Breast CancerALPANCT03144037
Adherence of Hispanic / Latina Breast Cancer - Patients to Adjuvant Aromatase Inhibitors
An observational study of Breast Cancer, run by Texas Tech University Health Sciences Center, El Paso at 1 site in United States.
Trial summary
This is an observational trial designed to assess prospectively the adherence rate to AIs among women with invasive breast cancer (stages I-III) currently receiving AI adjuvant therapy after standard local and systemic therapy. 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
- 152 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Apr 2017to 19 Mar 2021
- 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: Hispanic population is targeted, yet study is open for all those who qualify.
Who may be able to join
- Post - menopausal women with histologically confirmed hormonal positive (ER and/or PR) invasive breast cancer stages I - III with no evidence of metastatic disease (M0).
- Patient must have completed local treatment (surgery /radiation) and recovered from all side effects of chemotherapy and surgery.
- Patient must be on one of AI (steroidal or non-steroidal).
- Patient must be able to complete a demographic and the MMAS - 8 questionnaires in English or Spanish
Who cannot join
- < 18 years old
Trial locations and contacts
1 site in 1 country.
United States1 site
Texas Tech University HSC El Paso
El Paso, Texas, 79905
About this study
Official title: Adherence of Hispanic / Latina Breast Cancer - Patients to Adjuvant Aromatase Inhibitors - (AIs)
This is an observational trial designed to assess prospectively the adherence rate to AIs among women with invasive breast cancer (stages I-III) currently receiving AI adjuvant therapy after standard local and systemic therapy. We will study adherence by administrating the 8-item Morisky Medication Adherence Scale (MMAS - 8).
Read the detailed description
- Women with breast cancer seen at the Texas Tech Physicians Breast Care Center will be recruited during their routine follow-up visit with their medical oncologist.
- Post - menopausal women with histologically confirmed hormonal positive (ER and/or PR) invasive breast cancer stages I - III with no evidence of metastatic disease (M0).
- Patients must be on one of AI (steroidal or non-steroidal).
- Patient must have completed local treatment (surgery /radiation) and recovered from all side effects of chemotherapy and surgery.
- Patient must be able to complete a demographic and the MMAS - 8 questionnaires in English or Spanish.
- Conditions
- Breast Cancer
- Medical subject headings
- Breast Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence rate per the 8-item Morisky Medication Adherence Scale (MMAS - 8).
Primary endpoint of this study is to determine the adherence rate (high, medium and low) through the MMAS-8 among early stage breast cancer patients being treated at Texas Tech University Health Sciences Center El Paso (TTUHSC EP) where the majority of the patients are of Hispanic origin.
Measured: Every 6 months for up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2017
- Study start26 Apr 2017
- Primary completion19 Mar 2021
- Study completion19 Mar 2021
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.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 152 participants (actual)
Sponsor and investigators
- Lead sponsor
- Texas Tech University Health Sciences Center, El Paso
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alexander Philipovskiy, Texas Tech University Health Sciences Center, El Paso
- Investigators
- Alexander Philipovskiy, MD, PhD, Principal investigator, Texas Tech University Health Sciences Center, El Paso
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03144037
- Sponsor's protocol ID
- E17086
- Acronym
- ALPA
- Status last verified
- Mar 2021
- First submitted
- 4 May 2017
- Last updated
- 29 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adherence of Hispanic / Latina Breast Cancer - Patients to Adjuvant Aromatase Inhibitors - (AIs)
- ClinicalTrials.gov ID
- NCT03144037
- Acronym / sponsor ID
- ALPA / E17086
- Conditions
- Breast Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 152 participants (actual)
- Lead sponsor
- Texas Tech University Health Sciences Center, El PasoUniversity, hospital or other
- Study start
- 26 Apr 2017 (actual)
- Primary completion
- 19 Mar 2021 (actual)
- Study completion
- 19 Mar 2021 (actual)
- First posted
- 8 May 2017 (actual)
- 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.
This is an observational trial designed to assess prospectively the adherence rate to AIs among women with invasive breast cancer (stages I-III) currently receiving AI adjuvant therapy after standard local and systemic therapy. We will study adherence by administrating the 8-item Morisky Medication Adherence Scale (MMAS - 8).
Detailed description
- Women with breast cancer seen at the Texas Tech Physicians Breast Care Center will be recruited during their routine follow-up visit with their medical oncologist.
- Post - menopausal women with histologically confirmed hormonal positive (ER and/or PR) invasive breast cancer stages I - III with no evidence of metastatic disease (M0).
- Patients must be on one of AI (steroidal or non-steroidal).
- Patient must have completed local treatment (surgery /radiation) and recovered from all side effects of chemotherapy and surgery.
- Patient must be able to complete a demographic and the MMAS - 8 questionnaires in English or Spanish.
Study design
- Observational model
- Cohort
- 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
- Hispanic population is targeted, yet study is open for all those who qualify.
Key inclusion criteria (4 listed)
- Post - menopausal women with histologically confirmed hormonal positive (ER and/or PR) invasive breast cancer stages I - III with no evidence of metastatic disease (M0).
- Patient must have completed local treatment (surgery /radiation) and recovered from all side effects of chemotherapy and surgery.
- Patient must be on one of AI (steroidal or non-steroidal).
- Patient must be able to complete a demographic and the MMAS - 8 questionnaires in English or Spanish
Key exclusion criteria (1 listed)
- < 18 years old
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
Adherence rate per the 8-item Morisky Medication Adherence Scale (MMAS - 8).
Time frame: Every 6 months for up to 24 months
Primary endpoint of this study is to determine the adherence rate (high, medium and low) through the MMAS-8 among early stage breast cancer patients being treated at Texas Tech University Health Sciences Center El Paso (TTUHSC EP) where the majority of the patients are of Hispanic origin.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2021.
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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.
Alexander Philipovskiy, MD, PhD principal investigator
Texas Tech University Health Sciences Center, El Paso
1 site 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 Texas Tech University Health Sciences Center, El Paso at 1 site in United States.
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 4 inclusion and 1 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: finished, as of the sponsor's last update on 29 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Adherence rate per the 8-item Morisky Medication Adherence Scale (MMAS - 8). (time frame: Every 6 months for up to 24 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 29 Mar 2021.