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Study of Kadcyla + Perjeta Following Anthracyclines in Comparison w/Herceptin + Perjeta & a Taxane Following Anthracyclines as Adjuvant Therapy in Pts w/Operable HER2-positive Primary Breast Cancer
Overall Recruitment Status: Active, enrollment completed
 
Official Title
A RANDOMIZED, MULTICENTER, OPEN-LABEL, PHASE III TRIAL COMPARING TRASTUZUMAB PLUS PERTUZUMAB PLUS A TAXANE FOLLOWING ANTHRACYCLINES VERSUS TRASTUZUMAB EMTANSINE PLUS PERTUZUMAB FOLLOWING ANTHRACYCLINES AS ADJUVANT THERAPY IN PATIENTS WITH OPERABLE HER2?POSITIVE PRIMARY BREAST CANCER
 
Region Sponsors
California - Northern
Hoffmann-La Roche
 
Acronym KP IRB No.
CN-14-1809-B
 
Study Type Phase
Clinical Trial Phase III
 
Study Population Description
Breast Cancer
 
Purpose
This two-arm, randomized, open-label, multicenter study will evaluate the effica cy and safety of Kadcyla (trastuzumab emtansine, also known as T-DM1) in combina tion with Perjeta (pertuzumab) versus Herceptin (trastuzumab) in combination wit h Perjeta and a taxane as adjuvant therapy in patients with HER2-positive primar y invasive breast cancer. Following surgery and anthracycline-based chemotherapy, patients will receive either Kadcyla 3.6 mg/kg and Perjeta 420 mg intravenousl y (iv) every three weeks or Herceptin 6 mg/kg iv every three weeks in combinatio n with Perjeta and a taxane. Anticipated time on HER2 targeted study treatment i s up to 1 year.
 
Detailed Description
 
Gender Age Limit
Male & Female
 
Inclusion Criteria
  • Adult patients, >/= 18 years of age
  • Eastern Cooperative Oncology Group (ECOG) performance status
  • Non-metastatic histologically confirmed primary invasive breast carcinoma that was operable
  • HER2-positive breast cancer
  • Known hormone receptor status of the primary tumor
  • Adequately excised: patients must have undergone either breast-conserving surgery or mastectomy/nipple- or skin-sparing mastectomy
 
Exclusion Criteria
  • History of any prior (ipsi- and/or contralateral) invasive breast carcinoma
  • History of non-breast malignancies within the 5 years prior to study entry, except for carcinoma in situ (CIS) of the cervix, CIS of the colon, melanoma in situ, and basal cell and squamous cell carcinomas of the skin
  • Any clinical T4 tumor as defined by tumor-node-metastasis classification in UICC/AJCC 7th edition, including inflammatory breast cancer
  • For the currently diagnosed breast cancer, any previous systemic anti-cancer treatment (e.g., neoadjuvant or adjuvant), including, but not limited to, chemotherapy, anti-HER2 therapy (e.g., trastuzumab, trastuzumab emtansine, pertuzumab, lapatinib, neratinib, or other tyrosine kinase inhibitors), hormonal therapy, OR anti-cancer radiation therapy (RT) (intraoperative radiotherapy as a boost at the time of primary surgery is acceptable)
  • Previous therapy with anthracyclines, taxanes, or HER2-targeted therapy for any malignancy

 
Keywords and/or Specific Medical Conditions
  • Antimitotic Agents
  • Neoplasms by Site
  • Antineoplastic Agents
  • Pharmacologic Actions
  • Antineoplastic Agents, Phytogenic
  • Skin Diseases
  • Breast Diseases
  • Taxane
  • Breast Neoplasms
  • Therapeutic Uses
  • Maytansine
  • Trastuzumab
  • Mitosis Modulators
  • Tubulin Modulators
  • Molecular Mechanisms of Pharmacological Action
  • Oncology (Adult)
  • Neoplasms
 
KP Clinical Facility
  • Diablo Medical Center-Walnut Creek
  • Hayward Medical Center
  • Oakland Medical Center
  • Roseville Medical Center
  • Sacramento Medical Center
  • San Francisco Medical Center
  • Santa Clara Medical Center-Homestead
  • Santa Teresa Medical Center-San Jose
  • South San Francisco Medical Center
  • Vallejo Medical Center
 
Clinical Area
  • Oncology (Adult)


Principal Investigator:
Jennifer Suga, MD
Contact Information:
- Carlene Baily, RN
-(916) 973-6427
-Sacramento Medical Center
- Pam Mikowicz, RN
-(510) 752-6907
-Oakland Medical Center
- Beatriz Jio, RN
-(408) 851-4315
-Santa Clara Medical Center-Homestead


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