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Palbociclib Combined With an Aromatase Inhibitor in Breast Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04047758
Recruitment Status : Recruiting
First Posted : August 7, 2019
Last Update Posted : July 20, 2021
Sponsor:
Information provided by (Responsible Party):
Caigang Liu, Shengjing Hospital

Study Description
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Brief Summary:
Pfizer's innovative drug palbociclib (trade name: Ibrance®) got China National Drug Administration (CNDA) approval on July 31, 2018. Palbociclib combined with an aromatase inhibitor can be used to treat hormone receptor-positive/human epidermal growth factor receptor 2-negative locally advanced breast cancer or metastatic breast cancer. This brings more treatment options for hormone receptor-positive/human epidermal growth factor receptor 2-negative locally advanced breast cancer. How to scientifically evaluate the efficacy, tolerability, and safety of palbociclib combined with an aromatase inhibitor and to establish a more suitable treatment strategy for Chinese patients is one of the questions that need to be answered in clinical practice. This multi-center parallel-group randomized controlled trial will address on this issue.

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: Palbociclib + Letrozole Drug: Letrozole Phase 3

Detailed Description:

Breast cancer is one of the most common cancers in women. Once advanced, it is usually not cured. Studies have shown that patients with advanced breast cancer have a median survival of 2-3 years. For inoperable locally advanced breast cancer, systemic therapy is the first choice of treatment. Systemic treatments of hormone receptor-positive/human epidermal growth factor receptor 2-negative breast cancer mainly include endocrine monotherapy, multi-drug combination therapy and chemotherapy. The overall survival is similar between patients with hormone receptor-positive/human epidermal growth factor receptor 2-negative breast cancer receiving chemotherapy and those receiving endocrine therapy. But quality of life and progression-free survival of patients receiving endocrine therapy are superior to those of receiving chemotherapy. Therefore, both the National Comprehensive Cancer Network (NCCN) and the 2018 Chinese Expert Consensus on the Clinical Diagnosis and Treatment of Advanced Breast Carcinoma guidelines confirm that endocrine therapy is the preferred treatment for hormone receptor-positive/human epidermal growth factor receptor 2-negative breast cancer.

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 420 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : September 1, 2019
Estimated Primary Completion Date : September 30, 2021
Estimated Study Completion Date : September 30, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arms and Interventions
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Arm Intervention/treatment
Experimental: Palbociclib + Letrozole group
210 patients will be randomly assigned to receive treatment with palbociclib and letrozole (palbociclib + letrozole group) .
 Drug: 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.
Placebo Comparator: Letrozole group
210 patients will be randomly assigned to receive treatment with letrozole (letrozole group).
 Drug: 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.


Outcome Measures
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Primary Outcome Measures :
  1. Progression-free survival [ Time Frame: 24 months ]
    It is defined as the time from random assignment in a clinical trial to disease progression or death from any cause.


Secondary Outcome Measures :
  1. Overall survival [ Time Frame: 24 months ]
    The length of time from either the date of diagnosis or the start of treatment for cancer, that patients diagnosed with the disease are still alive.

  2. Functional Assessment of Cancer Therapy-Breast Cancer (FACT-B) [ Time Frame: 24 months ]
    The FACT-B scale is used for evaluating the survival of patients with breast cancer. The scale consists of 36 items covering physical well-being, social/family well-being, emotional well-being, and functional well-being domains. Higher FACT-B score indicates better heath.

  3. EuroQol five-dimension scale (ED-5Q) [ Time Frame: 24 months ]
    The ED-5Q is a widely used multidimensional measure of health-related quality of life. Higher ED-5Q score indicates better health.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with histological and imaging findings-confirmed hormone receptor-positive/human epidermal growth factor receptor 2-negative breast cancer;
  • 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:

  • Age < 18 years;
  • pregnant woman;
  • participating in other clinical trials.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04047758


Contacts
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Contact: Xi Gu +86-18940255116 jadegx@163.com

Locations
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China, Liaoning
Liaoning Cancer Hospital & Institute Recruiting
Shenyang, Liaoning, China
Contact: Hong Xu    +86-18900917779    xh4015@163.com   
Liaoning Provincial People's Hospital Recruiting
Shenyang, Liaoning, China
Contact: Qingfeng Liu    +86-17702486789    drliuqf1970@126.com   
Shengjing Hospital of China Medical University Recruiting
Shenyang, Liaoning, China
Contact: Caigang Liu    +86-18940254967    angel-s205@163.com   
Sponsors and Collaborators
Shengjing Hospital
Investigators
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Principal Investigator: Caigang Liu Shengjing Hospital
More Information
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Responsible Party: Caigang Liu, Director of Department of Breast Surgery, Shengjing Hospital
ClinicalTrials.gov Identifier: NCT04047758    
Other Study ID Numbers: Shengjing_002
First Posted: August 7, 2019    Key Record Dates
Last Update Posted: July 20, 2021
Last Verified: July 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Caigang Liu, Shengjing Hospital:
palbociclib
aromatase inhibitors
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Letrozole
Palbociclib
Antineoplastic Agents
Aromatase Inhibitors
 Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Protein Kinase Inhibitors