QUILT-2.015: A Study of AMG 479 With Exemestane or Fulvestrant in Postmenopausal Women With Hormone Receptor Positive Locally Advanced or Metastatic Breast Cancer
- Conditions
- Breast CancerBreast TumorsMetastatic Cancer
- Interventions
- Drug: Placebo
- Registration Number
- NCT00626106
- Lead Sponsor
- NantCell, Inc.
- Brief Summary
This is a randomized, double-blind, placebo-controlled, phase 2 study. Subjects will include postmenopausal women with confirmed HR-positive, locally advanced or metastatic breast cancer, who have disease progression during or within 12 months after completing prior adjuvant endocrine therapy or during the first prior endocrine therapy for metastatic disease.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 156
- Histologically or cytologically confirmed carcinoma of the breast with locally advanced or metastatic disease
- Confirmation of hormone receptor (HR) positive disease status
- Amenable to receive endocrine therapy
- Disease progression while receiving prior endocrine therapy for locally advanced or metastatic breast cancer
- Postmenopausal woman ≥ 18 years old
- HR-unknown or HR-negative disease
- Not amenable to endocrine therapy
- Central nervous system metastasis
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm A: AMG 479 12 mg/kg IV Q2W + Endocrine Therapy AMG 479 - Arm B: placebo IV Q2W + Endocrine Therapy Placebo -
- Primary Outcome Measures
Name Time Method Progression Free Survival (PFS) Subject completing study will be contacted by the study staff by telephone or at routine clinic visits approximately every 3 months, up to approximately 3 years and 6 months. PFS was defined as the time from randomization to the first observation of disease progression (as classified by modified RECIST), symptomatic deterioration or death due to any cause, whichever occurs first. Disease progression per RECIST is defined as at least a 20% increase in the sum of diameters of target lesions in reference to the smallest sum on study and an absolute increase of at least 5 mm; the appearance of any new lesions is also considered progression.
- Secondary Outcome Measures
Name Time Method Number of Participants With Adverse Events 30 days after the last dose of study treatment, up to 109 weeks Graded Using the National Cancer Institute(NCI) Common Terminology Criteria for Adverse Events(CTCAE) Version 3.0
Cmax of AMG 479 Subject completing study will be contacted by the study staff by telephone or at routine clinic visits approximately every 3 months, up to approximately 3 years and 6 months. Serum AMG 479 Concentrations After IV Administration of 12 mg/kg AMG 479 in combination with Exemestane, and in combination with Fulvestrant (Cmax).
Clinical Benefit and Objective Response Rate Subject completing study will be contacted by the study staff by telephone or at routine clinic visits approximately every 3 months, up to approximately 3 years and 6 months. Clinical benefit was defined as complete/partial response, or stable disease≥24 weeks per modified RECIST/local review.
Objective response rate was defined as complete/partial response per modified RECIST/local review.
Per Response Evaluation Criteria in Solid Tumors \[RECIST\]: a complete response is the disappearance of all target lesions; a partial response is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Stable disease is disease that is not complete, partial or progressive (PD = at least a 20% increase in the sum of diameters of target lesions in reference to the smallest sum on study)Duration of Response and Time-to-response Subject completing study will be contacted by the study staff by telephone or at routine clinic visits approximately every 3 months, up to approximately 3 years and 6 months. Duration of response was defined as time from the date of first confirmed response to the date of first disease progression or death due to any cause in a subset of subjects with confirmed response.
Time to response was defined as the interval in days from randomization to the first assessment of objective response (CR or PR).
A complete response is the disappearance of all target lesions; a partial response is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Progressive disease is at least a 20% increase in the sum of diameters of target lesions in reference to the smallest sum on study.Time To Progression, Time-to-treatment Failure, Overall Survival Subject completing study will be contacted by the study staff by telephone or at routine clinic visits approximately every 3 months, up to approximately 3 years and 6 months. Time to progression was defined as the time from date of randomization to the date of first occurrence of disease progression or death due to disease progression
Time to treatment failure was defined as the time from date of randomization to the earliest date of disease progression, death, or end of cycle \[last dose date + 1 cycle time: 14 days\] for the last dose of ganitumab or placebo regardless of the reason of discontinuation
Overall survival was defined as the time from randomization to death.
Progressive disease is at least a 20% increase in the sum of diameters of target lesions in reference to the smallest sum on study.Global Health Status Time-Adjusted AUC From start of study, on Day 1 of cycles 2, 3, and 4 and Day 1 every 3rd cycle thereafter, up to cycle 25 (Cycle = 28 days), approximately 700 days. Based on the European Organization Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ C-30) v3, a 30-item questionnaire comprised of 5 functional scales, 3 symptom scales, and 6 single item scales, all with scores ranging from 1=not at all to 4=very much, along with the Health-Related Quality of Life scale with scores ranging from 1=very poor to 7=excellent; and 2 questions from the Dermatology Life Quality Index (DLQI; scores ranged from 1=not at all to 4=very much). Summing of all these questions and standardizing yielded a total score ranging from 0-100; higher total scores = better quality of life.
AUC of the change from baseline of the mean total score over time were calculated using the linear trapezoidal rule. The time-adjusted AUC was calculated by dividing the AUC by the time interval between baseline and the last scheduled assessment, the difference was analyzed using analysis of covariance with baseline score and stratification factors as covariates.
Trial Locations
- Locations (1)
Research Site
🇬🇧Peterborough, United Kingdom