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A Phase II Clinical Trial Assessing the Safety of an Alternative Dosing Schedule of Palbociclib in Metastatic Hormone Receptor Positive Breast Cancer
Sponsor study identifier
interventional
55
1 country
2
Study Start
June 15, 2017
Actual (reported)Primary Completion
March 13, 2020
Actual (reported)Study Completion
March 31, 2023
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 31, 2023
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 19, 2016
Actual (reported)January 2, 2017
Actual (reported)June 15, 2017
Actual (reported)March 13, 2020
Actual (reported)March 15, 2021
Actual (reported)March 31, 2023
Actual (reported)Rate of Grade 3 or Higher Neutropenia
* 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
Through the first 29 days of treatment
Rate of Grade 3 or Higher Neutropenia
Through 30 day follow-up (estimated to be 25 months)
Rate of Palbociclib Dose Reduction
Through the completion of treatment (estimated to be 24 months)
Rate of Palbociclib Dose Interruption
Through the completion of treatment (estimated to be 24 months)
Rate of Palbociclib Discontinuation
Through the completion of treatment (estimated to be 24 months)
Adverse Event Profile of Palbociclib
Through the 30 day follow-up (estimated to be 25 months)
* 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
Palbociclib at a dose of 125 mg should be taken by mouth with food on a 5 days on/2 days off schedule
Patients who are receiving letrozole will take it daily by mouth, every day of each 28-day cycle, at a dose of 2.5 mg.
Washington University School of Medicine
St Louis, Missouri, 63110, United States
University of Nebraska
Lincoln, Nebraska, 68588, United States
Krishnamurthy J, Luo J, Suresh R, Ademuyiwa F, Rigden C, Rearden T, Clifton K, Weilbaecher K, Frith A, Roshal A, Tandra PK, Cherian M, Summa T, Haas B, Thomas S, Hernandez-Aya L, Bergqvist M, Peterson L, Ma CX. A phase II trial of an alternative schedule of palbociclib and embedded serum TK1 analysis. NPJ Breast Cancer. 2022 Mar 21;8(1):35. doi: 10.1038/s41523-022-00399-w.
Cynthia X Ma, M.D., Ph.D.
Washington University School of Medicine
55 participants (actual enrollment reported by the registry).
First Submitted
December 19, 2016
First Posted
January 2, 2017
Study Start
June 15, 2017
Actual (reported)Primary Completion
Patients who are receiving fulvestrant will receive it at a dose of 500 mg as two 5 mL intramuscular injections (one into each buttock) on Days 1 and 15 of Cycle 1 and then on Day 1 of each cycle thereafter.
Patients may consent to paired tumor biopsies at baseline and time of progression.
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- and peri-menopausal women only.
-Blood will be drawn at the following time points for serum, plasma, cfDNA, and germline DNA (only at baseline): * Baseline * C1D15 * C2D1 * Every 2-3 months thereafter (to coincide with imaging studies) * Time of progression
-Baseline, cycle 2 day 1, post 2 or 3 months of therapy (to coincide with first tumor imaging), and progression
-Baseline and progression
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
March 13, 2020
Actual (reported)Study Completion
March 31, 2023
Actual (reported)Last Updated
March 20, 2024
Results First Posted
March 15, 2021
Record last verified: 2024-02
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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