TriangleNCT01772472 · CITED IN SOURCE DOCUMENTS
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)
An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.
- Phase
- PHASE3
- Status at capture
- COMPLETED
- Registry last update
- 2025-07-22
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.
Open the original ClinicalTrials.gov record → · Download preserved record
What did the study report?
Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.
Participant flow
Baseline characteristics
Invasive Disease-free Survival (IDFS) Rate at 3 Years
IDFS Rate at 7 Years
IDFS Rate at 8 Years
IDFS Including Second Primary Non-breast Cancer (SPNBC) Rate at 3 Years
IDFS Including SPNBC Rate at 7 Years
IDFS Including SPNBC Rate at 8 Years
Disease-free Survival (DFS) Rate at 3 Years
DFS Rate at 7 Years
DFS Rate at 8 Years
Overall Survival (OS) Rate at 5 Years
OS Rate at 7 Years
OS Rate at 8 Years
Distant Recurrence-free Interval (DRFI) Rate at 3 Years
DRFI Rate at 7 Years
DRFI Rate at 8 Years
Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Percentage of Participants With Cardiac Events as Adjudicated by the Cardiac Review Committee
Percentage of Participants With Hepatotoxicity Events as Adjudicated by the Hepatic Review Committee
Number of Participants Who Discontinued Treatment Due to AEs
Number of Participants With AEs and SAEs Leading to Death
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Core 30 (QLQ-C30)
Change From Baseline in EORTC Quality of Life Questionnaire - Breast Cancer (QLQ-BR23)
Serum Concentrations of Trastuzumab Emtansine
Plasma Concentrations of Deacetyl Mercapto 1-Oxopropyl Maytansine (DM1)
Serum Concentrations of Trastuzumab
Serum Concentrations of Total Trastuzumab
Median Duration of Trastuzumab Emtansine Exposure
Number of Participants With Positive Anti-drug Antibodies (ADAs) to Trastuzumab Emtansine
Number of Participants With Positive ADAs to Trastuzumab
Adverse events
Limitations, agreements, and source contact
Who could take part
- eligibility Criteria
- 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
- healthy Volunteers
- false
- minimum Age
- 18 Years
- sex
- ALL
- std Ages
- ADULT
- OLDER_ADULT
Treatment arms and interventions
- arm Groups
- intervention Names
- Drug: trastuzumab
- label
- Trastuzumab
- type
- ACTIVE_COMPARATOR
- intervention Names
- Drug: trastuzumab emtansine
- label
- Trastuzumab emtansine
- type
- EXPERIMENTAL
- interventions
- arm Group Labels
- Trastuzumab
- description
- 6 mg/kg intravenously every 3 weeks, 14 cycles
- name
- trastuzumab
- type
- DRUG
- arm Group Labels
- Trastuzumab emtansine
- description
- 3.6 mg/kg intravenously every 3 weeks, 14 cycles
- name
- trastuzumab emtansine
- type
- DRUG
Study design
- allocation
- RANDOMIZED
- intervention Model
- PARALLEL
- masking Info
- masking
- NONE
- primary Purpose
- TREATMENT
Enrollment
- count
- 1486
- type
- ACTUAL
Registered outcome plans (not posted results)
- other Outcomes
- description
- IDFS event was defined as the first occurrence of any one of the following events: ipsilateral invasive breast tumor recurrence (i.e., an invasive breast cancer involving the same breast parenchyma as the original primary lesion); ipsilateral local-regional invasive breast cancer recurrence (i.e., an invasive breast cancer in the axilla, regional lymph nodes, chest wall and/or skin of the ipsilateral breast); distant recurrence (i.e., evidence of breast cancer in any anatomic site-other than the 2 above-mentioned sites - that has either been histologically confirmed or clinically diagnosed as recurrent invasive breast cancer); contralateral invasive breast cancer; death attributable to any cause including breast cancer, non-breast cancer or unknown cause . 7-year IDFS rate in ITT population was estimated using KM method and the percentage of participants who were event-free 7 years after randomization was estimated.
- measure
- IDFS Rate at 7 Years
- time Frame
- At Year 7
- description
- IDFS event was defined as the first occurrence of any one of the following events: ipsilateral invasive breast tumor recurrence (i.e., an invasive breast cancer involving the same breast parenchyma as the original primary lesion); ipsilateral local-regional invasive breast cancer recurrence (i.e., an invasive breast cancer in the axilla, regional lymph nodes, chest wall and/or skin of the ipsilateral breast); distant recurrence (i.e., evidence of breast cancer in any anatomic site-other than the 2 above-mentioned sites - that has either been histologically confirmed or clinically diagnosed as recurrent invasive breast cancer); contralateral invasive breast cancer; death attributable to any cause including breast cancer, non-breast cancer or unknown cause . 8-year IDFS rate in ITT population was estimated using KM method and the percentage of participants who were event-free 8 years after randomization was estimated.
- measure
- IDFS Rate at 8 Years
- time Frame
- At Year 8
- primary Outcomes
- description
- IDFS event was defined as the first occurrence of any one of the following events: ipsilateral invasive breast tumor recurrence (i.e., an invasive breast cancer involving the same breast parenchyma as the original primary lesion); ipsilateral local-regional invasive breast cancer recurrence (i.e., an invasive breast cancer in the axilla, regional lymph nodes, chest wall and/or skin of the ipsilateral breast); distant recurrence (i.e., evidence of breast cancer in any anatomic site-other than the 2 above-mentioned sites - that has either been histologically confirmed or clinically diagnosed as recurrent invasive breast cancer); contralateral invasive breast cancer; death attributable to any cause including breast cancer, non-breast cancer or unknown cause . 3-year IDFS rate in ITT population was estimated using Kaplan Meier (KM) method and the percentage of participants who were event-free 3 years after randomization was estimated.
- measure
- Invasive Disease-free Survival (IDFS) Rate at 3 Years
- time Frame
- At Year 3
- secondary Outcomes
- description
- IDFS including SPNBC was defined the same way as IDFS but including second primary non breast invasive cancer as an event (with the exception of non-melanoma skin cancers and carcinoma in situ \[CIS\] of any site). IDFS event was defined as outlined in the description for IDFS rate outcome measure (OM) number 1. 3-year IDFS including SPNBC rate in the ITT population was estimated using KM method, and the percentage of participants who were event-free 3 years after randomization was estimated.
- measure
- IDFS Including Second Primary Non-breast Cancer (SPNBC) Rate at 3 Years
- time Frame
- At Year 3
- description
- IDFS including SPNBC was defined the same way as IDFS but including second primary non breast invasive cancer as an event (with the exception of non-melanoma skin cancers and CIS of any site). IDFS event was defined as outlined in the description for IDFS rate OM number 1. 7-year IDFS including SPNBC rate in the ITT population was estimated using KM method, and the percentage of participants who were event-free 7 years after randomization was estimated.
- measure
- IDFS Including SPNBC Rate at 7 Years
- time Frame
- At Year 7
- description
- IDFS including SPNBC was defined the same way as IDFS but including second primary non breast invasive cancer as an event (with the exception of non-melanoma skin cancers and CIS of any site). IDFS event was defined as outlined in the description for IDFS rate OM number 1. 8-year IDFS including SPNBC rate in the ITT population was estimated using KM method, and the percentage of participants who were event-free 8 years after randomization was estimated.
- measure
- IDFS Including SPNBC Rate at 8 Years
- time Frame
- At Year 8
- description
- DFS was defined as the time between randomization and the date of the first occurrence of an IDFS event including SPNBC event or contralateral or ipsilateral ductal carcinoma in situ (DCIS). IDFS event was defined as outlined in the description for IDFS rate OM number 1. 3-year DFS rate in the ITT population was estimated using KM method, and the percentage of participants who were event-free 3 years after randomization was estimated.
- measure
- Disease-free Survival (DFS) Rate at 3 Years
- time Frame
- At Year 3
- description
- DFS was defined as the time between randomization and the date of the first occurrence of an IDFS event including SPNBC event or contralateral or ipsilateral DCIS. IDFS event was defined as outlined in the description for IDFS rate OM number 1. 7-year DFS rate in the ITT population was estimated using KM method, and the percentage of participants who were event-free 7 years after randomization was estimated.
- measure
- DFS Rate at 7 Years
- time Frame
- At Year 7
- description
- DFS was defined as the time between randomization and the date of the first occurrence of an IDFS event including SPNBC event or contralateral or ipsilateral DCIS. IDFS event was defined as outlined in the description for IDFS rate OM number 1. 8-year DFS rate in the ITT population was estimated using KM method, and the percentage of participants who were event-free 8 years after randomization was estimated.
- measure
- DFS Rate at 8 Years
- time Frame
- At Year 8
- description
- OS was defined as the time from randomization to death due to any cause. 5-year OS event-free rate in the ITT population was estimated using KM method, and the percentage of participants who were event-free 5 years after randomization was estimated.
- measure
- Overall Survival (OS) Rate at 5 Years
- time Frame
- At Year 5
- description
- OS was defined as the time from randomization to death due to any cause. 7-year OS event-free rate in the ITT population was estimated using KM method, and the percentage of participants who were event-free 7 years after randomization was estimated.
- measure
- OS Rate at 7 Years
- time Frame
- At Year 7
- description
- OS was defined as the time from randomization to death due to any cause. 8-year OS event-free rate in the ITT population was estimated using KM method, and the percentage of participants who were event-free 8 years after randomization was estimated.
- measure
- OS Rate at 8 Years
- time Frame
- At Year 8
- description
- DRFI was defined as the time between randomization and the date of distant breast cancer recurrence. 3-year DRFI event-free rate in the ITT population was estimated using KM method, and the percentage of participants who were event-free 3 years after randomization was estimated.
- measure
- Distant Recurrence-free Interval (DRFI) Rate at 3 Years
- time Frame
- At Year 3
- description
- DRFI was defined as the time between randomization and the date of distant breast cancer recurrence. 7-year DRFI event-free rate in the ITT population was estimated using KM method, and the percentage of participants who were event-free 7 years after randomization was estimated.
- measure
- DRFI Rate at 7 Years
- time Frame
- At Year 7
- description
- DRFI was defined as the time between randomization and the date of distant breast cancer recurrence. 8-year DRFI event-free rate in the ITT population was estimated using KM method, and the percentage of participants who were event-free 8 years after randomization was estimated.
- measure
- DRFI Rate at 8 Years
- time Frame
- At Year 8
Full study description
- brief 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.
Source references
- references
- citation
- Geyer CE Jr, Untch M, Huang CS, Mano MS, Mamounas EP, Wolmark N, Rastogi P, Schneeweiss A, Redondo A, Fischer HH, D'Hondt V, Conlin AK, Guarneri V, Wapnir IL, Jackisch C, Arce-Salinas C, Fasching PA, DiGiovanna MP, Crown JP, Wuelfing P, Shao Z, Rota Caremoli E, Bonnefoi HR, Hennessy BT, Stamatovic L, Castro-Salguero H, Brufsky AM, Knott A, Siddiqui A, Lambertini C, Boulet T, Nyawira B, Restuccia E, Loibl S; KATHERINE Study Group. Survival with Trastuzumab Emtansine in Residual HER2-Positive Breast Cancer. N Engl J Med. 2025 Jan 16;392(3):249-257. doi: 10.1056/NEJMoa2406070.
- pmid
- 39813643
- type
- DERIVED
- citation
- von Minckwitz G, Huang CS, Mano MS, Loibl S, Mamounas EP, Untch M, Wolmark N, Rastogi P, Schneeweiss A, Redondo A, Fischer HH, Jacot W, Conlin AK, Arce-Salinas C, Wapnir IL, Jackisch C, DiGiovanna MP, Fasching PA, Crown JP, Wulfing P, Shao Z, Rota Caremoli E, Wu H, Lam LH, Tesarowski D, Smitt M, Douthwaite H, Singel SM, Geyer CE Jr; KATHERINE Investigators. Trastuzumab Emtansine for Residual Invasive HER2-Positive Breast Cancer. N Engl J Med. 2019 Feb 14;380(7):617-628. doi: 10.1056/NEJMoa1814017. Epub 2018 Dec 5.
- pmid
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- type
- DERIVED
Source notices and limitations
Discovery and provenance
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