Investigation of Dual-HER2 Blockage Therapy in HER2-Positive Breast Cancer (exploratory randomized P-II)( JBCRG-16 NeoLath)
- Conditions
- Female patients with operative HER2 positive primary breast cancer
- Registration Number
- JPRN-UMIN000007576
- Lead Sponsor
- Japan Breast Cancer Research Group(JBCRG)
- Brief Summary
Poster:14th St.Gallen Breast Cancer Conference(2015) Symposia:The 23rd Annual Meeting of the Japanese Breast Cancer Society(2015)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- Female
- Target Recruitment
- 246
Not provided
(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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method pCR (including residual DCIS, breast only)
- Secondary Outcome Measures
Name Time Method (1) Safety (2) Clinical response rate (ORR) (3) Breast conservation rate (4) QpCR (5) pCR (including residual DCIS, breast + axillary) (6) SpCR