Metastatic Breast CancerPhase 3CompareNCT01084876
Demonstrate Efficacy and Safety of Metastatic Breast Cancer
A Phase 3 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 equivalence 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
- 475 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jun 2010to Mar 2015
- 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
- Are females
- Have Her 2 over-expression
- Have Eastern Cooperative Oncology Group (ECOG) Performance Status of 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, Randomised, Parallel Group, Phase III Study to Demonstrate Equivalent Efficacy and Comparable Safety of CT-P6 and Herceptin, Both in Combination With Paclitaxel, in Patients With Metastatic Breast Cancer
The purpose of the study is to demonstrate equivalence
Read the detailed description
Patients will receive CT-P6 or Herceptin every 3 weeks.
- Conditions
- Metastatic Breast Cancer
- Being tested
- CT-P6, Herceptin, Paclitaxel
- Keywords
- Herceptin, metastatic breast cancer, CT-P6, Her 2-positive
- 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
Administered every 3 weeks
HerceptinDrug
Also called Trastuzumab
Administered every 3 weeks
PaclitaxelDrug
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 intravenous (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 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 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 or discontinuation. Receives: Drug: Herceptin; Drug: Paclitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate
Best Overall Response (BOR) was derived from the overall response across all time points until after Cycle 8 using Independent Tumor Review Committee (ITRC) data in the FAS. Objective Response Rate (ORR) was defined as the number of patients with a BOR of complete response (CR) or partial response (PR) divided by the number of patients in the corresponding population, as assessed by Response Evaluation Criteria In Solid Tumours (RECIST) version 1.1.
Measured: 6 months (up to 24 weeks)
Secondary outcomes (7)
Time to Progression
Time from randomization to determined progressive disease, as assessed by RECIST version 1.1.
Measured: Through study completion, approximately 40 months
Time to Response
Time from randomization to observed tumor response (Complete Response or Partial Response), as assessed by RECIST 1.1
Measured: Through study completion, approximately 40 months
Progression Free Survival
Time from randomization to radiological progression or death from any cause, as assessed by RECIST 1.1
Measured: Through study completion, approximately 40 months
Overall Survival
The number of days between the date of randomization and the date of death from any cause.
Measured: Through study completion, approximately 40 months
Safety Endpoints; Cardiotoxicity
Mean change from baseline to endpoint assessment in left ventricular ejection fraction (LVEF) (%)
Measured: Through study completion, approximately 40 months
Safety Endpoints; Immunogenicity
Assessed by the proportion of patients with development of antibodies to study drug (positive anti-drug antibody [ADA] results after the first study drug infusion)
Measured: During treatment, median of 13 cycles (every cycle is 3 weeks)
Pharmacokinetic Endpoints; Ctroughss
Trough concentration at steady state
Measured: predose and at 1.5 hours (end of infusion) of each cycle
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 startJun 2010
- Primary completionJul 2012
- Study completionMar 2015
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 475 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
- NCT01084876
- Sponsor's protocol ID
- CT-P6/3.1
- Acronym
- Compare
- Status last verified
- Jan 2025
- First submitted
- 9 Mar 2010
- Last updated
- 11 Feb 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 11 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind, Randomised, Parallel Group, Phase III Study to Demonstrate Equivalent Efficacy and Comparable Safety of CT-P6 and Herceptin, Both in Combination With Paclitaxel, in Patients With Metastatic Breast Cancer
- ClinicalTrials.gov ID
- NCT01084876
- Acronym / sponsor ID
- Compare / CT-P6/3.1
- Conditions
- Metastatic Breast Cancer
- Keywords
- Herceptin, metastatic breast cancer, CT-P6, Her 2-positive
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 475 participants (actual)
- Lead sponsor
- CelltrionIndustry (pharma, biotech, devices)
- Study start
- Jun 2010 (actual)
- Primary completion
- Jul 2012 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 11 Mar 2010 (estimated)
- Results
- Posted 11 Feb 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 equivalence
Detailed description
Patients will receive CT-P6 or Herceptin every 3 weeks.
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 intravenous (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 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 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 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 Her 2 over-expression
- Have Eastern Cooperative Oncology Group (ECOG) Performance Status of 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-P6Administered every 3 weeks | Drug | CT-P6 & Paclitaxel |
| HerceptinAlso: TrastuzumabAdministered every 3 weeks | Drug | Herceptin & Paclitaxel |
| PaclitaxelAdministered every 3 weeks | Drug | CT-P6 & Paclitaxel, Herceptin & Paclitaxel |
Primary outcome
Objective Response Rate
Time frame: 6 months (up to 24 weeks)
Best Overall Response (BOR) was derived from the overall response across all time points until after Cycle 8 using Independent Tumor Review Committee (ITRC) data in the FAS. Objective Response Rate (ORR) was defined as the number of patients with a BOR of complete response (CR) or partial response (PR) divided by the number of patients in the corresponding population, as assessed by Response Evaluation Criteria In Solid Tumours (RECIST) version 1.1.
7 secondary outcomes
Time to Progression
Time frame: Through study completion, approximately 40 months
Time to Response
Time frame: Through study completion, approximately 40 months
Progression Free Survival
Time frame: Through study completion, approximately 40 months
Overall Survival
Time frame: Through study completion, approximately 40 months
Safety Endpoints; Cardiotoxicity
Time frame: Through study completion, approximately 40 months
Safety Endpoints; Immunogenicity
Time frame: During treatment, median of 13 cycles (every cycle is 3 weeks)
Pharmacokinetic Endpoints; Ctroughss
Time frame: predose and at 1.5 hours (end of infusion) of each cycle
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Metastatic Breast Cancer
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruiting
Augmented-Reality ICG Fluorescence Second-Look for Residual Nodal Disease After Axillary Dissection in Breast Cancer
Breast Cancer, Breast Neoplasms
RecruitingPhase 2
BrAin Metastasis in tripLe Negateive Breast Cancer: IvoneScimab and Trop2 ADC
Triple-Negative Breast Cancer (TNBC), Brain Metastases
RecruitingPhase 1/2
A Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Patients With Metastatic or Locally Advanced Breast Cancer
Metastatic Breast Cancer
RecruitingObservational study
Collection of CSF Samples From Participants With Metastatic Triple Negative Breast Cancer (TNBC) and HER2+ Breast Cancer With no Prior History Nor Active Radiographically Detectable Brain Metastases
Breast Cancer, Breast Carcinoma
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 3 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 11 Feb 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 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 11 Feb 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?
Objective Response Rate (time frame: 6 months (up to 24 weeks)). 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 11 Feb 2025.