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.

Completed

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

Official record

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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.

South Korea1 site

Samsung Medical Center
Seoul

Other trials in South Korea

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 groups in NCT01084863
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.

Feb 2010Dec 2023

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)

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

Results posted to the registry on 24 Jan 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
CT-P6 & Paclitaxel	76	60
Herceptin & Paclitaxel	67	56

Primary outcome: Area Under the Concentration Time Curve at Steady State (AUCss)

Time frame: 3, 6, 12, 24, 72, 168, 336, 504 hours predose. Mean (Standard Deviation). Unit: ug*h/mL

Measure	CT-P6 & Paclitaxel n = 51	Herceptin & Paclitaxel n = 49
Value	34400 (15000)	31800 (9820)

CT-P6 & Paclitaxel vs Herceptin & Paclitaxel: Geometric Mean Ratio: 104.57 (90% CI 93.64 to 116.78)

Population analysed: PK Analysis Set - Global (PKASg) was defined as all FAS patients who had achieved steady state by the 8th cycle, which required three consecutive similar trough concentrations.

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse event (AE) reporting extended from the date of informed consent until completion of the final visit. (Up to approximately 170 months). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
CT-P6 & Paclitaxel	12 of 76 (15.8%)	74 of 76 (97.4%)	2 of 76
Herceptin & Paclitaxel	19 of 67 (28.4%)	64 of 67 (95.5%)	3 of 67

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?

On the ClinicalTrials.gov record for NCT01084863.

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.