Demonstrate Efficacy and Safety of Metastatic Breast Cancer

NCT01084876 | Completed Phase 3 Results DMC

• 1 other identifier: CT-P6/3.1
• Study Type: interventional
• Target: 475
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study is to demonstrate equivalence

Conditions

Metastatic Breast Cancer

Keywords

Herceptin; metastatic breast cancer; CT-P6; Her 2-positive

Outcome Measures

Primary Outcomes (1)

• 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.

  6 months (up to 24 weeks)

Secondary Outcomes (7)

• Time to Progression

  Through study completion, approximately 40 months

• Time to Response

  Through study completion, approximately 40 months

• Progression Free Survival

  Through study completion, approximately 40 months

• Overall Survival

  Through study completion, approximately 40 months

• Safety Endpoints; Cardiotoxicity

  Through study completion, approximately 40 months

Study Arms (2)

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.

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.

Drug: Herceptin; Drug: Paclitaxel

Interventions

CT-P6 DRUG

Administered every 3 weeks

CT-P6 & Paclitaxel

Herceptin DRUG

Administered every 3 weeks

Also known as: Trastuzumab

Herceptin & Paclitaxel

Paclitaxel DRUG

Administered every 3 weeks

CT-P6 & Paclitaxel; Herceptin & Paclitaxel

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Are females
• Have Her 2 over-expression
• Have Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1

You may not qualify if:

• Current clinical or radiographic evidence central nervous system (CNS) metastases
• Current Known infection
• Pregnant or nursing mother

Sponsors & Collaborators

• Celltrion: lead

Study Sites (1)

Samsung Medical Center

Seoul, South Korea

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

CT-P6; Trastuzumab; Paclitaxel

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Results Point of Contact

• Title: Head of Clinical Planning Department
• Organization: Celltrion

contact@celltrion.com

82328505000

Study Officials

• Investigational Site

  Samsung Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 9, 2010
• First Posted: March 11, 2010
• Study Start: June 1, 2010
• Primary Completion: July 1, 2012
• Study Completion: March 1, 2015
• Last Updated: February 11, 2025
• Results First Posted: February 11, 2025

Record last verified: 2025-01

Locations

KR (1)