Female patients with operative HER2 positive primary breast cancer
Conditions
Interventions
Group A: ER-negative Lapatinib(L)+Trastuzumab(T) 6 weeks followed by L+T+paclitaxel (P) 12 weeks
Group B: ER-negative L+T 18 weeks followed by L+T+P 12 weeks
Group C: ER-positive L+T 6 weeks fol
Sponsors
Japan Breast Cancer Research Group(JBCRG)
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1.First key inclusion criteria (1)Age between 20 and 70 years (2)Female patients with primary breast cancer which is diagnosed as invasive cancer by needle biopsy or tissue biopsy. (3)Resectable primary breast cancer (T1c-3N0-1M0) with a tumor size <-7cm in diameter (multiple ipsilateral breast cancer is eligible when at least one lesion meets the eligibility criteria. However, each lesion has to be histologically evaluated). (4)The invasive component of the primary tumor is confirmed as HER2 positive (IHC 3+ or FISH+) (5) ER and PgR statuses are confirmed by IHC (6) no previous therapy for breast cancer (7) Pt has been confirned as suitable indication for primary systemic therapy (8)The primary lesion allows imaging evaluation at baseline and after the end of study treatment using the same modality either CT scan, MRI or ultrasonography. (9) Written informed concents 2. Secondary criteria By the pathological central review, HER2-positive invasive ductal carcionma has been confirmed. (1) ECOG performance status (PS) 0-1 (2) Laboratory test results meet the following criteria (within 14 days before registration) neutrophil count: =>1,500/mm3 Hemoglobin: => 9.0g/dL Platelet count: =>100,000/mm3 AST and ALT: <= 2.5 x upper limit of normal (ULN) established at site ALP: <= 2.5 x ULN Total bilirubin: <= 1.5 x ULN Serum creatinine: <= 1.5 x ULN (3) Baseline left ventricular ejection fraction (LVEF) => 50% measured by echocardiography or MUGA scan. (4) No QTc prolongation by electrocardiography (ECG) (QTc: <=470 msec) (5) No interstitial pneumonia or pulmonary fibrosis diagnosed by chest CT scan (6) In screening for hepatitis B, determinations of HBsAg is negative (7) If a patient's postmenopausal status cannot be confirmed, her pregnancy test must be negative (urinary or serum HCG negative) (excluding ovariectomized or hysterectomized patients)
Exclusion criteria
Exclusion criteria: (1)History or drug hypersensitivity that is relevant for the treatment in the study (i.e., past history of immediate or delayed hypersensitivity reaction to compounds chemically similar to lapatinib and its excipients) (2)Uncontrolled concurrent disease (3)Active infection, or pyrexia that indicates suspected infection (4)Symptoms of varicella (5)Pleural or pericardial effusion requiring treatment (6)Past gastric or small bowel resection, or malabsorption or gastrointestinal dysfunction, except for ulcerative colitis (7)Use of concomitant medication (e.g, CYP3A4 inhibitors/inducers) or non-drug therapy prohibited (8)Current chronic use of systemic corticosteroids; in ER-positive patients, current treatment with any drug product containing estrogen or any selective estrogen receptor modulator (9)Dementia or past history of serious psychiatric disease or current treatment for such a disease (10)Bilateral breast cancer whether synchronous or metachronous. Patients who had lobular carcinoma in situ [LCIS] in the contralateral breast may be enrolled. (11)Patients with multiple cancer except for adequately treated noninvasive cancer (DCIS/LCIS), nonmelanoma skin cancer, cervical cancer, thyroid cancer, early gastric cancer and early colorectal cancer. Lesions consistent with carcinoma in situ or intramucosal carcinoma that have been considered cured by local treatment are not included in multiple cancer. (12)Prior treatment with taxane anticancer drugs (13)Pregnant, lactating or women of childbearing potential (14)Participation in another clinical trial (15)Patients otherwise considered ineligible for enrollment in the study by the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| pCR (including residual DCIS, breast only) | — |
Secondary
| Measure | Time frame |
|---|---|
| (1) Safety (2) Clinical response rate (ORR) (3) Breast conservation rate (4) QpCR (5) pCR (including residual DCIS, breast + axillary) (6) SpCR | — |
Countries
Japan
Contacts
Public ContactHiroi Kasai
Kyoto University Hospital Translational Research Center
Outcome results
None listed