Her2-positive invasive breast cancer
Conditions
Interventions
Short term dual Her2 blockade arm:Short term dual Her2 blockade in combination with taxanes
Sponsors
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Eligibility
Sex/Gender
Female
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Age: 18 ~ 75 years old, female 2.Histologically diagnosed unilateral primary invasive breast cancer patient with pT1, pN0, and M0 disease; 3.HER2-positive, ie. iHC 3+ or IHC 2+ and FISH-positive according to ASCO CAP 2018 guidelines; 4.complete clinical pathological information; 5.ECOG 0-1; 6.Currently not pregnant or breast-feeding; 7.Fine organ function; 8.Have good compliance with planned treatment, understand the study process and sign a written informed consent;
Exclusion criteria
Exclusion criteria: 1.Bilateral or metastatic breast cancer; 2.Receiving neoadjuvant treatment; 3. Have significant heart disease: a) History of myocardial infarction, acute coronary syndrome, or coronary angioplasty/stent placement/bypass grafting within the past 6 months; b) New York Heart Association (NYHA) Class II-IV congestive heart failure (CHF) or NYHA Class III or IV CHF; 4. Other malignant tumors in the past 5 years, except for cured carcinoma in situ of the cervix and skin cancer without melanoma; 5. Patients with severe systemic infection or other serious diseases; 6. Known history of human immunodeficiency virus (HIV) infection, 7. Active hepatitis B or hepatitis C virus infection; 8. Patients who are known to be allergic or intolerant to the therapeutic drugs or their excipients; 9. Previous treatment with cytotoxic chemotherapy, endocrine therapy, biological therapy or radiation therapy for any reason; 10. Being/having been enrolled in a study of an investigational agent within 4 weeks prior to the first dose of study treatment and received study treatment or used an investigational device (12 months specified for an investigational drug or device with anticancer or antiproliferative properties); 11. Vaccination with a live vaccine within 30 days prior to the first dose of investigational drug. Live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/shingles, yellow fever, rabies, BCG, and typhoid vaccines, as well as nasal influenza vaccines 12. History of psychiatric illness or substance abuse that may affect compliance with trial requirements; 13. Patients of childbearing potential who are pregnant or lactating, and who refuse to take adequate contraceptive measures during this trial 14. Patients who are judged by the investigator to be unsuitable to participate in this study;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Disease-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival;Distant disease-free survival; | — |
Countries
China
Contacts
Public ContactXiaosong Chen
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Outcome results
None listed