Breast CancerNCT01277926
Patterns of Care in Hormone-receptor Positive, Advanced Breast Cancer
An observational study of Breast Cancer, run by AstraZeneca at 6 sites in Brazil.
Trial summary
The purpose of this study is to characterize the current patterns of care for patients with hormone-receptor-positive, advanced breast cancer who have failed one prior endocrine therapy in Brazil. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- How many people
- 7 participants
- Where
- 6 sitesBrazil
- Study dates
- Apr 2011to Dec 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
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
Study population: Primary care clinic
Who may be able to join
- Histological or cytological diagnosis of breast cancer
- Postmenopausal status at the time of enrolment, according to the following definitions:
- History of bilateral oophorectomy at any age
- Proven hormonal menopause
- Positive estrogen receptor (ER) and/or progesterone receptor (PR) by immuno
- Failure of one previous endocrine therapy in the adjuvant or metastatic setting
- Use of no more than one previous chemotherapy regimen in the neoadjuvant or adjuvant setting
- Indication to receive chemotherapy or endocrine therapy
Who cannot join
- Inability to comply with the study protocol
- Use of more than one previous endocrine therapy, regardless of the setting; -- Previous use of chemotherapy for metastatic disease
- Use of neoadjuvant endocrine therapy as the only previous type of endocrine therapy
- Serious medical, surgical or psychiatric comorbidity that, upon investigator's discretion, should preclude participation in the study.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Brazil6 sites
Research Site
Belo Horizonte
Research Site
Mogi das Cruzes
Research Site
Porto Alegre, Rio Grande do Sul
Research Site
Ribeirão Preto
Research Site
Rio de Janeiro, Rio de Janeiro
Research Site
São Paulo, São Paulo
About this study
Official title: Patterns of Care in Hormone-Receptor Positive, Advanced Breast Cancer in Brazil: A Prospective, Observational Study
The purpose of this study is to characterize the current patterns of care for patients with hormone-receptor-positive, advanced breast cancer who have failed one prior endocrine therapy in Brazil. To investigate patient-related, disease-related and physician-related characteristics that correlate with the use of either endocrine treatment or chemotherapy in such patients. And to evaluate patients' understanding of the treatment options and their participation in the choice.
- Conditions
- Breast Cancer
- Keywords
- Breast Cancer, Hormone Receptor Positive, Advanced Breast Cancer
- Medical subject headings
- Breast Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the treatment choice by the medical oncologist for each patient.
Measured: 12 months
Secondary outcomes (3)
To assess determinants of treatment choice
Measured: 12 months
To assess the duration of treatment with chemotherapy or endocrine therapy
Measured: 12 months
To evaluate the rate of treatment continuation at 6 months
Assess the profile of adverse events with each treatment modality and assess patient participation and understanding in treatment choice
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2011 (estimated)
- Study startApr 2011
- Primary completionDec 2012 (estimated)
- Study completionDec 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Paulo André Palhares Miranda, Doctor, Study director, MC Brazil
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01277926
- Sponsor's protocol ID
- NIS-OBR-DUM-2010/1
- Other IDs
- D6998L00002
- Status last verified
- Dec 2012
- First submitted
- 12 Jan 2011
- Last updated
- 6 Dec 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patterns of Care in Hormone-Receptor Positive, Advanced Breast Cancer in Brazil: A Prospective, Observational Study
- ClinicalTrials.gov ID
- NCT01277926
- Acronym / sponsor ID
- NIS-OBR-DUM-2010/1
- Conditions
- Breast Cancer
- Keywords
- Breast Cancer, Hormone Receptor Positive, Advanced Breast Cancer
- Study type
- Observational
- Recruitment status
- Terminated
- Enrolment
- 7 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Apr 2011
- Primary completion
- Dec 2012 (estimated)
- Study completion
- Dec 2012 (estimated)
- First posted
- 17 Jan 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to characterize the current patterns of care for patients with hormone-receptor-positive, advanced breast cancer who have failed one prior endocrine therapy in Brazil. To investigate patient-related, disease-related and physician-related characteristics that correlate with the use of either endocrine treatment or chemotherapy in such patients. And to evaluate patients' understanding of the treatment options and their participation in the choice.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Primary care clinic
Key inclusion criteria (8 listed)
- Histological or cytological diagnosis of breast cancer
- Postmenopausal status at the time of enrolment, according to the following definitions:
- Positive estrogen receptor (ER) and/or progesterone receptor (PR) by immuno
- Failure of one previous endocrine therapy in the adjuvant or metastatic setting
- Use of no more than one previous chemotherapy regimen in the neoadjuvant or adjuvant setting
Key exclusion criteria (4 listed)
- Inability to comply with the study protocol
- Use of more than one previous endocrine therapy, regardless of the setting; -- Previous use of chemotherapy for metastatic disease
- Use of neoadjuvant endocrine therapy as the only previous type of endocrine therapy
- Serious medical, surgical or psychiatric comorbidity that, upon investigator's discretion, should preclude participation in the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To assess the treatment choice by the medical oncologist for each patient.
Time frame: 12 months
3 secondary outcomes
To assess determinants of treatment choice
Time frame: 12 months
To assess the duration of treatment with chemotherapy or endocrine therapy
Time frame: 12 months
To evaluate the rate of treatment continuation at 6 months
Time frame: 12 months
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2012.
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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.
Paulo André Palhares Miranda, Doctor study director
MC Brazil
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by AstraZeneca at 6 sites in Brazil.
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 8 inclusion and 4 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 6 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Brazil. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
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?
To assess the treatment choice by the medical oncologist for each patient. (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Dec 2012; AzTrials last refreshed its copy on 8 Nov 2026.