Breast CancerHOHONCT01468246
The Young Women's Breast Cancer Study
An observational study of Breast Cancer, run by Dana-Farber Cancer Institute at 13 sites in 2 countries.
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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Breast Cancer
- How many people
- 1,302 participants
- Where
- 13 sitesin 2 countries
- Study dates
- Nov 2006to Jan 2035
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Study population: This study includes women who are newly-diagnosed with breast cancer. They must be 40 or younger at their diagnosis.
Who may be able to join
- 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
Who cannot join
- Inability to understand written and spoken English to the extent necessary to complete the questionnaires
- Absence of informed consent
Trial locations and contacts
13 sites in 2 countries.
13 sites in 2 countries
United States12 sites
University of Colorado Cancer Center
Aurora, Colorado, 80045
Beth-Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
Massachusetts General Hospital
Boston, Massachusetts, 02215
MGH/North Shore Cancer Center
Danvers, Massachusetts, 01923
Cape Cod Hospital
Hyannis, Massachusetts, 02601
Dana-Farber/New Hampshire Oncology-Hematology
Londonderry, New Hampshire, 03053
Lowell General Hospital
Lowell, Massachusetts, 01854
DF/BWCC at Milford Regional Medical Center
Milford, Massachusetts, 01757
Newton-Wellesley Hospital
Newton, Massachusetts, 02462
Mayo Clinic
Rochester, Minnesota, 55905
South Shore Hospital
South Weymouth, Massachusetts, 02190
About this study
Official title: 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.
Read the 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
- Keywords
- Breast Cancer, Cohort, Young Women, Survivorship, Fertility
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Young Women | Young women with newly diagnosed breast cancer |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 10 years
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.
Measured: 10 years
Secondary outcomes (1)
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.
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2011 (estimated)
- Study startNov 2006
- Primary completionJan 2035 (estimated)
- Study completionJan 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (49)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Dana-Farber Cancer InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,302 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dana-Farber Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ann H. Partridge, MD, MPH, Dana-Farber Cancer Institute
- Investigators
- Jeffrey Peppercorn, MD, Principal investigator, Massachusetts General HospitalSteven Come, MD, MPH, Principal investigator, Beth Israel Deaconess Medical CenterTherese Mulvey, MD, Principal investigator, Mass General/North-Shore Cancer CenterBlair Ardman, MD, Principal investigator, Lowell General HospitalLawrence Blaszkowsky, MD, Principal investigator, Newton-Wellesley HospitalFrank G Basile, MD, Principal investigator, Cape Cod HospitalEllen Warner, MD, Principal investigator, Sunnybrook Health Sciences CentreVirginia Borges, MD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01468246
- Sponsor's protocol ID
- 06-169
- Acronym
- HOHO
- Status last verified
- Jan 2026
- First submitted
- 5 Nov 2011
- Last updated
- 3 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
Publications
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 Treat. 2012 Feb;131(3):1061-6. doi: 10.1007/s10549-011-1872-9. Epub 2011 Nov 13.
PubMed 22080245Rosenberg 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 2012 Nov 7.
PubMed 23132765Rosenberg 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 cancer: a cross-sectional survey. Ann Intern Med. 2013 Sep 17;159(6):373-81. doi: 10.7326/0003-4819-159-6-201309170-00003.
PubMed 24042365Ruddy 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.
PubMed 24347383Ruddy 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: 10.1200/JCO.2013.52.8877. Epub 2014 Feb 24.
PubMed 24567428Rosenberg 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.28738. Epub 2014 May 28.
PubMed 24891236Rosenberg 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 Surg Oncol. 2015 Nov;22(12):3809-15. doi: 10.1245/s10434-015-4572-6. Epub 2015 May 1.
PubMed 25930247Borstelmann 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 13.
PubMed 25765893Collins 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 Cohort of Young Women. Oncologist. 2015 Jul;20(7):713-8. doi: 10.1634/theoncologist.2014-0412. Epub 2015 May 29.
PubMed 26025931Walker 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 17.
PubMed 26812461Rosenberg 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.
PubMed 26867710Goddard 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):177-187. doi: 10.1158/2159-8290.CD-16-0822. Epub 2016 Dec 14.
PubMed 27974414Olsen 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 Breast Cancers. Cancer Discov. 2017 Feb;7(2):202-217. doi: 10.1158/2159-8290.CD-16-0520. Epub 2016 Dec 14.
PubMed 27974415Park 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 2018 Jan 31.
PubMed 29525523von 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. doi: 10.1002/pon.5047. Epub 2019 Mar 13.
PubMed 30817075
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Helping Ourselves, Helping Others: The Young Women's Breast Cancer Study
- ClinicalTrials.gov ID
- NCT01468246
- Acronym / sponsor ID
- HOHO / 06-169
- Conditions
- Breast Cancer
- Keywords
- Breast Cancer, Cohort, Young Women, Survivorship, Fertility
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,302 participants (actual)
- Lead sponsor
- Dana-Farber Cancer InstituteUniversity, hospital or other
- Study start
- Nov 2006
- Primary completion
- Jan 2035 (estimated)
- Study completion
- Jan 2035 (estimated)
- First posted
- 9 Nov 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Young Women | – | –Young women with newly diagnosed breast cancer |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- This study includes women who are newly-diagnosed with breast cancer. They must be 40 or younger at their diagnosis.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- Inability to understand written and spoken English to the extent necessary to complete the questionnaires
- Absence of informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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).
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.
1 secondary outcome
Identify Predictors of Outcome
Time frame: 10 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2026.
- Results publication: PubMed 22080245Collins 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 Treat. 2012 Feb;131(3):1061-6. doi: 10.1007/s10549-011-1872-9. Epub 2011 Nov 13.
- Results publication: PubMed 23132765Rosenberg 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 2012 Nov 7.
- Results publication: PubMed 24042365Rosenberg 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 cancer: a cross-sectional survey. Ann Intern Med. 2013 Sep 17;159(6):373-81. doi: 10.7326/0003-4819-159-6-201309170-00003.
- Results publication: PubMed 24347383Ruddy 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.
- Results publication: PubMed 24567428Ruddy 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: 10.1200/JCO.2013.52.8877. Epub 2014 Feb 24.
- Results publication: PubMed 24891236Rosenberg 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.28738. Epub 2014 May 28.
- Results publication: PubMed 25930247Rosenberg 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 Surg Oncol. 2015 Nov;22(12):3809-15. doi: 10.1245/s10434-015-4572-6. Epub 2015 May 1.
- Results publication: PubMed 25765893Borstelmann 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 13.
- Results publication: PubMed 26025931Collins 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 Cohort of Young Women. Oncologist. 2015 Jul;20(7):713-8. doi: 10.1634/theoncologist.2014-0412. Epub 2015 May 29.
- Results publication: PubMed 26812461Walker 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 17.
- Results publication: PubMed 26867710Rosenberg 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.
- Results publication: PubMed 27974414Goddard 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):177-187. doi: 10.1158/2159-8290.CD-16-0822. Epub 2016 Dec 14.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeffrey Peppercorn, MD principal investigator
Massachusetts General Hospital
Steven Come, MD, MPH principal investigator
Beth Israel Deaconess Medical Center
Therese Mulvey, MD principal investigator
Mass General/North-Shore Cancer Center
13 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by Dana-Farber Cancer Institute at 13 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 3 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identify a cohort of young women (age 40 or younger) newly diagnosed with breast cancer (time frame: 10 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01468246, which also lists 49 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2026.