Breast CancerPhase 3NCT04047758
Palbociclib Combined With an Aromatase Inhibitor in Breast Cancer
A Phase 3 study testing Palbociclib + Letrozole and Letrozole in people with Breast Cancer, run by Shengjing Hospital at 3 sites in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Palbociclib + Letrozole and Letrozole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 420 participants
- Where
- 3 sitesChina
- Study dates
- 1 Sep 2019to 30 Sep 2022
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Age < 18 years;
- pregnant woman;
- participating in other clinical trials.
Trial locations and contacts
3 sites in 1 country.
China3 sites, 3 recruiting
- Recruiting
Liaoning Cancer Hospital & Institute
Shenyang, Liaoning
Hong Xu, +86-18900917779, xh4015@163.com
- Recruiting
Liaoning Provincial People's Hospital
Shenyang, Liaoning
Qingfeng Liu, +86-17702486789, drliuqf1970@126.com
- Recruiting
Shengjing Hospital of China Medical University
Shenyang, Liaoning
Caigang Liu, +86-18940254967, angel-s205@163.com
About this study
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
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.
Read the 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.
- Conditions
- Breast Cancer
- Being tested
- Palbociclib + Letrozole, Letrozole
- Keywords
- palbociclib, aromatase inhibitors
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Palbociclib + LetrozoleDrug
(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.
LetrozoleDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Palbociclib + Letrozole group | Experimental | 210 patients will be randomly assigned to receive treatment with palbociclib and letrozole (palbociclib + letrozole group) . Receives: Drug: Palbociclib + Letrozole |
| Letrozole group | Placebo comparator | 210 patients will be randomly assigned to receive treatment with letrozole (letrozole group). Receives: Drug: Letrozole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival
It is defined as the time from random assignment in a clinical trial to disease progression or death from any cause.
Measured: 24 months
Secondary outcomes (3)
Overall survival
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.
Measured: 24 months
Functional Assessment of Cancer Therapy-Breast Cancer (FACT-B)
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.
Measured: 24 months
EuroQol five-dimension scale (ED-5Q)
The ED-5Q is a widely used multidimensional measure of health-related quality of life. Higher ED-5Q score indicates better health.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2019
- Study start1 Sep 2019
- Primary completion30 Sep 2021 (estimated)
- Study completion30 Sep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Shengjing HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 420 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shengjing Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Caigang Liu, Shengjing Hospital
- Investigators
- Caigang Liu, Principal investigator, Shengjing Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04047758
- Sponsor's protocol ID
- Shengjing_002
- Status last verified
- Jul 2021
- First submitted
- 5 Aug 2019
- Last updated
- 20 Jul 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04047758
- Acronym / sponsor ID
- Shengjing_002
- Conditions
- Breast Cancer
- Keywords
- palbociclib, aromatase inhibitors
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 420 participants (estimated)
- Lead sponsor
- Shengjing HospitalUniversity, hospital or other
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 30 Sep 2021 (estimated)
- Study completion
- 30 Sep 2022 (estimated)
- First posted
- 7 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Palbociclib + Letrozole group | Experimental | Drug: Palbociclib + Letrozole210 patients will be randomly assigned to receive treatment with palbociclib and letrozole (palbociclib + letrozole group) . |
| Letrozole group | Placebo comparator | Drug: Letrozole210 patients will be randomly assigned to receive treatment with letrozole (letrozole group). |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- Age < 18 years;
- pregnant woman;
- participating in other clinical trials.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Drug | Palbociclib + Letrozole group |
| LetrozoleLetrozole (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. | Drug | Letrozole group |
Primary outcome
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.
3 secondary outcomes
Overall survival
Time frame: 24 months
Functional Assessment of Cancer Therapy-Breast Cancer (FACT-B)
Time frame: 24 months
EuroQol five-dimension scale (ED-5Q)
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Caigang Liu principal investigator
Shengjing Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Palbociclib + Letrozole and Letrozole in people with Breast Cancer, run by Shengjing Hospital at 3 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xi Gu (+86-18940255116, jadegx@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2021.