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Additional Support Program Via Text Messaging and Telephone-Based Counseling for Breast Cancer Patients Receiving Hormonal Therapy

StatusActive, Not Recruiting
PhasePhase 3
Started2021-02-15
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 2 months later Aug 31, 2026 → Oct 31, 2026
See other at-risk trials from Alliance for Clinical Trials in Oncology

Amendment history

2026-10-02
Primary completion pushed: 2026-08-31 → 2026-10-31
Completion pushed: 2026-08-31 → 2026-10-31
2025-09-05
Recruiting→Active, Not Recruiting Study Status, Study Design, Contacts/Locations v26
Trial statusRecruiting→Active, Not Recruiting
Primary completion date2026-10→2026-08-31
Completion date2026-10→2026-08-31
Enrollment targetestimated 1180→confirmed 1167
Study sites526 entries, revised
Rush-Copley Medical Center TrinityUI RegionalHealthcare MedicalMission CenterCancer and Blood - Fort Dodge AscensionBeacon BorgessKalamazoo Cancer Center SaintMercy LouisOncology and Hematology - Clayton-Clarkson Mercy Infusion Center - Chippewa Reading Hospital McGlinn Cancer andInstitute Breastat Institute-BallwinPhoenixville SaintVCU LouisMassey Cancer and Breast Institute-South City Phoenixville Hospital Virginia Commonwealth University/MasseyComprehensive Cancer Center
2025-06-24
Study Status, Contacts/Locations v25
Study sites525→526
2025-03-28
Study Status, Oversight, Conditions, Contacts/Locations v24
Study sites523→525
2025-01-14
Study Status, Oversight, Conditions, Contacts/Locations v23
Primary completion date2025-10→2026-10
Completion date2025-10→2026-10
Study sitescontacts updated at 399 of 523 sites
Show 22 earlier versions
2024-12-24
Study Status, Contacts/Locations v22
Study sites522→523
2024-10-24
Study Status, Contacts/Locations v21
Study sites521→522
2024-08-01
Study Status, Contacts/Locations v20
Study sites520→521
2024-05-23
Suspended→Recruiting Study Status, Contacts/Locations v19
Trial statusSuspended→Recruiting
Reason stoppedIntervention supply interruption→not stated
Study sites519→520
2023-04-03
Recruiting→Suspended Study Status, Contacts/Locations v18
Trial statusRecruiting→Suspended
Reason stoppednot stated→Intervention supply interruption
Study sites519 entries, revised
Hawaii Cancer Care - SavioWestridge Saint Alphonsus MedicalCancer Care Center-Nampa Trinity Health IHA Medical Group Hematology Oncology Consultants- Brighton Trinity Health IHA Medical Group Hematology Oncology Consultants- Canton Trinity Health IHA Medical Group Hematology Oncology Consultants- Chelsea Hospital MercyTrinity Health Grand Rapids Hospital Trinity Health Saint Mary's Saint Mary Mercy Livonia Hospital Trinity Health IHA Medical Group Hematology Oncology Consultants-Ann Arbor Campus Dayton Physicians LLC -Upper ValleyTroy Marshfield ClinicMedical Center-River Region at Stevens Poi [...] [...]
2022-06-03
Study Status, Contacts/Locations v17
Study sites515→519
2022-04-18
Study Status, Contacts/Locations v16
Study sites506→515
2022-03-22
Study Status, Contacts/Locations v15
Study sites480→506
2022-02-16
Study Status, Contacts/Locations v14
Study sites470→480
2022-01-11
Study Status, Contacts/Locations v13
Study sitesdetails revised at 15 of 470 sites
2021-12-13
Study Status, Contacts/Locations v12
Study sites466→470
2021-11-11
Study Status, Contacts/Locations v11
Study sites432→466
2021-10-11
Study Status, Contacts/Locations v10
Study sites366→432
2021-09-01
Study Status v9
Start date2020-12-10→2021-02-15
2021-08-16
Study Status, Contacts/Locations v8
Study sites338→366
2021-07-19
Study Status, Contacts/Locations v7
Study sites258→338
2021-06-09
Study Status, Contacts/Locations v6
Study sites214→258
2021-04-16
Study Status, Contacts/Locations v5
Study sites205→214
2021-03-05
Study Status, Contacts/Locations v4
Study sites167→205
2021-02-05
Study Status, Contacts/Locations v3
Study sites16→167
2021-01-08
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v2
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2020-12→confirmed 2020-12-10
Study sites0→16
2020-11-23
Study Status v1
Primary completion date2025-07→2025-10
Completion date2025-07→2025-10
Start date2020-10→2020-12
2020-05-05
Original filing
This phase III trial compares an additional support program (text message reminders and/or telephone-based counseling) with usual care in making sure breast cancer patients take their endocrine therapy medication as prescribed (medication adherence). Medication adherence is how well patients take the medication as prescribed by their doctors, and good medical adherence is when patients take medications correctly. Poor medication adherence has been shown to be a serious barrier to effective treatment for hormone receptor positive breast cancer patients. Adding text message reminders and/or telephone-based counseling to usual care may increase the number of days that patients take their endocrine therapy medication as prescribed.
Trial Details
NCT Number NCT04379570
Lead Sponsor Alliance for Clinical Trials in Oncology
Collaborators: National Cancer Institute (NCI)
Conditions Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage III Breast Cancer AJCC v8, HER2 Negative Breast Carcinoma, Hormone Receptor Positive Breast Carcinoma, Invasive Breast Carcinoma, Prognostic Stage I Breast Cancer AJCC v8, Prognostic Stage II Breast Cancer AJCC v8 +1 more
Enrollment 1,167 participants
Start Date 2021-02-15
Primary Completion 2026-10-31 (estimated)
Study Completion 2026-10-31 (estimated)
Updated on ClinicalTrials.gov 2026-10-01