Metastatic Breast CancerPhase 1/2CompareNCT01084863
Evaluate Safety, Efficacy and Pharmacokinetics
A Phase 1/2 study testing CT-P6, Herceptin and Paclitaxel in people with Metastatic Breast Cancer, run by Celltrion at 1 site in South Korea.
Trial summary
The purpose of the study is to demonstrate equivalent pharmacokinetics (PK) Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Metastatic Breast Cancer
- What is being tested?
- CT-P6, Herceptin and Paclitaxel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 143 participants
- Where
- 1 siteSouth Korea
- Study dates
- Feb 2010to Dec 2023
- Phase
- Phase 1/2
- 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
- Are females
- Have a Her 2 over-expression
- Have Eastern Cooperative Oncology Group (ECOG) 0 or 1
Who cannot join
- Current clinical or radiographic evidence central nervous system (CNS) metastases
- Current Known infection
- Pregnant or nursing mother
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Double-Blind, Randomized, Parallel Phase I/IIb Study to Evaluate Initial Safety and Efficacy, Comparative Pharmacokinetics, and Immunogenicity for CT-P6 and Herceptin in Metastatic Breast Cancer
The purpose of the study is to demonstrate equivalent pharmacokinetics (PK)
Read the detailed description
Patients will receive CT-P6 or Herceptin.
- Conditions
- Metastatic Breast Cancer
- Being tested
- CT-P6, Herceptin, Paclitaxel
- Keywords
- Herceptin, Her 2-positive, metastatic breast cancer, CT-P6
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CT-P6Drug
CT-P6: administered every 3 weeks
HerceptinDrug
Also called Trastuzumab
Herceptin: administered every 3 weeks
PaclitaxelDrug
Paclitaxel: administered every 3 weeks
| Study group | Role | What they receive |
|---|---|---|
| CT-P6 & Paclitaxel | Experimental | CT-P6 was administered at a loading dose of 8 mg/kg body weight by IV infusion over 90 minutes on Day 1, Cycle 1, then at 6 mg/kg repeated at 3-weekly intervals until disease progression, death, or discontinuation.
Paclitaxel was administered at a dose of 175 mg/m2 body surface area (BSA) as a continuous 3-hour IV infusion on the day following the first dose of study drug (CT-P6). If the first dose of study drug was well tolerated, subsequent doses of paclitaxel were given immediately after the next dose of study drug. Paclitaxel cycles were repeated every 3 weeks until disease progression, death, intolerable toxicity, or discontinuation. Receives: Drug: CT-P6; Drug: Paclitaxel |
| Herceptin & Paclitaxel | Active comparator | Herceptin was administered at a loading dose of 8 mg/kg body weight by IV infusion over 90 minutes on Day 1, Cycle 1, then at 6 mg/kg repeated at 3-weekly intervals until disease progression, death, or discontinuation.
Paclitaxel was administered at a dose of 175 mg/m2 body surface area (BSA) as a continuous 3-hour IV infusion on the day following the first dose of study drug (Herceptin). If the first dose of study drug was well tolerated, subsequent doses of paclitaxel were given immediately after the next dose of study drug. Paclitaxel cycles were repeated every 3 weeks until disease progression, death, intolerable toxicity, or discontinuation. Receives: Drug: Herceptin; Drug: Paclitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area Under the Concentration Time Curve at Steady State (AUCss)
Area under the concentration time curve at steady state (AUCss), defined as area under the concentration-time curve between Cycle 8 to Cycle 9. The primary endpoint was reached at 6 months (8 treatment cycle; Main Study Treatment Period).
Measured: 3, 6, 12, 24, 72, 168, 336, 504 hours predose
Secondary outcomes (5)
Trough Concentration at Steady State (CtroughSS)
Trough concentration at steady state (CtroughSS), defined as trough concentration at steady state. The secondary endpoint was reached at 6 months (8 treatment cycle; Main Study Treatment Period).
Measured: 3, 6, 12, 24, 72, 168, 336, 504 hours predose
Cardiotoxicity
Cardiac Ejection Fraction Assessment, defined as Mean change from baseline to endpoint assessment in left ventricular ejection fraction (LVEF, Unit: %) from the independent tumor review committee (ITRC).
Measured: Up to approximately 1 year
Immunogenicity
Immunogenicity, defined as proportion of patients with antibodies to study drug (positive for antidrug antibody [ADA] result after the first study infusion).
Measured: every 4 cycles (each cycle is 3 weeks), Up to approximately 5.5 years
Overall Response Rate (ORR; Complete Response [CR] Plus Partial Response [PR]) as Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
Overall response rate (ORR) based on best overall response (BOR) during the Main Study Treatment Period and up to 1-year treatment from the independent tumor review committee (ITRC) and Investigator.
ORR (complete response [CR] plus partial response [PR]), as assessed by Response Evaluation Criteria In Solid Tumours (RECIST) version 1.1 To be assigned a best ORR of PR or CR, changes in tumour assessments must be confirmed no less than 4 weeks after the criteria for response were met.
Measured: every 6 weeks (up to cycle 4) or 12 weeks (after cycle 4) (every cycle is 3 weeks), up to 6 months in Main treatment period and up to 1 year
Serum Human Epidermal Growth Factor Receptor-2 (HER-2) Shed Antigen Value
Serum Human epidermal growth factor receptor-2 (HER-2) shed antigen values at baseline (Cycle 1, Day 1) and the last assessments.
Measured: day 1 of each cycle (every cycle is 3 weeks), Up to approximately 5.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2010 (estimated)
- Study startFeb 2010
- Primary completionDec 2011
- Study completionDec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Metastatic Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 143 participants (actual)
Sponsor and investigators
- Lead sponsor
- Celltrion
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Investigational Site, Principal investigator, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01084863
- Sponsor's protocol ID
- CT-P6/1.1
- Acronym
- Compare
- Status last verified
- Jan 2025
- First submitted
- 5 Mar 2010
- Last updated
- 24 Jan 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Randomized, Parallel Phase I/IIb Study to Evaluate Initial Safety and Efficacy, Comparative Pharmacokinetics, and Immunogenicity for CT-P6 and Herceptin in Metastatic Breast Cancer
- ClinicalTrials.gov ID
- NCT01084863
- Acronym / sponsor ID
- Compare / CT-P6/1.1
- Conditions
- Metastatic Breast Cancer
- Keywords
- Herceptin, Her 2-positive, metastatic breast cancer, CT-P6
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 143 participants (actual)
- Lead sponsor
- CelltrionIndustry (pharma, biotech, devices)
- Study start
- Feb 2010 (actual)
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2023 (actual)
- First posted
- 11 Mar 2010 (estimated)
- Results
- Posted 24 Jan 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to demonstrate equivalent pharmacokinetics (PK)
Detailed description
Patients will receive CT-P6 or Herceptin.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CT-P6 & Paclitaxel | Experimental | Drug: CT-P6, Drug: PaclitaxelCT-P6 was administered at a loading dose of 8 mg/kg body weight by IV infusion over 90 minutes on Day 1, Cycle 1, then at 6 mg/kg repeated at 3-weekly intervals until disease progression, death, or discontinuation. Paclitaxel was administered at a dose of 175 mg/m2 body surface area (BSA) as a continuous 3-hour IV infusion on the day following the first dose of study drug (CT-P6). If the first dose of study drug was well tolerated, subsequent doses of paclitaxel were given immediately after the next dose of study drug. Paclitaxel cycles were repeated every 3 weeks until disease progression, death, intolerable toxicity, or discontinuation. |
| Herceptin & Paclitaxel | Active comparator | Drug: Herceptin, Drug: PaclitaxelHerceptin was administered at a loading dose of 8 mg/kg body weight by IV infusion over 90 minutes on Day 1, Cycle 1, then at 6 mg/kg repeated at 3-weekly intervals until disease progression, death, or discontinuation. Paclitaxel was administered at a dose of 175 mg/m2 body surface area (BSA) as a continuous 3-hour IV infusion on the day following the first dose of study drug (Herceptin). If the first dose of study drug was well tolerated, subsequent doses of paclitaxel were given immediately after the next dose of study drug. Paclitaxel cycles were repeated every 3 weeks until disease progression, death, intolerable toxicity, or discontinuation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Are females
- Have a Her 2 over-expression
- Have Eastern Cooperative Oncology Group (ECOG) 0 or 1
Key exclusion criteria (3 listed)
- Current clinical or radiographic evidence central nervous system (CNS) metastases
- Current Known infection
- Pregnant or nursing mother
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CT-P6CT-P6: administered every 3 weeks | Drug | CT-P6 & Paclitaxel |
| HerceptinAlso: TrastuzumabHerceptin: administered every 3 weeks | Drug | Herceptin & Paclitaxel |
| PaclitaxelPaclitaxel: administered every 3 weeks | Drug | CT-P6 & Paclitaxel, Herceptin & Paclitaxel |
Primary outcome
Area Under the Concentration Time Curve at Steady State (AUCss)
Time frame: 3, 6, 12, 24, 72, 168, 336, 504 hours predose
Area under the concentration time curve at steady state (AUCss), defined as area under the concentration-time curve between Cycle 8 to Cycle 9. The primary endpoint was reached at 6 months (8 treatment cycle; Main Study Treatment Period).
5 secondary outcomes
Trough Concentration at Steady State (CtroughSS)
Time frame: 3, 6, 12, 24, 72, 168, 336, 504 hours predose
Cardiotoxicity
Time frame: Up to approximately 1 year
Immunogenicity
Time frame: every 4 cycles (each cycle is 3 weeks), Up to approximately 5.5 years
Overall Response Rate (ORR; Complete Response [CR] Plus Partial Response [PR]) as Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
Time frame: every 6 weeks (up to cycle 4) or 12 weeks (after cycle 4) (every cycle is 3 weeks), up to 6 months in Main treatment period and up to 1 year
Serum Human Epidermal Growth Factor Receptor-2 (HER-2) Shed Antigen Value
Time frame: day 1 of each cycle (every cycle is 3 weeks), Up to approximately 5.5 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Investigational Site principal investigator
Samsung Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing CT-P6, Herceptin and Paclitaxel in people with Metastatic Breast Cancer, run by Celltrion at 1 site in South Korea.
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 3 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 24 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 24 Jan 2025). 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?
Area Under the Concentration Time Curve at Steady State (AUCss) (time frame: 3, 6, 12, 24, 72, 168, 336, 504 hours predose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Jan 2025.