Anatomic Stage I Breast Cancer AJCC v8Anatomic Stage II Breast Cancer AJCC v8Anatomic Stage III Breast Cancer AJCC v8HER2 Negative Breast CarcinomaHormone Receptor Positive Breast CarcinomaInvasive Breast CarcinomaPrognostic Stage I Breast Cancer AJCC v8Prognostic Stage II Breast Cancer AJCC v8Prognostic Stage III Breast Cancer AJCC v8
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.
Eligibility
Sex
FEMALE
Min age
18 Years
Max age
—
Healthy volunteers
No
• Women with an initial pathologically confirmed diagnosis of stage I-III, hormone receptor positive, HER2-neu negative, invasive breast cancer within 18 months (\>=548 days) prior to registration.
* If a patient has undergone neo-adjuvant chemotherapy and had no residual invasive disease at the time of surgery, eligibility can be based on a clinical stage I-III prior to treatment and pathologic confirmation of receptor status from a diagnostic biopsy.
* Hormone receptor positive is defined as estrogen receptor (ER) and/or progesterone receptor (PR) or both of \> 1%
* HER2-neu negative is defined as 0-1+ by immunohistochemical (IHC) analysis, or non-amplified by fluorescence in situ hybridization (FISH) analysis. If HER2-neu status is unknown due to insufficient tissue for evaluation, the patient is eligible
* Patients with synchronous primary tumor foci of different receptor phenotypes, whether in the same or contralateral breast, may be enrolled as long as one tumor focus meets the receptor criteria and the patient is otherwise eligible
Prior Treatment:
* Patients must have completed all planned cancer-directed surgery (except reconstruction surgery or oophorectomy)
* Patients must have completed all other adjuvant therapy (e.g., radiation and intravenous \[IV\] or oral chemotherapy) prior to registration
* Patients who will be taking a CDK4/6 inhibitor (e.g., abemaciclib, palbociclib, or ribociclib) during endocrine therapy are NOT permitted to enroll as this is considered ongoing adjuvant therapy
* Patients who have previously been on ET drug outside the 6-month window for any reason, including breast cancer prevention or high-risk non-malignant lesions (e.g., atypical ductal hyperplasia \[ADH\], lobular carcinoma in situ \[LCIS\]) are ineligible
• Patients must be taking a once daily endocrine therapy drug initiated within the 6 months prior to registration, OR have received a prescription for a once daily ET medication with stated intent to initiate within 6 weeks after registration.
* Patients who switch ET drugs prior to enrollment remain eligible as long as the total time since initiation of the first ET drug does not exceed 6 months prior to registration
* Patients who have stopped their ET drug prior to enrollment and not started another ET drug are ineligible
• No history of previous cancer as follows:
* Invasive or non-invasive breast cancer at any time
* Non-breast cancer, within the past 5 years, excluding non-melanoma skin cancer
* Patients with a history of high-risk breast lesions (e.g., atypical ductal hyperplasia - ADH, lobular carcinoma in situ - LCIS are eligible as long as they have not previously taken an endocrine therapy drug
• Patients must be willing to use a smart phone for study activities
* Patient is NOT to be deemed ineligible during the recruitment process if they do not have a smart phone
* A smart phone and service can be provided to the participant at no cost for the duration of the study activities if the participant meets at least one of the following criteria: (1) does not own a smart phone or (2) has limited data, minutes or texting plan or (3) their smart phone cannot support the Alliance electronic patient reported outcomes (ePRO) survey app. Study provided smart phones will be provided through the Ohio State University (OSU) partnership with Verizon Wireless.
* The CRP is ONLY to discuss this option with those patients who self-identify a phone-related barrier to participation, including: lack of a smart phone, insufficient phone plan (minutes/text/data), or a smart phone incompatible with the Alliance ePRO app
• Patients must be willing to use the AdhereTech medication electronic pill cap for the duration of study participation
* Patients must be willing to use the study-provided electronic pill cap as a medication event monitoring system each time ET drug is taken. Use of any other container (e.g., pill box, etc.) for ET drug during study period is not permitted
* Age \>= 18 years
* In order to complete the mandatory patient-completed measures, participants must be able to speak and read English
* Co-enrollment is allowed with the permission of the Alliance Executive Officer and both studies' Study Chairs
Primary outcome measure(s)
Endocrine therapy (ET) adherence at 12 months post-randomization — At 12 months post-randomization ET adherence at 12 months post-randomization will be measured by electronic pill monitoring cap (AdhereTech-reported) and defined as the proportion of patients within each arm who have taken their ET medication for at least 292 of 365 days.
Trial sites (526)
Facility
City
Region
Status
University of Alabama at Birmingham Cancer Center
Birmingham
Alabama
Fairbanks Memorial Hospital
Fairbanks
Alaska
Arizona Center for Cancer Care - Gilbert
Gilbert
Arizona
Arizona Center for Cancer Care-Peoria
Peoria
Arizona
Cancer Center at Saint Joseph's
Phoenix
Arizona
Arizona Center for Cancer Care - Phoenix
Phoenix
Arizona
Arizona Center for Cancer Care - Osborn
Scottsdale
Arizona
Arizona Center for Cancer Care - Scottsdale
Scottsdale
Arizona
Arizona Center for Cancer Care-Surprise
Surprise
Arizona
Mercy Hospital Fort Smith
Fort Smith
Arkansas
Kaiser Permanente-Anaheim
Anaheim
California
Kaiser Permanente-Deer Valley Medical Center
Antioch
California
Mission Hope Medical Oncology - Arroyo Grande
Arroyo Grande
California
Sutter Auburn Faith Hospital
Auburn
California
Kaiser Permanente-Baldwin Park
Baldwin Park
California
Kaiser Permanente-Bellflower
Bellflower
California
UCSF Cancer Center - Berkeley
Berkeley
California
Alta Bates Summit Medical Center-Herrick Campus
Berkeley
California
Enloe Medical Center
Chico
California
Adventist Health Cancer Care Center Chico
Chico
California
Kaiser Permanente Dublin
Dublin
California
Kaiser Permanente-Fontana
Fontana
California
Kaiser Permanente-Fremont
Fremont
California
Palo Alto Medical Foundation-Fremont
Fremont
California
Kaiser Permanente-Fresno
Fresno
California
Kaiser Permanente South Bay
Harbor City
California
Kaiser Permanente-Irvine
Irvine
California
Kaiser Permanente Los Angeles Medical Center
Los Angeles
California
Kaiser Permanente West Los Angeles
Los Angeles
California
Fremont - Rideout Cancer Center
Marysville
California
Kaiser Permanente-Modesto
Modesto
California
Palo Alto Medical Foundation-Camino Division
Mountain View
California
Kaiser Permanente-Oakland
Oakland
California
Kaiser Permanente-Ontario
Ontario
California
Desert Regional Medical Center
Palm Springs
California
Palo Alto Medical Foundation Health Care
Palo Alto
California
Kaiser Permanente - Panorama City
Panorama City
California
Kaiser Permanente-Richmond
Richmond
California
Kaiser Permanente-Riverside
Riverside
California
Kaiser Permanente-Roseville
Roseville
California
+ 486 more sites — see the full list on the official registry below.
More Alliance for Clinical Trials in Oncology trials in Israel
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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