Summary

for people ages 18 years and up (full criteria)
at Orange, California and other locations
study started
estimated completion

Description

Summary

This 2-arm, randomized, open-label study will evaluate the efficacy and safety of trastuzumab emtansine versus trastuzumab as adjuvant therapy in patients with HER2-positive breast cancer who have residual tumor present in the breast or axillary lymph nodes following preoperative therapy. Eligible patients will be randomized to receive either trastuzumab emtansine 3.6 mg/kg or trastuzumab 6 mg/kg intravenously every 3 weeks for 14 cycles. Radiotherapy and/or hormone therapy will be given in addition if indicated.

Official Title

A Randomized, Multicenter, Open-Label Phase III Study to Evaluate the Efficacy and Safety of Trastuzumab Emtansine Versus Trastuzumab as Adjuvant Therapy for Patients With HER2-Positive Primary Breast Cancer Who Have Residual Tumor Present Pathologically in the Breast or Axillary Lymph Nodes Following Preoperative Therapy

Keywords

Breast CancerBreast NeoplasmsNeoplasm, ResidualTrastuzumabAdo-trastuzumab emtansineMaytansinetrastuzumab emtansine

Eligibility

You can join if…

Open to people ages 18 years and up

  • Adult patient, >/= 18 years of age
  • HER2-positive breast cancer
  • Histologically confirmed invasive breast carcinoma
  • Clinical stage T1-4/N0-3/M0 at presentation (patients with T1a/bN0 tumors will not be eligible)
  • Completion of preoperative systemic chemotherapy and HER2-directed treatment consisting of at least 6 cycles of chemotherapy with a total duration of at least 16 weeks, including at least 9 weeks of trastuzumab and at least 9 weeks of taxane-based therapy
  • Adequate excision: surgical removal of all clinically evident disease in the breast and lymph nodes as specified in protocol
  • Pathological evidence of residual invasive carcinoma in the breast or axillary lymph nodes following completion of preoperative therapy
  • An interval of no more than 12 weeks between the date of surgery and the date of randomization
  • Known hormone-receptor status
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
  • Adequate hematologic, renal and liver function
  • Screening Left ventricular ejection fraction (LVEF) >/= 50% on echocardiogram (ECHO) or multiple-gated acquisition (MUGA) after receiving neoadjuvant chemotherapy and no decrease in LVEF by more than 15% absolute points from the pre-chemotherapy LVEF. Or, if pre-chemotherapy LVEF was not assessed, the screening LVEF must be >/= 55% after completion of neoadjuvant chemotherapy.
  • For women who are not postmenopausal or surgically sterile: agreement to remain abstinent or use single or combined contraceptive methods that result in a failure rate of < 1% per year during the treatment period and for at least 7 months after the last dose of study drug
  • Documentation of hepatitis B virus and hepatitis C virus serology is required

You CAN'T join if...

  • Stage IV (metastatic) breast cancer
  • History of any prior (ipsi- or contralateral breast cancer except lobular carcinoma in situ
  • Evidence of clinically evident gross residual or recurrent disease following preoperative therapy and surgery
  • Progressive disease during preoperative systemic therapy
  • Treatment with any anti-cancer investigational drug within 28 days prior to commencing study treatment
  • History of other malignancy within the last 5 years except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, Stage I uterine cancer, or other non-breast malignancies with a similar outcome to those mentioned above
  • Patients for whom radiotherapy would be recommended for breast cancer treatment but for whom it is contraindicated because of medical reasons
  • Current NCI CTCAE (Version 4.0) Grade >/= 2 peripheral neuropathy
  • History of exposure to the following cumulative doses of anthracyclines: Doxorubicin > 240 mg/m2; Epirubicin or Liposomal Doxorubicin-Hydrochloride (Myocet®) > 480 mg/m2; For other anthracyclines, exposure equivalent to doxorubicin > 240 mg/m2
  • Cardiopulmonary dysfunction as defined by protocol
  • Prior treatment with trastuzumab emtansine
  • Current severe, uncontrolled systemic disease
  • Pregnant or lactating women
  • Any known active liver disease, e.g. due to HBV, HCV, autoimmune hepatic disorders, or sclerosing cholangitis
  • Concurrent serious uncontrolled infections requiring treatment or known infection with HIV
  • History of intolerance, including Grade 3 to 4 infusion reaction or hypersensitivity to trastuzumab or murine proteins or any components of the product

Locations

  • Chao Family Comprehensive Cancer Center; UC Irvine Medical Center
    OrangeCalifornia92868United States
  • Breastlink Medical Group Inc
    Santa AnaCalifornia92705United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Hoffmann-La Roche
ID
NCT01772472
Phase
Phase 3
Study Type
Interventional
Last Updated