Palbociclib Combined With an Aromatase Inhibitor in Breast Cancer
NCT ID: NCT04047758
Last Updated: 2021-07-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
420 participants
INTERVENTIONAL
2019-09-01
2022-09-30
Brief Summary
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Detailed Description
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Palbociclib is a cyclin-dependent kinase (CDK) 4/6 inhibitor that reduces the proliferation of estrogen receptor-positive breast cancer cells by blocking cells from the G1 phase to the S phase. Pfizer's innovative drug palbociclib (trade name: Ibrance®) was approved by the China National Drug Administration on July 31, 2018 for the treatment of hormone receptor-positive/human epidermal growth factor receptor 2-negative locally advanced breast cancer or metastatic breast cancer. In addition, aromatase inhibitors such as letrozole (trade name: Femara ®) can prolong the progression-free survival in the first-line therapy for advanced breast cancer to 10-13 months. Palbociclib combined with letrozole has been shown to exhibit stronger inhibitory effects on phosphorylation of retinoblastoma gene (Rt), downstream signaling and tumor growth than monotherapy. Since 2015, palbociclib combined with letrozole has been recommended by the NCCN guideline as one treatment option for advanced breast cancer. However, since palbociclib has been approved for market entry in China for only 1 year, little is reported in China regarding large-sample clinical trials regarding the efficacy, tolerability, and safety of palbociclib combined with an aromatase inhibitor in hormone receptor-positive/human epidermal growth factor receptor 2-negative locally advanced breast cancer.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Palbociclib + Letrozole group
210 patients will be randomly assigned to receive treatment with palbociclib and letrozole (palbociclib + letrozole group) .
Palbociclib + Letrozole
(1) Palbociclib (trade name: Ibrance®; Pfizer Manufacturing Deutschland GmbH, Freiburg, Germany; imported drug license No. H20180040): 125 mg/capsule, 1 capsule by mouth once a day, for 21 successive days, followed by 7 days off treatment \[3 weeks on (days 1-21) and 1 week off (days 22-28)\], repeated every 28 days. (2) Letrozole (trade name: Femara®; Novartis Pharma Schweiz AG, Switzerland; imported drug license No. H20140149): 2.5 mg/table, 1 table by mouth once a day, continuously for a 28-day cycle.
Letrozole group
210 patients will be randomly assigned to receive treatment with letrozole (letrozole group).
Letrozole
Letrozole (trade name: Femara®; Novartis Pharma Schweiz AG, Switzerland; imported drug license No. H20140149): 2.5 mg/table, 1 table by mouth once a day, continuously for a 28-day cycle.
Interventions
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Palbociclib + Letrozole
(1) Palbociclib (trade name: Ibrance®; Pfizer Manufacturing Deutschland GmbH, Freiburg, Germany; imported drug license No. H20180040): 125 mg/capsule, 1 capsule by mouth once a day, for 21 successive days, followed by 7 days off treatment \[3 weeks on (days 1-21) and 1 week off (days 22-28)\], repeated every 28 days. (2) Letrozole (trade name: Femara®; Novartis Pharma Schweiz AG, Switzerland; imported drug license No. H20140149): 2.5 mg/table, 1 table by mouth once a day, continuously for a 28-day cycle.
Letrozole
Letrozole (trade name: Femara®; Novartis Pharma Schweiz AG, Switzerland; imported drug license No. H20140149): 2.5 mg/table, 1 table by mouth once a day, continuously for a 28-day cycle.
Eligibility Criteria
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Inclusion Criteria
* postmenopausal patients;
* eligible patients receiving one or more treatment strategies who are followed up in the center where they receive treatment;
* provision of written informed consent.
Exclusion Criteria
* pregnant woman;
* participating in other clinical trials.
18 Years
70 Years
FEMALE
No
Sponsors
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Shengjing Hospital
OTHER
Responsible Party
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Caigang Liu
Director of Department of Breast Surgery
Principal Investigators
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Caigang Liu
Role: PRINCIPAL_INVESTIGATOR
Shengjing Hospital
Locations
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Liaoning Cancer Hospital & Institute
Shenyang, Liaoning, China
Liaoning Provincial People's Hospital
Shenyang, Liaoning, China
Shengjing Hospital of China Medical University
Shenyang, Liaoning, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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Shengjing_002
Identifier Type: -
Identifier Source: org_study_id
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