Pyrotinib Combined With Brain Radiotherapy in Breast Cancer Patients With Brain Metastases
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. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT04582968 |
Recruitment Status :
Active, not recruiting
First Posted : October 12, 2020
Last Update Posted : January 18, 2023
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Breast Cancer Brain Metastases HER2-positive Breast Cancer | Other: Pyrotinib Plus Capecitabine combined with brain radiotherapy | Phase 1 Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 39 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Phase Ib/II Pilot Study of Pyrotinib Plus Capecitabine Combined With Brain Radiotherapy in HER2 Positive Breast Cancer Patients With Brain Metastases |
Actual Study Start Date : | January 2, 2020 |
Actual Primary Completion Date : | August 12, 2022 |
Estimated Study Completion Date : | August 12, 2023 |
Arm | Intervention/treatment |
---|---|
Experimental: Pyrotinib Plus Capecitabine combined with brain radiotherapy
Fractionated stereotactic radiotherapy(FSRT) or whole brain radiation therapy (WBRT) Drug: Pyrotinib combined with capecitabine pyrotinib 400 mg once daily; Capecitabine 1000 mg/m2 per day on day 1 through 14, every 21 days.
|
Other: Pyrotinib Plus Capecitabine combined with brain radiotherapy
Drug combined with radiation |
- Assess safety and tolerability of Pyrotinib Plus Capecitabine combined with brain radiotherapy(Phase Ib part) [ Time Frame: 8 weeks ]
AEs will be assessed according to CTCAE version 4.03.
(1)Initially 3 patients will be accrued and treated with combined therapy as a lead-in safety phase. Enrollment of the study will not proceed if patients in the safety lead-in phase experience unacceptable toxicities including neurologic, hematologic and other dose limiting toxicities.(see protocol) (b)If one of initially 3 patients has experienced unacceptable toxicities, 3 more patients will be accrued .
(3)If two or more patients are unable to complete radiation therapy (RT) due to toxicity related to Pyrotinib Plus Capecitabine combined with brain radiotherapy, accrual will be suspended and the study will be stopped.
(4) If 3+3 patients are able to complete the treatment without unacceptable toxicities, 6 more patients will be accrued in Ib part.
- Intracranial local tumor control rate (Phase II part) [ Time Frame: 2 years ]All intracranial progression
- Intracranial local tumor control rate with FSRT or WBRT [ Time Frame: 2 years ]Intracranial local tumor control rate
- Intracranial Progression-Free Survival (PFS) [ Time Frame: 2 years ]Time from the date of radiotherapy to the investigator-determined date of progression (determined by RANO) or death due to any cause, whichever occurs first
- Extracranial Progression-Free Survival (PFS) [ Time Frame: 2 years ]
- OS (overall survival) [ Time Frame: 3 years ]
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Pathologically confirmed HER2 positive advanced breast cancer
- Age>18 years. brain metastases confirmed by enhanced brain MRI
- KPS≥70
- Life expectancy of more than 12 weeks
- Prior therapy of oral dexamethasone not exceeding 16mg/d
- Time interval from prior therapy was more than 2 weeks, and evaluation of adverse events is no more than grade 1.
- Maximum diameter of intracranial metastases is less than 3cm measured by enhanced brain MRI(2-3mm)
- Prior endocrine therapy were allowed
- Anti-Her2 targeted treatment were allowed
-
Screening laboratory values must meet the following criteria( and should be obtained within 28 days prior to registration):
- Absolute Neutrophil Count (ANC) ≥ 1.5 x 109/L, Platelets≥ 90 x 109/L, Hemoglobin ≥ 90 g/L
- Aspartate aminotransferase/alanine aminotransferase (AST/ALT) ≤2.5 x ULN without liver metastasis,≤ 5 x ULN with liver metastases
- Serum BUN and creatinine ≤ 1.5 x Upper Limit of Normal (ULN)
- LVEF ≥ 50%
- QTcF < 480 ms
- INR≤1.5×ULN,APTT≤1.5×ULN
- Signed the informed consent form prior to patient entry
Exclusion Criteria:
- Leptomeningeal or hemorrhagic metastases
- uncontrolled epilepsy
- Severe complication: cardiovascular disease, end-stage renal disease, severe hepatic disease, infection etc.
- Pregnancy or lactation period, women of child-bearing age who are unwilling to accept contraceptive measures.
- Inability to complete enhanced MRI
- Patients who are difficult or unable to be followed-up
- Not suitable for inclusion for specific reasons judged by sponsor
- Patients unable to swallow, with chronic diarrhea, intestinal obstruction, or multiple factors that affect drug use and absorption
- History of allergy to pyrotinib or capetabine
- History of immunodeficiency, including HIV positive, active HBV/HCV or other acquired, congenital immunodeficiency disease, or organ transplantation history
- Previous use of pyrotinib combined with capetabine
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): NCT04582968
China | |
Fudan University Shanghai Cancer Center | |
Shanghai, China, 200032 |
Principal Investigator: | Xiaoli Yu, MD PhD | Fudan University |
Responsible Party: | Xiaoli Yu, Professor, Fudan University |
ClinicalTrials.gov Identifier: | NCT04582968 |
Other Study ID Numbers: |
FDRT-BC010 |
First Posted: | October 12, 2020 Key Record Dates |
Last Update Posted: | January 18, 2023 |
Last Verified: | January 2023 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
pyrotinib brain radiotherapy |
Breast Neoplasms Neoplasm Metastasis Brain Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Neoplastic Processes Pathologic Processes Central Nervous System Neoplasms |
Nervous System Neoplasms Brain Diseases Central Nervous System Diseases Nervous System Diseases Capecitabine Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Antineoplastic Agents |