The Young Women's Breast Cancer Study

Breast Cancer Clinical Trial

— HOHO  

Official title:

Helping Ourselves, Helping Others: The Young Women's Breast Cancer Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01468246
• Other study ID #: 06-169
• Status: Active, not recruiting
• Start date: November 2006
• Est. completion date: January 2026

Study information

• Verified date: April 2024
• Source: Dana-Farber Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

This is a longitudinal cohort study of young women with breast cancer. Over a 6-year period, the investigators aim to identify over 1,600 women age 40 and younger with newly diagnosed breast cancer from academic and community health care institutions. It is anticipated that 1,300 of these women will agree to participate in an observational study. Patient surveys, medical record review, and blood and tissue collection will be utilized. Women will be 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 10 year following diagnosis). The study will investigate short and long-term disease and treatment issues, and psychosocial concerns at baseline and in follow-up among a cohort of young women (age 40 or younger) newly diagnosed with breast cancer. The investigators aim to characterize the population of young women at diagnosis and in follow-up regarding disease and psychosocial outcomes (e.g., presentation and disease characteristics, treatment patterns and quality of care, short and long-term side effects, and psychosocial concerns including fertility, sexual functioning, and menopausal issues). The investigators will also 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. Ultimately, the investigators aim to develop predictors of outcome, and identify areas that may be amenable to intervention.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1302
• Est. completion date: January 2026
• Est. primary completion date: November 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Locations

Country	Name	City	State
Canada	Sunnybrook Health Sciences Centre	Toronto	Ontario
United States	University of Colorado Cancer Center	Aurora	Colorado
United States	Beth-Israel Deaconess Medical Center	Boston	Massachusetts
United States	Dana-Farber Cancer Institute	Boston	Massachusetts
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	MGH/North Shore Cancer Center	Danvers	Massachusetts
United States	Cape Cod Hospital	Hyannis	Massachusetts
United States	Dana-Farber/New Hampshire Oncology-Hematology	Londonderry	New Hampshire
United States	Lowell General Hospital	Lowell	Massachusetts
United States	DF/BWCC at Milford Regional Medical Center	Milford	Massachusetts
United States	Newton-Wellesley Hospital	Newton	Massachusetts
United States	Mayo Clinic	Rochester	Minnesota
United States	South Shore Hospital	South Weymouth	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Dana-Farber Cancer Institute

Countries where clinical trial is conducted

United States,  Canada, 

References & Publications (46)

Borstelmann NA, Gray TF, Gelber S, Rosenberg S, Zheng Y, Meyer M, Ruddy KJ, Schapira L, Come S, Borges V, Cadet T, Maramaldi P, Partridge AH. Psychosocial issues and quality of life of parenting partners of young women with breast cancer. Support Care Can — View Citation

Borstelmann NA, Rosenberg S, Gelber S, Zheng Y, Meyer M, Ruddy KJ, Schapira L, Come S, Borges V, Cadet T, Maramaldi P, Partridge AH. Partners of young breast cancer survivors: a cross-sectional evaluation of psychosocial concerns, coping, and mental healt — View Citation

Borstelmann NA, Rosenberg SM, Ruddy KJ, Tamimi RM, Gelber S, Schapira L, Come S, Borges V, Morgan E, Partridge AH. Partner support and anxiety in young women with breast cancer. Psychooncology. 2015 Dec;24(12):1679-85. doi: 10.1002/pon.3780. Epub 2015 Mar — View Citation

Collins LC, Gelber S, Marotti JD, White S, Ruddy K, Brachtel EF, Schapira L, Come SE, Borges VF, Schedin P, Warner E, Wensley T, Tamimi RM, Winer EP, Partridge AH. Molecular Phenotype of Breast Cancer According to Time Since Last Pregnancy in a Large Coho — View Citation

Collins 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 T — View Citation

Dominici L, Hu J, Zheng Y, Kim HJ, King TA, Ruddy KJ, Tamimi RM, Peppercorn J, Schapira L, Borges VF, Come SE, Warner E, Wong JS, Partridge AH, Rosenberg SM. Association of Local Therapy With Quality-of-Life Outcomes in Young Women With Breast Cancer. JAM — View Citation

Goddard ET, Hill RC, Nemkov T, D'Alessandro A, Hansen KC, Maller O, Mongoue-Tchokote S, Mori M, Partridge AH, Borges VF, Schedin P. The Rodent Liver Undergoes Weaning-Induced Involution and Supports Breast Cancer Metastasis. Cancer Discov. 2017 Feb;7(2):1 — View Citation

Guzman-Arocho YD, Rosenberg SM, Garber JE, Vardeh H, Poorvu PD, Ruddy KJ, Kirkner G, Snow C, Tamimi RM, Peppercorn J, Schapira L, Borges VF, Come SE, Brachtel EF, Marotti JD, Warner E, Partridge AH, Collins LC. Clinicopathological features and BRCA1 and B — View Citation

Kim HJ, Dominici L, Rosenberg SM, Zheng Y, Pak LM, Poorvu PD, Ruddy KJ, Tamimi R, Schapira L, Come SE, Peppercorn J, Borges VF, Warner E, Vardeh H, Collins LC, Gaither R, King TA, Partridge AH. Surgical Treatment After Neoadjuvant Systemic Therapy in Youn — View Citation

Krasne M, Ruddy KJ, Poorvu PD, Gelber SI, Tamimi RM, Schapira L, Peppercorn J, Come SE, Borges VF, Partridge AH, Rosenberg SM. Coping strategies and anxiety in young breast cancer survivors. Support Care Cancer. 2022 Nov;30(11):9109-9116. doi: 10.1007/s00 — View Citation

Kuijer A, Dominici LS, Rosenberg SM, Hu J, Gelber S, Di Lascio S, Wong JS, Ruddy KJ, Tamimi RM, Schapira L, Borges VF, Come SE, Sprunck-Harrild K, Partridge AH, King TA. Arm Morbidity After Local Therapy for Young Breast Cancer Patients. Ann Surg Oncol. 2 — View Citation

Lambertini M, Ameye L, Hamy AS, Zingarello A, Poorvu PD, Carrasco E, Grinshpun A, Han S, Rousset-Jablonski C, Ferrari A, Paluch-Shimon S, Cortesi L, Senechal C, Miolo G, Pogoda K, Perez-Fidalgo JA, De Marchis L, Ponzone R, Livraghi L, Estevez-Diz MDP, Vil — View Citation

Lambertini M, Blondeaux E, Bruzzone M, Perachino M, Anderson RA, de Azambuja E, Poorvu PD, Kim HJ, Villarreal-Garza C, Pistilli B, Vaz-Luis I, Saura C, Ruddy KJ, Franzoi MA, Sertoli C, Ceppi M, Azim HA Jr, Amant F, Demeestere I, Del Mastro L, Partridge AH — View Citation

Lambertini M, Ceppi M, Hamy AS, Caron O, Poorvu PD, Carrasco E, Grinshpun A, Punie K, Rousset-Jablonski C, Ferrari A, Paluch-Shimon S, Toss A, Senechal C, Puglisi F, Pogoda K, Perez-Fidalgo JA, De Marchis L, Ponzone R, Livraghi L, Estevez-Diz MDP, Villarr — View Citation

Lee GE, Rosenberg SM, Mayer EL, Borges V, Meyer ME, Schapira L, Come SE, Partridge AH. Contemporary management of breast cancer during pregnancy and subsequent lactation in a multicenter cohort of young women with breast cancer. Breast J. 2019 Nov;25(6):1 — View Citation

Lewinsohn R, Zheng Y, Rosenberg SM, Ruddy KJ, Tamimi RM, Schapira L, Peppercorn J, Borges VF, Come S, Snow C, Ginsburg ES, Partridge AH. Fertility Preferences and Practices Among Young Women With Breast Cancer: Germline Genetic Carriers Versus Noncarriers — View Citation

Olsen SN, Wronski A, Castano Z, Dake B, Malone C, De Raedt T, Enos M, DeRose YS, Zhou W, Guerra S, Loda M, Welm A, Partridge AH, McAllister SS, Kuperwasser C, Cichowski K. Loss of RasGAP Tumor Suppressors Underlies the Aggressive Nature of Luminal B Breas — View Citation

Pak LM, Gaither R, Rosenberg SM, Ruddy KJ, Tamimi RM, Peppercorn J, Schapira L, Borges VF, Come SE, Warner E, Snow C, Collins LC, King TA, Partridge AH. Tumor phenotype and concordance in synchronous bilateral breast cancer in young women. Breast Cancer R — View Citation

Park EM, Gelber S, Rosenberg SM, Seah DSE, Schapira L, Come SE, Partridge AH. Anxiety and Depression in Young Women With Metastatic Breast Cancer: A Cross-Sectional Study. Psychosomatics. 2018 May-Jun;59(3):251-258. doi: 10.1016/j.psym.2018.01.007. Epub 2 — View Citation

Parsons HA, Rhoades J, Reed SC, Gydush G, Ram P, Exman P, Xiong K, Lo CC, Li T, Fleharty M, Kirkner GJ, Rotem D, Cohen O, Yu F, Fitarelli-Kiehl M, Leong KW, Hughes ME, Rosenberg SM, Collins LC, Miller KD, Blumenstiel B, Trippa L, Cibulskis C, Neuberg DS, — View Citation

Poorvu PD, Gelber SI, Rosenberg SM, Ruddy KJ, Tamimi RM, Collins LC, Peppercorn J, Schapira L, Borges VF, Come SE, Warner E, Jakubowski DM, Russell C, Winer EP, Partridge AH. Prognostic Impact of the 21-Gene Recurrence Score Assay Among Young Women With N — View Citation

Poorvu PD, Gelber SI, Zheng Y, Ruddy KJ, Tamimi RM, Peppercorn J, Schapira L, Borges VF, Come SE, Lambertini M, Rosenberg SM, Partridge AH. Pregnancy after breast cancer: Results from a prospective cohort of young women with breast cancer. Cancer. 2021 Ap — View Citation

Poorvu PD, Hu J, Zheng Y, Gelber SI, Ruddy KJ, Tamimi RM, Peppercorn JM, Schapira L, Borges VF, Come SE, Warner E, Lambertini M, Rosenberg SM, Partridge AH. Treatment-related amenorrhea in a modern, prospective cohort study of young women with breast canc — View Citation

Rath M, Li Q, Li H, Lindstrom S, Miron A, Miron P, Dowton AE, Meyer ME, Larson BG, Pomerantz M, Seo JH, Collins LC, Vardeh H, Brachtel E, Come SE, Borges V, Schapira L, Tamimi RM, Partridge AH, Freedman M, Ruddy KJ. Evaluation of significant genome-wide a — View Citation

Rosenberg SM, Dominici LS, Gelber S, Poorvu PD, Ruddy KJ, Wong JS, Tamimi RM, Schapira L, Come S, Peppercorn JM, Borges VF, Partridge AH. Association of Breast Cancer Surgery With Quality of Life and Psychosocial Well-being in Young Breast Cancer Survivor — View Citation

Rosenberg SM, Ruddy KJ, Tamimi RM, Gelber S, Schapira L, Come S, Borges VF, Larsen B, Garber JE, Partridge AH. BRCA1 and BRCA2 Mutation Testing in Young Women With Breast Cancer. JAMA Oncol. 2016 Jun 1;2(6):730-6. doi: 10.1001/jamaoncol.2015.5941. — View Citation

Rosenberg SM, Sepucha K, Ruddy KJ, Tamimi RM, Gelber S, Meyer ME, Schapira L, Come SE, Borges VF, Golshan M, Winer EP, Partridge AH. Local Therapy Decision-Making and Contralateral Prophylactic Mastectomy in Young Women with Early-Stage Breast Cancer. Ann — View Citation

Rosenberg 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 — View Citation

Rosenberg 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 — View Citation

Rosenberg 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 — View Citation

Rosenberg SM, Vaz-Luis I, Gong J, Rajagopal PS, Ruddy KJ, Tamimi RM, Schapira L, Come S, Borges V, de Moor JS, Partridge AH. Employment trends in young women following a breast cancer diagnosis. Breast Cancer Res Treat. 2019 Aug;177(1):207-214. doi: 10.10 — View Citation

Rosenberg SM, Zheng Y, Gelber S, Ruddy KJ, Poorvu P, Sella T, Tamimi RM, Wassermann J, Schapira L, Borges VF, Come S, Peppercorn J, Sepucha KR, Partridge AH. Adjuvant endocrine therapy non-initiation and non-persistence in young women with early-stage bre — View Citation

Ruddy 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. — View Citation

Ruddy 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: 10.12 — View Citation

Schapira L, Zheng Y, Gelber SI, Poorvu P, Ruddy KJ, Tamimi RM, Peppercorn J, Come SE, Borges VF, Partridge AH, Rosenberg SM. Trajectories of fear of cancer recurrence in young breast cancer survivors. Cancer. 2022 Jan 15;128(2):335-343. doi: 10.1002/cncr. — View Citation

Sella T, Fell GG, Miller PG, Gibson CJ, Rosenberg SM, Snow C, Stover DG, Ruddy KJ, Peppercorn JM, Schapira L, Borges VF, Come SE, Warner E, Frank E, Neuberg DS, Ebert BL, Partridge AH. Patient perspectives on testing for clonal hematopoiesis of indetermin — View Citation

Sella T, Gelber SI, Poorvu PD, Kim HJ, Dominici L, Guzman-Arocho YD, Collins L, Ruddy KJ, Tamimi RM, Peppercorn JM, Schapira L, Borges VF, Come SE, Warner E, Snow C, Jakubowski DM, Russell CA, Winer EP, Rosenberg SM, Partridge AH. Response to neoadjuvant — View Citation

Sella T, Poorvu PD, Ruddy KJ, Gelber SI, Tamimi RM, Peppercorn JM, Schapira L, Borges VF, Come SE, Partridge AH, Rosenberg SM. Impact of fertility concerns on endocrine therapy decisions in young breast cancer survivors. Cancer. 2021 Aug 15;127(16):2888-2 — View Citation

Sella T, Ruddy KJ, Carey LA, Partridge AH. Optimal Endocrine Therapy in Premenopausal Women: A Pragmatic Approach to Unanswered Questions. JCO Oncol Pract. 2022 Mar;18(3):211-216. doi: 10.1200/OP.21.00482. Epub 2021 Oct 12. — View Citation

Sella T, Zheng Y, Tan-Wasielewski Z, Rosenberg SM, Poorvu PD, Tayob N, Ruddy KJ, Gelber SI, Tamimi RM, Schapira L, Come SE, Peppercorn JM, Borges VF, Partridge AH, Ligibel JA. Body weight changes and associated predictors in a prospective cohort of young — View Citation

Tesch ME, Rosenberg SM, Collins LC, Wong JS, Dominici L, Ruddy KJ, Tamimi R, Schapira L, Borges VF, Warner E, Come SE, Partridge AH. Clinicopathologic Features, Treatment Patterns, and Disease Outcomes in a Modern, Prospective Cohort of Young Women Diagno — View Citation

Vazquez D, Rosenberg S, Gelber S, Ruddy KJ, Morgan E, Recklitis C, Come S, Schapira L, Partridge AH. Posttraumatic stress in breast cancer survivors diagnosed at a young age. Psychooncology. 2020 Aug;29(8):1312-1320. doi: 10.1002/pon.5438. Epub 2020 Jul 9 — View Citation

von Hippel C, Rosenberg SM, Austin SB, Sprunck-Harrild K, Ruddy KJ, Schapira L, Come S, Borges VF, Partridge AH. Identifying distinct trajectories of change in young breast cancer survivors' sexual functioning. Psychooncology. 2019 May;28(5):1033-1040. do — View Citation

Waks AG, Kim D, Jain E, Snow C, Kirkner GJ, Rosenberg SM, Oh C, Poorvu PD, Ruddy KJ, Tamimi RM, Peppercorn J, Schapira L, Borges VF, Come SE, Brachtel EF, Warner E, Collins LC, Partridge AH, Wagle N. Somatic and Germline Genomic Alterations in Very Young — View Citation

Walker HE, Rosenberg SM, Stanton AL, Petrie KJ, Partridge AH. Perceptions, Attributions, and Emotions Toward Endocrine Therapy in Young Women with Breast Cancer. J Adolesc Young Adult Oncol. 2016 Mar;5(1):16-23. doi: 10.1089/jayao.2015.0051. Epub 2015 Dec — View Citation

Wassermann J, Gelber SI, Rosenberg SM, Ruddy KJ, Tamimi RM, Schapira L, Borges VF, Come SE, Meyer ME, Partridge AH. Nonadherent behaviors among young women on adjuvant endocrine therapy for breast cancer. Cancer. 2019 Sep 15;125(18):3266-3274. doi: 10.100 — View Citation

* Note: There are 46 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Identify a cohort of young women (age 40 or younger) newly diagnosed with breast cancer	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).	10 years
Primary	Specimen Collection	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.	10 years
Secondary	Identify Predictors of Outcome	Ultimately, the investigators aim to develop predictors of outcome and identify areas that may be amenable to intervention for young women with breast cancer.	10 years