 chills
|
3 Participants
|
|
Adverse Event Profile of Palbociclib
Grade 1-2 fatigue
|
22 Participants
|
|
Adverse Event Profile of Palbociclib
Grade 1-2 fever
|
3 Participants
|
|
Adverse Event Profile of Palbociclib
Grade 1-2 diverticulitis
|
1 Participants
|
|
Adverse Event Profile of Palbociclib
Grade 3-4 sepsis
|
1 Participants
|
|
Adverse Event Profile of Palbociclib
Grade 1-2 urinary tract infection
|
1 Participants
|
|
Adverse Event Profile of Palbociclib
Grade 1-2 bruising
|
1 Participants
|
|
Adverse Event Profile of Palbociclib
Grade 1-2 radiation recall reaction (dermatologic)
|
1 Participants
|
|
Adverse Event Profile of Palbociclib
Grade 1-2 alanine aminotransferase increased
|
4 Participants
|
|
Adverse Event Profile of Palbociclib
Grade 3-4 alanine aminotransferase increased
|
2 Participants
|
|
Adverse Event Profile of Palbociclib
Grade 1-2 alkaline phosphatase increased
|
4 Participants
|
|
Adverse Event Profile of Palbociclib
Grade 1-2 aspartate aminotransferase increased
|
4 Participants
|
|
Adverse Event Profile of Palbociclib
Grade 3-4 aspartate aminotransferase increased
|
1 Participants
|
|
Adverse Event Profile of Palbociclib
Grade 1-2 blood bilirubin increased
|
1 Participants
|
|
Adverse Event Profile of Palbociclib
Grade 1-2 creatinine increased
|
2 Participants
|
|
Adverse Event Profile of Palbociclib
Grade 1-2 hemoglobin increased
|
1 Participants
|
|
Adverse Event Profile of Palbociclib
Grade 1-2 lymphocyte count decreased
|
23 Participants
|
|
Adverse Event Profile of Palbociclib
Grade 3-4 lymphocyte count decreased
|
13 Participants
|
|
Adverse Event Profile of Palbociclib
Grade 1-2 neutrophil count decreased
|
22 Participants
|
|
Adverse Event Profile of Palbociclib
Grade 3-4 neutrophil count decreased
|
24 Participants
|
|
Adverse Event Profile of Palbociclib
Grade 1-2 platelet count decreased
|
21 Participants
|
|
Adverse Event Profile of Palbociclib
Grade 3-4 platelet count decreased
|
1 Participants
|
|
Adverse Event Profile of Palbociclib
Grade 1-2 weight loss
|
1 Participants
|
|
Adverse Event Profile of Palbociclib
Grade 3-4 weight loss
|
1 Participants
|
|
Adverse Event Profile of Palbociclib
Grade 1-2 white blood cell decreased
|
26 Participants
|
|
Adverse Event Profile of Palbociclib
Grade 3-4 white blood cell decreased
|
26 Participants
|
|
Adverse Event Profile of Palbociclib
Grade 1-2 anorexia
|
4 Participants
|
|
Adverse Event Profile of Palbociclib
Grade 3-4 hyperglycemia
|
1 Participants
|
|
Adverse Event Profile of Palbociclib
Grade 1-2 hypermagnesemia
|
1 Participants
|
|
Adverse Event Profile of Palbociclib
Grade 1-2 hypoalbuminemia
|
1 Participants
|
|
Adverse Event Profile of Palbociclib
Grade 1-2 hypocalcemia
|
1 Participants
|
|
Adverse Event Profile of Palbociclib
Grade 1-2 hypokalemia
|
2 Participants
|
|
Adverse Event Profile of Palbociclib
Grade 1-2 hyponatremia
|
1 Participants
|
|
Adverse Event Profile of Palbociclib
Grade 1-2 arthralgia
|
6 Participants
|
|
Adverse Event Profile of Palbociclib
Grade 1-2 arthritis
|
1 Participants
|
|
Adverse Event Profile of Palbociclib
Grade 1-2 back pain
|
1 Participants
|
|
Adverse Event Profile of Palbociclib
Grade 1-2 bone pain
|
1 Participants
|
|
Adverse Event Profile of Palbociclib
Grade 1-2 leg stiffness
|
1 Participants
|
|
Adverse Event Profile of Palbociclib
Grade 1-2 muscle cramps
|
1 Participants
|
|
Adverse Event Profile of Palbociclib
Grade 1-2 myalgia
|
3 Participants
|
|
Adverse Event Profile of Palbociclib
Grade 1-2 neck pain
|
1 Participants
|
|
Adverse Event Profile of Palbociclib
Grade 1-2 osteonecrosis of jaw
|
1 Participants
|
|
Adverse Event Profile of Palbociclib
Grade 1-2 pain in extremity
|
1 Participants
|
|
Adverse Event Profile of Palbociclib
Grade 1-2 dizziness
|
4 Participants
|
|
Adverse Event Profile of Palbociclib
Grade 3-4 dizziness
|
1 Participants
|
|
Adverse Event Profile of Palbociclib
Grade 1-2 dysgeusia
|
5 Participants
|
|
Adverse Event Profile of Palbociclib
Grade 1-2 headache
|
2 Participants
|
|
Adverse Event Profile of Palbociclib
Grade 1-2 spasticity
|
1 Participants
|
|
Adverse Event Profile of Palbociclib
Grade 1-2 depression
|
1 Participants
|
|
Adverse Event Profile of Palbociclib
Grade 1-2 insomnia
|
3 Participants
|
|
Adverse Event Profile of Palbociclib
Grade 1-2 mood swings
|
1 Participants
|
|
Adverse Event Profile of Palbociclib
Grade 1-2 breast pain
|
1 Participants
|
|
Adverse Event Profile of Palbociclib
Grade 1-2 vaginal dryness
|
1 Participants
|
|
Adverse Event Profile of Palbociclib
Grade 1-2 epistaxis
|
2 Participants
|
|
Adverse Event Profile of Palbociclib
Grade 1-2 sore throat
|
1 Participants
|
|
Adverse Event Profile of Palbociclib
Grade 1-2 voice alteration
|
1 Participants
|
|
Adverse Event Profile of Palbociclib
Grade 1-2 alopecia
|
19 Participants
|
|
Adverse Event Profile of Palbociclib
Grade 1-2 brittle nails
|
1 Participants
|
|
Adverse Event Profile of Palbociclib
Grade 1-2 dry skin
|
2 Participants
|
|
Adverse Event Profile of Palbociclib
Grade 1-2 hyperhidrosis
|
3 Participants
|
|
Adverse Event Profile of Palbociclib
Grade 1-2 itchy skin
|
3 Participants
|
|
Adverse Event Profile of Palbociclib
Grade 1-2 nail loss
|
1 Participants
|
|
Adverse Event Profile of Palbociclib
Grade 1-2 oral fissure
|
1 Participants
|
|
Adverse Event Profile of Palbociclib
Grade 1-2 rash acneiform
|
1 Participants
|
|
Adverse Event Profile of Palbociclib
Grade 1-2 rash maculo-papular
|
1 Participants
|
|
Adverse Event Profile of Palbociclib
Grade 1-2 hot flashes
|
12 Participants
|
|
Adverse Event Profile of Palbociclib
Grade 1-2 hypertension
|
2 Participants
|
|
Adverse Event Profile of Palbociclib
Grade 3-4 thromboembolic event
|
1 Participants
|
SECONDARY outcome
Timeframe: 1 year* PFS will be followed from start of treatment to time of progression or death, whichever occurs first. * Progressive disease: At least a 20% increase in the sum of the 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. (Note: the appearance of one or more new lesions is also considered progressions).
Outcome measures
| Measure |
Palbociclib + Letrozole or + Fulvestrant
n=54 Participants
* Palbociclib should be taken by mouth with food on a 5 days on/2 days off schedule (meaning: on Days 1-5, 8-12, 15-19, and 22-26 of each 28-day cycle).
* Patients who are receiving letrozole will take it daily by mouth, every day of each 28-day cycle.
* Patients who are receiving fulvestrant will receive it as two intramuscular injections (one into each buttock) on Days 1 and 15 of Cycle 1 and then on Day 1 of each cycle thereafter.
* Goserelin is given as a subcutaneous injection every 28 days. It is preferred to be given on Day 1 of each cycle, but it may be administered on any day of the treatment cycle to accommodate its specific Q28-day cycle. It will be given to pre- or peri-menopausal women only.
* Optional research biopsy at baseline and progression
* Blood for research at baseline, cycle 1 day 15, cycle 2 day 1, every 2-3 months (to coincide with imaging studies), and time of progression
|
|---|---|
|
Kaplan-Meier Estimate of Progression-free Survival (PFS)
|
67.911 percentage of participants-Kaplan Meier
Interval 52.934 to 79.025
|
SECONDARY outcome
Timeframe: Time of progression (estimated to be 24 months)* Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm, dDisappearance of all non-target lesions and normalization of tumor marker level. All lymph nodes must be non-pathological in size (\<10 mm short axis). * Partial Response (PR): At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters
Outcome measures
| Measure |
Palbociclib + Letrozole or + Fulvestrant
n=54 Participants
* Palbociclib should be taken by mouth with food on a 5 days on/2 days off schedule (meaning: on Days 1-5, 8-12, 15-19, and 22-26 of each 28-day cycle).
* Patients who are receiving letrozole will take it daily by mouth, every day of each 28-day cycle.
* Patients who are receiving fulvestrant will receive it as two intramuscular injections (one into each buttock) on Days 1 and 15 of Cycle 1 and then on Day 1 of each cycle thereafter.
* Goserelin is given as a subcutaneous injection every 28 days. It is preferred to be given on Day 1 of each cycle, but it may be administered on any day of the treatment cycle to accommodate its specific Q28-day cycle. It will be given to pre- or peri-menopausal women only.
* Optional research biopsy at baseline and progression
* Blood for research at baseline, cycle 1 day 15, cycle 2 day 1, every 2-3 months (to coincide with imaging studies), and time of progression
|
|---|---|
|
Overall Response Rate (Complete Response + Partial Response)
|
18 Participants
|
SECONDARY outcome
Timeframe: Time of progression (estimated to be 24 months)* Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm, dDisappearance of all non-target lesions and normalization of tumor marker level. All lymph nodes must be non-pathological in size (\<10 mm short axis). * Partial Response (PR): At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters * Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.
Outcome measures
| Measure |
Palbociclib + Letrozole or + Fulvestrant
n=54 Participants
* Palbociclib should be taken by mouth with food on a 5 days on/2 days off schedule (meaning: on Days 1-5, 8-12, 15-19, and 22-26 of each 28-day cycle).
* Patients who are receiving letrozole will take it daily by mouth, every day of each 28-day cycle.
* Patients who are receiving fulvestrant will receive it as two intramuscular injections (one into each buttock) on Days 1 and 15 of Cycle 1 and then on Day 1 of each cycle thereafter.
* Goserelin is given as a subcutaneous injection every 28 days. It is preferred to be given on Day 1 of each cycle, but it may be administered on any day of the treatment cycle to accommodate its specific Q28-day cycle. It will be given to pre- or peri-menopausal women only.
* Optional research biopsy at baseline and progression
* Blood for research at baseline, cycle 1 day 15, cycle 2 day 1, every 2-3 months (to coincide with imaging studies), and time of progression
|
|---|---|
|
Clinical Benefit Rate (Complete Response + Partial Response + Stable Disease) for at Least 6 Months)
|
45 Participants
|
Adverse Events
Palbociclib + Letrozole or + Fulvestrant
Serious events: 15 serious events
Other events: 54 other events
Deaths: 3 deaths
Serious adverse events
| Measure |
Palbociclib + Letrozole or + Fulvestrant
n=54 participants at risk
* Palbociclib should be taken by mouth with food on a 5 days on/2 days off schedule (meaning: on Days 1-5, 8-12, 15-19, and 22-26 of each 28-day cycle).
* Patients who are receiving letrozole will take it daily by mouth, every day of each 28-day cycle.
* Patients who are receiving fulvestrant will receive it as two intramuscular injections (one into each buttock) on Days 1 and 15 of Cycle 1 and then on Day 1 of each cycle thereafter.
* Goserelin is given as a subcutaneous injection every 28 days. It is preferred to be given on Day 1 of each cycle, but it may be administered on any day of the treatment cycle to accommodate its specific Q28-day cycle. It will be given to pre- or peri-menopausal women only.
* Optional research biopsy at baseline and progression
* Blood for research at baseline, cycle 1 day 15, cycle 2 day 1, every 2-3 months (to coincide with imaging studies), and time of progression
|
|---|---|
|
Cardiac disorders
Chest pain - cardiac
|
1.9%
1/54 • Adverse events were collected from start of treatment through 30 days following completion of treatment.
|
|
Cardiac disorders
Myocardial infarction
|
1.9%
1/54 • Adverse events were collected from start of treatment through 30 days following completion of treatment.
|
|
Gastrointestinal disorders
Constipation
|
1.9%
1/54 • Adverse events were collected from start of treatment through 30 days following completion of treatment.
|
|
Gastrointestinal disorders
Dysphagia
|
1.9%
1/54 • Adverse events were collected from start of treatment through 30 days following completion of treatment.
|
|
Gastrointestinal disorders
Nausea
|
3.7%
2/54 • Adverse events were collected from start of treatment through 30 days following completion of treatment.
|
|
Gastrointestinal disorders
Vomiting
|
3.7%
2/54 • Adverse events were collected from start of treatment through 30 days following completion of treatment.
|
|
General disorders
Death
|
5.6%
3/54 • Adverse events were collected from start of treatment through 30 days following completion of treatment.
|
|
General disorders
Fever
|
1.9%
1/54 • Adverse events were collected from start of treatment through 30 days following completion of treatment.
|
|
General disorders
Generalized weakness
|
1.9%
1/54 • Adverse events were collected from start of treatment through 30 days following completion of treatment.
|
|
Infections and infestations
Cellulitis
|
5.6%
3/54 • Adverse events were collected from start of treatment through 30 days following completion of treatment.
|
|
Infections and infestations
Sepsis
|
1.9%
1/54 • Adverse events were collected from start of treatment through 30 days following completion of treatment.
|
|
Infections and infestations
Urinary tract infection
|
3.7%
2/54 • Adverse events were collected from start of treatment through 30 days following completion of treatment.
|
|
Investigations
Alanine aminotransferase increased
|
1.9%
1/54 • Adverse events were collected from start of treatment through 30 days following completion of treatment.
|
|
Investigations
Aspartate aminotransferase increased
|
1.9%
1/54 • Adverse events were collected from start of treatment through 30 days following completion of treatment.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.9%
1/54 • Adverse events were collected from start of treatment through 30 days following completion of treatment.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
1.9%
1/54 • Adverse events were collected from start of treatment through 30 days following completion of treatment.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
1.9%
1/54 • Adverse events were collected from start of treatment through 30 days following completion of treatment.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
1.9%
1/54 • Adverse events were collected from start of treatment through 30 days following completion of treatment.
|
|
Nervous system disorders
Cognitive disturbance
|
1.9%
1/54 • Adverse events were collected from start of treatment through 30 days following completion of treatment.
|
|
Renal and urinary disorders
Acute kidney injury
|
3.7%
2/54 • Adverse events were collected from start of treatment through 30 days following completion of treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
1.9%
1/54 • Adverse events were collected from start of treatment through 30 days following completion of treatment.
|
|
Vascular disorders
Hypotension
|
1.9%
1/54 • Adverse events were collected from start of treatment through 30 days following completion of treatment.
|
|
Vascular disorders
Superficial thrombophlebitis
|
1.9%
1/54 • Adverse events were collected from start of treatment through 30 days following completion of treatment.
|
|
Vascular disorders
Thromboembolic event
|
3.7%
2/54 • Adverse events were collected from start of treatment through 30 days following completion of treatment.
|
Other adverse events
| Measure |
Palbociclib + Letrozole or + Fulvestrant
n=54 participants at risk
* Palbociclib should be taken by mouth with food on a 5 days on/2 days off schedule (meaning: on Days 1-5, 8-12, 15-19, and 22-26 of each 28-day cycle).
* Patients who are receiving letrozole will take it daily by mouth, every day of each 28-day cycle.
* Patients who are receiving fulvestrant will receive it as two intramuscular injections (one into each buttock) on Days 1 and 15 of Cycle 1 and then on Day 1 of each cycle thereafter.
* Goserelin is given as a subcutaneous injection every 28 days. It is preferred to be given on Day 1 of each cycle, but it may be administered on any day of the treatment cycle to accommodate its specific Q28-day cycle. It will be given to pre- or peri-menopausal women only.
* Optional research biopsy at baseline and progression
* Blood for research at baseline, cycle 1 day 15, cycle 2 day 1, every 2-3 months (to coincide with imaging studies), and time of progression
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
79.6%
43/54 • Adverse events were collected from start of treatment through 30 days following completion of treatment.
|
|
Blood and lymphatic system disorders
Gout
|
3.7%
2/54 • Adverse events were collected from start of treatment through 30 days following completion of treatment.
|
|
Cardiac disorders
Chest pain - cardiac
|
3.7%
2/54 • Adverse events were collected from start of treatment through 30 days following completion of treatment.
|
|
Cardiac disorders
Sinus tachycardia
|
1.9%
1/54 • Adverse events were collected from start of treatment through 30 days following completion of treatment.
|
|
Ear and labyrinth disorders
Tinnitus
|
1.9%
1/54 • Adverse events were collected from start of treatment through 30 days following completion of treatment.
|
|
Ear and labyrinth disorders
Vertigo
|
7.4%
4/54 • Adverse events were collected from start of treatment through 30 days following completion of treatment.
|
|
Eye disorders
Blurred vision
|
7.4%
4/54 • Adverse events were collected from start of treatment through 30 days following completion of treatment.
|
|
Eye disorders
Cataract
|
5.6%
3/54 • Adverse events were collected from start of treatment through 30 days following completion of treatment.
|
|
Eye disorders
Dry eye
|
3.7%
2/54 • Adverse events were collected from start of treatment through 30 days following completion of treatment.
|
|
Eye disorders
Eye lid pain
|
1.9%
1/54 • Adverse events were collected from start of treatment through 30 days following completion of treatment.
|
|
Eye disorders
Photophobia
|
1.9%
1/54 • Adverse events were collected from start of treatment through 30 days following completion of treatment.
|
|
Eye disorders
Red eye
|
1.9%
1/54 • Adverse events were collected from start of treatment through 30 days following completion of treatment.
|
|
Eye disorders
Watering eyes
|
3.7%
2/54 • Adverse events were collected from start of treatment through 30 days following completion of treatment.
|
|
Gastrointestinal disorders
Abdominal pain
|
3.7%
2/54 • Adverse events were collected from start of treatment through 30 days following completion of treatment.
|
|
Gastrointestinal disorders
Broken tooth
|
3.7%
2/54 • Adverse events were collected from start of treatment through 30 days following completion of treatment.
|
|
Gastrointestinal disorders
C. difficile
|
1.9%
1/54 • Adverse events were collected from start of treatment through 30 days following completion of treatment.
|
|
Gastrointestinal disorders
Constipation
|
27.8%
15/54 • Adverse events were collected from start of treatment through 30 days following completion of treatment.
|
|
Gastrointestinal disorders
Diarrhea
|
55.6%
30/54 • Adverse events were collected from start of treatment through 30 days following completion of treatment.
|
|
Gastrointestinal disorders
Dry lips
|
3.7%
2/54 • Adverse events were collected from start of treatment through 30 days following completion of treatment.
|
|
Gastrointestinal disorders
Dry mouth
|
1.9%
1/54 • Adverse events were collected from start of treatment through 30 days following completion of treatment.
|
|
Gastrointestinal disorders
Dyspepsia
|
37.0%
20/54 • Adverse events were collected from start of treatment through 30 days following completion of treatment.
|
|
Gastrointestinal disorders
Dysphagia
|
9.3%
5/54 • Adverse events were collected from start of treatment through 30 days following completion of treatment.
|
|
Gastrointestinal disorders
Gastric ulcer
|
1.9%
1/54 • Adverse events were collected from start of treatment through 30 days following completion of treatment.
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
3.7%
2/54 • Adverse events were collected from start of treatment through 30 days following completion of treatment.
|
|
Gastrointestinal disorders
Gingival pain
|
1.9%
1/54 • Adverse events were collected from start of treatment through 30 days following completion of treatment.
|
|
Gastrointestinal disorders
Hematochezia
|
1.9%
1/54 • Adverse events were collected from start of treatment through 30 days following completion of treatment.
|
|
Gastrointestinal disorders
Hemorrhoidal hemorrhage
|
1.9%
1/54 • Adverse events were collected from start of treatment through 30 days following completion of treatment.
|
|
Gastrointestinal disorders
Hemorrhoids
|
1.9%
1/54 • Adverse events were collected from start of treatment through 30 days following completion of treatment.
|
|
Gastrointestinal disorders
Mucositis oral
|
31.5%
17/54 • Adverse events were collected from start of treatment through 30 days following completion of treatment.
|
|
Gastrointestinal disorders
Nausea
|
53.7%
29/54 • Adverse events were collected from start of treatment through 30 days following completion of treatment.
|
|
Gastrointestinal disorders
Oral dysesthesia
|
1.9%
1/54 • Adverse events were collected from start of treatment through 30 days following completion of treatment.
|
|
Gastrointestinal disorders
Oral pain
|
1.9%
1/54 • Adverse events were collected from start of treatment through 30 days following completion of treatment.
|
|
Gastrointestinal disorders
Stomach pain
|
1.9%
1/54 • Adverse events were collected from start of treatment through 30 days following completion of treatment.
|
|
Gastrointestinal disorders
Toothache
|
3.7%
2/54 • Adverse events were collected from start of treatment through 30 days following completion of treatment.
|
|
Gastrointestinal disorders
Vomiting
|
31.5%
17/54 • Adverse events were collected from start of treatment through 30 days following completion of treatment.
|
|
General disorders
Breast pain
|
7.4%
4/54 • Adverse events were collected from start of treatment through 30 days following completion of treatment.
|
|
General disorders
Buttock pain
|
5.6%
3/54 • Adverse events were collected from start of treatment through 30 days following completion of treatment.
|
|
General disorders
Chills
|
24.1%
13/54 • Adverse events were collected from start of treatment through 30 days following completion of treatment.
|
|
General disorders
Cold sensitivity
|
1.9%
1/54 • Adverse events were collected from start of treatment through 30 days following completion of treatment.
|
|
General disorders
Cold sweats
|
1.9%
1/54 • Adverse events were collected from start of treatment through 30 days following completion of treatment.
|
|
General disorders
Common cold
|
7.4%
4/54 • Adverse events were collected from start of treatment through 30 days following completion of treatment.
|
|
General disorders
Dilation of appendix with periappendiceal fat stranding seen on CT
|
1.9%
1/54 • Adverse events were collected from start of treatment through 30 days following completion of treatment.
|
|
General disorders
Edema face
|
1.9%
1/54 • Adverse events were collected from start of treatment through 30 days following completion of treatment.
|
|
General disorders
Edema limbs
|
33.3%
18/54 • Adverse events were collected from start of treatment through 30 days following completion of treatment.
|
|
General disorders
Edema trunk
|
3.7%
2/54 • Adverse events were collected from start of treatment through 30 days following completion of treatment.
|
|
General disorders
Fatigue
|
61.1%
33/54 • Adverse events were collected from start of treatment through 30 days following completion of treatment.
|
|
General disorders
Fever
|
16.7%
9/54 • Adverse events were collected from start of treatment through 30 days following completion of treatment.
|
|
General disorders
Flu-like symptoms
|
3.7%
2/54 • Adverse events were collected from start of treatment through 30 days following completion of treatment.
|
|
General disorders
Gait disturbance
|
1.9%
1/54 • Adverse events were collected from start of treatment through 30 days following completion of treatment.
|
|
General disorders
Generalized weakness
|
1.9%
1/54 • Adverse events were collected from start of treatment through 30 days following completion of treatment.
|
|
General disorders
Groin pain
|
1.9%
1/54 • Adverse events were collected from start of treatment through 30 days following completion of treatment.
|
|
General disorders
Intrascapular pain
|
1.9%
1/54 • Adverse events were collected from start of treatment through 30 days following completion of treatment.
|
|
General disorders
Leg pain
|
1.9%
1/54 • Adverse events were collected from start of treatment through 30 days following completion of treatment.
|
|
General disorders
Localized edema
|
1.9%
1/54 • Adverse events were collected from start of treatment through 30 days following completion of treatment.
|
|
General disorders
Non-cardiac chest pain
|
7.4%
4/54 • Adverse events were collected from start of treatment through 30 days following completion of treatment.
|
|
General disorders
Pain
|
25.9%
14/54 • Adverse events were collected from start of treatment through 30 days following completion of treatment.
|
|
General disorders
Wrist pain
|
1.9%
1/54 • Adverse events were collected from start of treatment through 30 days following completion of treatment.
|
|
Immune system disorders
Allergic reaction
|
5.6%
3/54 • Adverse events were collected from start of treatment through 30 days following completion of treatment.
|
|
Infections and infestations
Bladder infection
|
1.9%
1/54 • Adverse events were collected from start of treatment through 30 days following completion of treatment.
|
|
Infections and infestations
Bronchitis
|
7.4%
4/54 • Adverse events were collected from start of treatment through 30 days following completion of treatment.
|
|
Infections and infestations
COVID-19
|
9.3%
5/54 • Adverse events were collected from start of treatment through 30 days following completion of treatment.
|
|
Infections and infestations
Diverticulitis
|
1.9%
1/54 • Adverse events were collected from start of treatment through 30 days following completion of treatment.
|
|
Infections and infestations
Fungal toe infection
|
1.9%
1/54 • Adverse events were collected from start of treatment through 30 days following completion of treatment.
|
|
Infections and infestations
Lung infection
|
5.6%
3/54 • Adverse events were collected from start of treatment through 30 days following completion of treatment.
|
|
Infections and infestations
Otitis media
|
1.9%
1/54 • Adverse events were collected from start of treatment through 30 days following completion of treatment.
|
|
Infections and infestations
Paronychia
|
1.9%
1/54 • Adverse events were collected from start of treatment through 30 days following completion of treatment.
|
|
Infections and infestations
Pharyngitis
|
1.9%
1/54 • Adverse events were collected from start of treatment through 30 days following completion of treatment.
|
|
Infections and infestations
Respiratory syncytial virus (RSV)
|
1.9%
1/54 • Adverse events were collected from start of treatment through 30 days following completion of treatment.
|
|
Infections and infestations
Rhinovirus
|
1.9%
1/54 • Adverse events were collected from start of treatment through 30 days following completion of treatment.
|
|
Infections and infestations
Sepsis
|
1.9%
1/54 • Adverse events were collected from start of treatment through 30 days following completion of treatment.
|
|
Infections and infestations
Sinusitis
|
16.7%
9/54 • Adverse events were collected from start of treatment through 30 days following completion of treatment.
|
|
Infections and infestations
Skin infection
|
7.4%
4/54 • Adverse events were collected from start of treatment through 30 days following completion of treatment.
|
|
Infections and infestations
Tooth infection
|
7.4%
4/54 • Adverse events were collected from start of treatment through 30 days following completion of treatment.
|
|
Infections and infestations
Upper respiratory infection
|
16.7%
9/54 • Adverse events were collected from start of treatment through 30 days following completion of treatment.
|
|
Infections and infestations
Urinary tract infection
|
13.0%
7/54 • Adverse events were collected from start of treatment through 30 days following completion of treatment.
|
|
Infections and infestations
Vaginal infection
|
1.9%
1/54 • Adverse events were collected from start of treatment through 30 days following completion of treatment.
|
|
Infections and infestations
Wound infection
|
1.9%
1/54 • Adverse events were collected from start of treatment through 30 days following completion of treatment.
|
|
Infections and infestations
Yeast infection
|
1.9%
1/54 • Adverse events were collected from start of treatment through 30 days following completion of treatment.
|
|
Injury, poisoning and procedural complications
Bruising
|
3.7%
2/54 • Adverse events were collected from start of treatment through 30 days following completion of treatment.
|
|
Injury, poisoning and procedural complications
Bug bite
|
5.6%
3/54 • Adverse events were collected from start of treatment through 30 days following completion of treatment.
|
|
Injury, poisoning and procedural complications
Burn
|
3.7%
2/54 • Adverse events were collected from start of treatment through 30 days following completion of treatment.
|
|
Injury, poisoning and procedural complications
Fall
|
20.4%
11/54 • Adverse events were collected from start of treatment through 30 days following completion of treatment.
|
|
Injury, poisoning and procedural complications
Fracture
|
1.9%
1/54 • Adverse events were collected from start of treatment through 30 days following completion of treatment.
|
|
Injury, poisoning and procedural complications
Head injury
|
3.7%
2/54 • Adverse events were collected from start of treatment through 30 days following completion of treatment.
|
|
Injury, poisoning and procedural complications
Puncture wound
|
1.9%
1/54 • Adverse events were collected from start of treatment through 30 days following completion of treatment.
|
|
Injury, poisoning and procedural complications
Radiation recall reaction (dermatologic)
|
1.9%
1/54 • Adverse events were collected from start of treatment through 30 days following completion of treatment.
|
|
Injury, poisoning and procedural complications
Snake bite
|
1.9%
1/54 • Adverse events were collected from start of treatment through 30 days following completion of treatment.
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
1.9%
1/54 • Adverse events were collected from start of treatment through 30 days following completion of treatment.
|
|
Investigations
Activated partial thromboplastin time prolonged
|
1.9%
1/54 • Adverse events were collected from start of treatment through 30 days following completion of treatment.
|
|
Investigations
Alanine aminotransferase increased
|
33.3%
18/54 • Adverse events were collected from start of treatment through 30 days following completion of treatment.
|
|
Investigations
Alkaline phosphatase increased
|
29.6%
16/54 • Adverse events were collected from start of treatment through 30 days following completion of treatment.
|
|
Investigations
Aspartate aminotransferase increased
|
35.2%
19/54 • Adverse events were collected from start of treatment through 30 days following completion of treatment.
|
|
Investigations
Blood bilirubin increased
|
1.9%
1/54 • Adverse events were collected from start of treatment through 30 days following completion of treatment.
|
|
Investigations
Creatinine increased
|
33.3%
18/54 • Adverse events were collected from start of treatment through 30 days following completion of treatment.
|
|
Investigations
Hemoglobin increased
|
1.9%
1/54 • Adverse events were collected from start of treatment through 30 days following completion of treatment.
|
|
Investigations
INR increased
|
1.9%
1/54 • Adverse events were collected from start of treatment through 30 days following completion of treatment.
|
|
Investigations
Lymphocyte count decreased
|
74.1%
40/54 • Adverse events were collected from start of treatment through 30 days following completion of treatment.
|
|
Investigations
Lymphocyte count increased
|
1.9%
1/54 • Adverse events were collected from start of treatment through 30 days following completion of treatment.
|
|
Investigations
Neutrophil count decreased
|
87.0%
47/54 • Adverse events were collected from start of treatment through 30 days following completion of treatment.
|
|
Investigations
Platelet count decreased
|
42.6%
23/54 • Adverse events were collected from start of treatment through 30 days following completion of treatment.
|
|
Investigations
Weight gain
|
1.9%
1/54 • Adverse events were collected from start of treatment through 30 days following completion of treatment.
|
|
Investigations
Weight loss
|
11.1%
6/54 • Adverse events were collected from start of treatment through 30 days following completion of treatment.
|
|
Investigations
White blood cell count decreased
|
96.3%
52/54 • Adverse events were collected from start of treatment through 30 days following completion of treatment.
|
|
Metabolism and nutrition disorders
Anorexia
|
35.2%
19/54 • Adverse events were collected from start of treatment through 30 days following completion of treatment.
|
|
Metabolism and nutrition disorders
Dehydration
|
5.6%
3/54 • Adverse events were collected from start of treatment through 30 days following completion of treatment.
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
31.5%
17/54 • Adverse events were collected from start of treatment through 30 days following completion of treatment.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
20.4%
11/54 • Adverse events were collected from start of treatment through 30 days following completion of treatment.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
31.5%
17/54 • Adverse events were collected from start of treatment through 30 days following completion of treatment.
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
1.9%
1/54 • Adverse events were collected from start of treatment through 30 days following completion of treatment.
|
|
Metabolism and nutrition disorders
Hypernatremia
|
11.1%
6/54 • Adverse events were collected from start of treatment through 30 days following completion of treatment.
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
1.9%
1/54 • Adverse events were collected from start of treatment through 30 days following completion of treatment.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
14.8%
8/54 • Adverse events were collected from start of treatment through 30 days following completion of treatment.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
31.5%
17/54 • Adverse events were collected from start of treatment through 30 days following completion of treatment.
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
5.6%
3/54 • Adverse events were collected from start of treatment through 30 days following completion of treatment.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
25.9%
14/54 • Adverse events were collected from start of treatment through 30 days following completion of treatment.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
3.7%
2/54 • Adverse events were collected from start of treatment through 30 days following completion of treatment.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
35.2%
19/54 • Adverse events were collected from start of treatment through 30 days following completion of treatment.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
9.3%
5/54 • Adverse events were collected from start of treatment through 30 days following completion of treatment.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
35.2%
19/54 • Adverse events were collected from start of treatment through 30 days following completion of treatment.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
5.6%
3/54 • Adverse events were collected from start of treatment through 30 days following completion of treatment.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
29.6%
16/54 • Adverse events were collected from start of treatment through 30 days following completion of treatment.
|
|
Musculoskeletal and connective tissue disorders
Back spasms
|
3.7%
2/54 • Adverse events were collected from start of treatment through 30 days following completion of treatment.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
13.0%
7/54 • Adverse events were collected from start of treatment through 30 days following completion of treatment.
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
1.9%
1/54 • Adverse events were collected from start of treatment through 30 days following completion of treatment.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
3.7%
2/54 • Adverse events were collected from start of treatment through 30 days following completion of treatment.
|
|
Musculoskeletal and connective tissue disorders
Knee pain
|
5.6%
3/54 • Adverse events were collected from start of treatment through 30 days following completion of treatment.
|
|
Musculoskeletal and connective tissue disorders
Leg stiffness
|
1.9%
1/54 • Adverse events were collected from start of treatment through 30 days following completion of treatment.
|
|
Musculoskeletal and connective tissue disorders
Muscle cramp
|
3.7%
2/54 • Adverse events were collected from start of treatment through 30 days following completion of treatment.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
1.9%
1/54 • Adverse events were collected from start of treatment through 30 days following completion of treatment.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
20.4%
11/54 • Adverse events were collected from start of treatment through 30 days following completion of treatment.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
7.4%
4/54 • Adverse events were collected from start of treatment through 30 days following completion of treatment.
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis of jaw
|
3.7%
2/54 • Adverse events were collected from start of treatment through 30 days following completion of treatment.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
18.5%
10/54 • Adverse events were collected from start of treatment through 30 days following completion of treatment.
|
|
Musculoskeletal and connective tissue disorders
Sacroliac joint pain
|
1.9%
1/54 • Adverse events were collected from start of treatment through 30 days following completion of treatment.
|
|
Musculoskeletal and connective tissue disorders
Shoulder pain
|
1.9%
1/54 • Adverse events were collected from start of treatment through 30 days following completion of treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung cancer
|
1.9%
1/54 • Adverse events were collected from start of treatment through 30 days following completion of treatment.
|
|
Nervous system disorders
Dizziness
|
37.0%
20/54 • Adverse events were collected from start of treatment through 30 days following completion of treatment.
|
|
Nervous system disorders
Dysgeusia
|
20.4%
11/54 • Adverse events were collected from start of treatment through 30 days following completion of treatment.
|
|
Nervous system disorders
Facial nerve disorder
|
1.9%
1/54 • Adverse events were collected from start of treatment through 30 days following completion of treatment.
|
|
Nervous system disorders
Headache
|
38.9%
21/54 • Adverse events were collected from start of treatment through 30 days following completion of treatment.
|
|
Nervous system disorders
Memory impairment
|
3.7%
2/54 • Adverse events were collected from start of treatment through 30 days following completion of treatment.
|
|
Nervous system disorders
Paresthesia
|
1.9%
1/54 • Adverse events were collected from start of treatment through 30 days following completion of treatment.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
16.7%
9/54 • Adverse events were collected from start of treatment through 30 days following completion of treatment.
|
|
Nervous system disorders
Right arm numbness
|
1.9%
1/54 • Adverse events were collected from start of treatment through 30 days following completion of treatment.
|
|
Nervous system disorders
Sinus pain
|
3.7%
2/54 • Adverse events were collected from start of treatment through 30 days following completion of treatment.
|
|
Nervous system disorders
Spasticity
|
1.9%
1/54 • Adverse events were collected from start of treatment through 30 days following completion of treatment.
|
|
Nervous system disorders
Syncope
|
1.9%
1/54 • Adverse events were collected from start of treatment through 30 days following completion of treatment.
|
|
Psychiatric disorders
Agitation
|
1.9%
1/54 • Adverse events were collected from start of treatment through 30 days following completion of treatment.
|
|
Psychiatric disorders
Anxiety
|
16.7%
9/54 • Adverse events were collected from start of treatment through 30 days following completion of treatment.
|
|
Psychiatric disorders
Confusion
|
1.9%
1/54 • Adverse events were collected from start of treatment through 30 days following completion of treatment.
|
|
Psychiatric disorders
Depression
|
20.4%
11/54 • Adverse events were collected from start of treatment through 30 days following completion of treatment.
|
|
Psychiatric disorders
Hallucinations
|
1.9%
1/54 • Adverse events were collected from start of treatment through 30 days following completion of treatment.
|
|
Psychiatric disorders
Insomnia
|
37.0%
20/54 • Adverse events were collected from start of treatment through 30 days following completion of treatment.
|
|
Psychiatric disorders
Mood swings
|
1.9%
1/54 • Adverse events were collected from start of treatment through 30 days following completion of treatment.
|
|
Renal and urinary disorders
Urinary frequency
|
5.6%
3/54 • Adverse events were collected from start of treatment through 30 days following completion of treatment.
|
|
Renal and urinary disorders
Urinary retention
|
1.9%
1/54 • Adverse events were collected from start of treatment through 30 days following completion of treatment.
|
|
Renal and urinary disorders
Urine discoloration
|
1.9%
1/54 • Adverse events were collected from start of treatment through 30 days following completion of treatment.
|
|
Reproductive system and breast disorders
Vaginal discharge
|
1.9%
1/54 • Adverse events were collected from start of treatment through 30 days following completion of treatment.
|
|
Reproductive system and breast disorders
Vaginal dryness
|
3.7%
2/54 • Adverse events were collected from start of treatment through 30 days following completion of treatment.
|
|
Reproductive system and breast disorders
Vaginal itching
|
1.9%
1/54 • Adverse events were collected from start of treatment through 30 days following completion of treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
11.1%
6/54 • Adverse events were collected from start of treatment through 30 days following completion of treatment.
|
|
Respiratory, thoracic and mediastinal disorders
COPD
|
1.9%
1/54 • Adverse events were collected from start of treatment through 30 days following completion of treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
35.2%
19/54 • Adverse events were collected from start of treatment through 30 days following completion of treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
29.6%
16/54 • Adverse events were collected from start of treatment through 30 days following completion of treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
9.3%
5/54 • Adverse events were collected from start of treatment through 30 days following completion of treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
1.9%
1/54 • Adverse events were collected from start of treatment through 30 days following completion of treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal inflammation
|
1.9%
1/54 • Adverse events were collected from start of treatment through 30 days following completion of treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
13.0%
7/54 • Adverse events were collected from start of treatment through 30 days following completion of treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal drainage
|
1.9%
1/54 • Adverse events were collected from start of treatment through 30 days following completion of treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal dryness
|
1.9%
1/54 • Adverse events were collected from start of treatment through 30 days following completion of treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
3.7%
2/54 • Adverse events were collected from start of treatment through 30 days following completion of treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal drip
|
7.4%
4/54 • Adverse events were collected from start of treatment through 30 days following completion of treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
1.9%
1/54 • Adverse events were collected from start of treatment through 30 days following completion of treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
1.9%
1/54 • Adverse events were collected from start of treatment through 30 days following completion of treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
16.7%
9/54 • Adverse events were collected from start of treatment through 30 days following completion of treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Voice alteration
|
1.9%
1/54 • Adverse events were collected from start of treatment through 30 days following completion of treatment.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
40.7%
22/54 • Adverse events were collected from start of treatment through 30 days following completion of treatment.
|
|
Skin and subcutaneous tissue disorders
Bilateral nares sores
|
1.9%
1/54 • Adverse events were collected from start of treatment through 30 days following completion of treatment.
|
|
Skin and subcutaneous tissue disorders
Blister
|
1.9%
1/54 • Adverse events were collected from start of treatment through 30 days following completion of treatment.
|
|
Skin and subcutaneous tissue disorders
Brittle nail
|
3.7%
2/54 • Adverse events were collected from start of treatment through 30 days following completion of treatment.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
13.0%
7/54 • Adverse events were collected from start of treatment through 30 days following completion of treatment.
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
1.9%
1/54 • Adverse events were collected from start of treatment through 30 days following completion of treatment.
|
|
Skin and subcutaneous tissue disorders
Erythema right breast
|
1.9%
1/54 • Adverse events were collected from start of treatment through 30 days following completion of treatment.
|
|
Skin and subcutaneous tissue disorders
Fever blister
|
1.9%
1/54 • Adverse events were collected from start of treatment through 30 days following completion of treatment.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
13.0%
7/54 • Adverse events were collected from start of treatment through 30 days following completion of treatment.
|
|
Skin and subcutaneous tissue disorders
Itchy skin
|
5.6%
3/54 • Adverse events were collected from start of treatment through 30 days following completion of treatment.
|
|
Skin and subcutaneous tissue disorders
Nail loss
|
1.9%
1/54 • Adverse events were collected from start of treatment through 30 days following completion of treatment.
|
|
Skin and subcutaneous tissue disorders
Oral fissure
|
1.9%
1/54 • Adverse events were collected from start of treatment through 30 days following completion of treatment.
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
5.6%
3/54 • Adverse events were collected from start of treatment through 30 days following completion of treatment.
|
|
Skin and subcutaneous tissue disorders
Rash maculopapular
|
18.5%
10/54 • Adverse events were collected from start of treatment through 30 days following completion of treatment.
|
|
Skin and subcutaneous tissue disorders
Shoulder nodule
|
1.9%
1/54 • Adverse events were collected from start of treatment through 30 days following completion of treatment.
|
|
Skin and subcutaneous tissue disorders
Skin bump
|
3.7%
2/54 • Adverse events were collected from start of treatment through 30 days following completion of treatment.
|
|
Skin and subcutaneous tissue disorders
Stomach rash
|
1.9%
1/54 • Adverse events were collected from start of treatment through 30 days following completion of treatment.
|
|
Skin and subcutaneous tissue disorders
Tender nail bed
|
1.9%
1/54 • Adverse events were collected from start of treatment through 30 days following completion of treatment.
|
|
Vascular disorders
Hot flashes
|
38.9%
21/54 • Adverse events were collected from start of treatment through 30 days following completion of treatment.
|
|
Vascular disorders
Hypertension
|
66.7%
36/54 • Adverse events were collected from start of treatment through 30 days following completion of treatment.
|
|
Vascular disorders
Lymphedema
|
7.4%
4/54 • Adverse events were collected from start of treatment through 30 days following completion of treatment.
|
|
Vascular disorders
Thromboembolic event
|
5.6%
3/54 • Adverse events were collected from start of treatment through 30 days following completion of treatment.
|
Additional Information
Cynthia X. Ma, M.D., Ph.D.
Washington University School of Medicine
Phone: 314-362-9383
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place