Breast Cancer Clinical Trial
Official title:
Phase I Clinical Trials Investigating the Potential Efficacy of Axitinib in Patients With a BRCA 1/2 Mutations Independent of HER2 Expression With Progression After Previous Treatment
Verified date | July 2023 |
Source | Lynkcell Europe |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This Clinical Trial is investigating the potential efficacy of axitinib after genetic testing in BRCA 1/2 Mutation patients, regardless of HER2 expression, who have progressed after at least one line of standard treatment or for whom there is no consensus treatment approach. The use of Axitinib may help physicians plan for more effective patient care in combination with existing treatment protocols.
Status | Enrolling by invitation |
Enrollment | 30 |
Est. completion date | November 9, 2024 |
Est. primary completion date | September 24, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - histologically and immunohistochemically confirmed status of the tumor process - ?ale or female, age = 18 years - Karnofsky performance status = 60 - signed informed consent and willingness/ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures Exclusion Criteria: - Grade 3 bleeding NCI CTCAE prior to study enrollment - cardiac arrhythmias =2 according to NCI CTCAE with a corrected QT interval (QTcF) on the screening ECG >480 ms. - pregnancy or breastfeeding. All female subjects of reproductive potential must have a negative pregnancy test (serum) prior to enrollment. Male subjects must be surgically sterile or must consent to the use of effective contraception during therapy. - severe acute or chronic psychiatric condition or disorder with risk associated with participation in the study - congestive heart failure (CHF) class III or higher according to the New York Heart Association (NYHA) - subjects with arterial thrombotic events / venous thrombosis in the previous 12 months (axitinib has never been studied in this population) |
Country | Name | City | State |
---|---|---|---|
Ukraine | Trials TEAM | Dnipro | |
Ukraine | Trials TEAM | Kyiv |
Lead Sponsor | Collaborator |
---|---|
Lynkcell Europe |
Ukraine,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Antitumor effect of axitinib (INLYTA) among patients with solid tumors with BRCA 1/2 mutations independent of HER2 expression, with progression after previous treatment, including radiotherapy | Percent reduction of longest diameter of tumor and (or) metastases in millimeters | up to 90 days |
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