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Completed

NCT Number: NCT02162667

Efficacy and Safety Evaluating Study of CT-P6 in 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.

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Key information

Conditions

HER2-positive Carcinoma of Breast

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Buenos Aires, Argentina

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Trastuzumab

Drug

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

Other names: Herceptin

Primary outcomes

  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)

    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.

Secondary outcomes

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

    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 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.

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

    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 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.

  3. Overall Response Rate (ORR) From Local Review

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

    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.

  4. Disease-free Survival

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

    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.

  5. Progression-Free Survival

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

    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.

  6. Overall Survival

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

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

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

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

    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.

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

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

    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.

  9. Trough Serum Concentration (Ctrough) in Each Cycle

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

    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.

Sponsors and collaborators

Lead sponsor

Celltrion

Industry

Collaborators

  • Nippon Kayaku Co., Ltd.

Registry information

Official study 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

Important dates

Study start
2014
Primary completion
2016
Study completion
2018
First posted
Jun 13, 2014
Registry last updated
Aug 3, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.