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

Study Overview
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Brief Summary
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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.

Official Title
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An International, Randomized, Double-blind, Placebo-controlled, Phase 2 Study of AMG 479 With Exemestane or Fulvestrant in Postmenopausal Women With Hormone Receptor Positive Locally Advanced or Metastatic Breast Cancer

Conditions
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Breast Cancer, Breast Tumors, Metastatic Cancer

Intervention / Treatment
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* Drug: AMG 479 or placebo administered with either exemestane or fulvestrant
* Drug: AMG 479 or placebo administered with either exemestane or fulvestrant
* Drug: AMG 479 or placebo administered with either exemestane or fulvestrant


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: HR-unknown or HR-negative disease Not amenable to endocrine therapy Central nervous system metastasis

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br> | Drug: AMG 479 or placebo administered with either exemestane or fulvestrant<br>* Arm 2 - placebo with exemestane or fulvestrant<br>|
| Active Comparator: Investigational Product<br> | Drug: AMG 479 or placebo administered with either exemestane or fulvestrant<br>* Arm 1 - AMG 479 administered with exemestane or fulvestrant<br>|
| Other: Roll-over<br> | Drug: AMG 479 or placebo administered with either exemestane or fulvestrant<br>* Arm 3 - roll over to open-label AMG 479 with exemestane or fulvestrant<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression free survival (PFS), as measured by Response Evaluation Criteria in Solid Tumors criteria (modified RECIST) per local review |  | Subject completing study will be contacted by the study staff by telephone or at routine clinic visits approximately every 3 months for up to 4 years after the last patient starts the study treatment for a max of 5 years and 3 months for any patient | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of adverse events, abnormal laboratory values, and anti-AMG 479 antibody formation |  | Subject completing study will be contacted by the study staff by telephone or at routine clinic visits approximately every 3 months for up to 4 years after the last patient starts the study treatment for a max of 5 years and 3 months for any patient | 
| PK parameters of AMG 479 |  | Subject completing study will be contacted by the study staff by telephone or at routine clinic visits approximately every 3 months for up to 4 years after the last patient starts the study treatment for a max of 5 years and 3 months for any patient | 
| Breast cancer related symptoms, health related quality of life, and skin toxicity burden |  | Subject completing study will be contacted by the study staff by telephone or at routine clinic visits approximately every 3 months for up to 4 years after the last patient starts the study treatment for a max of 5 years and 3 months for any patient | 
| Clin benefit(complete/partial response,or stable disease≥24 wks per modified RECIST/local review),objective response rate(complete/partial response per modified RECIST/local review),duration of response,TTP,time-to-response,time-to-tx failure,survival |  | Subject completing study will be contacted by the study staff by telephone or at routine clinic visits approximately every 3 months for up to 4 years after the last patient starts the study treatment for a max of 5 years and 3 months for any patient | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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postmenopausal, hormone receptor positive, locally advanced, metastatic