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HER2-positive Carcinoma of BreastPhase 3NCT02162667

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

A Phase 3 study testing Trastuzumab in people with HER2-positive Carcinoma of Breast, run by Celltrion at 98 sites in 22 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
HER2-positive Carcinoma of Breast
What is being tested?
Trastuzumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
562 participants
Where
98 sitesin 22 countries
Study dates
Jun 2014to Oct 2018
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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).

Who cannot join

  • 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.

Trial locations and contacts

98 sites in 22 countries.

98 sites in 22 countries

Russia16 sites

  • Study site

    Arkhangelsk, 163045

  • Study site

    Kazan', 420029

  • Study site

    Krasnoyarsk, 660133

  • Study site

    Kursk, 305035

  • Study site

    Moscow, 115478

  • Study site

    Moscow, 143423

  • Study site

    Nizhny Novgorod, 603081

  • Study site

    Novosibirsk, 630099

  • Study site

    Obninsk, 249036

  • Study site

    Omsk

  • Study site

    Saint Petersburg, 188663

  • Study site

    Saint Petersburg, 194017

  • Study site

    Saint Petersburg, 197022

  • Study site

    Saint Petersburg, 197758

  • Study site

    Samara, 443066

  • Study site

    Saransk, 430032

Other trials in Russia

India11 sites

  • Study site

    Bangalore, 560099

  • Study site

    Chennai, 600017

  • Study site

    Chennai, 600035

  • Study site

    Delhi, 110095

  • Study site

    Jaipur, 302017

  • Study site

    Kolkata, 700016

  • Study site

    Mumbai, 400 012

  • Study site

    Nashik, 422004

  • Study site

    Nashik, 422005

  • Study site

    New Delhi, 110076

  • Study site

    Pune, 411001

Other trials in India

Ukraine10 sites

  • Study site

    Cherkasy, 18009

  • Study site

    Donetsk, 83092

  • Study site

    Kharkiv, 61070

  • Study site

    Kherson, 73000

  • Study site

    Khmelnytskyi, 29000

  • Study site

    Poltava, 36021

  • Study site

    Sumy, 40022

  • Study site

    Uzhhorod, 88014

  • Study site

    Vinnytsia, 21029

  • Study site

    Zaporizhzhya, 69040

Other trials in Ukraine

Philippines7 sites

  • Study site

    Cebu, 6000

  • Study site

    City of Taguig, 1634

  • Study site

    Makati, 1229

  • Study site

    Manila, 1008

  • Study site

    Pasig, 1600

  • Study site

    Quezon City, 1102

  • Study site

    San Juan City, 1502

Other trials in Philippines

Argentina6 sites

  • Study site

    Buenos Aires, 1185

  • Study site

    Córdoba, X5006IKK

  • Study site

    Quilmes, B1878DVB

  • Study site

    Rosario, S2000KDS

  • Study site

    San Salvador de Jujuy, 4600

  • Study site

    Santa Rosa, 6300

Other trials in Argentina

Romania6 sites

  • Study site

    Brasov, 500152

  • Study site

    Bucharest, 010976

  • Study site

    Bucharest, 022328

  • Study site

    Cluj-Napoca, 400015

  • Study site

    Cluj-Napoca, 400058

  • Study site

    Suceava, 720237

Other trials in Romania

South Africa6 sites

  • Study site

    Cape Town, 7570

  • Study site

    George, 6530

  • Study site

    Johannesburg, 2193

  • Study site

    Johannesburg, 2196

  • Study site

    Port Elizabeth, 6045

  • Study site

    Pretoria, 0002

Other trials in South Africa

Georgia5 sites

  • Study site

    Tbilisi, 0112

  • Study site

    Tbilisi, 0144

  • Study site

    Tbilisi, 0159

  • Study site

    Tbilisi, 0177

  • Study site

    Tbilisi, 0186

Other trials in Georgia

Italy4 sites

  • Study site

    Bari, 70124

  • Study site

    Pavia, 27100

  • Study site

    Piacenza, 29100

  • Study site

    Rimini, 47900

Other trials in Italy

Peru4 sites

  • Study site

    Arequipa, 4020

  • Study site

    Arequipa

  • Study site

    Lima, 34

  • Study site

    Trujillo

Other trials in Peru

Belarus3 sites

  • Study site

    Brest, 224027

  • Study site

    Minsk, 220013

  • Study site

    Minsk, 223040

Other trials in Belarus

Poland3 sites

  • Study site

    Gdansk, 80219

  • Study site

    Lodz, 93513

  • Study site

    Warsaw, 04125

Other trials in Poland

Taiwan3 sites

  • Study site

    Kaohsiung City, 807

  • Study site

    Taichung, 40447

  • Study site

    Taipei, 100

Other trials in Taiwan

Chile2 sites

  • Study site

    Santiago, 6640166

  • Study site

    Temuco, 4810469

Other trials in Chile

Hungary2 sites

  • Study site

    Budapest, 1083

  • Study site

    Debrecen, 4032

Other trials in Hungary

Latvia2 sites

  • Study site

    Daugavpils, LV-5417

  • Study site

    Riga, LV-1079

Other trials in Latvia

Mexico2 sites

  • Study site

    Acapulco, 39670

  • Study site

    Monterrey, 64710

Other trials in Mexico

Spain2 sites

  • Study site

    Seville, 41071

  • Study site

    Zaragoza, 50009

Other trials in Spain

Bosnia and Herzegovina1 site

  • Study site

    Sarajevo, 71000

Other trials in Bosnia and Herzegovina

France1 site

  • Study site

    Nancy, 54511

Other trials in France

Japan1 site

  • Study site

    Tokyo

Other trials in Japan

Portugal1 site

  • Study site

    Lisbon, 1099023

Other trials in Portugal

About this study

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

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.

Being tested
Trastuzumab

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TrastuzumabDrug

    Also called Herceptin

    Trastuzumab 6mg/kg is ongoing to be administered for both arms after 8mg/kg loading dose.

Study groups in NCT02162667
Study groupRoleWhat they receive
CT-P6ExperimentalNot described
Receives: Drug: Trastuzumab
TrastuzumabActive comparatorNot described
Receives: Drug: Trastuzumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The Percentage of Patients Achieving Pathological Complete Response Defined as the Absence of Invasion Tumor Cells in the Breast and in Axillary Lymph Nodes, Regardless of Ductal Carcinoma in Situ (DCIS)

    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.

    Measured: After Neo-adjuvant therapy and Surgery (up to 30 weeks)

Secondary outcomes (9)

  1. The Percentage of Patients Achieving Pathological Complete Response (pCR) of the Breast Regardless of DCIS With Positive or Unknown Nodal Status

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

    The secondary endpoint, other than pCR of breast and axillary nodes ragardless of DCIS which was primary endpoint, will be assessed using resected bio-specimens collected in breast and axilla during a surgery.

    Measured: After Neo-adjuvant therapy and Surgery (up to 30 weeks)

  2. The Percentage of Patients Achieving Pathological Complete Response of the Breast and Axillary Nodes With Absence of DCIS

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

    The secondary endpoint, other than pCR of breast and axillary nodes ragardless of DCIS which was primary endpoint, will be assessed using resected bio-specimens collected in breast and axilla during a surgery.

    Measured: After Neo-adjuvant therapy and Surgery (up to 30 weeks)

  3. Overall Response Rate (ORR) From Local Review

    The ORR was defined as the proportion of patients with a BOR of CR or PR as assessed by RECIST guideline Version 1.1 during the Nedadjuvant Period.

    Measured: After Neo-adjuvant therapy (up to 24 weeks)

  4. Disease-free Survival

    Patients who underwent breast surgery were included in the DFS analysis. Disease-free survival was defined as the interval between the date of breast surgery and disease progression, recurrence, or death from any cause, whichever occurred first. Only a recurrence or progression of disease that occurred before beginning another anticancer therapy was regarded as an event.

    Measured: Up to 3 years from the day of last patient enrollment (during whole study period)

  5. Progression-Free Survival

    Progression-free survival was defined as the interval between randomization and disease progression, recurrence, or death from any cause, whichever occurred first. Only a recurrence or progression of disease that occurred before beginning another anticancer therapy was regarded as an event.

    Measured: Up to 3 years from the day of last patient enrollment (during whole study period)

  6. Overall Survival

    Overall survival was defined as the interval between randomization and death from any cause.

    Measured: Up to 3 years from the day of last patient enrollment (during whole study period)

  7. The Number of Patients Who Had Progressive Disease or Recurrence

    If recurrence or progression of disease occurred at any time during the study, the progressed tumor site was recorded in the "recurrence or progression of disease" eCRF page as local, regional, or distant, with diagnostic method and whether positive cytology or histology or not.

    The resulting recurrence or progression of disease information was summarized as secondary endpoint.

    Measured: Up to 3 years from the day of last patient enrollment (during whole study period)

  8. Maximum Serum Concentration After Administration (Cmax) in Each Cycle

    Pharmacokinetic samples were collected before study drug (CT-P6 or US-licensed Herceptin) administration (within 15 minutes prior to the beginning of the study drug infusion) and within 15 minutes after the end of the study drug infusion for each cycle during the Neoadjuvant Period. After the completion of treatment, an additional PK sample was collected at the EOT1.

    Measured: End of each treatment cycles, up to 24 weeks (during neoadjuvant period)

  9. Trough Serum Concentration (Ctrough) in Each Cycle

    Pharmacokinetic samples were collected before study drug (CT-P6 or US-licensed Herceptin) administration (within 15 minutes prior to the beginning of the study drug infusion) and within 15 minutes after the end of the study drug infusion for each cycle during the Neoadjuvant Period. After the completion of treatment, an additional PK sample was collected at the EOT1.

    Measured: Pre-infusion of cycles 1 to 8 during neoadjuvant period

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Jun 2014 (estimated)
  2. Study startJun 2014
  3. Primary completion26 May 2016
  4. Study completionOct 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
562 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02162667
Sponsor's protocol ID
CT-P6 3.2
Other IDs
2013-004525-84
Status last verified
Oct 2019
First submitted
11 Jun 2014
Last updated
3 Aug 2022
Data monitoring committee
Yes

Publications

  • Stebbing J, Baranau YV, Baryash V, Manikhas A, Moiseyenko V, Dzagnidze G, Zhavrid E, Boliukh D, Pikiel J, Eniu AE, Li RK, Tiangco B, Lee SJ, Kim S. Long-term efficacy and safety of CT-P6 versus trastuzumab in patients with HER2-positive early breast cancer: final results from a randomized phase III trial. Breast Cancer Res Treat. 2021 Aug;188(3):631-640. doi: 10.1007/s10549-021-06240-5. Epub 2021 Jun 20.

    PubMed 34148205

  • Esteva FJ, Baranau YV, Baryash V, Manikhas A, Moiseyenko V, Dzagnidze G, Zhavrid E, Boliukh D, Stroyakovskiy D, Pikiel J, Eniu AE, Li RK, Rusyn AV, Tiangco B, Lee SJ, Lee SY, Yu SY, Stebbing J. Efficacy and safety of CT-P6 versus reference trastuzumab in HER2-positive early breast cancer: updated results of a randomised phase 3 trial. Cancer Chemother Pharmacol. 2019 Oct;84(4):839-847. doi: 10.1007/s00280-019-03920-4. Epub 2019 Aug 19.

    PubMed 31428820

  • Stebbing J, Baranau Y, Baryash V, Manikhas A, Moiseyenko V, Dzagnidze G, Zhavrid E, Boliukh D, Stroyakovskii D, Pikiel J, Eniu A, Komov D, Morar-Bolba G, Li RK, Rusyn A, Lee SJ, Lee SY, Esteva FJ. CT-P6 compared with reference trastuzumab for HER2-positive breast cancer: a randomised, double-blind, active-controlled, phase 3 equivalence trial. Lancet Oncol. 2017 Jul;18(7):917-928. doi: 10.1016/S1470-2045(17)30434-5. Epub 2017 Jun 4.

    PubMed 28592386

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Trastuzumab in people with HER2-positive Carcinoma of Breast, run by Celltrion at 98 sites in 22 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 98 sites in Russia, India, Ukraine, Philippines, Argentina and 17 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 29 Oct 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The Percentage of Patients Achieving Pathological Complete Response Defined as the Absence of Invasion Tumor Cells in the Breast and in Axillary Lymph Nodes, Regardless of Ductal Carcinoma in Situ (DCIS) (time frame: After Neo-adjuvant therapy and Surgery (up to 30 weeks)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02162667, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2022; AzTrials last refreshed its copy on 26 Oct 2026.

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