Study of Anastrozole +/- AZD8931 in Postmenopausal Women With Endocrine Therapy Naive Breast Cancer (MINT)

AstraZeneca

Status and phase: Terminated; Phase 2

Conditions: Breast Cancer; Neoplasms; Breast Neoplasms

Treatments: Drug: Placebo; Drug: anastrozole; Drug: AZD8931

Study type: Interventional

Funder types: Industry

Identifiers

NCT01151215

D0102C00004

Details and patient eligibility

About

The main purpose of this study is to compare progression free survival in patients treated with AZD8931 given in combination with anastrozole versus anastrozole alone. The secondary objective is to investigate the safety and tolerability of AZD8931 given in combination with anastrozole.

Enrollment: 482 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients that have locally advanced or metastatic breast cancer. Lesions should not be amenable to surgery or radiation of curative intent
• Hormone therapy-naive
• Estimated life expectancy of more than 12 weeks

Exclusion criteria

• Last dose of prior anti-cancer therapy received within 14 days (or longer if required)
• Any eye injury or corneal surgery within 3 months prior to receiving first dose of study drug.
• Currently receiving (and unwilling to discontinue) oestrogen replacement therapy. (last dose <7 days prior to randomisation)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

482 participants in 3 patient groups, including a placebo group

1

Experimental group

Description:

AZD8931 40mg (bd) plus anastrozole 1mg (od)

Treatment:

Drug: AZD8931

Drug: anastrozole

2

Experimental group

Description:

AZD8931 20mg (bd) plus anastrozole 1mg (od)

Treatment:

Drug: AZD8931

Drug: anastrozole

3

Placebo Comparator group

Description:

Placebo (bd) plus anastrozole 1mg (od)

Treatment:

Drug: Placebo

Drug: anastrozole