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Technetium Tc 99m Sulfur Colloid Injection for Tracing Sentinel Nodes in Breast Cancer

CompletedPhase 3

Sponsor: HTA Co., Ltd.

Conditions: Sentinel Nodes, Breast Cancer

Interventions: Technetium Tc 99m Sulfur Colloid Injection, Mitoxantrone Hydrochloride Injection for Tracing

Countries: China

The aim of the study is a prospective multicentre phase-3 study that aims to evaluate the detection rate of sentinel lymph node in patients with breast cancer. To compare the detection rates of Technetium Tc 99m Sulfur Colloid Injection(99mTc-SC) and Mitoxantrone Hydrochloride Injection for Tracing(MHI) for lymphatic tracing in patients with breast cancer.

Eligibility overview

Sex: FEMALE

Age: 18 Years to 70 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion criteria

1. Able to understand and voluntarily sign a written informed consent.
2. Female subjects aged 18-70 years ( including 18 and 70 years ).
3. Histologically confirmed diagnosis of invasive breast cancer or primary invasive breast cancer or ductal carcinoma in situ (DCIS) ；
4. Clinical stage 1 or 2；
5. For subjects undergoing surgical treatment, axillary sentinel lymph node biopsy is part of the surgical plan；
6. The axillary lymph nodes were negative by imaging examination or confirmed by fine needle aspiration.
7. Conventional preoperative examination showed no clear surgical contraindications Exclusion criteria

1)Participants are allergic to the test drug or its excipients or have a history of severe drug allergy ; 2)Participants with prior surgery for breast cancer or neoadjuvant chemotherapy ; 3)inflammatory breast cancer ; 4)Ipsilateral axillary clinical examination or imaging examination positive or puncture lymph node pathology positive, no breast cancer histopathological diagnosis or no puncture pathological examination ; 5)Have received any form of breast augmentation surgery ; 6)Participants with liver or kidney dysfunction, ALT, AST\>2.5 times ULN, Bilirubin \>1.5 times ULN, Serum creatinine \>1.5 times, or Investigators believe that liver and / or kidney damage to the extent that patients should not participate in this study;； 7)With serious or uncontrollable diseases : such as severe cardiovascular and cerebrovascular diseases ( blood disease, chronic congestive heart failure NYHA classification ≥ III level, etc. ), severe pulmonary insufficiency ( one second rate FEV1 / FVC \< 50 % or FEV1 \< 50 % predicted value or maximum ventilation volume per minute MVV \< 50L / min ), psychiatric patients ; 8)Participants with active infection of infectious diseases screening ( hepatitis B surface antigen, hepatitis C antibody, syphilis antibody, HIV antibody ) ; 9)participated in clinical trials of other drugs within 3 months before screening; 10)) Patients with positive pregnancy test or pregnancy plan during lactation or screening period to 3 months after administration and unwilling to take effective contraceptive measures or egg donation plan; 11)Investigators considered that it was not suitable for the patients to participate in this trial

Locations (1)

Beijing, Beijing Municipality, China