The Young Women's Breast Cancer Study

Active, not recruiting

• Conditions: Breast Cancer

• Registration Number: NCT01468246
• Lead Sponsor: Dana-Farber Cancer Institute

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.

Study Timeline

• Study Start: 2006-11
• Study First Submitted: 2011-11-05
• Study First Submitted QC: 2011-11-08
• Study First Posted: 2011-11-09
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-22
• Last Update Posted: 2024-04-24
• Primary Completion: 2025-11
• Study Completion: 2026-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 1302

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

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Exclusion Criteria

• Inability to understand written and spoken English to the extent necessary to complete the questionnaires
• Absence of informed consent

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Identify a cohort of young women (age 40 or younger) newly diagnosed with breast cancer	10 years	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).
Specimen Collection	10 years	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.

Secondary Outcome Measures

Name	Time	Method
Identify Predictors of Outcome	10 years	Ultimately, the investigators aim to develop predictors of outcome and identify areas that may be amenable to intervention for young women with breast cancer.

Trial Locations

Locations (13)

Massachusetts General Hospital; 🇺🇸 Boston, 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

Cape Cod Hospital; 🇺🇸 Hyannis, Massachusetts, United States

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States

University of Colorado Cancer Center; 🇺🇸 Aurora, Colorado, United States

Sunnybrook Health Sciences Centre; 🇨🇦 Toronto, Ontario, Canada

Beth-Israel Deaconess Medical Center; 🇺🇸 Boston, Massachusetts, United States

MGH/North Shore Cancer Center; 🇺🇸 Danvers, Massachusetts, United States

Dana-Farber Cancer Institute; 🇺🇸 Boston, Massachusetts, United States

Dana-Farber/New Hampshire Oncology-Hematology; 🇺🇸 Londonderry, New Hampshire, United States

Lowell General Hospital; 🇺🇸 Lowell, Massachusetts, United States