Clinical trial · Interventional
S1105: Text-Messaging Intervention to Reduce Early Discontinuation of AI Therapy in Women With Early-Stage Breast Cancer
S1105, Randomized Trial Of Text-Messaging Intervention To Reduce Early Discontinuation Of Adjuvant Aromatase Inhibitor Therapy In Women With Early Stage Breast Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
RATIONALE: Measuring how text-message affects treatment compliance in women with breast cancer may help doctors plan the best treatment. PURPOSE: This randomized trial studies how well text-message works in reducing early discontinuation of aromatase inhibitor therapy in patients with early-stage breast cancer who underwent breast surgery.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Text message reminder | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Text message reminder
- description
- Patients undergo a text message education checklist involving confirmation of cellular telephone capability to receive text messages, how to retrieve and read messages, including a confirmation evaluation, at baseline and at any time a patient obtains a new cellular telephone. Patients then receive a text message twice a week at 8 o'clock in the morning (for each time zone) for up to 3 years. Additionally, patients receive standard follow-up care.
- interventionNames
- Behavioral: Text message reminder
- type
- NO_INTERVENTION
- label
- No text message reminder
- description
- Patients receive standard follow-up care.
Primary outcomes (1)
- measure
- Time to first evidence of adherence failure (discontinuation)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Patients must be women with a diagnosis of histologically confirmed, primary invasive, hormone-sensitive (estrogen receptor-positive \[ER\]/progesterone receptor \[PR\]-positive) adenocarcinoma of the breast (Stage I, II or III) with no evidence of recurrent or metastatic disease (M0) * Patients must have a mobile phone that can receive text messages and must currently use or be willing to learn to use text messaging PATIENT CHARACTERISTICS: * Patients must be postmenopausal, as defined by at least one of the following: * ≥ 12 months since the last menstrual period * Prior bilateral oophorectomy * Previous hysterectomy with one or both ovaries left in place (or previous hysterectomy in which documentation of bilateral oophorectomy is unavailable) AND follicle-stimulating hormone (FSH) values consistent with the institutional normal values for the postmenopausal state; FSH levels must be obtained within 28 days prior to registration * Patients must be willing to provide urine specimen to test for the presence of aromatase inhibitor within 28 days of randomization and at each 3-month clinic visit for 3 years * Patients must have the ability to speak and read English * Patients must have a Zubrod performance status of 0 - 2 * No other prior malignancy (i.e., other than as noted on disease characteristics) is allowed except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer for which the patient has been disease-free for \> 5 years * Patients are allowed to participate in another clinical trial as long as it does not interfere with daily intake of aromatase-inhibitor therapy PRIOR CONCURRENT THERAPY: * Patients must be post adjuvant chemotherapy (if to be utilized) and primary curative surgery and must have recovered from all side-effects of the surgery * Trastuzumab (Herceptin) given alone after cytotoxic chemotherapy is considered adjuvant chemotherapy; patients would be eligible upon completion of Herceptin as long as the other eligibility criteria are met * Patients must be currently taking an aromatase inhibitor (AI), have completed at least one month of AI therapy, be within the first 5 years of planned AI therapy, and have at least 3 years remaining before completion of planned AI therapy Exclusion criteria: Insufficient evidence of post-menopausal status; metastatic or recurrent disease; currently receiving chemotherapy.
References
Publications (1)
- DERIVEDHershman DL, Unger JM, Hillyer GC, Moseley A, Arnold KB, Dakhil SR, Esparaz BT, Kuan MC, Graham ML 2nd, Lackowski DM, Edenfield WJ, Dayao ZR, Henry NL, Gralow JR, Ramsey SD, Neugut AI. Randomized Trial of Text Messaging to Reduce Early Discontinuation of Adjuvant Aromatase Inhibitor Therapy in Women With Early-Stage Breast Cancer: SWOG S1105. J Clin Oncol. 2020 Jul 1;38(19):2122-2129. doi: 10.1200/JCO.19.02699. Epub 2020 May 5. PMID 32369401