Status:
UNKNOWN
Efficacy and Safety of Adjuvant Docetaxel and Trastuzumab in Stage I HER2-positive Breast Cancer
Lead Sponsor:
Second Affiliated Hospital, School of Medicine, Zhejiang University
Conditions:
HER2-positive Breast Cancer
Adjuvant Therapy
Eligibility:
FEMALE
18-70 years
Phase:
PHASE2
PHASE3
Brief Summary
Among women with stage I HER2-positive breast cancer, adjuvant weekly paclitaxel plus trastuzumab (PH, qw×12) is one of the standard therapies. However, it is quite inconvenient for patients to receiv...
Detailed Description
HER2-positive breast cancer accounts for about 20% of invasive breast cancers and was historically associated with poor clinical outcomes. Trastuzumab, a humanized monoclonal antibody that binds HER2,...
Eligibility Criteria
Inclusion
- Female aged 18 - 70 years old;
- The histopathological confirm of invasive breast cancer;
- HER-2 positive: immuno-histochemistry (IHC) 3+ or fluorescence in situ hybridization (FISH) confirmed amplification of erbb2 gene;
- Tumor must be ≤ 2cm in greatest dimension, negative axillary lymph node or with micrometastasis (axillary nodes with tumor clusters ≤ 0.2cm);
- No more than 90 days from the patient's most recent breast surgery for this breast cancer;
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1;
- Adequate bone marrow function: neutrophil ≥ 1500/mm\^3, hemoglobin ≥ 9 g/dl, and platelets ≥ 100,000/mm\^3;
- Adequate liver and renal function: creatinine ≤ 1.5 folds of the upper limit of normal value; aspartate aminotransferase and alanine aminotransferase ≤ 1.5 folds of the upper limit of normal value, aspartate aminotransferase and alanine aminotransferase ≤ 2 folds of the upper limit of normal value for patient with Gilbert 's syndrome;
- Left ventricular ejection fraction (LVEF) ≥ 50%;
- Willing and able to sign informed consent.
Exclusion
- Any of the following due to teratogenic potential of chemotherapy: pregnant women, nursing women, women of childbearing potential who are unwilling to employ adequate contraception;
- Locally advanced tumors at diagnosis, including tumors fixed to the chest wall, peau d'orange, skin ulcerations/nodules, or clinical inflammatory changes;
- History of prior chemotherapy in the past 5 years;
- History of prior trastuzumab therapy;
- Patients with a history of previous invasive breast cancer;
- Active, unresolved infection;
- Prior history of any other malignancy in the past 5 years, except for early stage tumors of the skin or cervix treated with curative intent;
- Can not tolerate or be allergic to chemotherapy, anti-HER-2 therapy or pharmaceutical materials such as benzyl alcohol;
- ≥ grade 2 neuropathy;
- Active cardiac disease: Any prior myocardial infarction (asymptomatic changes on EKG suggestive of old myocardial infarction is not an exclusion); Documented congestive heart failure (CHF); Current use of any therapy specifically for CHF; Current uncontrolled hypertension (diastolic \>100 mmHg or systolic \> 200 mmHg); Clinically significant pericardial effusion;
- The antibody of hepatitis C virus, HIV or Treponema pallidum positive; HBsAg positive and hepatitis B virus DNA in peripheral blood ≥ 10\^3 copy/mL；
- Enrollment on other Investigational studies within 30 days;
- Not allowed by the investigators.
Key Trial Info
Start Date :
January 31 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2025
Estimated Enrollment :
190 Patients enrolled
Trial Details
Trial ID
NCT05189067
Start Date
January 31 2022
End Date
June 30 2025
Last Update
January 12 2022
Active Locations (1)
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1
2nd Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, China, 310000