Not yet recruiting NCT04158856
Adjuvant Dual Anti-HER2 Therapy in Patients With Small, Node-negative, HER2-positive Breast Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Pyrotinib, Trastuzumab.
- Who it may be relevant to
- Registry conditions: HER2-positive Breast Cancer. Basic parameters: 18 years — 70 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Adjuvant Dual Anti-HER2 Therapy in Patients With Tumors < 8mm, Node-negative, HER2-positive Breast Cancer :a Single-group Arm, Open-label, Prospective, Phase 2 Study
Overview
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.
Interventions
- Drug Pyrotinib
400mg po every day - Drug Trastuzumab
Trastuzumab is administered at a loading dose of 8 mg/kg IV followed by 6 mg/kg every 21 days
Primary outcome measures
- Disease-free Survival [Time frame: 5 years]
Secondary outcome measures (4)
- Breast Cancer Specific Survival [Time frame: 5 years]
- Overall Survival [Time frame: 5 years]
- Treatment-related adverse events [Time frame: up to 3 months]
- Change of LVEF after treatment [Time frame: up to 3 months]
Eligibility criteria
Inclusion criteria
- Women aged 18-70 years old
- Have finished radical operation
- Histologically confirmed invasive ductal carcinoma (IDCA)
- According to AJCC ,pT<8mm, pN0, no evidence for metastasis
- 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.
- Should have tumor tissue available and sufficient for multi-spots sampling.
- It has been <84 days since the date of definitive surgery, and there is adequate wound healing as determined by the Treating Physician.
- Has Eastern Cooperative Oncology Group (ECOG) Performance Score 0-1, expected survival time > 12 months
- Cardiac function had to be within normal limits (left ventricular ejection fraction \[LVEF\] ≥50%), as established by multiple gated acquisition scan or echocardiography.
- Adequate bone marrow function, adequate liver and renal function, and adequate coagulation function.
- 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.
- Written informed consent according to the local ethics committee requirements.
Exclusion criteria
- pT≥8mm or node positive
- Metastatic breast cancer
- Any prior systemic or loco-regional treatment of breast cancer, including chemotherapy in 28 days
- With a history of malignant tumor except uterine cervix cancer in situ or skin basal cell carcinoma
- 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
- Has symptomatic peripheral neuropathy > grade 2 according to NCI
- Known severe allergy to any drugs in this study
- Has cardiac dysfunction or lung dysfunction defined as follows:
- grade ≥3 CHF according to NCI CTCAE v 5.0 or NYHA≥II
- angina which requires drug control, cardiac infraction, and any other vascular disease with apparent clinical symptoms
- uncontrolled high-risk arrhythmia
- uncontrolled hypertension
- Has active hepatitis B or hepatitis C with abnormal liver function tests (LFTs) or is known to be HIV positive
- Patient is pregnant or breast feeding
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT04158856 · SHERO