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Trial record 89 of 193 for:    Oral Cancer | ( Map: Mexico )

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

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ClinicalTrials.gov Identifier: NCT01151215
Recruitment Status : Terminated (Futility)
First Posted : June 28, 2010
Results First Posted : May 8, 2014
Last Update Posted : July 25, 2014
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Neoplasms Breast Neoplasms Breast Cancer Drug: AZD8931 Drug: anastrozole Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 482 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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 Naive, Locally Advanced or Metastatic Breast Cancer (MINT).
Study Start Date : June 2010
Actual Primary Completion Date : January 2013
Actual Study Completion Date : January 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
Drug Information available for: Anastrozole

Arm Intervention/treatment
Experimental: 1
AZD8931 40mg (bd) plus anastrozole 1mg (od)
Drug: AZD8931
Tablet, oral, bd

Drug: anastrozole
Tablet, oral, od
Other Name: Arimidex

Experimental: 2
AZD8931 20mg (bd) plus anastrozole 1mg (od)
Drug: AZD8931
Tablet, oral, bd

Drug: anastrozole
Tablet, oral, od
Other Name: Arimidex

Placebo Comparator: 3
Placebo (bd) plus anastrozole 1mg (od)
Drug: anastrozole
Tablet, oral, od
Other Name: Arimidex

Drug: Placebo
Tablet, oral




Primary Outcome Measures :
  1. Progression Free Survival as Evaluated by Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 [ Time Frame: Tumour assessment by RECIST 1.1 every 12 weeks until data cut-off at 31 August 2012 ]
    Time from the date of randomization until the date of objective disease progression (as per RECIST 1.1) or the date of death (by any cause in the absence of progression). Disease progression is defined using RECIST 1.1 as >=20% increase in the sum of longest diameters of target lesions and an absolute increase of >=5mm, taking as reference the smallest sum of longest diameters of target lesions since study start, or unequivocal progression in non-target lesions, or appearance of any new lesions.


Secondary Outcome Measures :
  1. Compare the Overall Survival in Patients Treated With AZD8931 in Combination With Anastrozole Versus Anastrozole Alone [ Time Frame: Following progression, patients were contacted at 12 weekly intervals until data cut-off at 31 August 2012 to determine survival status ]
    Time from the date of randomization to the date of death (by any cause)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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:

  • 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01151215


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Sponsors and Collaborators
AstraZeneca
Investigators
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Study Director: Dr Serban Ghiorghiu, MD AstraZeneca
Principal Investigator: Stephen Johnston, MA, PhD, FRCP The Royal Marsden Hospital, London

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01151215     History of Changes
Other Study ID Numbers: D0102C00004
First Posted: June 28, 2010    Key Record Dates
Results First Posted: May 8, 2014
Last Update Posted: July 25, 2014
Last Verified: July 2014
Keywords provided by AstraZeneca:
Cancer
tumour
breast cancer
metastatic
secondary
locally advanced
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Anastrozole
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Aromatase Inhibitors
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs