The Young Women's Breast Cancer Study

NCT ID: NCT01468246

Last Updated: 2025-04-22

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 1302 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2006-11-30
• Study Completion Date: 2026-01-31

Brief 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.

Detailed 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.

Conditions

Breast Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Young Women

Young women with newly diagnosed breast cancer

No interventions assigned to this group

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Dana-Farber Cancer Institute

OTHER

Sponsor Role: lead

Responsible Party

Ann H. Partridge, MD, MPH

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jeffrey Peppercorn, MD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Steven Come, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Beth Israel Deaconess Medical Center

Therese Mulvey, MD

Role: PRINCIPAL_INVESTIGATOR

Mass General/North-Shore Cancer Center

Blair Ardman, MD

Role: PRINCIPAL_INVESTIGATOR

Lowell General Hospital

Lawrence Blaszkowsky, MD

Role: PRINCIPAL_INVESTIGATOR

Newton-Wellesley Hospital

Frank G Basile, MD

Role: PRINCIPAL_INVESTIGATOR

Cape Cod Hospital

Ellen Warner, MD

Role: PRINCIPAL_INVESTIGATOR

Sunnybrook Health Sciences Centre

Virginia Borges, MD

Role: PRINCIPAL_INVESTIGATOR

University of Colorado, Denver

Kathryn Ruddy, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Katherina Zabicki Calvillo, MD, FACS

Role: PRINCIPAL_INVESTIGATOR

South Shore Hospital

Jeanna Walsh, MD

Role: PRINCIPAL_INVESTIGATOR

Dana-Farber/New Hampshire Oncology-Hematology

Natalie Sinclair, MD

Role: PRINCIPAL_INVESTIGATOR

DF/BWCC at Milford Regional Medical Center

Locations

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

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

South Shore Hospital

South Weymouth, Massachusetts, United States

Mayo Clinic

Rochester, Minnesota, United States

Dana-Farber/New Hampshire Oncology-Hematology

Londonderry, New Hampshire, United States

Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada

Countries

United States; Canada

References

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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. Clin Breast Cancer. 2023 Apr;23(3):317-323. doi: 10.1016/j.clbc.2022.12.012. Epub 2022 Dec 22.

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Reference Type: DERIVED

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Rosenberg SM, Zheng Y, Ruddy K, Poorvu PD, Snow C, Kirkner GJ, Meyer ME, Tamimi RM, Schapira L, Peppercorn J, Come S, Borges VF, Warner E, Gelber S, Collins L, Winer EP, Partridge AH. Helping ourselves, helping others: the Young Women's Breast Cancer Study (YWS) - a multisite prospective cohort study to advance the understanding of breast cancer diagnosed in women aged 40 years and younger. BMJ Open. 2024 Jul 1;14(6):e081157. doi: 10.1136/bmjopen-2023-081157.

Reference Type: DERIVED

PMID: 38951008 (View on PubMed)

Other Identifiers

06-169

Identifier Type: -

Identifier Source: org_study_id