Clinical trial NCT02491892: A Study of Pertuzumab in Participants With Metastatic Breast Cancer
Official title: Open-Label, Phase II, Multicenter, Randomized Study of Efficacy and Safety for Two Different Doses of a Recombinant Humanized Antibody to HER2 (rhuMAb 2C4) Administered Every 3 Weeks to Patients With Metastatic Breast Cancer With Low Expression of HER2
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Breast Cancer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2015-07-08
Enrollment: 79
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will evaluate the efficacy and safety of pertuzumab (rhuMAb 2C4) in participants with metastatic breast cancer which has progressed during or after standard chemotherapy and which is not amenable to curative therapy. Those who are maintaining a response to therapy or who have stable disease at the end of the formal study period will continue treatment until disease progression or unacceptable toxicity. Approximately 120 participants will be enrolled.


Eligibility criteria: Inclusion Criteria:

* Females at least 18 years of age
* Histologically-confirmed metastatic breast cancer with low HER2 expression and at least one measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST)
* Karnofsky performance status at least 80%
* Disease progression on/after up to 2 different chemotherapy regimens, including an anthracycline-containing therapy
* Left ventricular ejection fraction (LVEF) at least 50%
* Adequate liver function

Exclusion Criteria:

* Pleural effusions, ascites, or bone lesions as the only manifestation(s) of cancer
* Pulmonary or central nervous system (CNS) metastases
* Chemotherapy, radiotherapy, or immunotherapy within 4 weeks; or hormone therapy within 2 weeks of Day 1
* Previous treatment with any drug that targets the HER2 receptor family
* Previous treatment with corticosteroids as cancer therapy
* History of significant cardiac disease
* Major surgery or trauma within 4 weeks of Day 1
* Pregnant or lactating women

Primary outcomes:
measure: Percentage of Participants Achieving a Best Overall Response of Confirmed Complete Response (CR) or Partial Response (PR)
timeFrame: Up to approximately 1 year (at Baseline; every 6 weeks for the first 8 cycles, then every 12 weeks until progression or death; and up to 4 weeks after initial response)
Secondary outcomes:
measure: Time to Response Among Participants Achieving a Best Overall Response of Confirmed CR or PR
timeFrame: Up to approximately 1 year (at Baseline; every 6 weeks for the first 8 cycles, then every 12 weeks until progression or death; and up to 4 weeks after initial response)
measure: Duration of Response Among Participants Achieving a Best Overall Response of Confirmed CR or PR
timeFrame: Up to approximately 1 year (at Baseline; every 6 weeks for the first 8 cycles, then every 12 weeks until progression or death; and up to 4 weeks after initial response)
measure: Percentage of Participants Achieving a Best Overall Response of Confirmed CR
timeFrame: Up to approximately 1 year (at Baseline; every 6 weeks for the first 8 cycles, then every 12 weeks until progression or death; and up to 4 weeks after initial response)
measure: Duration of Response Among Participants Achieving a Best Overall Response of Confirmed CR
timeFrame: Up to approximately 1 year (at Baseline; every 6 weeks for the first 8 cycles, then every 12 weeks until progression or death; and up to 4 weeks after initial response)
measure: Number of Participants Who Experienced PD or Death
timeFrame: Up to approximately 1 year (at Baseline; every 6 weeks for the first 8 cycles, then every 12 weeks until progression or death; and up to 4 weeks after initial response)
measure: Time to Progression
timeFrame: Up to approximately 1 year (at Baseline; every 6 weeks for the first 8 cycles, then every 12 weeks until progression or death; and up to 4 weeks after initial response)
measure: Number of Participants Who Experienced PD or Withdrew From the Study Early
timeFrame: Up to approximately 1 year (at Baseline; every 6 weeks for the first 8 cycles, then every 12 weeks until progression or death; and up to 4 weeks after initial response)
measure: Time to Treatment Failure
timeFrame: Up to approximately 1 year (at Baseline; every 6 weeks for the first 8 cycles, then every 12 weeks until progression or death; and up to 4 weeks after initial response)
measure: Percentage of Participants Who Died
timeFrame: Up to approximately 2 years (from start of treatment until death)
measure: Overall Survival
timeFrame: Up to approximately 2 years (from start of treatment until death)
measure: Percentage of Participants Achieving a Best Overall Response of SD
timeFrame: Up to approximately 1 year (at Baseline; every 6 weeks for the first 8 cycles, then every 12 weeks until progression or death; and up to 4 weeks after initial response)
measure: Apparent Half-Life (t1/2) of Pertuzumab
timeFrame: Pre-dose and within 15 minutes of the end of infusion on Day 1 of each cycle, and on Days 8 and 15 of Cycles 1 and 2
measure: Maximum Plasma Concentration (Cmax) of Pertuzumab
timeFrame: Pre-dose and within 15 minutes of the end of infusion on Day 1 of each cycle, and on Days 8 and 15 of Cycles 1 and 2
measure: Time to Maximum Plasma Concentration (Tmax) of Pertuzumab
timeFrame: Pre-dose and within 15 minutes of the end of infusion on Day 1 of each cycle, and on Days 8 and 15 of Cycles 1 and 2
measure: Area Under the Concentration-Time Curve (AUC) of Pertuzumab
timeFrame: Pre-dose and within 15 minutes of the end of infusion on Day 1 of each cycle, and on Days 8 and 15 of Cycles 1 and 2
measure: Systemic Clearance (CL) of Pertuzumab
timeFrame: Pre-dose and within 15 minutes of the end of infusion on Day 1 of each cycle, and on Days 8 and 15 of Cycles 1 and 2
measure: Volume of Distribution at Steady State (Vss) of Pertuzumab
timeFrame: Pre-dose and within 15 minutes of the end of infusion on Day 1 of each cycle, and on Days 8 and 15 of Cycles 1 and 2
measure: Mean Residence Time (MRT) of Pertuzumab
timeFrame: Pre-dose and within 15 minutes of the end of infusion on Day 1 of each cycle, and on Days 8 and 15 of Cycles 1 and 2
measure: Number of Participants Experiencing a Drop in Left Ventricular Ejection Fraction (LVEF) to a Value of Less Than 50%
timeFrame: Up to approximately 1 year (at Baseline; at the end of Cycles 2, 4, 8, 12, and 16; and up to 7 weeks following the last infusion)
Other outcomes:
Locations:
city: Camperdown
country: Australia
city: Fitzroy
country: Australia
city: Geelong
country: Australia
city: Namur
country: Belgium
city: Helsinki
country: Finland
city: Tampere
country: Finland
city: Hamburg
country: Germany
city: Herne
country: Germany
city: München
country: Germany
city: Milano
country: Italy
city: Parma
country: Italy
city: Amsterdam
country: Netherlands
city: Barcelona
country: Spain
city: Barcelona
country: Spain
city: Valencia
country: Spain
city: Edinburgh
country: United Kingdom
city: London
country: United Kingdom
city: Manchester
country: United Kingdom
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_CHAIR
References: