Last updated: October 26, 2022
Sponsor: Ruijin Hospital
Overall Status: Active - Recruiting
Phase
2
Condition
Breast Cancer
Cancer
Treatment
N/AClinical Study ID
NCT03907800
RJBC1801
Ages > 18 Female
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Written informed consent for all study according to local regulatory requirementsprior to beginning specific protocol procedures.
- Age at diagnosis ≥ 18 years, female.
- Histologically confirmed diagnosis of HER2-opsitive or triple-negative breast cancer.ER/PR-negativity is defined as ≤1% stained cells; HER2-positivity is defined as IHC 3+or in-situ hybridisation (ISH) ratio >2.0.
- cT2-4NanyM0 or cTanyN1-3M0
- ECOG ≤ 1, LVEF ≥ 55%.
- Laboratory requirements: for hematology, absolute neutrophil count (ANC) ≥ 1.5 × 109 /L and platelets ≥ 100 × 109 / L and hemoglobin ≥ 90 g/L; for hepatic function, totalbilirubin ≤ 1.5 × UNL, AST and ALT ≤ 2.5 × UNL; for renal function, SCr ≤ 1.5 × UNL
- Patients must be available and compliant for treatment and follow-up.
Exclusion
Exclusion Criteria:
- Prior chemotherapy, endocrine therapy or radiation therapy for any malignancy.
- Known or suspected congestive heart failure (> NYHA I)
- Currently active infection or severe symptomatic visceral disease.
- Definite contraindications for the use of corticosteroids or known hypersensitivityreaction to one of the compounds or incorporated substances used in this protocol
- rior malignancy with a disease-free survival of < 5 years, except curatively treatedbasalioma of the skin, pTis of the cervix uteri.
- Participation in another clinical trial with any investigational, not marketed drugwithin 30 days prior to study entry.
- Pregnant or lactating patients. Patients of childbearing potential must implementadequate non-hormonal contraceptive measures (barrier methods, intrauterinecontraceptive devices, sterilization) during study treatment.
Study Design
Total Participants: 100
Study Start date:
April 01, 2019
Estimated Completion Date:
October 31, 2022
Connect with a study center
Ruijin Hospital
Shanghai, 200025
ChinaActive - Recruiting

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