Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 1:14 PM
Ignite Modification Date:
2025-12-24 @ 1:14 PM
NCT ID:
NCT03983395
Eligibility Criteria:
Inclusion Criteria:
* Females with HER2-positive \[IHC 2 +, with FISH confirmation\] or 3+ \[IHC or FISH\] metastatic breast cancer that has progressed on last therapy. No more than 4 lines of therapy in metastatic setting (of which no more than 2 lines should be anti-HER2 antibody-based therapy).
* Measurable disease, defined as per RECIST v1.1.
* Eastern Cooperative Oncology Group (ECOG ) performance-status score of 2 or less
* Adequate bone marrow, renal, and liver function.
* Recovered from any previous surgery and no history of major surgery within the last 28 days prior to start of study drug
* Must be willing to undergo pre-treatment and on-treatment biopsies in Part 1 and Part 2.
Exclusion Criteria:
* Any suspected or proven immunocompromised state, or infections, such as history of positive human immunodeficiency virus (HIV), known active or chronic hepatitis B virus (HBV) or hepatitis C virus (HCV).
* Any history or evidence of clinically significant cardiovascular disease.
* Evidence of clinically significant cardiovascular and respiratory conditions
* Previous antineoplastic treatment with immune checkpoint regulator or comparable immunotherapy within 8 weeks of starting study drug.
* Chemotherapy, radiotherapy, molecular-targeted therapy, or biological therapies (including HER2-directed therapies) within 4 weeks of starting study drug
* Hormone therapy within 2 weeks of starting study medications.
* Diagnosed with another malignancy that requires active therapy
* Brain metastases that require directed therapy.
* Has not recovered from any therapy related toxicities from previous treatments.
* Use of any investigational drug within 4 weeks from the start of study drug.
* Any condition that, in the opinion of the Investigator, would interfere with evaluation of the study drug or interpretation of subject safety or study results.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT03983395
Study Brief:
Protocol Section:
NCT03983395