Phase 2
Completed N=156
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
Breast Cancer · Breast Tumors · Metastatic cancer
Source: ClinicalTrials.gov NCT00626106 ↗
Enrolled (actual)
156
Serious AEs
23.2%
Results posted
Sep 2024
Primary outcomePrimary: Progression Free Survival (PFS) — 3.9; 5.7 Months
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression Free Survival (PFS) |
3.9; 5.7 | — |
| SECONDARY Number of Participants With Adverse Events |
105; 47 | — |
| SECONDARY Cmax of AMG 479 |
231; 257; 289; 225; 267; 268 | — |
| SECONDARY Clinical Benefit and Objective Response Rate |
5; 4; 22; 10 | — |
| SECONDARY Duration of Response and Time-to-response |
22.1; 19.5; 26.5; 31.7 | — |
| SECONDARY Time To Progression, Time-to-treatment Failure, Overall Survival |
17.0; 24.6; 15.8; 21.6; 96.6; NA | — |
| SECONDARY Global Health Status Time-Adjusted AUC |
1.56; 1.59 | 0.542 |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00626106). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.