The Young Women's Breast Cancer Study (HOHO)

January 30, 2026 updated by: Ann H. Partridge, MD, MPH, Dana-Farber Cancer Institute

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

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.

Study Overview

Status

Active, not recruiting

Conditions

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 Type

Observational

Enrollment (Actual)

1302

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, 3M5
        • Sunnybrook Health Sciences Centre
  • United States
    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado Cancer Center
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Dana-Farber Cancer Institute
      • Boston, Massachusetts, United States, 02215
        • Massachusetts General Hospital
      • Boston, Massachusetts, United States, 02215
        • Beth-Israel Deaconess Medical Center
      • Danvers, Massachusetts, United States, 01923
        • MGH/North Shore Cancer Center
      • Hyannis, Massachusetts, United States, 02601
        • Cape Cod Hospital
      • Lowell, Massachusetts, United States, 01854
        • Lowell General Hospital
      • Milford, Massachusetts, United States, 01757
        • DF/BWCC at Milford Regional Medical Center
      • Newton, Massachusetts, United States, 02462
        • Newton-Wellesley Hospital
      • South Weymouth, Massachusetts, United States, 02190
        • South Shore Hospital
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic
    • New Hampshire
      • Londonderry, New Hampshire, United States, 03053
        • Dana-Farber/New Hampshire Oncology-Hematology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

This study includes women who are newly-diagnosed with breast cancer. They must be 40 or younger at their diagnosis.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Young Women
Young women with newly diagnosed breast cancer

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Identify a cohort of young women (age 40 or younger) newly diagnosed with breast cancer
Time Frame: 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).
10 years
Specimen Collection
Time Frame: 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.
10 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Identify Predictors of Outcome
Time Frame: 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.
10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dana-Farber Cancer Institute

Investigators

  • Principal Investigator: Virginia Borges, MD, University of Colorado, Denver
  • Principal Investigator: Jeffrey Peppercorn, MD, Massachusetts General Hospital
  • Principal Investigator: Steven Come, MD, MPH, Beth Israel Deaconess Medical Center
  • Principal Investigator: Therese Mulvey, MD, Mass General/North-Shore Cancer Center
  • Principal Investigator: Blair Ardman, MD, Lowell General Hospital
  • Principal Investigator: Lawrence Blaszkowsky, MD, Newton-Wellesley Hospital
  • Principal Investigator: Frank G Basile, MD, Cape Cod Hospital
  • Principal Investigator: Ellen Warner, MD, Sunnybrook Health Sciences Centre
  • Principal Investigator: Kathryn Ruddy, MD, MPH, Mayo Clinic
  • Principal Investigator: Katherina Zabicki Calvillo, MD, FACS, South Shore Hospital
  • Principal Investigator: Jeanna Walsh, MD, Dana-Farber/New Hampshire Oncology-Hematology
  • Principal Investigator: Natalie Sinclair, MD, DF/BWCC at Milford Regional Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2006

Primary Completion (Estimated)

January 1, 2035

Study Completion (Estimated)

January 1, 2035

Study Registration Dates

First Submitted

November 5, 2011

First Submitted That Met QC Criteria

November 8, 2011

First Posted (Estimated)

November 9, 2011

Study Record Updates

Last Update Posted (Actual)

February 3, 2026

Last Update Submitted That Met QC Criteria

January 30, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 06-169

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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