- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04334330
Palbociclib, Trastuzumab,Pyrotinib and Fulvestrant Treatment in Patients With Brain Metastasis From ER/PR Positive, HER-2 Positive Breast Cancer: A Multi-center, Prospective Study in China
April 24, 2022 updated by: wang shusen, Sun Yat-sen University
Palbociclib, Trastuzumab, Pyrotinib and Fulvestrant Treatment in Patients With Brain Metastasis From ER/PR Positive, HER-2 Positive Breast Cancer: A Multi-center, Prospective Study in China
The objective of this study is to evaluate the efficacy of combination of palbociclib, trastuzumab and pyrotinib with fulvestrant in ER/PR positive and HER2-positive breast cancer patients with brain metastasis.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
34
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Guangdong
-
Guangzhou, Guangdong, China, 510060
- Recruiting
- State Key Laboratory of Oncology in South China, Sun Yat-sen University Cancer Center
-
Contact:
- Ruoxi Hong, MD
- Phone Number: 862087342693
- Email: hongrx@sysucc.org.cn
-
Guangzhou, Guangdong, China, 510060
- Recruiting
- Shusen Wang
-
Contact:
- Whusen Wang, MD
- Phone Number: 8613926168469
- Email: wangshs@sysucc.org.cn
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria
- Age greater than 18 years old
- Female patients aged 18 years or older
- Histologically confirmed ER/PR positive, HER2-positive metastatic breast cancer (ER/PR≥1% by IHC; HER-2 3+ by immunohistochemistry (IHC); if IHC score of 2, fluorescence in situ hybridization (FISH) ratio must be greater than 2.0; if FISH less than 2.0, HER2 copy number must be greater than 6; NOTE: Brain lesions are not required to have pathologic confirmation)
- Patients must have a life expectancy of at least 12 weeks at the time of registration
- Eastern Cooperative Oncology Group (ECOG) performance status >= 2
- Measurable disease in the brain, defined as at least 1 lesion measuring >= 10 mm on MRI at the time of registration
- If patients are on corticosteroids, they must have been on a stable or decreasing dose >= 5 days prior to obtaining their baseline gadolinium (Gd)-magnetic resonance imaging (MRI) of brain; this MRI is to be obtained within 28 days of registration; NOTE: If patient needs escalation of steroids prior to therapy, or are on unstable doses of steroids they are not eligible
- Patients who have a history of hypersensitivity reaction to one of the compounds or incorporated substances used in this protocol; AND/OR patients who have had prior exposure to fulvestrant, everolimus, pyrotinib or CDK4/6 inhibitors and had a disease progression during treatment are not eligible.
- Patients must not have received systemic therapy within 2 weeks of initiating palbociclib; NOTE: For patients on trastuzumab, they can remain on the drug; no break or washout period required
- Patients must exhibit adequate bone marrow, liver, and renal function, within 14 days prior to registration, defined as:
- Absolute neutrophil count (ANC) >= 1,000/mm^3 (growth factor support is permitted)
- Platelets >= 50,000/mm^3 (may be reached by transfusion)
- Hemoglobin >= 10 gm/dl (may be reached by transfusion)
- Glutamate pyruvate transaminase (GPT)/glutamate oxaloacetate transaminase (GOT) < 3 x upper limit of normal (ULN) (or < 5 x ULN in case of liver metastasis)
- Bilirubin < 3 x ULN (or < 5 x ULN in case of liver metastasis)
- Creatinine < 1.5 x ULN
- Women of childbearing age must have a serum pregnancy test within 7 days before enrollment, and the result should be negative, and are willing to use a medically recognized high-efficiency contraceptive during the study period and within 1 year after the last administration of the study drug.
- Has not undergone a hysterectomy or bilateral oophorectomy
- Has had menses at any time in the preceding 12 consecutive months (and therefore has not been naturally postmenopausal for > 12 months)
- Female patients must have a negative urine pregnancy test within 7 days prior to registration; if urine test is positive, it should be followed by serum pregnancy test
- Patients must sign an informed consent prior to registration and before undergoing any study-specific procedures indicating that they are aware of the investigational nature of this study
- Patient must have the ability to comply with all study requirements
Exclusion Criteria
- Any uncontrolled neurological symptom attributed to CNS metastasis
- Brain metastasis must not be impending herniation or other significant vasogenic edema requiring increasing steroid doses; lesions must not have frank hemorrhage
- Patients with leptomeningeal disease are not eligible for participation
- Patients have been treated with WBRT. The selected intracranial target lesion has received local treatment (surgical resection or SRS). Acute effects related to surgery or SRS have not recover
- Any significant medical illnesses or infection that, in the investigator's opinion, cannot be adequately controlled with appropriate therapy or would compromise the patient's ability to tolerate this therapy are not eligible for participation
- Known human immunodeficiency virus (HIV) positive status
- Known active hepatitis B and/or C
- Patients who have a history of hypersensitivity reaction to one of the compounds or incorporated substances used in this protocol; AND/OR patients who have had prior exposure to compounds of similar chemical or biologic composition to palbociclib or lapatinibpyrotinib and PD during treatment are not eligible.
- Patients being treated with any other experimental agents/clinical trials are not eligible for participation; if the patient is on any investigational agent, a wash-out period of minimum 2 weeks prior to registration is mandatory for the patient to be eligible for the study
- Inability to swallow capsules, malabsorption syndrome or gastrointestinal disease that severely affects the absorption of study drugs, major resection of the stomach or small bowel, or gastric bypass procedure
- Patients who have an uncontrolled intercurrent illness including, but not limited to any of the following, are not eligible:
- Ongoing or active infection requiring systemic treatment
- Symptomatic congestive heart failure
- Unstable angina pectoris
- Cardiac arrhythmia: except atrial fibrillation (AF) and supraventricular tachycardia (SVT) that are controlled by medication
- Psychiatric illness/social situations that would limit compliance with study requirements
- Any other illness or condition that the treating investigator feels would interfere with study compliance or would compromise the patient's safety or study endpoints
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Treatment group
|
ER/PR positive, HER2-positive breast cancer patients with brain metastatic lesions receive palbociclib PO daily on days 1-21, combined with trastuzumab IV every three weeks, pyrotinib PO daily and fulvestrant IM every 4 weeks.
Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Objective response rate in the CNS
Time Frame: Up to 3 years
|
Assess the response rate in the CNS by MRI according to modified Response Assessment in modified RECIST 1.1 criteria.
Objective CNS response is defined as at least 30% decrease in the sum of diameters of CNS target lesions in the absence of new lesions (defined as ≥ 6 mm), increased steroid use, progressive neurological symptoms, and progressive extra-CNS disease as assessed by RECIST 1.1.
Confirmatory scans are not required.
|
Up to 3 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall Survival
Time Frame: Up to 3 years
|
OS is defined as the time from treatment initiation until death due to any cause
|
Up to 3 years
|
Progression Free Survival
Time Frame: Up to 3 years
|
PFS is defined as the time from treatment initiation to documented disease progression
|
Up to 3 years
|
Overall Response Rate
Time Frame: Up to 3 years
|
Evaluate systemic ORR defined as partial response or complete response assessed by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
|
Up to 3 years
|
Time to CNS progression
Time Frame: Up to 3 years
|
Time to CNS progression will be defined as the time from treatment initiation to documented disease progression (modified RECIST 1.1 criteria) in the CNS
|
Up to 3 years
|
Time to radiotherapy
Time Frame: Up to 3 years
|
Time to radiotherapy is defined as the time from the date of inclusion to the date of event defined as the initiation of radiotherapy
|
Up to 3 years
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in quality of life in patients receiving study drug combination
Time Frame: At baseline, 2 months and 4 months
|
Quality of life measures will be assessed at baseline, 2 months and 4 and will be collected using patient reported outcome questionnaires: Functional Assessment of Cancer Therapy-Brain (FACT-Br), EORTC QLQ-BR23
|
At baseline, 2 months and 4 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
December 4, 2020
Primary Completion (ANTICIPATED)
December 30, 2023
Study Completion (ANTICIPATED)
December 31, 2024
Study Registration Dates
First Submitted
April 2, 2020
First Submitted That Met QC Criteria
April 2, 2020
First Posted (ACTUAL)
April 6, 2020
Study Record Updates
Last Update Posted (ACTUAL)
May 2, 2022
Last Update Submitted That Met QC Criteria
April 24, 2022
Last Verified
April 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Skin Diseases
- Neoplasms
- Neoplasms by Site
- Breast Diseases
- Neoplastic Processes
- Central Nervous System Neoplasms
- Nervous System Neoplasms
- Breast Neoplasms
- Neoplasm Metastasis
- Brain Neoplasms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Antineoplastic Agents, Hormonal
- Antineoplastic Agents, Immunological
- Protein Kinase Inhibitors
- Hormone Antagonists
- Estrogen Antagonists
- Estrogen Receptor Antagonists
- Trastuzumab
- Fulvestrant
- Palbociclib
Other Study ID Numbers
- SCBCS025
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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