Demonstrate Efficacy and Safety of Metastatic Breast Cancer

Browse trials for

• Breast Neoplasms 12,544

Keywords

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

Breast Neoplasms

12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.

This study's enrollment of 475 is above the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.

Lead sponsor

Celltrion is the lead sponsor of 76 studies on the registry; 3 are open to participants now.

Of its 18 completed or terminated interventional studies of FDA-regulated products, 13 (72%) have results posted.

Study arms

• Experimental
  CT-P6 & Paclitaxel

  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

• Active comparator
  Herceptin & Paclitaxel

  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

• DrugCT-P6

  Administered every 3 weeks

• DrugHerceptin

  Administered every 3 weeks

  Also known as: Trastuzumab

• DrugPaclitaxel

  Administered every 3 weeks

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.

   Time frame: 6 months (up to 24 weeks)

Secondary outcomes

1. Time to Progression

   Time from randomization to determined progressive disease, as assessed by RECIST version 1.1.

   Time frame: Through study completion, approximately 40 months

2. Time to Response

   Time from randomization to observed tumor response (Complete Response or Partial Response), as assessed by RECIST 1.1

   Time frame: Through study completion, approximately 40 months

3. Progression Free Survival

   Time from randomization to radiological progression or death from any cause, as assessed by RECIST 1.1

   Time frame: Through study completion, approximately 40 months

4. Overall Survival

   The number of days between the date of randomization and the date of death from any cause.

   Time frame: Through study completion, approximately 40 months

5. Safety Endpoints; Cardiotoxicity

   Mean change from baseline to endpoint assessment in left ventricular ejection fraction (LVEF) (%)

   Time frame: Through study completion, approximately 40 months

6. 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)

   Time frame: During treatment, median of 13 cycles (every cycle is 3 weeks)

7. Pharmacokinetic Endpoints; Ctroughss

   Trough concentration at steady state

   Time frame: predose and at 1.5 hours (end of infusion) of each cycle

Baseline characteristics

4 further baseline measures are reported on the registry.