Rate of Grade 3 or Higher Neutropenia
| Group | Value (Participants) |
|---|---|
| Palbociclib + Letrozole or + Fulvestrant | 10 |
Trial · Interventional
CompletedPhase 2Results postedRegistry dataUnited States
1 trial · 1 completed · 1 with posted results
Alternative Dosing Schedule of Palbociclib in Metastatic Hormone Receptor Positive Breast Cancer
NCT0300797915 Jun 2017 to 31 Mar 2023
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
The investigators propose to conduct a study to test an alternative dosing schedule of palbociclib. With the current three-week on and one week off schedule, a significant number of patients develop grade 3 or higher degree of neutropenia and require dose reduction and sometimes discontinuation. This potentially compromises the efficacy of the drug. In addition, as the half-life of palbociclib is 27 hours, 1 week break with the standard 3 weeks on and 1 week off dosing schedule could potentially lead to recovery of Rb phosphorylation during the off week. Hence, the investigators propose a 5 days on and 2 days off schedule each week without any weeks off drug. Although the cumulative doses each 28-day cycle is roughly the same with this schedule compared to conventional dosing, the bone marrow is not exposed to the drug continuously for 21 days and rather gets frequent breaks from therapy. The investigators hypothesize that the 5 days on and 2 days off schedule is more tolerable with less frequent high grade neutropenia and dose interruption/reduction. In addition, this schedule also provides for a more continuous drug delivery to the patient since there is not a week's break in therapy, which could ultimately prove to be more efficacious.
Experimental
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
Outcomes the sponsor listed as primary.
Rate of Grade 3 or Higher Neutropenia
Time frame · Through the first 29 days of treatment
* 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
Rate of Grade 3 or Higher Neutropenia
Time frame · Through 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. * 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
Rate of Palbociclib Dose Reduction
Time frame · Through the completion of treatment (estimated to be 24 months)
-Percentage of participants who have a palbociclib dose reduction during treatment
Rate of Palbociclib Dose Interruption
Time frame · Through the completion of treatment (estimated to be 24 months)
-Percentage of participants who have a palbociclib dose interruption during treatment
Rate of Palbociclib Discontinuation
Time frame · Through the completion of treatment (estimated to be 24 months)
-Percentage of participants who discontinue palbociclib due to adverse event
Adverse Event Profile of Palbociclib
Time frame · 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.
Kaplan-Meier Estimate of Progression-free Survival (PFS)
Time frame · 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).
Overall Response Rate (Complete Response + Partial Response)
Time frame · 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
Clinical Benefit Rate (Complete Response + Partial Response + Stable Disease) for at Least 6 Months)
Time frame · 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.
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
| Group | Value (Participants) |
|---|---|
| Palbociclib + Letrozole or + Fulvestrant | 10 |
| Group | Value (Participants) |
|---|---|
| Palbociclib + Letrozole or + Fulvestrant | 23 |
| Group | Value (Participants) |
|---|---|
| Palbociclib + Letrozole or + Fulvestrant | 13 |
| Group | Value (Participants) |
|---|---|
| Palbociclib + Letrozole or + Fulvestrant | 39 |
| Group | Value (Participants) |
|---|---|
| Palbociclib + Letrozole or + Fulvestrant | 2 |
| Group | Value (Participants) |
|---|---|
| Palbociclib + Letrozole or + Fulvestrant | 31 |
| Group | Value (percentage of participants-Kaplan Meier) |
|---|---|
| Palbociclib + Letrozole or + Fulvestrant | 67.911 |
| Group | Value (Participants) |
|---|---|
| Palbociclib + Letrozole or + Fulvestrant | 18 |
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| 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 | 3 / 54 | 15 / 54 | 54 / 54 |
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