Clinical T1-2N0M0, HER2 positive primary breast cancer
Conditions
Interventions
Anti-HER2 therapy and chemotherapy is performed for clinical cT1-2N0M0 HER2 positive primary breast cancer.
Primary chemotherapy + anti-HER2 therapy
(1) AC/EC therapy + THP therapy
AC/EC therapy (ant
q3w (every 3 week) as 1cycle, perform 3 or 4 cycles.
THP therapy
q3w (every 3 week) as 1cycle, perform 3 or 4 cycles.
(2) TCHP therapy
Docetaxel + carboplatin + trastuzumab + pertuzumab
q3w (every 3 week) as 1cycle, perform 5 or 6 cycles.
(3) PacHP therapy
Paclitax
HP therapy) + radiation therapy are performed.
(1) Additional anti-HER2 therapy
Perform HP therapy every 3 week, up to total 18 cycles.
(2) Radiation therapy
Total breast irradiation
total 50Gy/25Fr, or 42.56Gy/16Fr.
Boost
16Gy/8Fr.
(3) Endocrine therapy
Patients with either ER-positive or PgR-positive by IHC analysis receive the following endocrine therapy for 5 years depending on the menopausal status.
A) Tamoxifen +
Sponsors
FUJISAWA Tomomi
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: (1) Histologically documented as invasive ductal carcinoma of breast. (2)Histologically documented as 1. ER and PR receptors are investigated via IHC analysis. 2. HER2 positivity is defined as either of the following local laboratory assessment: In situ hybridization (ISH) -amplified (ratio of HER2 to CEP17 > 2.0 or singleprobe average HER2 gene copy number >6 signals/cell), or IHC 3+ (3) In primary resion, breast sonography and breast MRI meet the following, 1. Diameter defined all modality is under 5cm 2. There are no multiple lesions in the ipsilateral breast (4) No axillary LN metastasis is defined by sonography, (5) No distant metastasis defined as 1. Chest ; Chest CT or FDG-PET/CT or FDG-PET/MRI 2. Abdomen ; Abdomen CT or FDG-PET/CT or FDG-PET/MRI 3. Bone ; Bone Scan or FDG-PET/CT or FDG-PET/MRI 4. Brain ; no need to explain with no symptom. (6) No Bilateral breast cancer (7) Women aged 20-74 years (8) ECOG performance status of 0 or 1 (9) A measurable lesion is not required. (10) Previously treatments are followed, 1. No prior chemotherapy or targeted systemic therapy for other cancer within 5years. 2. No prior radiation therapy within the breast, chest-wall. 3. No prior anticancer drug treatment, endocrine therapy, or surgery for the purpose of treating breast cancer. Endocrine therapy for the purpose of alleviating menopausal symptoms, surgical biopsy or sentinel lymph node biopsy for diagnosis is allowed. (11) Comorbidity is as, 1.No DCIS, invasive cancer. 2. No Scleroderma or systemic lupus erythematosus 3. No Li Fraumeni syndrome (12) No BRCA mutation is evaluated. (13) Both upper arms can be lifted in the supine position. (14) Adequate hematologic and end-organ function, defined by the adequate laboratory results obtained within 28 days prior to the first enrollment . 1. ANC >= 1500 cells/mm3 2. Hemoglobin >= 9.0 g/dL (Patients are not transfused or receive erythropoietic treatment to meet this criterion.) 3. Platelet count >= 100,000/ mm3 4. Serum bilirubin <= 1.5 mg/dL 5.AST, ALT <= 100 U/L 6. Creatinine <= 1.2 mg/dL (15) Ejection fraction of cardiac function is defined over 50% (16) Signed Informed Consent Form
Exclusion criteria
Exclusion criteria: (1) Active malignancies curatively treated with no evidence of disease for >= 5 years prior to randomization. (2) No MRI enforcement due to hypersensitivity of Gadolinium enhancement, Claustrophobia, metal-embedment. (3) Infection with care. (4) Fever up 38 degree. (5) Childbearing potential, delivery after 28 days, breastfeeding (6) Mental disorders. (7) Continuously take steroids or immunosuppressive drugs. (8) Poorly controlled Diabetes mellitus. (9) Poorly controlled Hypertension. (10) Unstable anjina or history of cardiac infarction within 6months. (11) Congestive heart failure deserved class II of New York Heart Association(NYHA), poorly controlled Dilated or Hypertrophic cardiomyopathy. (12) Severe arrhythmia need to cure (except Atrial fibrillation, Paroxysmal supraventricular tachycardia ) (13)Interstitial pneumonia, pulmonary fibrosis, severe emphysema diagnosed chest CT scan. (14) HBs Ag+
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 3 year survival rate with no distant metastasis | — |
Secondary
| Measure | Time frame |
|---|---|
| Distant Free Survival rate, OverAll Survival rate, Recurrence free survival, Breast-operation free survival rate, Local recurrence rate, Cosmetic change rate, Adverse event rate, non-CR match rate | — |
Contacts
Public ContactMiho Nishi
GunmaPrefectural Cancer Center
Outcome results
None listed