SHERO: Adjuvant Dual Anti-HER2 Therapy in Patients With Small, Node-negative, HER2-positive Breast Cancer
Study Details
Study Description
Brief Summary
This phase II trial aims to study the efficacy and safety of adjuvant Pyrotinib plus trastuzumab in patients with tumors <8mm, node-negative, HER2-positive breast cancer.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 2 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Experimental Arm adjuvant Pyrotinib plus Trastuzumab |
Drug: Pyrotinib
400mg po every day
Other Names:
Drug: Trastuzumab
Trastuzumab is administered at a loading dose of 8 mg/kg IV followed by 6 mg/kg every 21 days
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Disease-free Survival [5 years]
stimated percentage of patients alive and disease-free at 5 years from randomization or censored at date of last follow-up.
Secondary Outcome Measures
- Breast Cancer Specific Survival [5 years]
Estimated percentage of patients alive and disease-free at 5 years from randomization, where breast cancer specific survival is defined as the time from randomization to death from breast cancer relapse; or censored at date last known alive.
- Overall Survival [5 years]
Estimated percentage of patients alive and disease-free at 5 years from randomization, where overall survival is defined as the time from randomization to death from any cause; or censored at date last known alive.
- Treatment-related adverse events [up to 3 months]
Incidence and severity of adverse events as assessed by NCI CTCAE V5.0
- Change of LVEF after treatment [up to 3 months]
The change of LVEF after 3 months treatment compared to the baseline LVEF
Eligibility Criteria
Criteria
Inclusion Criteria:
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Women aged 18-70 years old
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Have finished radical operation
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Histologically confirmed invasive ductal carcinoma (IDCA)
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According to AJCC ,pT<8mm, pN0, no evidence for metastasis
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Operation specimens are available for ER, progesterone receptor (PR) and HER2 detection, patients should be HER2 positive tumor (IHC staining of 3+ [uniform, intense membrane staining of >30% of invasive tumor cells], or a FISH result of .6 HER2 gene copies per nucleus or a FISH ratio [HER2 gene signals to chromosome 17 signals] of >2.2), nuclear grade 3.
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Should have tumor tissue available and sufficient for multi-spots sampling.
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It has been <84 days since the date of definitive surgery, and there is adequate wound healing as determined by the Treating Physician.
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Has Eastern Cooperative Oncology Group (ECOG) Performance Score 0-1, expected survival time > 12 months
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Cardiac function had to be within normal limits (left ventricular ejection fraction [LVEF] ≥50%), as established by multiple gated acquisition scan or echocardiography.
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Adequate bone marrow function, adequate liver and renal function, and adequate coagulation function.
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Women with potential child-bearing must have a negative pregnancy test (urine or serum) within 7 days of drug administration and agree to use an acceptable and effective method of contraception to avoid pregnancy during the study.
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Written informed consent according to the local ethics committee requirements.
Exclusion Criteria:
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pT≥8mm or node positive
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Metastatic breast cancer
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Any prior systemic or loco-regional treatment of breast cancer, including chemotherapy in 28 days
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With a history of malignant tumor except uterine cervix cancer in situ or skin basal cell carcinoma
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Patients with medical conditions that indicate intolerant to adjuvant target therapy and related treatment, including severe infection, coagulation disorder, active peptic ulcer, coagulation disorder, connective tissue disease or myelo-suppressive disease
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Has symptomatic peripheral neuropathy > grade 2 according to NCI
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Known severe allergy to any drugs in this study
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Has cardiac dysfunction or lung dysfunction defined as follows:
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grade ≥3 CHF according to NCI CTCAE v 5.0 or NYHA≥II
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angina which requires drug control, cardiac infraction, and any other vascular disease with apparent clinical symptoms
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uncontrolled high-risk arrhythmia
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uncontrolled hypertension
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Has active hepatitis B or hepatitis C with abnormal liver function tests (LFTs) or is known to be HIV positive
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Patient is pregnant or breast feeding
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- xuexin he
Investigators
- Study Chair: Xuexin He, MD, Seaond Affiliated Hospital, Zhejiang University, School of Medicine
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- SHERO