A study to evaluate the Efficacy and Safety of AZD8931 in Combination with Anastrozole, compared to Anastrozole alone in Post-menopausal Women With Locally-advanced or Metastatic Breast Cancer.

A Phase II, Randomised, Double-blind, Placebo-controlled, Multi-centre Study to Assess the Efficacy and Safety of AZD8931 In Combination with Anastrozole, Compared to Anastrozole alone, in Post-menopausal Women With Hormone Receptor-positive, Endocrine Therapy-naÃ¯ve, Locally-advanced or Metastatic Breast Cancer. - MINT

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2010/091/002961

Enrollment

345

Registered

2011-02-08

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Locally advanced or Metastatic Breast Cancer Health Condition 2: C509- Malignant neoplasm of breast of unspecified site

Interventions

Intervention1: AZD8931: Tablet to be taken orally bd. Medication will continue until documented disease progression or until they wish to withdraw or until the investigator / delegate determines disco

Eligibility

Inclusion criteria

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

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)

Design outcomes

Primary

Measure	Time frame
Progression free survival as evaluated by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1Timepoint: Every 12 weeks	—

Secondary

Measure	Time frame
Compare the effect of AZD8931 in combination with anastrozole on Health Related Quality of Life (HRQoL) versus anastrozole alone.Timepoint: Quality of life questionnaires to be completed at four weekly visits until week 24 and then 12 weekly thereafter;Compare the overall survival in patients treated with AZD8931 in combination with anastrozole versus anastrozole alone.Timepoint: Following progression, patients will be contacted at 12 weekly intervals to determine survival status;To investigate the safety and tolerability of AZD8931 given in combination with anastrozole, as measured by pulse, blood pressure, ECG, echocardiogram, laboratory assessments and physical exam.Timepoint: Routine safety monitoring at four weekly visits until week 24 and then 12 weekly visits up to treatment discontinuation or withdrawal	—

Measure

Time frame

Compare the effect of AZD8931 in combination with anastrozole on Health Related Quality of Life (HRQoL) versus anastrozole alone.Timepoint: Quality of life questionnaires to be completed at four weekly visits until week 24 and then 12 weekly thereafter;Compare the overall survival in patients treated with AZD8931 in combination with anastrozole versus anastrozole alone.Timepoint: Following progression, patients will be contacted at 12 weekly intervals to determine survival status;To investigate the safety and tolerability of AZD8931 given in combination with anastrozole, as measured by pulse, blood pressure, ECG, echocardiogram, laboratory assessments and physical exam.Timepoint: Routine safety monitoring at four weekly visits until week 24 and then 12 weekly visits up to treatment discontinuation or withdrawal

—

Countries

Brazil, Canada, Czech Republic, Democratic People's Republic of Korea, Finland, India, Japan, Mexico, Peru, Philippines, Poland, Russian Federation, South Africa, Thailand, Ukraine, United Kingdom, United States of America

Contacts

Public ContactDr Ramesh Jagannathan

AstraZeneca Pharma India Ltd.

ramesh.jagannathan@astrazeneca.com8067748515

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026