A Study Evaluating Trastuzumab Emtansine Plus Pertuzumab Compared With Chemotherapy Plus Trastuzumab and Pertuzumab for Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Breast Cancer
NCT ID: NCT02131064
Last Updated: 2019-07-02
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
444 participants
INTERVENTIONAL
2014-06-25
2018-05-29
Brief Summary
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Treatment can be stopped due to disease recurrence, unacceptable toxicity, withdrawal of consent, or study termination.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Trastuzumab (TCH) + Pertuzumab
Participants will receive pertuzumab 840 milligrams (mg) (loading dose) and 420 mg (maintenance dose) intravenous (IV) infusion followed by trastuzumab 8 milligrams per kilogram (mg/kg) (loading dose) and 6 mg/kg (maintenance dose) IV infusion followed by docetaxel 75 milligrams per square meter (mg/m\^2) IV infusion and carboplatin at a dose to achieve an area under the curve (AUC) of 6 milligrams per milliliter\* minute (mg/mL\*min) IV infusion every 3 weeks (q3w) for 6 cycles in neoadjuvant period. Participants will receive pertuzumab 840 mg (loading dose) and 420 mg (maintenance dose) IV infusion followed by trastuzumab 8 mg/kg (loading dose) and 6 mg/kg (maintenance dose) IV infusion q3w for rest of the cycles (12 cycles) in adjuvant period (up to a total of 18 cycles).
Carboplatin
Carboplatin IV infusion at a dose to achieve an AUC of 6 mg\*min/mL q3w
Docetaxel
Docetaxel 75 mg/m\^2 IV infusion q3w
Pertuzumab
Pertuzumab 840 mg (loading dose); and 420 mg (maintenance dose) IV infusion q3w
Trastuzumab
Trastuzumab 8 mg/kg (loading dose); and 6 mg/kg (maintenance dose) IV infusion q3w
Trastuzumab Emtansine (T-DM1) + Pertuzumab
Participants will receive pertuzumab 840 mg (loading dose) and 420 mg (maintenance dose) IV infusion followed by trastuzumab emtansine 3.6 mg/kg IV infusion q3w for a total of 18 cycles (6 cycles of neoadjuvant period and 12 cycles of adjuvant period).
Pertuzumab
Pertuzumab 840 mg (loading dose); and 420 mg (maintenance dose) IV infusion q3w
Trastuzumab Emtansine
Trastuzumab Emtansine 3.6 mg/kg IV infusion q3w
Interventions
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Carboplatin
Carboplatin IV infusion at a dose to achieve an AUC of 6 mg\*min/mL q3w
Docetaxel
Docetaxel 75 mg/m\^2 IV infusion q3w
Pertuzumab
Pertuzumab 840 mg (loading dose); and 420 mg (maintenance dose) IV infusion q3w
Trastuzumab
Trastuzumab 8 mg/kg (loading dose); and 6 mg/kg (maintenance dose) IV infusion q3w
Trastuzumab Emtansine
Trastuzumab Emtansine 3.6 mg/kg IV infusion q3w
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* HER2-positive breast cancer
* Participants with multifocal tumors (more than one tumor confined to the same quadrant as the primary tumor) are eligible provided all discrete lesions are sampled and centrally confirmed as HER2 positive
* Stage at presentation: cT2-cT4, cN0-cN3, cM0, according to American Joint Committee on Cancer (AJCC) staging system
* Known hormone receptor status of the primary tumor
* Participant agreement to undergo mastectomy or breast-conserving surgery after neoadjuvant therapy
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* Baseline Left Ventricular Ejection Fraction (LVEF) \>/= 55 percent (%) measured by echocardiogram (ECHO) or multiple-gated acquisition (MUGA)
* Effective contraception as defined by protocol
Exclusion Criteria
* Participants who have received prior anti-cancer therapy for breast cancer except those participants with a history of breast lobular carcinoma in situ (LCIS) that was surgically managed or ductal carcinoma in situ (DCIS) treated exclusively with mastectomy. In case of prior history of LCIS/DCIS, \>5 years must have passed from surgery until diagnosis of current breast cancer
* Participants with multicentric (multiple tumors involving more than 1 quadrant) or bilateral breast cancer
* Participants who have undergone incisional and/or excisional biopsy of primary tumor and/or axillary lymph nodes
* Axillary lymph node dissection or positive sentinel lymph node prior to start of neoadjuvant therapy
* History of concurrent or previously non-breast malignancies except for appropriately treated (1) non-melanoma skin cancer and (2) in situ carcinomas, including cervix, colon, and skin. A participant with previous invasive non-breast cancer is eligible provided he/she has been disease-free \>/= 5 years
* Treatment with any investigational drug within 28 days prior to randomization
* Current National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version (v) 4.0
* Any significant concurrent medical or surgical conditions or findings that would jeopardize the participant's safety or ability to complete the study
* Current pregnancy or breastfeeding
18 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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St. Jude Heritage Healthcare; Virgiia K.Crosson Can Ctr
Fullerton, California, United States
Cancer Care Assoc Med Group
Los Angeles, California, United States
Coastal Integrative Cancer Care
San Luis Obispo, California, United States
Central Coast Medical Oncology
Santa Maria, California, United States
UCLA Hematology/Oncology
Santa Monica, California, United States
Memorial Cancer Institute
Hollywood, Florida, United States
Md Anderson Cancer Center Orlando
Orlando, Florida, United States
New England Cancer Specialists
Scarborough, Maine, United States
Comprehensive Cancer Centers of Nevada - Henderson
Henderson, Nevada, United States
ProHEALTH Care Associates LLP
Lake Success, New York, United States
Montefiore Medical Center
The Bronx, New York, United States
Hope A Women's Cancer Center
Asheville, North Carolina, United States
Levine Cancer Institute
Charlotte, North Carolina, United States
Roper Bon Secours St. Francis Cancer Center
Charleston, South Carolina, United States
Sarah Cannon Research Institute
Nashville, Tennessee, United States
MD Anderson Cancer Center
Houston, Texas, United States
UZ Antwerpen
Edegem, , Belgium
UZ Leuven Gasthuisberg
Leuven, , Belgium
Clinique Saint-Joseph
Liège, , Belgium
Clinique Ste-Elisabeth, Pharmacie
Namur, , Belgium
Sint Augustinus Wilrijk
Wilrijk, , Belgium
Cross Cancer Institute ; Dept of Medical Oncology
Edmonton, Alberta, Canada
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada
St. Michael'S Hospital
Toronto, Ontario, Canada
Chum Hospital Notre Dame
Montreal, Quebec, Canada
McGill University; Sir Mortimer B Davis Jewish General Hospital; Oncology
Montreal, Quebec, Canada
CHU de Québec - Hôpital du Saint-Sacrement / ONCOLOGY
Québec, , Canada
Ico - Paul Papin
Angers, , France
HOPITAL JEAN MINJOZ; Oncologie
Besançon, , France
Hopital Morvan
Brest, , France
CHD Les Oudairies
La Roche-sur-Yon, , France
Centre Oscar Lambret
Lille, , France
Institut Paoli Calmettes
Marseille, , France
Centre Catherine De Sienne
Nantes, , France
Centre Rene Gauducheau
Saint-Herblain, , France
Nouvel Hopital Civil - CHU Strasbourg
Strasbourg, , France
Klinikum Sindelfingen-Böblingen; Frauenklinik
Böblingen, , Germany
Luisenkrankenhaus GmbH, Brustzentrum
Düsseldorf, , Germany
Universitätsklinikum Erlangen; Frauenklinik
Erlangen, , Germany
Universitätsklinikum Mainz
Mainz, , Germany
Interdisziplinäres Onkologisches Zentrum
München, , Germany
Moscow City Oncology Hospital #62
Moscovskaya Oblast, Moscow Oblast, Russia
Regional Oncology Hospital Of Kursk; Chemotherapy
Kislino, Kursk Region, , Russia
S.I. Russian Oncological Research Center n.a. N.N. Blokhin
Moscow, , Russia
State Inst. Of Healthcare Orenburg Regional Clinical Oncology Dis
Orenburg, , Russia
Saint-Petersburg City Clinical Oncology Dispensary
Saint Petersburg, , Russia
Railway Clinical Hospital on Saratov - 2 Station Oao "Rzhd"
Saratov, , Russia
National Cancer Center
Gyeonggi-do, , South Korea
Seoul National University Bundang Hospital
Gyeonggi-do, , South Korea
Seoul National University Hospital
Seoul, , South Korea
Severance Hospital
Seoul, , South Korea
Asan Medical Center - Oncology
Seoul, , South Korea
Samsung Medical Center
Seoul, , South Korea
Corporacio Sanitaria Parc Tauli; Servicio de Oncologia
Sabadell, Barcelona, Spain
IInstituto Oncologico de San Sebastian, Oncologikoa; Servicio de Oncologia
Donostia / San Sebastian, Guipuzcoa, Spain
Hospital Universitari de Lleida Arnau de Vilanova
Lleida, Lerida, Spain
Complejo Hospitalario Universitario A Coruña (CHUAC, Materno Infantil), Oncología
A Coruña, , Spain
Hospital Nuestra Señora de Sonsoles; servicio de Oncologia
Ávila, , Spain
Hospital del Mar; Servicio de Oncologia
Barcelona, , Spain
Fundacio Santa Creu I Sant Pau
Barcelona, , Spain
Complejo Hospitalario de Jaen
Jaén, , Spain
Hospital General Universitario Gregorio Marañon; Servicio de Oncologia
Madrid, , Spain
Hospital Universitario Clínico San Carlos; Servicio de Oncologia
Madrid, , Spain
Centro Integral Oncologico Clara Campal (CIOCC); Dirección Médica
Madrid, , Spain
Hospital Quiron de Madrid; Servicio de Oncologia
Madrid, , Spain
Hospital Universitario Virgen de la Victoria
Málaga, , Spain
Hospital Universitario Virgen del Rocio
Seville, , Spain
Hospital Clinico Universitario de Valencia
Valencia, , Spain
Hospital Universitario Miguel Servet; Servicio Oncologia
Zaragoza, , Spain
Kaohsiung Medical Uni Chung-Ho Hospital; Dept of Surgery
Kaohsiung City, , Taiwan
National Taiwan Uni Hospital
Taipei, , Taiwan
Mackay Memorial Hospital; Dept of Surgery
Taipei, , Taiwan
Koo Foundation Sun Yat-Sen Cancer Center; Hemato-Oncology
Taipei, , Taiwan
Taipei Veterans General Hospital
Taipei, , Taiwan
Tri-Service General Hospital
Taipei, , Taiwan
Cherkassy Regional Oncological Hospital
Cherkassy, , Ukraine
State Medical Academy; Oncology
Dnipropetrovsk, , Ukraine
Karkiv Regional Oncology Center
Kharkiv, , Ukraine
Lvov State Regional Center
Lviv, , Ukraine
Countries
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References
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de Haas SL, Slamon DJ, Martin M, Press MF, Lewis GD, Lambertini C, Prat A, Lopez-Valverde V, Boulet T, Hurvitz SA. Tumor biomarkers and efficacy in patients treated with trastuzumab emtansine + pertuzumab versus standard of care in HER2-positive early breast cancer: an open-label, phase III study (KRISTINE). Breast Cancer Res. 2023 Jan 11;25(1):2. doi: 10.1186/s13058-022-01587-z.
Hurvitz SA, Martin M, Jung KH, Huang CS, Harbeck N, Valero V, Stroyakovskiy D, Wildiers H, Campone M, Boileau JF, Fasching PA, Afenjar K, Spera G, Lopez-Valverde V, Song C, Trask P, Boulet T, Sparano JA, Symmans WF, Thompson AM, Slamon D. Neoadjuvant Trastuzumab Emtansine and Pertuzumab in Human Epidermal Growth Factor Receptor 2-Positive Breast Cancer: Three-Year Outcomes From the Phase III KRISTINE Study. J Clin Oncol. 2019 Sep 1;37(25):2206-2216. doi: 10.1200/JCO.19.00882. Epub 2019 Jun 3.
Hurvitz SA, Martin M, Symmans WF, Jung KH, Huang CS, Thompson AM, Harbeck N, Valero V, Stroyakovskiy D, Wildiers H, Campone M, Boileau JF, Beckmann MW, Afenjar K, Fresco R, Helms HJ, Xu J, Lin YG, Sparano J, Slamon D. Neoadjuvant trastuzumab, pertuzumab, and chemotherapy versus trastuzumab emtansine plus pertuzumab in patients with HER2-positive breast cancer (KRISTINE): a randomised, open-label, multicentre, phase 3 trial. Lancet Oncol. 2018 Jan;19(1):115-126. doi: 10.1016/S1470-2045(17)30716-7. Epub 2017 Nov 23.
Other Identifiers
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TRIO021
Identifier Type: OTHER
Identifier Source: secondary_id
2012-004879-38
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
BO28408
Identifier Type: -
Identifier Source: org_study_id
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