A study of AZD8931 and anastrozole for hormone receptor positive advanced breast cancer (MINT)

Not Applicable

• Conditions: -C50 Malignant neoplasm of breast; Malignant neoplasm of breast; C50

• Registration Number: PER-109-09
• Lead Sponsor: ASTRAZENECA PERU S.A.,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-01-28
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Status: Complete
• Sex: Female
• Target Recruitment: 0

Inclusion Criteria

• Provision of signed, written informed consent prior to any study specific procedures
• Post menopausal females defined as: natural menopause with menses > 1 year ago; or radiation-induced oophorectomy with last menses >1 year ago; or chemotherapy induced menopause with 1 year interval since last menses; or serum FSH and LH and plasma oestradiol levels in the post menopausal range for the institution; or bilateral oophorectomy
• Patients with histologic or cytologic diagnosis of breast cancer with evidence of locally advanced or metastatic disease. Lesions should not be amenable to surgery or radiation of curative intent
• Documented ER- and/or PgR positive breast cancer
• Patients must be endocrine therapy naive i.e. they have never received endocrine therapy (e.g. tamoxifen, aromatase inhibitors etc.) for their breast cancer.
• At least one lesion (measurable and/or non-measurable) that can be accurately assessed at baseline by computed tomography (CT), magnetic resonance imaging (MRI) or plain x ray and is suitable for repeat assessment
• World Health Organisation (WHO) performance status 0 or 1
• Estimated life expectancy of more than 12 weeks.
• Patients receiving bisphosphonate therapy for skeletal related events must have been on their current dose for at least 5 days prior to randomisation. If they are expected to require bisphosphonate therapy at any time during the study it must be commenced at least 5 days prior to randomisation.
• Patients receiving ongoing treatment with angiotensin converting enzyme (ACE) inibitors, postassium sparing diuretics or potassium supplements must have been on therapy for at least 2 weeks with no changes in dose in that time. Similarly, patients receiving a stable or decreasing dose regime of steroids or systemic (oral) anit-cholinergic (anti-muscarinic) medication are allowed.
• Consent to the provision of tumour from both diagnostic and/or re biopsy samples where available.

Exclusion Criteria

• Patients must not have received more than 1 prior chemotherapy regimen for their breast cancer.
• Trastuzumab or lapatinib eligible (as confirmed by local testing practices or treatment availability)
• Any prior therapy with an inhibitor of ErbB1 (EGFR) or ErbB2 (HER2) (eg, lapatinib)
• Inadequate bone marrow reserve as demonstrated by an absolute neutrophil count <1.5 x 109/L or platelet count <100 x 109/L
• Inadequate renal function as demonstrated by serum creatinine >1.5 x upper limit of normal (ULN), or creatinine clearance <50mL/min
• Haemoglobin < 9g/dL (5.59 mmol/L), any blood transfusion must be >14 days prior to the determination of the haemoglobin levels
• Inadequate liver function
• Resting ECG with measurable QTc interval of >450msec at 2 or more time points within a 24 hour period
• Cardiac ejection fraction outside institutional range of normal or =50% (whichever is higher) as measured by echocardiogram (or multiple uptake gated acquisition scan (MUGA) if an echocardiogram cannot be performed or is inconclusive)
• Known uncontrolled or symptomatic angina, arrythmias or congestive heart failure; evidence of transmural infarction on ECG, poorly controlled hypertension (systolic >180 mmHg or diastolic >100 mmHg), significant valvular disease or history of high risk dysrrhythmia (such as ventricular fibrillation or ventricular tachycardia [includes ventricular triplets])
• Past medical history of interstitial lung disease, drug-induced interstitial lung disease, radiation pneumonitis which required steroid treatment, or any evidence of clinically active interstitial lung disease
• Active or uncontrolled systemic disease which in the investigator’s opinion makes it undesirable for the patient to participate in the trial or which would jeopardise compliance with the protocol
• History or repeated unexplained episodes of syncope/dizziness
• Medical diagnosis of acne rosacea, psoriasis, severe atopic eczema
• Concurrent second primary malignancy (except in situ carcinoma of the cervix). Patients with a prior cancer are eligible if they are disease-free with no evidence of recurrence or relapse in the past 5 years.
• Unresolved toxicity >CTC grade 2 (except alopecia) from previous anti-cancer therapy
• Prior exposure to anthracyclines or mitoxantrone with cumulative exposure in excess of 360 mg/m2 for doxorubicin, 720 mg/m2 for epirubicin, or 72 mg/m2 for mitoxantrone
• Unable to discontinue medication with agents designated as having a risk of Torsades de Pointes due to QT prolongation. Guidance on medicines to avoid and on washout periods is given in Appendix E to this protocol
• Unable to discontinue any medication or herbal supplement with know moderate or potent inhibitory effect on CYP3A4 or CYP2D6, or potent inducing effects on CYP3A4 or CYP2D6. Such drugs must have been discontinued for an appropriate period prior to starting AZD8931. Guidance on medicines to avoid and on washout periods is given in appendix E to this protocol
• Known hype

Study & Design

• Study Type: Interventional
• Study Design: Not specified