Clinical trial · Observational
Chemotherapy Decisions and Outcomes in Older Women With Newly Diagnosed Breast Cancer
Observational Cohort Study: Chemotherapy Decisions and Outcomes in Women Age 65 or Older With Operable, Newly Diagnosed Breast Cancer
NCT00068328CI-TRIAL-00028982completedClinicalTrials.gov clinicaltrialsProvenance
- 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: Studying how older women make treatment decisions and how these decisions affect the outcome of treatment may help doctors plan more effective treatments and improve patient quality of life. PURPOSE: This clinical trial is studying how a patient's treatment preferences and decisions about chemotherapy affect the outcome of treatment in older women with newly diagnosed breast cancer.
Conditions
Conditions (2)
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 |
| Psychosocial Effects of Cancer and Its Treatment | Breast Neoplasm | PROBABILISTIC | 0.70 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| psychosocial assessment and care | Procedure | — | UNRESOLVED |
| quality-of-life assessment | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Group 1
- description
- Patients participate in interviews over 30-45 minutes at baseline, at 6 months, and at 1 and 2 years. Patients are followed annually for at least 5 years.
- interventionNames
- Procedure: psychosocial assessment and care
- Procedure: quality-of-life assessment
Primary outcomes (1)
- measure
- quality of life
- timeFrame
- Up to 5 years
Secondary outcomes (2)
- measure
- disease free survival
- timeFrame
- Up to 5 years
- measure
- mortality rate
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 65 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed primary adenocarcinoma of the breast * Operable disease * Invasive and unilateral tumor * No more than 20 weeks since diagnosis * T1-4 (tumor size ≥ 1 cm), N0, M0 OR * T1-4, N1-3, M0 * No prior carcinoma in situ, lobular carcinoma in situ, ductal carcinoma in situ, or invasive breast cancer * Hormone receptor status: * Any estrogen receptor status PATIENT CHARACTERISTICS: Age * 65 and over Sex * Female Other * No other malignancy except those for which the patient has completed treatment AND is considered to be at less than 30% risk of recurrence * History of non-melanoma skin cancer allowed * Sufficient cognitive function to consent to and complete interviews * English or Spanish speaking
References
Publications (6)
- RESULTMandelblatt JS, Faul LA, Luta G, Makgoeng SB, Isaacs C, Taylor K, Sheppard VB, Tallarico M, Barry WT, Cohen HJ. Patient and physician decision styles and breast cancer chemotherapy use in older women: Cancer and Leukemia Group B protocol 369901. J Clin Oncol. 2012 Jul 20;30(21):2609-14. doi: 10.1200/JCO.2011.40.2909. Epub 2012 May 21. PMID 22614985
- RESULTMandelblatt JS, Sheppard VB, Hurria A, Kimmick G, Isaacs C, Taylor KL, Kornblith AB, Noone AM, Luta G, Tallarico M, Barry WT, Hunegs L, Zon R, Naughton M, Winer E, Hudis C, Edge SB, Cohen HJ, Muss H; Cancer Leukemia Group B. Breast cancer adjuvant chemotherapy decisions in older women: the role of patient preference and interactions with physicians. J Clin Oncol. 2010 Jul 1;28(19):3146-53. doi: 10.1200/JCO.2009.24.3295. Epub 2010 Jun 1. PMID 20516438
- RESULTMandelblatt J, Sheppard V, Hurria A, et al.: Patient preference as a determinant of breast cancer adjuvant chemotherapy use in older women: CALGB #369901. [Abstract] J Clin Oncol 27 (Suppl 15): A-9544, 2009.
- RESULTKreling B, Figueiredo MI, Sheppard VL, Mandelblatt JS. A qualitative study of factors affecting chemotherapy use in older women with breast cancer: barriers, promoters, and implications for intervention. Psychooncology. 2006 Dec;15(12):1065-76. doi: 10.1002/pon.1042. PMID 16598833
- DERIVEDBluethmann SM, Alfano CM, Clapp JD, Luta G, Small BJ, Hurria A, Cohen HJ, Sugarman S, B Muss H, Isaacs C, Mandelblatt JS. Cognitive function and discontinuation of adjuvant hormonal therapy in older breast cancer survivors: CALGB 369901 (Alliance). Breast Cancer Res Treat. 2017 Oct;165(3):677-686. doi: 10.1007/s10549-017-4353-y. Epub 2017 Jun 26. PMID 28653250
- DERIVEDMandelblatt JS, Cai L, Luta G, Kimmick G, Clapp J, Isaacs C, Pitcher B, Barry W, Winer E, Sugarman S, Hudis C, Muss H, Cohen HJ, Hurria A. Frailty and long-term mortality of older breast cancer patients: CALGB 369901 (Alliance). Breast Cancer Res Treat. 2017 Jul;164(1):107-117. doi: 10.1007/s10549-017-4222-8. Epub 2017 Mar 31.