Breast CancerNCT03818087
Elevate! : An Elderly Breast Cancer Cohort Study
An observational study of Breast Cancer, run by Dana-Farber Cancer Institute at 4 sites in United States.
Trial summary
This study is focused on understanding how the investigators can improve upon breast cancer and health outcomes for older participants with breast cancer. Read more about this study
- Who is it for?
- Ages 70 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Observational cohort
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 253 participants
- Where
- 4 sitesUnited States
- Study dates
- 19 Feb 2019to 1 Nov 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 70 years and older
- Women only
- No healthy volunteers
- Older adult
Study population: Age 70 or older at the time of diagnosis
Who may be able to join
- Age 70 or older at the time of diagnosis (as indicated by the date of breast biopsy)
- No more than 67 patients (1/3) will be aged 70-74, with the remaining patients on study ages 75 or older
- Any gender is eligible
- Invasive, non-metastatic breast cancer at diagnosis
- Those with prior diagnoses of pre-invasive (DCIS) or invasive breast cancer are eligible as long as their current diagnosis is felt by the treating provider to represent a NEW non-metastatic primary invasive breast cancer (e.g. someone with a nodal recurrence from prior disease are not eligible but those with a new contralateral breast cancer 3 years after a first breast cancer would be eligible)
- Any breast cancer subtype is allowed
Show all 11Show fewer
- Breast cancer-diagnosing biopsy within 90 days of enrollment
- Receiving or will receive medical oncology care (+/- surgical and radiation oncology treatments) at the participating center: DFCI/satellites and affiliate sites
- Patients must be able to understand, speak, and read English or assign a designated caregiver/proxy for the duration of the study who understands, speaks, and reads English and who is willing to assist with filling out the survey components which do not have a validated, translated version. This is because the surveys are not readily available in multiple languages as a whole, although some components (such as the Geriatric Assessment and PROs are readily available in multiple languages).
- If a patient scores 11 or higher on the baseline Orientation-Memory-Concentration Test done at baseline (Appendix E), a proxy/designee must then be assigned to help the patient fill out the questionnaires for the duration of the study in order to participate. The treating provider will also be notified about the cognitive impairment.
- Ability to provide informed consent
Who cannot join
- Pathological or clinical stage 0, IV disease
- Those with nodal or metastatic recurrences at the time of enrollment
- Unable to speak and read English AND no designee who speaks and reads English, as above
- Unable to provide informed consent
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Northern Light Cancer Care
Bangor, Maine, 04401
Brigham and Women Hospital
Boston, Massachusetts, 02215
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
Lifespan Cancer Institute
Providence, Rhode Island, 02903
About this study
Official title: Elevate! : Improving Outcomes for Older Patients With Breast Cancer:a Longitudinal Cohort and Patient Engagement Study
This study is focused on understanding how the investigators can improve upon breast cancer and health outcomes for older participants with breast cancer.
Read the detailed description
This study is focused on understanding how the investigators can improve upon breast cancer and health outcomes for older participants with breast cancer, a group of participants who often have low risk cancers, but who may do worse than younger participants with the same kind of cancers. Researchers want to better understand the experiences, barriers, and changes in physical function older participants with breast cancer have.
- Conditions
- Breast Cancer
- Being tested
- Observational cohort
- Keywords
- Breast Cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observational cohortBehavioural
Patients will be followed by collecting clinical data, biospecimens, and quality of life assessments over a period of five years from registration.
| Study group | Role | What they receive |
|---|---|---|
| Elevate | Participants over the age of 70 years old with early-stage breast cancer will be recruited. Receives: Behavioral: Observational cohort |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adjuvant treatment recommendations
Report treatment recommendations made to patients enrolled on the cohort
Measured: 7 years
Adherence to hormonal therapy
We will survey patients on adherence
Measured: 7 years
Barriers to treatment and adherence
We will survey patients on the reasons for adherence and poor adherence
Measured: 7 years
Treatment patterns by age and other characteristics
We will examine treatment receipt and patterns by subtype of disease
Measured: 7 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2019
- Study start19 Feb 2019
- Primary completion1 Dec 2027 (estimated)
- Study completion1 Nov 2028 (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 Dana-Farber Cancer InstituteThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 253 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dana-Farber Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Susan G. Komen Breast Cancer Foundation
- Responsible party
- Principal investigator, Rachel Freedman, MD, MPH, Dana-Farber Cancer Institute
- Investigators
- Rachel A Freedman, MD, MPH, Principal investigator, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03818087
- Sponsor's protocol ID
- 18-634
- Status last verified
- Dec 2025
- First submitted
- 19 Dec 2018
- Last updated
- 19 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: \[contact information for Sponsor- Investigator or designee\]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Elevate! : Improving Outcomes for Older Patients With Breast Cancer:a Longitudinal Cohort and Patient Engagement Study
- ClinicalTrials.gov ID
- NCT03818087
- Acronym / sponsor ID
- 18-634
- Conditions
- Breast Cancer
- Keywords
- Breast Cancer
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 253 participants (actual)
- Lead sponsor
- Dana-Farber Cancer InstituteUniversity, hospital or other
- Collaborators
- Susan G. Komen Breast Cancer Foundation
- Study start
- 19 Feb 2019 (actual)
- Primary completion
- 1 Dec 2027 (estimated)
- Study completion
- 1 Nov 2028 (estimated)
- First posted
- 28 Jan 2019 (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 study is focused on understanding how the investigators can improve upon breast cancer and health outcomes for older participants with breast cancer.
Detailed description
This study is focused on understanding how the investigators can improve upon breast cancer and health outcomes for older participants with breast cancer, a group of participants who often have low risk cancers, but who may do worse than younger participants with the same kind of cancers. Researchers want to better understand the experiences, barriers, and changes in physical function older participants with breast cancer have.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Elevate | – | Behavioral: Observational cohortParticipants over the age of 70 years old with early-stage breast cancer will be recruited. |
Who may qualify
- Ages
- 70 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Age 70 or older at the time of diagnosis
Key inclusion criteria (11 listed)
- Age 70 or older at the time of diagnosis (as indicated by the date of breast biopsy)
- No more than 67 patients (1/3) will be aged 70-74, with the remaining patients on study ages 75 or older
- Any gender is eligible
- Invasive, non-metastatic breast cancer at diagnosis
- Those with prior diagnoses of pre-invasive (DCIS) or invasive breast cancer are eligible as long as their current diagnosis is felt by the treating provider to represent a NEW non-metastatic primary invasive breast cancer (e.g. someone with a nodal recurrence from prior disease are not eligible but those with a new contralateral breast cancer 3 years after a first breast cancer would be eligible)
Key exclusion criteria (4 listed)
- Pathological or clinical stage 0, IV disease
- Those with nodal or metastatic recurrences at the time of enrollment
- Unable to speak and read English AND no designee who speaks and reads English, as above
- Unable to provide informed consent
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 |
|---|---|---|
| Observational cohortPatients will be followed by collecting clinical data, biospecimens, and quality of life assessments over a period of five years from registration. | Behavioural | Elevate |
Primary outcome
Adjuvant treatment recommendations
Time frame: 7 years
Report treatment recommendations made to patients enrolled on the cohort
Adherence to hormonal therapy
Time frame: 7 years
We will survey patients on adherence
Barriers to treatment and adherence
Time frame: 7 years
We will survey patients on the reasons for adherence and poor adherence
Treatment patterns by age and other characteristics
Time frame: 7 years
We will examine treatment receipt and patterns by subtype of disease
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2025.
- Individual participant dataSharing planned: Yes. The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: [contact information for Sponsor- Investigator or designee]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
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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.
Rachel A Freedman, MD, MPH principal investigator
Dana-Farber Cancer Institute
4 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 Dana-Farber Cancer Institute at 4 sites 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 11 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: under way, not looking for participants, as of the sponsor's last update on 19 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
This study is still under way. Results are not available in the source record yet.
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?
Adjuvant treatment recommendations (time frame: 7 years). The study lists 4 primary outcomes in all. 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 19 Dec 2025.