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The Young Women's Breast Cancer Study (HOHO)

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Dana-Farber Cancer Institute
Sponsor:
Information provided by (Responsible Party):
Ann H. Partridge, MD, MPH, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:
NCT01468246
First received: November 5, 2011
Last updated: July 1, 2014
Last verified: July 2014

November 5, 2011
July 1, 2014
November 2006
November 2025   (final data collection date for primary outcome measure)
  • Identify a cohort of young women (age 40 or younger) newly diagnosed with breast cancer [ Time Frame: 10 years ] [ Designated as safety issue: No ]
    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 [ Time Frame: 10 years ] [ Designated as safety issue: No ]
    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.
Same as current
Complete list of historical versions of study NCT01468246 on ClinicalTrials.gov Archive Site
Identify Predictors of Outcome [ Time Frame: 10 years ] [ Designated as safety issue: No ]
Ultimately, the investigators aim to develop predictors of outcome and identify areas that may be amenable to intervention for young women with breast cancer.
Same as current
Not Provided
Not Provided
 
The Young Women's Breast Cancer Study
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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

The investigators are collecting blood and tumor specimens.

Non-Probability Sample

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

Breast Cancer
Not Provided
Young Women
Young women with newly diagnosed breast cancer

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
1300
January 2026
November 2025   (final data collection date for primary outcome measure)

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
Female
18 Years to 40 Years
No
Contact: Ann H Partridge, MD, MPH 617-632-3800 ahpartridge@partners.org
United States,   Canada
 
NCT01468246
06-169
No
Ann H. Partridge, MD, MPH, Dana-Farber Cancer Institute
Dana-Farber Cancer Institute
Not Provided
Principal Investigator: Lidia Schapira, MD Massachusetts General Hospital
Principal Investigator: Steven Come, MD, MPH Beth Israel Deaconess Medical Center
Principal Investigator: Karen Krag, MD Mass General/North-Shore Cancer Center
Principal Investigator: Blair Ardman, MD Lowell General Hospital
Principal Investigator: Caroline Block, MD Newton-Wellesley Hospital
Principal Investigator: Frank G Basile, MD Cape Cod Healthcare
Principal Investigator: Ellen Warner, MD Sunnybrook Health Sciences Centre
Principal Investigator: Virginia Borges, MD University of Colorado, Denver
Principal Investigator: Kathryn Ruddy, MD, MPH Mayo Clinic
Principal Investigator: Katherina Zabicki Calvillo, MD, FACS South Shore Hospital
Dana-Farber Cancer Institute
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP