HR+/HER2- Early Breast CancerIMPACT PTNCT07521202
IMPLEMENTING PATIENTS' COMPETENCE IN ORAL EBC THERAPY PERSISTENCE
A study testing Standardized patient coaching in people with HR+/HER2- Early Breast Cancer, run by Institut fuer Frauengesundheit at 1 site in Germany.
Trial summary
The goal of this interventional study is to evaluate the effect of standardized patient coaching on treatment adherence among patients taking abemaciclib. The main question it aims to answer is, whether standardized coaching leads to patients taking abemaciclib much more consistently. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- HR+/HER2- Early Breast Cancer
- What is being tested?
- Standardized patient coaching
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 257 participants
- Where
- 1 siteGermany
- Study dates
- Oct 2026to Jun 2030
- Phase
- Interventional
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Women age 18 or older at time of ICF signature
- Patients with HRpos/HER2neg early breast cancer who are treated with oral, commercially available prescribed abemaciclib in combination with endocrine therapy. Patients can be included if abemaciclib therapy was started no more than 28 days ago
- Patients treated with abemaciclib according to the SmPC and each center´s medical practice
- Informed consent given prior to the starting study activities
Who cannot join
- Women who are pregnant or lactating
- Patients with contraindications against abemaciclib according to the current SmPC
- Patients who are not eligible for the study due to severe comorbidities, unavailability or any other relevant reason according to the treating physician
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site
Department of Obstetrics and Gynaecology
Erlangen, Bavaria, 91054
Prof. Dr. med. Peter A. Fasching, +4991318533572, fk-studienzentrale@uk-erlangen.de
About this study
Official title: A Scientific Study Evaluating Therapy Persistence in Patients With Hormone Receptor-positive, HER2-negative Early Breast Cancer Under Adjuvant Treatment With Abemaciclib Who Receive Standardized Patient Education and Counselling.
The goal of this interventional study is to evaluate the effect of standardized patient coaching on treatment adherence among patients taking abemaciclib.
The main question it aims to answer is, whether standardized coaching leads to patients taking abemaciclib much more consistently. Researchers will therefore compare therapy adherence of patients receiving standardized coaching to patients receiving routine care.
Participants will be asked to answer several questionnaires.
- Conditions
- HR+/HER2- Early Breast Cancer
- Being tested
- Standardized patient coaching
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standardized patient coachingBehavioural
Standardized patient coaching based on the Multinational Association of Supportive Care in Cancer (MASCC) Oral Agent Teaching Tool© (MOATT)
| Study group | Role | What they receive |
|---|---|---|
| Standardized patient coaching | Experimental | Patients receive standardized coaching based on the Multinational Association of Supportive Care in Cancer (MASCC) Oral Agent Teaching Tool© (MOATT) Receives: Behavioral: Standardized patient coaching |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to discontinuation
Time to permanent discontinuation of abemaciclib therapy
Measured: From enrollment until 1 year or time of permanent discontinuation of abemaciclib, which ever comes first
Secondary outcomes (4)
Persistence rate
Abemaciclib persistence rate (defined as ongoing abemaciclib therapy)
Measured: At 6 and 12 months after therapy start
Satisfaction with Information about Medicines Scale (SIMS-D)
This scale assess the patient´s knowledge about their treatment. The total score ranges from 0 to 17, with higher scores indicating a higher degree of overall satisfaction with information received.
Measured: At 6 and 12 months after therapy start
Medication Adherence Rate Scale (MARS-D)
A total score ranges from 5 to 25 for adherence with higher scores indicating higher self-treported adherence.
Measured: At 6 and 12 months after therapy start
Bloem's patient typology questionnaire
This 6-item instrument classifies patients into four segments: 1) High Acceptance / High Control (Active/Adjusted): Good mental, low care need. 2) Low Acceptance / High Control (Struggling/Active): High need for support to accept the situation. 3) High Acceptance / Low Control (Resigned/Passive): High need for educational/proactive support. 4) Low Acceptance / Low Control (Vulnerable/Anxious): Highest care need, requires intense supportive care.
Measured: At 6 and 12 months after therapy start
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2026
- Study startOct 2026 (estimated)
- Primary completionJun 2029 (estimated)
- Study completionJun 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HR+/HER2- Early 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 257 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut fuer Frauengesundheit
- Sponsor type
- University, hospital or other
- Collaborators
- Lilly Deutschland GmbH Germany
- Responsible party
- Sponsor
- Investigators
- Peter A. Fasching, Prof. Dr. med., Study chair, Department of Obstetrics and Gynaecology, Uniklinikum Erlangen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07521202
- Sponsor's protocol ID
- IFG-01-2025
- Acronym
- IMPACT PT
- Status last verified
- Sep 2026
- First submitted
- 27 Mar 2026
- Last updated
- 10 Sep 2026
- 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 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Scientific Study Evaluating Therapy Persistence in Patients With Hormone Receptor-positive, HER2-negative Early Breast Cancer Under Adjuvant Treatment With Abemaciclib Who Receive Standardized Patient Education and Counselling.
- ClinicalTrials.gov ID
- NCT07521202
- Acronym / sponsor ID
- IMPACT PT / IFG-01-2025
- Conditions
- HR+/HER2- Early Breast Cancer
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 257 participants (estimated)
- Lead sponsor
- Institut fuer FrauengesundheitUniversity, hospital or other
- Collaborators
- Lilly Deutschland GmbH Germany
- Study start
- Oct 2026 (estimated)
- Primary completion
- Jun 2029 (estimated)
- Study completion
- Jun 2030 (estimated)
- First posted
- 9 Apr 2026 (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.
The goal of this interventional study is to evaluate the effect of standardized patient coaching on treatment adherence among patients taking abemaciclib.
The main question it aims to answer is, whether standardized coaching leads to patients taking abemaciclib much more consistently. Researchers will therefore compare therapy adherence of patients receiving standardized coaching to patients receiving routine care.
Participants will be asked to answer several questionnaires.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Standardized patient coaching | Experimental | Behavioral: Standardized patient coachingPatients receive standardized coaching based on the Multinational Association of Supportive Care in Cancer (MASCC) Oral Agent Teaching Tool© (MOATT) |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Women age 18 or older at time of ICF signature
- Patients with HRpos/HER2neg early breast cancer who are treated with oral, commercially available prescribed abemaciclib in combination with endocrine therapy. Patients can be included if abemaciclib therapy was started no more than 28 days ago
- Patients treated with abemaciclib according to the SmPC and each center´s medical practice
- Informed consent given prior to the starting study activities
Key exclusion criteria (3 listed)
- Women who are pregnant or lactating
- Patients with contraindications against abemaciclib according to the current SmPC
- Patients who are not eligible for the study due to severe comorbidities, unavailability or any other relevant reason according to the treating physician
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 |
|---|---|---|
| Standardized patient coachingStandardized patient coaching based on the Multinational Association of Supportive Care in Cancer (MASCC) Oral Agent Teaching Tool© (MOATT) | Behavioural | Standardized patient coaching |
Primary outcome
Time to discontinuation
Time frame: From enrollment until 1 year or time of permanent discontinuation of abemaciclib, which ever comes first
Time to permanent discontinuation of abemaciclib therapy
4 secondary outcomes
Persistence rate
Time frame: At 6 and 12 months after therapy start
Satisfaction with Information about Medicines Scale (SIMS-D)
Time frame: At 6 and 12 months after therapy start
Medication Adherence Rate Scale (MARS-D)
Time frame: At 6 and 12 months after therapy start
Bloem's patient typology questionnaire
Time frame: At 6 and 12 months after therapy start
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 10 Sep 2026.
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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.
Peter A. Fasching, Prof. Dr. med. study chair
Department of Obstetrics and Gynaecology, Uniklinikum Erlangen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standardized patient coaching in people with HR+/HER2- Early Breast Cancer, run by Institut fuer Frauengesundheit at 1 site in Germany.
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 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: opening soon, as of the sponsor's last update on 10 Sep 2026. 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 Germany. 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?
Contact Sponsor's study office (+49 15739466438, studien@ifg-erlangen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to discontinuation (time frame: From enrollment until 1 year or time of permanent discontinuation of abemaciclib, which ever comes first). 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 10 Sep 2026.