Clinical trial · Interventional
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
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Breast Tumors | Breast Neoplasm | ALIAS | 0.90 |
| Metastatic Cancer | Malignant Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| AMG 479 | Drug | Ganitumab | ALIAS |
| Placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Arm A: AMG 479 12 mg/kg IV Q2W + Endocrine Therapy
- interventionNames
- Drug: AMG 479
- type
- PLACEBO_COMPARATOR
- label
- Arm B: placebo IV Q2W + Endocrine Therapy
- interventionNames
- Drug: Placebo
Primary outcomes (1)
- measure
- Progression Free Survival (PFS)
- timeFrame
- 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.
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- BACKGROUNDRobertson JF, Ferrero JM, Bourgeois H, Kennecke H, de Boer RH, Jacot W, McGreivy J, Suzuki S, Zhu M, McCaffery I, Loh E, Gansert JL, Kaufman PA. Ganitumab with either exemestane or fulvestrant for postmenopausal women with advanced, hormone-receptor-positive breast cancer: a randomised, controlled, double-blind, phase 2 trial. Lancet Oncol. 2013 Mar;14(3):228-35. doi: 10.1016/S1470-2045(13)70026-3. Epub 2013 Feb 13. PMID 23414585