An interventional study of Palbociclib and Placebo oral capsule in Breast Cancer, Breast Diseases and Breast Neoplasms, sponsored by Zhejiang Cancer Hospital. Status unknown. Open to female participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-12-07.
Sponsored by Zhejiang Cancer Hospital · Not applicable, Interventional, and Treatment
This study will look at effects the combination of palbociclib and dose-dense neoadjuvant chemotherapy may have on triple negative breast cancer tumours which have not yet been treated.
Patients will be randomized to one of two treatment arms (1:1 ratio). Dose-Dense neoadjuvant chemotherapy in the first 8 weeks of will be: epirubicin (90mg/m2) and cyclophosphamide (600mg/m2), followed by paclitaxel (80mg / m2) after 8 weeks, cycled every 14 days for total 8 cycles.
Palbociclib will be administered orally as 125mg capsules, daily on a schedule of 3 weeks (21 days) on, 1 week (7 days) off of a 4 week [28 days] cycle.
Arm I: Palbociclib combined with Dose-Dense neoadjuvant chemotherapy for total 16 weeks.
Arm II: Placebo combined with Dose-Dense neoadjuvant chemotherapy for total 16 weeks.
Note:
Following completion of study therapy, surgery will be scheduled for 18-20 weeks post-randomization.
Post-surgical treatment will be at the discretion of treating clinician, following postoperative pathology.
After week 16 (end of study therapy) all patients should continue Palbociclib for one year.
Toxicity will be graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events version 4.0 (CTCAE v4.0).
12,815 studies on the registry are indexed under Breast Neoplasms; 2,920 are open to participants now.
This study's planned enrollment of 100 is above the median of 72 across 9,494 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Zhejiang Cancer Hospital is the lead sponsor of 281 studies on the registry; 116 are open to participants now.
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Exclusion Criteria:
Arm I: Palbociclib combined with Dose-Dense neoadjuvant chemotherapy for total 16 weeks.
Drug: Palbociclib · Drug: Epirubicin · Drug: Cyclophosphamide · Drug: Paclitaxel
Arm II: Placebo combined with Dose-Dense neoadjuvant chemotherapy for total 16 weeks.
Drug: Placebo oral capsule · Drug: Epirubicin · Drug: Cyclophosphamide · Drug: Paclitaxel
Palbociclib will be administered orally as 125mg capsules, daily on a schedule of 3 weeks (21 days) on, 1 week (7 days) off of a 4 week \[28 days\] cycle.
Placebo oral capsule will be administered orally as 125mg capsules, daily on a schedule of 3 weeks (21 days) on, 1 week (7 days) off of a 4 week \[28 days\] cycle.
Epirubicin (90mg/m2, D1) cycled every 14 days for the first 4 cycles.
Cyclophosphamide (600mg/m2, D1) cycled every 14 days for the first 4 cycles.
Paclitaxel (80mg/m2, D1) cycled every 14 days for the later 4 cycles.
pCR
Percentage of Participants With Pathological Complete Response (pCR) at the Time of Surgery.
Time frame: Through study completion, an average of 1 year.
DFS
Disease-free Survival
Time frame: Following surgery until Year 3
ORR
Objective Response Rate (ORR) during neoadjuvant period
Time frame: Through study completion, an average of 1 year.
AEs
Number and severity of adverse events.Toxicity will be graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events version 4.0 (CTCAE v4.0).
Time frame: baseline and weekly through 12 months after randomization
No study locations are listed for this record.
Plan to share: Undecided
No publications or documents are linked to this record.
Start is estimated for Dec 2018; primary completion for Dec 2019, 12 months later.
Of 2,272 non-industry interventional studies with no phase under Breast Neoplasms, half reached primary completion within 34 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 69. This study's planned 12 months is below that.
Counting every sponsor, half of 2,345 studies reached it within 34 months; a quarter within 16 and three quarters within 69.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Nov 2018. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Palbociclib