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A study to investigate the effectiveness of trastuzumab emtansine compared with trastuzumab in a type of breast cancer (called HER2 positive breast cancer) for patients who still have signs of tumours after receiving previous treatment and undergoing surgery (KATHERINE)
A Study of Trastuzumab Emtansine Versus Trastuzumab as Adjuvant Therapy in Patients With HER2-Positive Breast Cancer Who Have Residual Tumor in the Breast or Axillary Lymph Nodes Following Preoperative Therapy (KATHERINE)
Cancer Breast Cancer Breast Cancer HER-2 Positive HER2-Positive Breast Cancer
Basic Details
Sponsor
Hoffmann-La Roche
Phase
Phase 3
Trial Identifier
NCT01772472, BO27938, 2012-002018-37
Condition
Breast Cancer
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
Trial 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.
Eligibility Criteria
All
≥18 Years
No
Inclusion Criteria
- 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
Exclusion Criteria
- 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
The source of the below information is public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc.. It has been summarised and edited into simpler language. For more information about this clinical study see the For Expert tab on the specific ForPatients page or follow these links to https://clinicaltrials.gov and/or https://euclinicaltrials.eu and/or https://www.isrctn.com.
The information is taken directly from public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc., and has not been edited.
Results Disclaimer
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Study results
RO_BO27938_interim-results-summary-dec 2018-english.pdf
(PDF, 14.2 MB)
LPS BO27938 KATHERINE Final Results January 2025 English
(PDF, 0.5 MB)
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For the latest version of this information please go to www.forpatients.roche.com