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

NantCell

Status and phase: Completed; Phase 2

Conditions: Metastatic Cancer; Breast Tumors; Breast Cancer

Treatments: Drug: Placebo; Drug: AMG 479

Study type: Interventional

Funder types: Industry

Identifiers

NCT00626106

20060362

QUILT-2.015 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 156 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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156 participants in 2 patient groups, including a placebo group

Arm A: AMG 479 12 mg/kg IV Q2W + Endocrine Therapy

Active Comparator group

Treatment:

Drug: AMG 479

Arm B: placebo IV Q2W + Endocrine Therapy

Placebo Comparator group

Treatment:

Drug: Placebo