Breast CancerNCT00003787
Women's Healthy Eating and Living Study
An observational study of Breast Cancer, run by University of California, San Diego at 7 sites in United States.
Trial summary
RATIONALE: Dietary fats, fruits, vegetables, and fiber may affect the risk of breast cancer recurrence. PURPOSE: Randomized clinical trial to determine the effectiveness of a diet rich in vegetables, fruit, and fiber and low in fat in women who have been treated for stage I, stage II, or stage III breast cancer. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- educational/counseling intervention and therapeutic dietary intervention
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 3,088 participants
- Where
- 7 sitesUnited States
- Study dates
- Mar 1995to 31 Dec 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Women who were diagnosed with early-stage breast cancer within the previous 4 years, and are between the ages of 18-74
DISEASE CHARACTERISTICS: Primary operable stage I (tumors at least 1 cm), stage II, and stage IIIA invasive breast carcinoma Treatment within the past 4 years by total mastectomy and axillary dissection, or breast sparing surgical removal of cancer with clear macroscopic margins and axillary dissection followed by adjuvant breast radiation No evidence of recurrent disease or new breast cancer since completion of initial local treatment confirmed within the past 6 months by physician evaluation, except stage I mastectomy, for which physician evaluation can be within 1 year prior to randomization Hormone receptor status: Not specified
PATIENT CHARACTERISTICS: Age: 18 to 70 at time of diagnosis Sex: Female Menopausal status: Not specified Performance status: Not specified Life expectancy: At least 10 years (excluding breast cancer) Hematopoietic: Not specified Hepatic: No cirrhosis Renal: Not specified Other: Not pregnant Accessible geographically and by telephone Able to communicate dietary data via 24-hour food recall Able to commit to the intervention schedule No comorbidity requiring a specific diet or taking a medication which contraindicates consuming a high fiber diet (e.g., systemic scleroderma, other digestive malabsorption syndromes, and insulin dependent diabetes) No other primary or recurrent invasive cancer within the past 10 years except nonmelanoma skin cancer or carcinoma in situ of the cervix
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No concurrent chemotherapy Endocrine therapy: No concurrent estrogen replacement therapy, including vaginal estrogen creams Radiotherapy: See Disease Characteristics Surgery: See Disease Characteristics Other: No concurrent enrollment in another clinical trial that has dietary restrictions or endpoints similar to this study
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
University of Texas - MD Anderson Cancer Center
Houston, Texas, 77030
University of California San Diego Cancer Center
La Jolla, California, 92093-0658
Permanente Medical Group (060)
Oakland, California, 94611-5400
Center for Health Research - Portland
Portland, Oregon, 97227-1110
University of California Davis School of Medicine
Sacramento, California, 95616
Arizona Cancer Center
Tucson, Arizona, 85724
Northern California Cancer Center
Union City, California, 94587
About this study
Official title: Dietary Intervention in Women Who Have Been Treated For Stage I, Stage II, or Stage III Breast Cancer: Women's Healthy Eating and Living (WHEL) Study
RATIONALE: Dietary fats, fruits, vegetables, and fiber may affect the risk of breast cancer recurrence.
PURPOSE: Randomized clinical trial to determine the effectiveness of a diet rich in vegetables, fruit, and fiber and low in fat in women who have been treated for stage I, stage II, or stage III breast cancer.
Read the detailed description
OBJECTIVES: I. Determine whether a diet rich in vegetables, fruit, and fiber and low in fat is associated with a longer breast cancer event-free interval in breast cancer survivors. II. Motivate an intervention group of breast cancer survivors to adopt and maintain a dietary pattern that is rich in vegetables, fruit, and fiber and low in fat. III. Demonstrate that the intervention can produce significant changes in circulating carotenoid and estrogen biomarkers compared to a healthy control diet. IV. Test whether the probability of a secondary cancer event is associated with change in self-reported dietary intake, circulating carotenoid concentrations, and circulating estrogen concentrations.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to age (under 55 vs 55 and over at time of diagnosis), stage of tumor (stage I and at least 1 cm vs stage II/IIIA), and clinical site. Patients are randomized to one of two healthy dietary regimens: Arm I: Patients are taught to follow a dietary pattern that will produce significant changes in circulating carotenoid and estrogen biomarkers. Arm II: Patients are assigned to follow dietary guidelines established by the National Cancer Institute and the USDA. All patients participate in 24 hour dietary recalls, cooking classes, as well as complete several questionnaires, at baseline and then at 12, 24 or 36, 48, and 72 months; a randomly selected 50% sample participate in recall at 6 months. Patients are followed by telephone every 6 months for an average of 6 years.
PROJECTED ACCRUAL: A total of 3,000 women will be accrued for this study within 5 years.
- Conditions
- Breast Cancer
- Being tested
- educational/counseling intervention, therapeutic dietary intervention
- Keywords
- stage I breast cancer, stage II breast cancer, stage IIIA breast cancer, recurrent breast cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
educational/counseling interventionBehavioural
therapeutic dietary interventionBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Intervention | high fiber, high vegetable, low-fat diet Receives: Behavioral: educational/counseling intervention; Behavioral: therapeutic dietary intervention | |
| Control | NCI-recommended diet Receives: Behavioral: therapeutic dietary intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Breast Cancer Recurrence
Measured: Lifetime
Secondary outcomes (1)
Mortality
Measured: Lifetime
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2004 (estimated)
- Study startMar 1995
- Primary completionMar 2007
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (31)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by University of California, San DiegoThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 3,088 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI), Susan G. Komen Breast Cancer Foundation
- Responsible party
- Principal investigator, John P. Pierce, University of California, San Diego
- Investigators
- John P. Pierce, PhD, Study chair, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00003787
- Sponsor's protocol ID
- UCSD-980919
- Other IDs
- CDR0000066920, UCSD-WHEL, NCI-G99-1508
- Status last verified
- Jun 2019
- First submitted
- 1 Nov 1999
- Last updated
- 10 Jun 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Hyder JA, Thomson CA, Natarajan L, Madlensky L, Pu M, Emond J, Kealey S, Rock CL, Flatt SW, Pierce JP; WHEL Study Group. Adopting a plant-based diet minimally increased food costs in WHEL Study. Am J Health Behav. 2009 Sep-Oct;33(5):530-9. doi: 10.5993/ajhb.33.5.6.
PubMed 19296743Yost KJ, Haan MN, Levine RA, Gold EB. Comparing SF-36 scores across three groups of women with different health profiles. Qual Life Res. 2005 Jun;14(5):1251-61. doi: 10.1007/s11136-004-6673-8.
PubMed 16047501Caan BJ, Emond JA, Su HI, Patterson RE, Flatt SW, Gold EB, Newman VA, Rock CL, Thomson CA, Pierce JP. Effect of postdiagnosis weight change on hot flash status among early-stage breast cancer survivors. J Clin Oncol. 2012 May 1;30(13):1492-7. doi: 10.1200/JCO.2011.36.8597. Epub 2012 Mar 19.
PubMed 22430275Nechuta SJ, Caan BJ, Chen WY, Lu W, Chen Z, Kwan ML, Flatt SW, Zheng Y, Zheng W, Pierce JP, Shu XO. Soy food intake after diagnosis of breast cancer and survival: an in-depth analysis of combined evidence from cohort studies of US and Chinese women. Am J Clin Nutr. 2012 Jul;96(1):123-32. doi: 10.3945/ajcn.112.035972. Epub 2012 May 30.
PubMed 22648714Al-Delaimy WK, Flatt SW, Natarajan L, Laughlin GA, Rock CL, Gold EB, Caan BJ, Parker BA, Pierce JP. IGF1 and risk of additional breast cancer in the WHEL study. Endocr Relat Cancer. 2011 Mar 3;18(2):235-44. doi: 10.1530/ERC-10-0121. Print 2011 Apr.
PubMed 21263044Bertram LA, Stefanick ML, Saquib N, Natarajan L, Patterson RE, Bardwell W, Flatt SW, Newman VA, Rock CL, Thomson CA, Pierce JP. Physical activity, additional breast cancer events, and mortality among early-stage breast cancer survivors: findings from the WHEL Study. Cancer Causes Control. 2011 Mar;22(3):427-35. doi: 10.1007/s10552-010-9714-3. Epub 2010 Dec 24.
PubMed 21184262Emond JA, Patterson RE, Natarajan L, Laughlin GA, Gold EB, Pierce JP. Sex hormone concentrations and the risk of breast cancer recurrence in postmenopausal women without hot flashes. Cancer Epidemiol Biomarkers Prev. 2011 May;20(5):939-45. doi: 10.1158/1055-9965.EPI-10-1240. Epub 2011 Mar 17.
PubMed 21415358Jacobs ET, Thomson CA, Flatt SW, Al-Delaimy WK, Hibler EA, Jones LA, Leroy EC, Newman VA, Parker BA, Rock CL, Pierce JP. Vitamin D and breast cancer recurrence in the Women's Healthy Eating and Living (WHEL) Study. Am J Clin Nutr. 2011 Jan;93(1):108-17. doi: 10.3945/ajcn.2010.30009. Epub 2010 Oct 27.
PubMed 20980485Madlensky L, Natarajan L, Tchu S, Pu M, Mortimer J, Flatt SW, Nikoloff DM, Hillman G, Fontecha MR, Lawrence HJ, Parker BA, Wu AH, Pierce JP. Tamoxifen metabolite concentrations, CYP2D6 genotype, and breast cancer outcomes. Clin Pharmacol Ther. 2011 May;89(5):718-25. doi: 10.1038/clpt.2011.32. Epub 2011 Mar 23.
PubMed 21430657Paxton RJ, Jones LA, Chang S, Hernandez M, Hajek RA, Flatt SW, Natarajan L, Pierce JP. Was race a factor in the outcomes of the Women's Health Eating and Living Study? Cancer. 2011 Aug 15;117(16):3805-13. doi: 10.1002/cncr.25957. Epub 2011 Feb 11.
PubMed 21319157Gold EB, Pierce JP, Natarajan L, Stefanick ML, Laughlin GA, Caan BJ, Flatt SW, Emond JA, Saquib N, Madlensky L, Kealey S, Wasserman L, Thomson CA, Rock CL, Parker BA, Karanja N, Jones V, Hajek RA, Pu M, Mortimer JE. Dietary pattern influences breast cancer prognosis in women without hot flashes: the women's healthy eating and living trial. J Clin Oncol. 2009 Jan 20;27(3):352-9. doi: 10.1200/JCO.2008.16.1067. Epub 2008 Dec 15.
PubMed 19075284Pierce JP, Natarajan L, Caan BJ, Flatt SW, Kealey S, Gold EB, Hajek RA, Newman VA, Rock CL, Pu M, Saquib N, Stefanick ML, Thomson CA, Parker B. Dietary change and reduced breast cancer events among women without hot flashes after treatment of early-stage breast cancer: subgroup analysis of the Women's Healthy Eating and Living Study. Am J Clin Nutr. 2009 May;89(5):1565S-1571S. doi: 10.3945/ajcn.2009.26736F. Epub 2009 Apr 1.
PubMed 19339393Rock CL, Natarajan L, Pu M, Thomson CA, Flatt SW, Caan BJ, Gold EB, Al-Delaimy WK, Newman VA, Hajek RA, Stefanick ML, Pierce JP; Women's Healthy Eating and Living Study Group. Longitudinal biological exposure to carotenoids is associated with breast cancer-free survival in the Women's Healthy Eating and Living Study. Cancer Epidemiol Biomarkers Prev. 2009 Feb;18(2):486-94. doi: 10.1158/1055-9965.EPI-08-0809. Epub 2009 Feb 3.
PubMed 19190138Hernandez-Valero MA, Thomson CA, Hernandez M, Tran T, Detry MA, Theriault RL, Hajek RA, Pierce JP, Flatt SW, Caan BJ, Jones LA. Comparison of baseline dietary intake of Hispanic and matched non-Hispanic white breast cancer survivors enrolled in the Women's Healthy Eating and Living study. J Am Diet Assoc. 2008 Aug;108(8):1323-9. doi: 10.1016/j.jada.2008.05.008.
PubMed 18656572Mortimer JE, Flatt SW, Parker BA, Gold EB, Wasserman L, Natarajan L, Pierce JP; WHEL Study Group. Tamoxifen, hot flashes and recurrence in breast cancer. Breast Cancer Res Treat. 2008 Apr;108(3):421-6. doi: 10.1007/s10549-007-9612-x. Epub 2007 May 31.
PubMed 17541741
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dietary Intervention in Women Who Have Been Treated For Stage I, Stage II, or Stage III Breast Cancer: Women's Healthy Eating and Living (WHEL) Study
- ClinicalTrials.gov ID
- NCT00003787
- Acronym / sponsor ID
- UCSD-980919
- Conditions
- Breast Cancer
- Keywords
- stage I breast cancer, stage II breast cancer, stage IIIA breast cancer, recurrent breast cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,088 participants (actual)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), Susan G. Komen Breast Cancer Foundation
- Study start
- Mar 1995
- Primary completion
- Mar 2007 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 3 Jun 2004 (estimated)
- 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.
RATIONALE: Dietary fats, fruits, vegetables, and fiber may affect the risk of breast cancer recurrence.
PURPOSE: Randomized clinical trial to determine the effectiveness of a diet rich in vegetables, fruit, and fiber and low in fat in women who have been treated for stage I, stage II, or stage III breast cancer.
Detailed description
OBJECTIVES: I. Determine whether a diet rich in vegetables, fruit, and fiber and low in fat is associated with a longer breast cancer event-free interval in breast cancer survivors. II. Motivate an intervention group of breast cancer survivors to adopt and maintain a dietary pattern that is rich in vegetables, fruit, and fiber and low in fat. III. Demonstrate that the intervention can produce significant changes in circulating carotenoid and estrogen biomarkers compared to a healthy control diet. IV. Test whether the probability of a secondary cancer event is associated with change in self-reported dietary intake, circulating carotenoid concentrations, and circulating estrogen concentrations.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to age (under 55 vs 55 and over at time of diagnosis), stage of tumor (stage I and at least 1 cm vs stage II/IIIA), and clinical site. Patients are randomized to one of two healthy dietary regimens: Arm I: Patients are taught to follow a dietary pattern that will produce significant changes in circulating carotenoid and estrogen biomarkers. Arm II: Patients are assigned to follow dietary guidelines established by the National Cancer Institute and the USDA. All patients participate in 24 hour dietary recalls, cooking classes, as well as complete several questionnaires, at baseline and then at 12, 24 or 36, 48, and 72 months; a randomly selected 50% sample participate in recall at 6 months. Patients are followed by telephone every 6 months for an average of 6 years.
PROJECTED ACCRUAL: A total of 3,000 women will be accrued for this study within 5 years.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | – | Behavioral: educational/counseling intervention, Behavioral: therapeutic dietary interventionhigh fiber, high vegetable, low-fat diet |
| Control | – | Behavioral: therapeutic dietary interventionNCI-recommended diet |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women who were diagnosed with early-stage breast cancer within the previous 4 years, and are between the ages of 18-74
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 |
|---|---|---|
| educational/counseling intervention | Behavioural | Intervention |
| therapeutic dietary intervention | Behavioural | Control, Intervention |
Primary outcome
Breast Cancer Recurrence
Time frame: Lifetime
1 secondary outcome
Mortality
Time frame: Lifetime
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2019.
- Background: PubMed 19296743Hyder JA, Thomson CA, Natarajan L, Madlensky L, Pu M, Emond J, Kealey S, Rock CL, Flatt SW, Pierce JP; WHEL Study Group. Adopting a plant-based diet minimally increased food costs in WHEL Study. Am J Health Behav. 2009 Sep-Oct;33(5):530-9. doi: 10.5993/ajhb.33.5.6.
- Background: PubMed 16047501Yost KJ, Haan MN, Levine RA, Gold EB. Comparing SF-36 scores across three groups of women with different health profiles. Qual Life Res. 2005 Jun;14(5):1251-61. doi: 10.1007/s11136-004-6673-8.
- Results publication: PubMed 22430275Caan BJ, Emond JA, Su HI, Patterson RE, Flatt SW, Gold EB, Newman VA, Rock CL, Thomson CA, Pierce JP. Effect of postdiagnosis weight change on hot flash status among early-stage breast cancer survivors. J Clin Oncol. 2012 May 1;30(13):1492-7. doi: 10.1200/JCO.2011.36.8597. Epub 2012 Mar 19.
- Results publication: PubMed 22648714Nechuta SJ, Caan BJ, Chen WY, Lu W, Chen Z, Kwan ML, Flatt SW, Zheng Y, Zheng W, Pierce JP, Shu XO. Soy food intake after diagnosis of breast cancer and survival: an in-depth analysis of combined evidence from cohort studies of US and Chinese women. Am J Clin Nutr. 2012 Jul;96(1):123-32. doi: 10.3945/ajcn.112.035972. Epub 2012 May 30.
- Results publication: PubMed 21263044Al-Delaimy WK, Flatt SW, Natarajan L, Laughlin GA, Rock CL, Gold EB, Caan BJ, Parker BA, Pierce JP. IGF1 and risk of additional breast cancer in the WHEL study. Endocr Relat Cancer. 2011 Mar 3;18(2):235-44. doi: 10.1530/ERC-10-0121. Print 2011 Apr.
- Results publication: PubMed 21184262Bertram LA, Stefanick ML, Saquib N, Natarajan L, Patterson RE, Bardwell W, Flatt SW, Newman VA, Rock CL, Thomson CA, Pierce JP. Physical activity, additional breast cancer events, and mortality among early-stage breast cancer survivors: findings from the WHEL Study. Cancer Causes Control. 2011 Mar;22(3):427-35. doi: 10.1007/s10552-010-9714-3. Epub 2010 Dec 24.
- Results publication: PubMed 21415358Emond JA, Patterson RE, Natarajan L, Laughlin GA, Gold EB, Pierce JP. Sex hormone concentrations and the risk of breast cancer recurrence in postmenopausal women without hot flashes. Cancer Epidemiol Biomarkers Prev. 2011 May;20(5):939-45. doi: 10.1158/1055-9965.EPI-10-1240. Epub 2011 Mar 17.
- Results publication: PubMed 20980485Jacobs ET, Thomson CA, Flatt SW, Al-Delaimy WK, Hibler EA, Jones LA, Leroy EC, Newman VA, Parker BA, Rock CL, Pierce JP. Vitamin D and breast cancer recurrence in the Women's Healthy Eating and Living (WHEL) Study. Am J Clin Nutr. 2011 Jan;93(1):108-17. doi: 10.3945/ajcn.2010.30009. Epub 2010 Oct 27.
- Results publication: PubMed 21430657Madlensky L, Natarajan L, Tchu S, Pu M, Mortimer J, Flatt SW, Nikoloff DM, Hillman G, Fontecha MR, Lawrence HJ, Parker BA, Wu AH, Pierce JP. Tamoxifen metabolite concentrations, CYP2D6 genotype, and breast cancer outcomes. Clin Pharmacol Ther. 2011 May;89(5):718-25. doi: 10.1038/clpt.2011.32. Epub 2011 Mar 23.
- Results publication: PubMed 21319157Paxton RJ, Jones LA, Chang S, Hernandez M, Hajek RA, Flatt SW, Natarajan L, Pierce JP. Was race a factor in the outcomes of the Women's Health Eating and Living Study? Cancer. 2011 Aug 15;117(16):3805-13. doi: 10.1002/cncr.25957. Epub 2011 Feb 11.
- Results publication: PubMed 19075284Gold EB, Pierce JP, Natarajan L, Stefanick ML, Laughlin GA, Caan BJ, Flatt SW, Emond JA, Saquib N, Madlensky L, Kealey S, Wasserman L, Thomson CA, Rock CL, Parker BA, Karanja N, Jones V, Hajek RA, Pu M, Mortimer JE. Dietary pattern influences breast cancer prognosis in women without hot flashes: the women's healthy eating and living trial. J Clin Oncol. 2009 Jan 20;27(3):352-9. doi: 10.1200/JCO.2008.16.1067. Epub 2008 Dec 15.
- Results publication: PubMed 19339393Pierce JP, Natarajan L, Caan BJ, Flatt SW, Kealey S, Gold EB, Hajek RA, Newman VA, Rock CL, Pu M, Saquib N, Stefanick ML, Thomson CA, Parker B. Dietary change and reduced breast cancer events among women without hot flashes after treatment of early-stage breast cancer: subgroup analysis of the Women's Healthy Eating and Living Study. Am J Clin Nutr. 2009 May;89(5):1565S-1571S. doi: 10.3945/ajcn.2009.26736F. Epub 2009 Apr 1.
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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. This study is not recruiting at the moment.
John P. Pierce, PhD study chair
University of California, San Diego
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by University of California, San Diego at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: finished, as of the sponsor's last update on 10 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Breast Cancer Recurrence (time frame: Lifetime). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00003787, which also lists 31 linked publications.
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 Jun 2019.