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Breast CancerPhase 2NCT04334330

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

A Phase 2 study testing Palbociclib, Trastuzumab, Pyrotinib and Fulvestrant in people with Breast Cancer and Brain Metastases, run by Sun Yat-sen University at 2 sites in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Breast Cancer, Brain Metastases
What is being tested?
Palbociclib, Trastuzumab, Pyrotinib and Fulvestrant
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
34 participants
Where
2 sitesChina
Study dates
4 Dec 2020to 31 Dec 2024
Phase
Phase 2
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 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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
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  • 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

Trial locations and contacts

2 sites in 1 country.

China2 sites, 2 recruiting

  • Shusen Wang

    Guangzhou, Guangdong, 510060

    Whusen Wang, MD, 8613926168469, wangshs@sysucc.org.cn

    Recruiting

  • State Key Laboratory of Oncology in South China, Sun Yat-sen University Cancer Center

    Guangzhou, Guangdong, 510060

    Ruoxi Hong, MD, 862087342693, hongrx@sysucc.org.cn

    Recruiting

Other trials in China

About this study

Official title: 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.

Being tested
Palbociclib, Trastuzumab, Pyrotinib and Fulvestrant
Keywords
breast cancer, brain metastasis, Palbociclib, CDK4/6 inhibitor, pyrotinib, fulvestrant, trastuzumab, HER2-positive, ER/PR positive, hormonal receptor positive
Medical subject headings
Breast Neoplasms, Brain Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Palbociclib, Trastuzumab, Pyrotinib and FulvestrantDrug

    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.

Study groups in NCT04334330
Study groupRoleWhat they receive
Treatment groupExperimentalNot described
Receives: Drug: Palbociclib, Trastuzumab, Pyrotinib and Fulvestrant

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Objective response rate in the CNS

    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.

    Measured: Up to 3 years

Secondary outcomes (5)

  1. Overall Survival

    OS is defined as the time from treatment initiation until death due to any cause

    Measured: Up to 3 years

  2. Progression Free Survival

    PFS is defined as the time from treatment initiation to documented disease progression

    Measured: Up to 3 years

  3. Overall Response Rate

    Evaluate systemic ORR defined as partial response or complete response assessed by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1

    Measured: Up to 3 years

  4. Time to CNS progression

    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

    Measured: Up to 3 years

  5. Time to radiotherapy

    Time to radiotherapy is defined as the time from the date of inclusion to the date of event defined as the initiation of radiotherapy

    Measured: Up to 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Apr 2020
  2. Study start4 Dec 2020
  3. Primary completion30 Dec 2023 (estimated)
  4. Study completion31 Dec 2024 (estimated)

Resources

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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
34 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04334330
Sponsor's protocol ID
SCBCS025
Status last verified
Apr 2022
First submitted
2 Apr 2020
Last updated
2 May 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Chen D, Xu F, Lu Y, Xia W, Du C, Xiong D, Song D, Shi Y, Yuan Z, Zheng Q, Jiang K, An X, Xue C, Huang J, Bi X, Chen M, Zhang J, Wang S, Hong R. Pyrotinib and trastuzumab plus palbociclib and fulvestrant in HR+/HER2+ breast cancer patients with brain metastasis. NPJ Breast Cancer. 2024 Jun 13;10(1):45. doi: 10.1038/s41523-024-00646-2.

    PubMed 38871705

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Palbociclib, Trastuzumab, Pyrotinib and Fulvestrant in people with Breast Cancer and Brain Metastases, run by Sun Yat-sen University at 2 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 22 inclusion and 17 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 2 May 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective response rate in the CNS (time frame: Up to 3 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04334330, which also lists 1 linked publication.

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 2 May 2022.

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