Clinical trial · Observational
The Young Women's Breast Cancer Study
Helping Ourselves, Helping Others: The Young Women's Breast Cancer Study
- 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)
The investigators are conducting a longitudinal cohort study of young women with breast cancer. The investigators identify women age 40 and younger with newly-diagnosed breast cancer from academic and community healthcare institutions. After women consent to the study, they fill-out surveys and give blood samples, and the investigators collect tissue from their breast cancer tumor after it is removed. Women are surveyed every 6 months for the first 3 years after diagnosis, then yearly thereafter for an additional 7 years (for a total follow-up of at least 10 years following diagnosis). The study investigates short and long-term disease and treatment issues, tumor biology and the relationship to patient outcomes, and psychosocial concerns at baseline and in follow-up among a cohort of young women who are newly-diagnosed with breast cancer.
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 (0)
Data not yet available
Design
Arms and outcomes
Arms (1)
- label
- Young Women
- description
- Young women with newly diagnosed breast cancer
Primary outcomes (2)
- measure
- Identify a cohort of young women (age 40 or younger) newly diagnosed with breast cancer
- timeFrame
- 10 years
- description
- Characterize the population of young women at diagnosis and in follow-up regarding disease and psychosocial outcomes (e.g., presentation and disease characteristics including evaluating women with metastatic disease, reported frequency and factors associated with genetic testing, treatment patterns and quality of care, short and long-term side effects, and psychosocial concerns including fertility, sexual functioning, and menopausal issues).
- measure
- Specimen Collection
- timeFrame
- 10 years
- description
- Collect tumor and blood specimens to characterize the tumors, and bank for future studies including molecular evaluations of disease characteristics, genetic variability and hormonal levels in blood.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 40 Years
Show eligibility criteria text
Inclusion Criteria: * Female * Diagnosis of breast cancer * Age 40 or younger at diagnosis * Informed consent obtained from patient * Ability to understand written and spoken English to the extent necessary to complete the questionnaires Exclusion Criteria: * Inability to understand written and spoken English to the extent necessary to complete the questionnaires * Absence of informed consent
References
Publications (49)
- RESULTCollins LC, Marotti JD, Gelber S, Cole K, Ruddy K, Kereakoglow S, Brachtel EF, Schapira L, Come SE, Winer EP, Partridge AH. Pathologic features and molecular phenotype by patient age in a large cohort of young women with breast cancer. Breast Cancer Res Treat. 2012 Feb;131(3):1061-6. doi: 10.1007/s10549-011-1872-9. Epub 2011 Nov 13. PMID 22080245
- RESULTRosenberg SM, Tamimi RM, Gelber S, Ruddy KJ, Kereakoglow S, Borges VF, Come SE, Schapira L, Winer EP, Partridge AH. Body image in recently diagnosed young women with early breast cancer. Psychooncology. 2013 Aug;22(8):1849-55. doi: 10.1002/pon.3221. Epub 2012 Nov 7. PMID 23132765
- RESULTRosenberg SM, Tracy MS, Meyer ME, Sepucha K, Gelber S, Hirshfield-Bartek J, Troyan S, Morrow M, Schapira L, Come SE, Winer EP, Partridge AH. Perceptions, knowledge, and satisfaction with contralateral prophylactic mastectomy among young women with breast cancer: a cross-sectional survey. Ann Intern Med. 2013 Sep 17;159(6):373-81. doi: 10.7326/0003-4819-159-6-201309170-00003. PMID 24042365
- RESULTRuddy KJ, Gelber S, Tamimi RM, Schapira L, Come SE, Meyer ME, Winer EP, Partridge AH. Breast cancer presentation and diagnostic delays in young women. Cancer. 2014 Jan 1;120(1):20-5. doi: 10.1002/cncr.28287. Epub 2013 Nov 11. PMID 24347383
- RESULTRuddy KJ, Gelber SI, Tamimi RM, Ginsburg ES, Schapira L, Come SE, Borges VF, Meyer ME, Partridge AH. Prospective study of fertility concerns and preservation strategies in young women with breast cancer. J Clin Oncol. 2014 Apr 10;32(11):1151-6. doi: 10.1200/JCO.2013.52.8877. Epub 2014 Feb 24. PMID 24567428
- RESULTRosenberg SM, Tamimi RM, Gelber S, Ruddy KJ, Bober SL, Kereakoglow S, Borges VF, Come SE, Schapira L, Partridge AH. Treatment-related amenorrhea and sexual functioning in young breast cancer survivors. Cancer. 2014 Aug 1;120(15):2264-71. doi: 10.1002/cncr.28738. Epub 2014 May 28. PMID 24891236