S1105: Text-Messaging Intervention to Reduce Early Discontinuation of AI Therapy in Women With Early-Stage Breast Cancer
This study is currently recruiting participants.
Verified April 2013 by Southwest Oncology Group
Sponsor:
Southwest Oncology Group
Collaborator:
Information provided by (Responsible Party):
Southwest Oncology Group
ClinicalTrials.gov Identifier:
NCT01515800
First received: January 21, 2012
Last updated: April 2, 2013
Last verified: April 2013
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Breast Cancer |
Behavioral: Text message reminder |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label |
| Official Title: | S1105, Randomized Trial Of Text-Messaging Intervention To Reduce Early Discontinuation Of Adjuvant Aromatase Inhibitor Therapy In Women With Early Stage Breast Cancer |
Resource links provided by NLM:
Further study details as provided by Southwest Oncology Group:
Primary Outcome Measures:
- Time to first evidence of adherence failure (discontinuation) [ Time Frame: Every 3 months after randomization ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Adherence effect of text message compared to usual care using the patient self-report responses to AI Usage form [ Time Frame: Every 3 months after randomization ] [ Designated as safety issue: No ]
- Relationship between randomized arm and various participant, site and health insurance characteristics [ Time Frame: Every 3 months after randomization ] [ Designated as safety issue: No ]Relationship between randomized arm and the following factors: age group, stage, years of therapy, education, race/ethnicity, teaching hospital versus community hospital, AI-related side effects, insurance status, and prescription co-pay status.
- Reasons for early discontinuation of AI therapy among intervention arm and control arm as assessed by quality-of-life questionnaires [ Time Frame: Every 3 months after randomization ] [ Designated as safety issue: No ]
- Time to last evidence of adherence [ Time Frame: Every 3 months after randomization ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 692 |
| Study Start Date: | June 2012 |
| Estimated Study Completion Date: | March 2018 |
| Estimated Primary Completion Date: | March 2018 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Text message reminder
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.
|
Behavioral: Text message reminder
Receive text message
|
|
No Intervention: No text message reminder
Patients receive standard follow-up care.
|
Detailed Description:
OBJECTIVES:
Primary
- To determine the efficacy of a reminder message, sent by text message to mobile phones twice weekly, to improve adherence to adjuvant aromatase inhibitor (AI) therapy as determined by urinary AI levels in women with early-stage hormone-sensitive breast cancer versus usual care.
Secondary
- To compare the effect of a reminder message sent twice weekly to mobile phones as compared to usual care to improve adherence to adjuvant AI therapy according to self-report.
- To explore the efficacy of the text message intervention for reducing early discontinuation as compared to usual care at 12, 24, and 36 months of adjuvant AI therapy in subgroups of breast cancer patients as defined by age group, stage, year of therapy, education, race/ethnicity, teaching hospital versus community hospital, AI-related side effects (as determined by serial questionnaires), insurance status, and prescription co-pay status.
- To explore the reasons for early discontinuation of AI therapy in those who do discontinue in the intervention and control group by querying quality of life as assessed by the Functional Assessment of Cancer Therapy-Endocrine Subscales (FACT-ES) and symptoms and other issues related to hormonal therapy at each follow-up visit, using the Brief Pain Inventory (BPI-SF), and at annual visits the Beliefs about Medicine Questionnaire (BQM) and the Treatment Satisfaction Questionnaire for Medication (TSQM).
- To conduct a sensitivity analysis assessing time to last evidence of adherence.
OUTLINE: This is a multicenter study. Patients are stratified according to length of time on aromatase inhibitor (AI) (< 12 months vs 12-24 months), and type of AI (anastrozole vs letrozole vs exemestane). Patients are randomized to 1 of 2 intervention arms.
- Arm I: 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.
- Arm II: Patients receive standard follow-up care. Patients undergo urine sample collection at baseline and periodically during study for aromatase inhibitor level analysis and future translational studies.
Patients complete the Functional Assessment of Cancer Therapy-Endocrine Subscales (FACT-ES), the Brief Pain Inventory (BPI-SF), Beliefs about Medicine Questionnaire (BQM), and the Treatment Satisfaction Questionnaire for Medication (TSQM) questionnaires at baseline and periodically during study. Patients in arm I also complete the Cell Phone and Text Messaging Use Questionnaire at baseline and periodically during study.
In both arms, patients are followed up every 3 months for up to 3 years from registration.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
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 recurent disease; currently receiving chemotherapy.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01515800
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Contacts
| Contact: Patricia O'Kane | 210-614-8808 ext 1011 | pokane@swog.org |
| Contact: Dana B Sparks, MAT | 210-614-8808 ext 1004 | dsparks@swog.org |
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| United States, Alaska | |
| Alaska Regional Hospital Cancer Center | Recruiting |
| Anchorage, Alaska, United States, 99508 | |
| Contact: Saul E. Rivkin, MD 206-386-2441 | |
| United States, Arkansas | |
| Hembree Mercy Cancer Center at St. Edward Mercy Medical Center | Recruiting |
| Fort Smith, Arkansas, United States, 72903 | |
| Contact: John D. Wells, MD 479-484-4700 | |
| Arkansas Cancer Research Center at University of Arkansas for Medical Sciences | Recruiting |
| Little Rock, Arkansas, United States, 72205 | |
| Contact: Clinical Trial Office - Arkansas Cancer Research Center at Uni 501-686-8274 | |
| United States, California | |
| Kaiser Permanente - Deer Valley | Recruiting |
| Antioch, California, United States, 94531 | |
| Contact: Louis Fehrenbacher, MD 707-651-2577 | |
| Kaiser Permanente - Fremont | Recruiting |
| Fremont, California, United States, 94538 | |
| Contact: Louis Fehrenbacher, MD 707-651-2577 | |
| Kaiser Permanente Fresno Medical Center | Recruiting |
| Fresno, California, United States, 93720 | |
| Contact: Louis Fehrenbacher, MD 707-651-2577 | |
| California Cancer Center - Woodward Park Office | Recruiting |
| Fresno, California, United States, 93720 | |
| Contact: Dina Ibrahim 559-451-3647 | |
| Kaiser Permanente Medical Center - Hayward | Recruiting |
| Hayward, California, United States, 94545 | |
| Contact: Louis Fehrenbacher, MD 707-651-2577 | |
| Kaiser Permanente Medical Center - Oakland | Recruiting |
| Oakland, California, United States, 94611 | |
| Contact: Louis Fehrenbacher, MD 707-651-2577 | |
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| Redwood City, California, United States, 94063 | |
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| Richmond, California, United States, 94801 | |
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| Roseville, California, United States, 95661 | |
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| Sacramento, California, United States, 95823 | |
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| San Rafael, California, United States, 94903 | |
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| Hartford, Connecticut, United States, 06105 | |
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| OnCare Hawaii, Incorporated - Lusitana | Recruiting |
| Honolulu, Hawaii, United States, 96813 | |
| Contact: Jeffrey L. Berenberg, MD 808-433-4089 | |
| Queen's Cancer Institute at Queen's Medical Center | Recruiting |
| Honolulu, Hawaii, United States, 96813 | |
| Contact: Jeffrey L. Berenberg, MD 808-433-4089 | |
| Tripler Army Medical Center | Recruiting |
| Honolulu, Hawaii, United States, 96859 | |
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| Castle Medical Center | Recruiting |
| Kailua, Hawaii, United States, 96734 | |
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| Lihue, Hawaii, United States, 96766 | |
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| United States, Idaho | |
| Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center | Recruiting |
| Boise, Idaho, United States, 83706 | |
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| United States, Illinois | |
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| Decatur, Illinois, United States, 62526 | |
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| Sherman Hospital | Recruiting |
| Elgin, Illinois, United States, 60123 | |
| Contact: James L. Wade, MD 217-876-6617 | |
| Cardinal Bernardin Cancer Center at Loyola University Medical Center | Recruiting |
| Maywood, Illinois, United States, 60153 | |
| Contact: Clinical Trials Office - Cardinal Bernardin Cancer Center 708-226-4357 | |
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| Mount Vernon, Illinois, United States, 62864 | |
| Contact: Bethany G. Sleckman, MD 314-251-7057 | |
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| Springfield, Illinois, United States, 62781-0001 | |
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| United States, Indiana | |
| St. Francis Hospital and Health Centers - Beech Grove Campus | Recruiting |
| Beech Grove, Indiana, United States, 46107 | |
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| Richmond, Indiana, United States, 47374 | |
| Contact: Howard M. Gross, MD 937-832-1093 | |
| United States, Iowa | |
| Genesis Regional Cancer Center at Genesis Medical Center | Recruiting |
| Davenport, Iowa, United States, 52803 | |
| Contact: George Kovach, MD 563-421-1960 | |
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| Cancer Center of Kansas, PA - Chanute | Recruiting |
| Chanute, Kansas, United States, 66720 | |
| Contact: Shaker R. Dakhil, MD, FACP 316-262-4467 | |
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| Dodge City, Kansas, United States, 67801 | |
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| Fort Scott, Kansas, United States, 66701 | |
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| Cancer Center of Kansas-Independence | Recruiting |
| Independence, Kansas, United States, 67301 | |
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| Cancer Center of Kansas, PA - Kingman | Recruiting |
| Kingman, Kansas, United States, 67068 | |
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| Lawrence Memorial Hospital | Recruiting |
| Lawrence, Kansas, United States, 66044 | |
| Contact: Shaker R. Dakhil, MD, FACP 316-262-4467 | |
| Cancer Center of Kansas, PA - Liberal | Recruiting |
| Liberal, Kansas, United States, 67901 | |
| Contact: Shaker R. Dakhil, MD, FACP 316-262-4467 | |
| Cancer Center of Kansas, PA - Newton | Recruiting |
| Newton, Kansas, United States, 67114 | |
| Contact: Shaker R. Dakhil, MD, FACP 316-262-4467 | |
| Cancer Center of Kansas, PA - Parsons | Recruiting |
| Parsons, Kansas, United States, 67357 | |
| Contact: Shaker R. Dakhil, MD, FACP 316-262-4467 | |
| Cancer Center of Kansas, PA - Pratt | Recruiting |
| Pratt, Kansas, United States, 67124 | |
| Contact: Shaker R. Dakhil, MD, FACP 316-262-4467 | |
| Cancer Center of Kansas, PA - Salina | Recruiting |
| Salina, Kansas, United States, 67401 | |
| Contact: Shaker R. Dakhil, MD, FACP 316-262-4467 | |
| Cotton-O'Neil Cancer Center | Recruiting |
| Topeka, Kansas, United States, 66606 | |
| Contact: Clinical Trials Office - Cotton-O'Neil Cancer Center 785-270-4963 | |
| Cancer Center of Kansas, PA - Wellington | Recruiting |
| Wellington, Kansas, United States, 67152 | |
| Contact: Shaker R. Dakhil, MD, FACP 316-262-4467 | |
| Cancer Center of Kansas, PA - Wichita | Recruiting |
| Wichita, Kansas, United States, 67214 | |
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| Cancer Center of Kansas, PA - Medical Arts Tower | Recruiting |
| Wichita, Kansas, United States, 67208 | |
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| Associates in Womens Health, PA - North Review | Recruiting |
| Wichita, Kansas, United States, 67208 | |
| Contact: Shaker R. Dakhil, MD, FACP 316-262-4467 | |
| CCOP - Wichita | Recruiting |
| Wichita, Kansas, United States, 67214 | |
| Contact: Shaker R. Dakhil, MD, FACP 316-262-4467 | |
| Via Christi Cancer Center at Via Christi Regional Medical Center | Recruiting |
| Wichita, Kansas, United States, 67214 | |
| Contact: Shaker R. Dakhil, MD, FACP 316-262-4467 | |
| Cancer Center of Kansas, PA - Winfield | Recruiting |
| Winfield, Kansas, United States, 67156 | |
| Contact: Shaker R. Dakhil, MD, FACP 316-262-4467 | |
| United States, Louisiana | |
| Feist-Weiller Cancer Center at Louisiana State University Health Sciences | Recruiting |
| Shreveport, Louisiana, United States, 71130-3932 | |
| Contact: Clinical Trials Office - Feist-Weiller Cancer Center at Louisi 318-813-1412 | |
| Highland Clinic | Recruiting |
| Shreveport, Louisiana, United States, 71105 | |
| Contact: Gary V. Burton 318-213-0380 | |
| United States, Massachusetts | |
| Boston University Cancer Research Center | Recruiting |
| Boston, Massachusetts, United States, 02118 | |
| Contact: Clinical Trials Office - Boston University Cancer Research Cen 617-638-8265 | |
| United States, Michigan | |
| Saint Joseph Mercy Cancer Center | Recruiting |
| Ann Arbor, Michigan, United States, 48106-0995 | |
| Contact: Philip J. Stella, MD 734-712-1000 | |
| CCOP - Michigan Cancer Research Consortium | Recruiting |
| Ann Arbor, Michigan, United States, 48106 | |
| Contact: Philip J. Stella, MD 734-712-1000 | |
| Battle Creek Health System Cancer Care Center | Recruiting |
| Battle Creek, Michigan, United States, 49017 | |
| Contact: Gilbert D. Padula 616-966-8000 | |
| Mecosta County Medical Center | Recruiting |
| Big Rapids, Michigan, United States, 49307 | |
| Contact: Gilbert D. Padula 231-796-8691 | |
| Oakwood Cancer Center at Oakwood Hospital and Medical Center | Recruiting |
| Dearborn, Michigan, United States, 48123-2500 | |
| Contact: Clinical Trials Office - Oakwood Cancer Center at Oakwood Hosp 313-593-8090 | |
| Josephine Ford Cancer Center at Henry Ford Hospital | Recruiting |
| Detroit, Michigan, United States, 48202 | |
| Contact: Robert A. Chapman, MD 313-916-1332 | |
| Genesys Hurley Cancer Institute | Recruiting |
| Flint, Michigan, United States, 48503 | |
| Contact: Clinical Trials Office - Genesys Hurley Cancer Institute 810-762-8057 | |
| Hurley Medical Center | Recruiting |
| Flint, Michigan, United States, 48503 | |
| Contact: Clinical Trials Office - Hurley Medical Center 810-762-8057 | |
| Lacks Cancer Center at Saint Mary's Health Care | Recruiting |
| Grand Rapids, Michigan, United States, 49503 | |
| Contact: Gilbert D. Padula 616-752-5222 | |
| CCOP - Grand Rapids | Recruiting |
| Grand Rapids, Michigan, United States, 49503 | |
| Contact: Gilbert D. Padula 616-391-1230 | |
| Butterworth Hospital at Spectrum Health | Recruiting |
| Grand Rapids, Michigan, United States, 49503 | |
| Contact: Gilbert D. Padula 616-391-2799 | |
| Van Elslander Cancer Center at St. John Hospital and Medical Center | Recruiting |
| Grosse Pointe Woods, Michigan, United States, 48236 | |
| Contact: Clincial Trials Office - Van Elslander Cancer Center at St. Jo 313-343-3166 | |
| Foote Memorial Hospital | Recruiting |
| Jackson, Michigan, United States, 49201 | |
| Contact: Philip J. Stella, MD 734-712-1000 | |
| Sparrow Regional Cancer Center | Recruiting |
| Lansing, Michigan, United States, 48912-1811 | |
| Contact: Clinical Trials Office - Sparrow Regional Cancer Center 517-364-2890 | |
| St. Mary Mercy Hospital | Recruiting |
| Livonia, Michigan, United States, 48154 | |
| Contact: Philip J. Stella, MD 734-712-1000 | |
| Mercy General Health Partners | Recruiting |
| Muskegon, Michigan, United States, 49444 | |
| Contact: Gilbert D. Padula 231-672-2000 | |
| St. Joseph Mercy Oakland | Recruiting |
| Pontiac, Michigan, United States, 48341-2985 | |
| Contact: Philip J. Stella, MD 734-712-1000 | |
| Mercy Regional Cancer Center at Mercy Hospital | Recruiting |
| Port Huron, Michigan, United States, 48060 | |
| Contact: Philip J. Stella, MD 734-712-1000 | |
| Spectrum Health Reed City Hospital | Recruiting |
| Reed City, Michigan, United States, 49677 | |
| Contact: Gilbert D. Padula 231-832-3271 | |
| Seton Cancer Institute at Saint Mary's - Saginaw | Recruiting |
| Saginaw, Michigan, United States, 48601 | |
| Contact: Clinical Trials Office - Seton Cancer Institute - Saginaw 989-776-8411 | |
| Providence Cancer Institute at Providence Hospital - Southfield Campus | Recruiting |
| Southfield, Michigan, United States, 48075 | |
| Contact: Anibal Drelichman, MD, MPH, FACP 313-552-0620 | |
| Munson Medical Center | Recruiting |
| Traverse City, Michigan, United States, 49684 | |
| Contact: Gilbert D. Padula 231-935-6202 | |
| St. John Macomb Hospital | Recruiting |
| Warren, Michigan, United States, 48093 | |
| Contact: Philip J. Stella, MD 734-712-1000 | |
| United States, Missouri | |
| Saint Francis Medical Center | Recruiting |
| Cape Girardeau, Missouri, United States, 63703 | |
| Contact: Bethany G. Sleckman, MD 314-251-7057 | |
| Mercy Clinic Cancer and Hematology - Rolla | Recruiting |
| Rolla, Missouri, United States, 65401 | |
| Contact: Robert L. Carolla 573-458-6379 | |
| David C. Pratt Cancer Center at St. John's Mercy | Recruiting |
| Saint Louis, Missouri, United States, 63141 | |
| Contact: Clinical Trials Office - David C. Pratt Cancer Center at St. J 314-251-6770 | |
| CCOP - St. Louis-Cape Girardeau | Recruiting |
| Saint Louis, Missouri, United States, 63141 | |
| Contact: Bethany G. Sleckman, MD 314-251-7057 | |
| Midwest Hematology Oncology Group, Incorporated | Recruiting |
| Saint Louis, Missouri, United States, 63109 | |
| Contact: Bethany G. Sleckman, MD 314-251-7057 | |
| CCOP - Cancer Research for the Ozarks | Recruiting |
| Springfield, Missouri, United States, 65802 | |
| Contact: Robert L. Carolla 417-269-4520 | |
| St. John's Regional Health Center | Recruiting |
| Springfield, Missouri, United States, 65804 | |
| Contact: Robert L. Carolla 417-820-2000 | |
| Hulston Cancer Center at Cox Medical Center South | Recruiting |
| Springfield, Missouri, United States, 65807 | |
| Contact: Robert L. Carolla 417-269-5257 | |
| United States, Montana | |
| Billings Clinic - Downtown | Recruiting |
| Billings, Montana, United States, 59107-7000 | |
| Contact: Clinical Trials Office - Billings Clinic - Downtown 800-996-2663 research@billingsclinic.org | |
| CCOP - Montana Cancer Consortium | Recruiting |
| Billings, Montana, United States, 59101 | |
| Contact: Benjamin T. Marchello, MD 406-238-6290 | |
| St. Vincent Healthcare Cancer Care Services | Recruiting |
| Billings, Montana, United States, 59101 | |
| Contact: Benjamin T. Marchello, MD 406-238-6290 | |
| Hematology-Oncology Centers of the Northern Rockies - Billings | Recruiting |
| Billings, Montana, United States, 59102 | |
| Contact: Benjamin T. Marchello, MD 406-238-6290 | |
| Bozeman Deaconess Cancer Center | Recruiting |
| Bozeman, Montana, United States, 59715 | |
| Contact: Benjamin T. Marchello, MD 406-238-6290 | |
| Great Falls Clinic - Main Facility | Recruiting |
| Great Falls, Montana, United States, 59405 | |
| Contact: Benjamin T. Marchello, MD 406-238-6290 | |
| Sletten Cancer Institute at Benefis Healthcare | Recruiting |
| Great Falls, Montana, United States, 59405 | |
| Contact: Benjamin T. Marchello, MD 406-238-6290 | |
| St. Peter's Hospital | Recruiting |
| Helena, Montana, United States, 59601 | |
| Contact: Benjamin T. Marchello, MD 406-238-6290 | |
| Kalispell Regional Medical Center | Recruiting |
| Kalispell, Montana, United States, 59901 | |
| Contact: Benjamin T. Marchello, MD 406-238-6290 | |
| Glacier Oncology, PLLC | Recruiting |
| Kalispell, Montana, United States, 59901 | |
| Contact: Benjamin T. Marchello, MD 406-238-6290 | |
| Montana Cancer Center at St. Patrick Hospital and Health Sciences Center | Recruiting |
| Missoula, Montana, United States, 59807 | |
| Contact: Clinical Trials Office - Montana Cancer Center at St. Patrick 406-329-7029 | |
| Montana Cancer Specialists at Montana Cancer Center | Recruiting |
| Missoula, Montana, United States, 59807-7877 | |
| Contact: Clinical Trials Office - Montana Cancer Specialists at Montana 406-238-6962 | |
| United States, Nebraska | |
| Good Samaritan Cancer Center at Good Samaritan Hospital | Recruiting |
| Kearney, Nebraska, United States, 68848-1990 | |
| Contact: Clinical Trials Office - Good Samaritan Cancer Center at Good 308-865-7963 | |
| United States, New Mexico | |
| Hematology Oncology Associates, PC | Recruiting |
| Albuquerque, New Mexico, United States, 87106 | |
| Contact: Melanie E. Royce, MD, PhD 505-272-6057 | |
| Lovelace Medical Center - Downtown | Recruiting |
| Albuquerque, New Mexico, United States, 87102 | |
| Contact: Melanie E. Royce, MD, PhD 505-272-6057 | |
| University of New Mexico Cancer Center | Recruiting |
| Albuquerque, New Mexico, United States, 87131-5636 | |
| Contact: Clinical Trials Office - University of New Mexico Cancer Cente 505-272-6972 | |
| Presbyterian Cancer Treatment Center at Presbyterian Kaseman Hospital | Recruiting |
| Albuquerque, New Mexico, United States, 87110 | |
| Contact: Melanie E. Royce, MD, PhD 505-272-6057 | |
| New Mexico Cancer Care Associates | Recruiting |
| Santa Fe, New Mexico, United States, 87505 | |
| Contact: Clinical Trials Office - New Mexico Cancer Care Associates 505-955-7910 | |
| United States, New York | |
| Falck Cancer Center at Arnot Ogden Medical Center | Recruiting |
| Elmira, New York, United States, 14905 | |
| Contact: Clinical Trials Office - Falck Cancer Center at Arnot Ogden Me 607-271-7000 | |
| Tucker Center for Cancer Care at Orange Regional Medical Center | Recruiting |
| Middletown, New York, United States, 10940-4199 | |
| Contact: Clinical Trials Office - Tucker Center for Cancer Care at Oran 845-342-7609 | |
| Winthrop University Hospital | Recruiting |
| Mineola, New York, United States, 11501 | |
| Contact: Nina D'Abreo 516-663-9500 | |
| Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center | Recruiting |
| New York, New York, United States, 10032 | |
| Contact: Clinical Trials Office - Herbert Irving Comprehensive Cancer C 212-305-8615 | |
| James P. Wilmot Cancer Center at University of Rochester Medical Center | Recruiting |
| Rochester, New York, United States, 14642 | |
| Contact: Jonathan W. Friedberg 585-275-5345 | |
| Highland Hospital of Rochester | Recruiting |
| Rochester, New York, United States, 14620 | |
| Contact: Jonathan W. Friedberg 585-473-2200 | |
| United States, North Carolina | |
| Waverly Hematology Oncology | Recruiting |
| Cary, North Carolina, United States, 27518 | |
| Contact: Mark L. Graham, MD 919-233-8585 | |
| Wayne Memorial Hospital, Incorporated | Recruiting |
| Goldsboro, North Carolina, United States, 27534 | |
| Contact: James N. Atkins, MD 919-580-0000 | |
| Pardee Memorial Hospital | Recruiting |
| Hendersonville, North Carolina, United States, 28791 | |
| Contact: James E. Radford, MD 828-692-8045 | |
| Iredell Memorial Hospital | Recruiting |
| Statesville, North Carolina, United States, 28677 | |
| Contact: Ruby A. Grimm, MD 704-873-2219 | |
| Forsyth Regional Cancer Center at Forsyth Medical Center | Recruiting |
| Winston-Salem, North Carolina, United States, 27103 | |
| Contact: Clinical Trials Office - Forsyth Regional Cancer Center at For 336-277-8887 | |
| United States, Ohio | |
| McDowell Cancer Center at Akron General Medical Center | Recruiting |
| Akron, Ohio, United States, 44307 | |
| Contact: Esther H. Rehmus, MD 330-344-6505 | |
| Adena Regional Medical Center | Recruiting |
| Chillicothe, Ohio, United States, 45601 | |
| Contact: Clinical Trials Office - Adena Regional Medical Center 877-779-7585 | |
| CCOP - Columbus | Recruiting |
| Columbus, Ohio, United States, 43215 | |
| Contact: J. Philip Kuebler, MD, PhD 614-442-3130 | |
| Mount Carmel Health - West Hospital | Recruiting |
| Columbus, Ohio, United States, 43222 | |
| Contact: J. Philip Kuebler, MD, PhD 614-442-3130 | |
| Doctors Hospital at Ohio Health | Recruiting |
| Columbus, Ohio, United States, 43228 | |
| Contact: Clinical Trials Office - Doctors Hospital at Ohio Health 614-566-3275 | |
| Riverside Methodist Hospital Cancer Care | Recruiting |
| Columbus, Ohio, United States, 43214-3998 | |
| Contact: Clinical Trials Office - Riverside Methodist Hospital Cancer C 614-566-4475 | |
| Grant Medical Center Cancer Care | Recruiting |
| Columbus, Ohio, United States, 43215 | |
| Contact: Clinical Trials Office - Grant Medical Center Cancer Care 614-566-4475 | |
| David L. Rike Cancer Center at Miami Valley Hospital | Recruiting |
| Dayton, Ohio, United States, 45409 | |
| Contact: Clinical Trials Office - David L. Rike Cancer Center at Miami 937-208-2079 | |
| CCOP - Dayton | Recruiting |
| Dayton, Ohio, United States, 45420 | |
| Contact: Howard M. Gross, MD 937-832-1093 | |
| Samaritan North Cancer Care Center | Recruiting |
| Dayton, Ohio, United States, 45415 | |
| Contact: Howard M. Gross, MD 937-832-1093 | |
| Good Samaritan Hospital | Recruiting |
| Dayton, Ohio, United States, 45406 | |
| Contact: Howard M. Gross, MD 937-832-1093 | |
| Grandview Hospital | Recruiting |
| Dayton, Ohio, United States, 45405 | |
| Contact: Howard M. Gross, MD 937-832-1093 | |
| Grady Memorial Hospital | Recruiting |
| Delaware, Ohio, United States, 43015 | |
| Contact: J. Philip Kuebler, MD, PhD 614-442-3130 | |
| Blanchard Valley Medical Associates | Recruiting |
| Findlay, Ohio, United States, 45840 | |
| Contact: Howard M. Gross, MD 937-832-1093 | |
| Middletown Regional Hospital | Recruiting |
| Franklin, Ohio, United States, 45005-1066 | |
| Contact: Howard M. Gross, MD 937-832-1093 | |
| Wayne Hospital | Recruiting |
| Greenville, Ohio, United States, 45331 | |
| Contact: Howard M. Gross, MD 937-832-1093 | |
| Charles F. Kettering Memorial Hospital | Recruiting |
| Kettering, Ohio, United States, 45429 | |
| Contact: Clinical Trials Office - Charles F. Kettering Memorial Hospita 937-298-3399 ext 57556 | |
| Fairfield Medical Center | Recruiting |
| Lancaster, Ohio, United States, 43130 | |
| Contact: J. Philip Kuebler, MD, PhD 614-442-3130 | |
| Strecker Cancer Center at Marietta Memorial Hospital | Recruiting |
| Marietta, Ohio, United States, 45750 | |
| Contact: J. Philip Kuebler, MD, PhD 614-442-3130 | |
| Knox Community Hospital | Recruiting |
| Mount Vernon, Ohio, United States, 43050 | |
| Contact: J. Philip Kuebler, MD, PhD 614-442-3130 | |
| Licking Memorial Cancer Care Program at Licking Memorial Hospital | Recruiting |
| Newark, Ohio, United States, 43055 | |
| Contact: J. Philip Kuebler, MD, PhD 614-442-3130 | |
| Southern Ohio Medical Center Cancer Center | Recruiting |
| Portsmouth, Ohio, United States, 45662 | |
| Contact: J. Philip Kuebler, MD, PhD 614-442-3130 | |
| Community Hospital of Springfield and Clark County | Recruiting |
| Springfield, Ohio, United States, 45505 | |
| Contact: J. Philip Kuebler, MD, PhD 614-442-3130 | |
| UVMC Cancer Care Center at Upper Valley Medical Center | Recruiting |
| Troy, Ohio, United States, 45373-1300 | |
| Contact: Clinical Trials Office - UVMC Cancer Care Center at Upper Vall 937-440-4842 | |
| Mount Carmel St. Ann's Cancer Center | Recruiting |
| Westerville, Ohio, United States, 43081 | |
| Contact: J. Philip Kuebler, MD, PhD 614-442-3130 | |
| United States Air Force Medical Center - Wright-Patterson | Recruiting |
| Wright-Patterson Afb, Ohio, United States, 45433-5529 | |
| Contact: Brandon J. Cutler 937-257-9133 | |
| Ruth G. McMillan Cancer Center at Greene Memorial Hospital | Recruiting |
| Xenia, Ohio, United States, 45385 | |
| Contact: Howard M. Gross, MD 937-832-1093 | |
| Genesis - Good Samaritan Hospital | Recruiting |
| Zanesville, Ohio, United States, 43701 | |
| Contact: Clinical Trials Office - Genesis - Good Samaritan Hospital 740-454-5232 | |
| United States, Oregon | |
| Clackamas Radiation Oncology Center | Recruiting |
| Clackamas, Oregon, United States, 97015 | |
| Contact: Kelly S. Perlewitz 503-513-3300 | |
| Providence Milwaukie Hospital | Recruiting |
| Milwaukie, Oregon, United States, 97222 | |
| Contact: Kelly S. Perlewitz 503-513-8300 | |
| Providence Newberg Medical Center | Recruiting |
| Newberg, Oregon, United States, 97132 | |
| Contact: Kelly S. Perlewitz 503-537-1555 | |
| Willamette Falls Hospital | Recruiting |
| Oregon City, Oregon, United States, 97045 | |
| Contact: Kelly S. Perlewitz 503-650-6758 | |
| Kaiser Permanente Health Care - Portland | Recruiting |
| Portland, Oregon, United States, 97227 | |
| Contact: Nagendra Tirumali, MD 503-331-6500 | |
| CCOP - Columbia River Oncology Program | Recruiting |
| Portland, Oregon, United States, 97225 | |
| Contact: Kelly S. Perlewitz 503-216-6260 | |
| Providence St. Vincent Medical Center | Recruiting |
| Portland, Oregon, United States, 97225 | |
| Contact: Clinical Trials Office - Providence St. Vincent Medical Center 503-215-6412 | |
| Providence Cancer Center at Providence Portland Medical Center | Recruiting |
| Portland, Oregon, United States, 97213-2967 | |
| Contact: Clinical Trials Office - Providence Cancer Center at Providenc 503-215-6412 | |
| United States, South Carolina | |
| Bon Secours St. Francis Health System | Recruiting |
| Greenville, South Carolina, United States, 29601 | |
| Contact: Clinical Trails Office - Bon Secours St. Francis Health System 864-255-1713 | |
| Cancer Centers of the Carolinas - Faris Road | Recruiting |
| Greenville, South Carolina, United States, 29605 | |
| Contact: Jeffrey K. Giguere, MD, FACP 864-987-7000 | |
| CCOP - Greenville | Recruiting |
| Greenville, South Carolina, United States, 29615 | |
| Contact: Jeffrey K. Giguere, MD, FACP 864-987-7000 | |
| Cancer Centers of the Carolinas - Grove Commons | Recruiting |
| Greenville, South Carolina, United States, 29605 | |
| Contact: Clinical Trials Office - Cancer Centers of the Carolinas 864-241-6251 | |
| Cancer Centers of the Carolinas - Greer Medical Oncology | Recruiting |
| Greer, South Carolina, United States, 29650 | |
| Contact: Jeffrey K. Giguere, MD, FACP 864-987-7000 | |
| Cancer Centers of the Carolinas - Seneca | Recruiting |
| Seneca, South Carolina, United States, 29672 | |
| Contact: Jeffrey K. Giguere, MD, FACP 864-987-7000 | |
| Cancer Centers of the Carolinas - Spartanburg | Recruiting |
| Spartanburg, South Carolina, United States, 29307 | |
| Contact: Jeffrey K. Giguere, MD, FACP 864-987-7000 | |
| CCOP - Upstate Carolina | Recruiting |
| Spartanburg, South Carolina, United States, 29303 | |
| Contact: Clinical Trials Office - CCOP - Upstate Carolina 800-486-5941 | |
| Gibbs Regional Cancer Center at Spartanburg Regional Medical Center | Recruiting |
| Spartanburg, South Carolina, United States, 29303 | |
| Contact: Clinical Trials Office - Gibbs Regional Cancer Center 800-486-5941 | |
| United States, Texas | |
| Brooke Army Medical Center | Recruiting |
| Fort Sam Houston, Texas, United States, 78234-6200 | |
| Contact: Clinical Trials Office - Brooke Army Medical Center 210-916-4837 | |
| United States, Utah | |
| American Fork Hospital | Recruiting |
| American Fork, Utah, United States, 84003 | |
| Contact: Derrick S. Haslem 801-855-3300 | |
| Sandra L. Maxwell Cancer Center | Recruiting |
| Cedar City, Utah, United States, 84720 | |
| Contact: Derrick S. Haslem 801-585-0550 | |
| Logan Regional Hospital | Recruiting |
| Logan, Utah, United States, 84321 | |
| Contact: Derrick S. Haslem 435-716-1000 | |
| Jon and Karen Huntsman Cancer Center at Intermountain Medical Center | Recruiting |
| Murray, Utah, United States, 84157 | |
| Contact: Derrick S. Haslem 801-507-3800 | |
| Val and Ann Browning Cancer Center at McKay-Dee Hospital Center | Recruiting |
| Ogden, Utah, United States, 84403 | |
| Contact: Clinical Trials Office - McKay-Dee Hospital Center 801-387-7426 | |
| Utah Valley Regional Medical Center - Provo | Recruiting |
| Provo, Utah, United States, 84604 | |
| Contact: Clinical Trials Office - Utah Valley Regional Medical Center - 801-357-7965 | |
| Dixie Regional Medical Center - East Campus | Recruiting |
| Saint George, Utah, United States, 84770 | |
| Contact: Clinical Trials Office - Dixie Regional Medical Center - East 435-688-4167 | |
| LDS Hospital | Recruiting |
| Salt Lake City, Utah, United States, 84143 | |
| Contact: Derrick S. Haslem 801-408-1819 | |
| United States, Washington | |
| Island Hospital Cancer Care Center at Island Hospital | Recruiting |
| Anacortes, Washington, United States, 98221 | |
| Contact: Saul E. Rivkin, MD 206-386-2441 | |
| St. Joseph Cancer Center | Recruiting |
| Bellingham, Washington, United States, 98225 | |
| Contact: Saul E. Rivkin, MD 206-386-2441 | |
| Olympic Hematology and Oncology | Recruiting |
| Bremerton, Washington, United States, 98310 | |
| Contact: Saul E. Rivkin, MD 206-386-2441 | |
| Highline Medical Center Cancer Center | Recruiting |
| Burien, Washington, United States, 98166 | |
| Contact: Saul E. Rivkin, MD 206-386-2441 | |
| Swedish Medical Center - Issaquah Campus | Recruiting |
| Issaquah, Washington, United States, 98029 | |
| Contact: Saul E. Rivkin, MD 206-386-2441 | |
| Columbia Basin Hematology | Recruiting |
| Kennewick, Washington, United States, 99336 | |
| Contact: Saul E. Rivkin, MD 206-386-2441 | |
| Skagit Valley Hospital Cancer Care Center | Recruiting |
| Mount Vernon, Washington, United States, 98274 | |
| Contact: Saul E. Rivkin, MD 206-386-2441 | |
| Harrison Poulsbo Hematology and Onocology | Recruiting |
| Poulsbo, Washington, United States, 98370 | |
| Contact: Saul E. Rivkin, MD 206-386-2441 | |
| Harborview Medical Center | Recruiting |
| Seattle, Washington, United States, 98104 | |
| Contact: Saul E. Rivkin, MD 206-386-2441 | |
| Fred Hutchinson Cancer Research Center | Recruiting |
| Seattle, Washington, United States, 98109 | |
| Contact: Saul E. Rivkin, MD 206-386-2441 | |
| Group Health Central Hospital | Recruiting |
| Seattle, Washington, United States, 98112 | |
| Contact: Clinical Trials Office - Group Health Central Hospital 206-287-2900 | |
| University Cancer Center at University of Washington Medical Center | Recruiting |
| Seattle, Washington, United States, 98195 | |
| Contact: Saul E. Rivkin, MD 206-386-2441 | |
| Polyclinic First Hill | Recruiting |
| Seattle, Washington, United States, 98122 | |
| Contact: Saul E. Rivkin, MD 206-386-2441 | |
| Swedish Cancer Institute at Swedish Medical Center - First Hill Campus | Recruiting |
| Seattle, Washington, United States, 98122-4307 | |
| Contact: Saul E. Rivkin, MD 206-386-2441 | |
| Minor and James Medical, PLLC | Recruiting |
| Seattle, Washington, United States, 98104 | |
| Contact: Saul E. Rivkin, MD 206-386-2441 | |
| North Puget Oncology at United General Hospital | Recruiting |
| Sedro-Woolley, Washington, United States, 98284 | |
| Contact: Saul E. Rivkin, MD 206-386-2441 | |
| Evergreen Hematology and Oncology, PS | Recruiting |
| Spokane, Washington, United States, 99218 | |
| Contact: Saul E. Rivkin, MD 206-386-2441 | |
| Cancer Care Northwest - Spokane South | Recruiting |
| Spokane, Washington, United States, 99202 | |
| Contact: Clinical Trials Office - Cancer Care Northwest - Spokane South 509-228-1083 | |
| Southwest Washington Medical Center Cancer Center | Recruiting |
| Vancouver, Washington, United States, 98664 | |
| Contact: Kelly S. Perlewitz 360-514-2174 | |
| Wenatchee Valley Medical Center | Recruiting |
| Wenatchee, Washington, United States, 98801-2028 | |
| Contact: Clinical Trials Office - Wenatchee Valley Medical Center 509-665-5800 | |
| United States, Wyoming | |
| Rocky Mountain Oncology | Recruiting |
| Casper, Wyoming, United States, 82609 | |
| Contact: Benjamin T. Marchello, MD 406-238-6290 | |
Sponsors and Collaborators
Southwest Oncology Group
Investigators
| Principal Investigator: | Alfred I. Neugut, MD, PhD | Herbert Irving Comprehensive Cancer Center |
More Information
Additional Information:
No publications provided
| Responsible Party: | Southwest Oncology Group |
| ClinicalTrials.gov Identifier: | NCT01515800 History of Changes |
| Other Study ID Numbers: | CDR0000723653, S1105, U10CA037429 |
| Study First Received: | January 21, 2012 |
| Last Updated: | April 2, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Southwest Oncology Group:
|
estrogen receptor-positive breast cancer progesterone receptor-positive breast cancer stage IA breast cancer |
stage IB breast cancer stage II breast cancer stage IIIA breast cancer |
Additional relevant MeSH terms:
|
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases |
Aromatase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 23, 2013