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Efficacy and Safety Evaluating Study of CT-P6 in Her2 Positive Early Breast Cancer

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ClinicalTrials.gov Identifier: NCT02162667
Recruitment Status : Completed
First Posted : June 13, 2014
Last Update Posted : August 8, 2019
Sponsor:
Collaborator:
Nippon Kayaku Co., Ltd.
Information provided by (Responsible Party):
Celltrion

Brief Summary:
This study will determine whether CT-P6 and Herceptin are equivalent in patients with early-stage breast cancer undergoing neoadjuvant chemotherapy. Our hypothesis is that the pathologic complete response rate will be equivalent in patients treated with neoadjuvant CT-P6 or Herceptin. Patients will receive 8 cycles of neoadjuvant systemic therapy and up to 10 cycles of therapy in the adjuvant setting.

Condition or disease Intervention/treatment Phase
HER2-positive Carcinoma of Breast Drug: Trastuzumab Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 562 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Phase 3 Efficacy and Safety Study of CT-P6 and Herceptin as Neoadjuvant and Adjuvant Treatment in Patients With Her2-positive Early Breast Cancer
Actual Study Start Date : June 2014
Actual Primary Completion Date : May 26, 2016
Actual Study Completion Date : October 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
Drug Information available for: Trastuzumab

Arm Intervention/treatment
Experimental: CT-P6 Drug: Trastuzumab
Trastuzumab 6mg/kg is ongoing to be administered for both arms after 8mg/kg loading dose.
Other Name: Herceptin

Active Comparator: Trastuzumab Drug: Trastuzumab
Trastuzumab 6mg/kg is ongoing to be administered for both arms after 8mg/kg loading dose.
Other Name: Herceptin




Primary Outcome Measures :
  1. Equivalence to Herceptin as determined by pCR (pathological Complete Response) [ Time Frame: After Neo-adjuvant therapy and Surgery (up to 30 weeks) ]

    Subject who went through Neoadjuvant period completely (24 weeks), will receive surgery within 3-6 weeks after last treatment of neoadjuvant period.

    The primary endpoint, Pathological complete response, will be assessed using resected bio-specimens collected in breast and axilla during a surgery.




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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient who has histologically confirmed and newly diagnosed breast cancer
  • Patient who has clinical stage I, II, or IIIa operable breast cancer according to AJCC (American Joint Committee on Cancer) Breast Cancer Staging 7th edition
  • Patient who has HER2-positive status confirmed locally, defined as 3+ score by IHC (immuno-histochemistry).

Exclusion Criteria:

  • Patient who has bilateral breast cancer
  • Patient who has received prior treatment for breast cancer, including chemotherapy, biologic therapy, hormone therapy, immunotherapy, radiation or surgery, including any prior therapy with anthracyclines.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02162667


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Locations
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Argentina
Buenos Aires, Argentina, 1185
Córdoba, Argentina, X5006IKK
Quilmes, Argentina, B1878DVB
Rosario, Argentina, S2000KDS
San Salvador De Jujuy, Argentina, 4600
Santa Rosa, Argentina, 6300
Belarus
Brest, Belarus, 224027
Minsk, Belarus, 220013
Minsk, Belarus, 223040
Bosnia and Herzegovina
Sarajevo, Bosnia and Herzegovina, 71000
Brazil
Barretos, Brazil, 14784-400
Brasilia, Brazil, 70910-900
Caxias Do Sul, Brazil, 95070-560
Curitiba, Brazil, 81520-060
Goiânia, Brazil, 74605-070
Ijuí, Brazil, 98700-000
Jaú, Brazil, 17210-120
Joaçaba, Brazil, 89600-000
Lajeado, Brazil, 95900-000
Natal, Brazil, 59075-740
Porto Alegre, Brazil, 90050-170
Porto Alegre, Brazil, 90160-093
Porto Alegre, Brazil, 90610-000
Recife, Brazil, 50070-170
Ribeirão Preto, Brazil, 14010-000
Sorocaba, Brazil, 18035-300
São Paulo, Brazil, 01224-010
São Paulo, Brazil, 01317-000
São Paulo, Brazil, 01509-010
São Paulo, Brazil, 03102-002
Chile
Santiago, Chile, 6640166
Temuco, Chile, 4810469
Ecuador
Guayaquil, Ecuador, EC090313
Guayaquil, Ecuador, EC90313
Machala, Ecuador, EC070213
Quito, Ecuador, EC170411
France
Nancy, France, 54511
Georgia
Tbilisi, Georgia, 0112
Tbilisi, Georgia, 0144
Tbilisi, Georgia, 0159
Tbilisi, Georgia, 0177
Tbilisi, Georgia, 0186
Greece
Larissa, Greece, 41110
Hungary
Budapest, Hungary, 1083
Debrecen, Hungary, 4032
India
Bangalore, India, 560099
Chennai, India, 600017
Chennai, India, 600035
Delhi, India, 110095
Jaipur, India, 302017
Kolkata, India, 700016
Mumbai, India, 400 012
Nashik, India, 422004
Nashik, India, 422005
New Delhi, India, 110076
Pune, India, 411001
Italy
Bari, Italy, 70124
Pavia, Italy, 27100
Piacenza, Italy, 29100
Rimini, Italy, 47900
Japan
Tokyo, Japan
Latvia
Daugavpils, Latvia, LV-5417
Riga, Latvia, LV-1079
Mexico
Acapulco, Mexico, 39670
Monterrey, Mexico, 64710
Peru
Arequipa, Peru, 4020
Arequipa, Peru
Lima, Peru, 34
Trujillo, Peru
Philippines
Cebu, Philippines, 6000
Makati, Philippines, 1229
Manila, Philippines, 1008
Pasig, Philippines, 1600
Quezon City, Philippines, 1102
San Juan City, Philippines, 1502
Taguig, Philippines, 1634
Poland
Gdansk, Poland, 80219
Lodz, Poland, 93513
Warsaw, Poland, 04125
Portugal
Lisbon, Portugal, 1099023
Romania
Brasov, Romania, 500152
Bucharest, Romania, 010976
Bucharest, Romania, 022328
Cluj-Napoca, Romania, 400015
Cluj-Napoca, Romania, 400058
Suceava, Romania, 720237
Russian Federation
Arkhangelsk, Russian Federation, 163045
Kazan, Russian Federation, 420029
Krasnoyarsk, Russian Federation, 660133
Kursk, Russian Federation, 305035
Moscow, Russian Federation, 115478
Moscow, Russian Federation, 143423
Nizhny Novgorod, Russian Federation, 603081
Novosibirsk, Russian Federation, 630099
Obninsk, Russian Federation, 249036
Omsk, Russian Federation
Samara, Russian Federation, 443066
Saransk, Russian Federation, 430032
St. Petersburg, Russian Federation, 188663
St. Petersburg, Russian Federation, 194017
St. Petersburg, Russian Federation, 197022
St. Petersburg, Russian Federation, 197758
Serbia
Kragujevac, Serbia, 34000
South Africa
Cape Town, South Africa, 7570
George, South Africa, 6530
Johannesburg, South Africa, 2193
Johannesburg, South Africa, 2196
Port Elizabeth, South Africa, 6045
Pretoria, South Africa, 0002
Spain
Sevilla, Spain, 41071
Zaragoza, Spain, 50009
Taiwan
Kaohsiung, Taiwan, 807
Taichung City, Taiwan, 40447
Taipei, Taiwan, 100
Thailand
Bangkok, Thailand, 10330
Turkey
Adana, Turkey, 1330
Ankara, Turkey, 6100
Ankara, Turkey, 06500
Gaziantep, Turkey, 27100
Ukraine
Cherkasy, Ukraine, 18009
Donetsk, Ukraine, 83092
Kharkiv, Ukraine, 61070
Kherson, Ukraine, 73000
Khmel'nyts'kyy, Ukraine, 29000
Poltava, Ukraine, 36021
Sumy, Ukraine, 40022
Uzhhorod, Ukraine, 88014
Vinnytsya, Ukraine, 21029
Zaporizhzhia, Ukraine, 69040
Sponsors and Collaborators
Celltrion
Nippon Kayaku Co., Ltd.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Celltrion
ClinicalTrials.gov Identifier: NCT02162667     History of Changes
Other Study ID Numbers: CT-P6 3.2
2013-004525-84 ( EudraCT Number )
First Posted: June 13, 2014    Key Record Dates
Last Update Posted: August 8, 2019
Last Verified: August 2019
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Trastuzumab
Antineoplastic Agents, Immunological
Antineoplastic Agents