NeoplasmsPhase 2MINTNCT01151215
Study of Anastrozole +/- AZD8931 in Postmenopausal Women With Endocrine Therapy Naive Breast Cancer
A Phase 2 study testing AZD8931 and anastrozole in people with Neoplasms and Breast Neoplasms, run by AstraZeneca at 60 sites in 18 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Neoplasms, Breast Neoplasms, Breast Cancer
- What is being tested?
- AZD8931 and anastrozole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 482 participants
- Where
- 60 sitesin 18 countries
- Study dates
- Jun 2010to Jan 2013
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
60 sites in 18 countries.
60 sites in 18 countries
United Kingdom8 sites
Research Site
Birmingham
Research Site
Bournemouth
Research Site
Coventry
Research Site
Leicester
Research Site
London
Research Site
Nottingham
Research Site
Surrey
Research Site
Wythenshawe, Manchester
Brazil6 sites
Research Site
Belo Horizonte
Research Site
Goiânia
Research Site
Ijuí
Research Site
Porto Alegre
Research Site
Rio de Janeiro
Research Site
São Paulo
India6 sites
Research Site
Bangalore
Research Site
Hyderabad
Research Site
Mumbai
Research Site
Pune
Research Site
Trivandrum
Research Site
Vellore
Japan4 sites
Research Site
Niigata
Research Site
Osaka
Research Site
Ota-shi
Research Site
Sapporo
Mexico4 sites
Research Site
Durango
Research Site
Juchitán
Research Site
Mérida
Research Site
Monterrey
Philippines4 sites
Research Site
Iloilo City
Research Site
Lipa City
Research Site
Pasay
Research Site
Quezon City
Poland4 sites
Research Site
Bialystok
Research Site
Elblag
Research Site
Krakow
Research Site
Warsaw
Canada3 sites
Research Site
Montreal, Quebec
Research Site
Ottawa, Ontario
Research Site
Vancouver, British Columbia
Russia3 sites
Research Site
Kuzmolovsky
Research Site
Moscow
Research Site
Saint Petersburg
About this study
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).
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.
- Conditions
- Neoplasms, Breast Neoplasms, Breast Cancer
- Being tested
- AZD8931, anastrozole, Placebo
- Keywords
- Cancer, tumour, breast cancer, metastatic, secondary, locally advanced
- Medical subject headings
- Neoplasms, Breast Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZD8931Drug
Tablet, oral, bd
anastrozoleDrug
Also called Arimidex
Tablet, oral, od
PlaceboDrug
Tablet, oral
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | AZD8931 40mg (bd) plus anastrozole 1mg (od) Receives: Drug: AZD8931; Drug: anastrozole |
| 2 | Experimental | AZD8931 20mg (bd) plus anastrozole 1mg (od) Receives: Drug: AZD8931; Drug: anastrozole |
| 3 | Placebo comparator | Placebo (bd) plus anastrozole 1mg (od) Receives: Drug: anastrozole; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival as Evaluated by Response Evaluation Criteria In Solid Tumors (RECIST) 1.1
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.
Measured: Tumour assessment by RECIST 1.1 every 12 weeks until data cut-off at 31 August 2012
Secondary outcomes (1)
Compare the Overall Survival in Patients Treated With AZD8931 in Combination With Anastrozole Versus Anastrozole Alone
Time from the date of randomization to the date of death (by any cause)
Measured: Following progression, patients were contacted at 12 weekly intervals until data cut-off at 31 August 2012 to determine survival status
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2010 (estimated)
- Study startJun 2010
- Primary completionJan 2013
- Study completionJan 2013
Why it stopped: Futility
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for NeoplasmsStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 482 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dr Serban Ghiorghiu, MD, Study director, AstraZenecaStephen Johnston, MA, PhD, FRCP, Principal investigator, The Royal Marsden Hospital, London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01151215
- Sponsor's protocol ID
- D0102C00004
- Acronym
- MINT
- Status last verified
- Jul 2014
- First submitted
- 15 Jun 2010
- Last updated
- 25 Jul 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Johnston S, Basik M, Hegg R, Lausoontornsiri W, Grzeda L, Clemons M, Dreosti L, Mann H, Stuart M, Cristofanilli M. Inhibition of EGFR, HER2, and HER3 signaling with AZD8931 in combination with anastrozole as an anticancer approach: Phase II randomized study in women with endocrine-therapy-naive advanced breast cancer. Breast Cancer Res Treat. 2016 Nov;160(1):91-99. doi: 10.1007/s10549-016-3979-5. Epub 2016 Sep 21.
PubMed 27654971
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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).
- ClinicalTrials.gov ID
- NCT01151215
- Acronym / sponsor ID
- MINT / D0102C00004
- Conditions
- Neoplasms, Breast Neoplasms, Breast Cancer
- Keywords
- Cancer, tumour, breast cancer, metastatic, secondary, locally advanced
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Futility
- Enrolment
- 482 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Jun 2010
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 28 Jun 2010 (estimated)
- Results
- Posted 8 May 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: AZD8931, Drug: anastrozoleAZD8931 40mg (bd) plus anastrozole 1mg (od) |
| 2 | Experimental | Drug: AZD8931, Drug: anastrozoleAZD8931 20mg (bd) plus anastrozole 1mg (od) |
| 3 | Placebo comparator | Drug: anastrozole, Drug: PlaceboPlacebo (bd) plus anastrozole 1mg (od) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AZD8931Tablet, oral, bd | Drug | 1, 2 |
| anastrozoleAlso: ArimidexTablet, oral, od | Drug | 1, 2, 3 |
| PlaceboTablet, oral | Drug | 3 |
Primary outcome
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.
1 secondary outcome
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 27654971Johnston S, Basik M, Hegg R, Lausoontornsiri W, Grzeda L, Clemons M, Dreosti L, Mann H, Stuart M, Cristofanilli M. Inhibition of EGFR, HER2, and HER3 signaling with AZD8931 in combination with anastrozole as an anticancer approach: Phase II randomized study in women with endocrine-therapy-naive advanced breast cancer. Breast Cancer Res Treat. 2016 Nov;160(1):91-99. doi: 10.1007/s10549-016-3979-5. Epub 2016 Sep 21.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr Serban Ghiorghiu, MD study director
AstraZeneca
Stephen Johnston, MA, PhD, FRCP principal investigator
The Royal Marsden Hospital, London
60 sites in 18 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AZD8931 and anastrozole in people with Neoplasms and Breast Neoplasms, run by AstraZeneca at 60 sites in 18 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 25 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 60 sites in United Kingdom, Brazil, India, Japan, Mexico and 13 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 May 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01151215, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2014.