Hodgkin's DiseaseNCT00165308
Tamoxifen in the Prevention of Breast Cancer in Hodgkin's Disease Survivors
A study testing Tamoxifen in people with Hodgkin's Disease and Breast Cancer, run by Dana-Farber Cancer Institute at 2 sites in United States.
Trial summary
The purpose of this study is determine whether or not tamoxifen reduces the chance of Hodgkin's Disease survivors developing breast cancer. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women only
- Conditions the study is for
- Hodgkin's Disease, Breast Cancer
- What is being tested?
- Tamoxifen
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 2 sitesUnited States
- Study dates
- Apr 2001to Jun 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Females diagnosed with Hodgkin's Disease at age < 35 years
- > 5 years from mantle or chest radiation
- Current age > 30 years
- Has completed childbearing
- Willingness to discontinue use of oral contraceptives or other hormonal contraception for duration of the study
Who cannot join
- History of secondary malignancy after Hodgkin's disease, except thyroid cancer of basal cell cancer
- Recurrence of Hodgkin's disease in the 5 years before study entry
- Current participation in any other cancer prevention study
- Current or prior use of tamoxifen
- Current use of coumadin
- History of deep venous thrombosis, pulmonary embolism, or a condition known to be associated with hypercoagulability
Show all 9Show fewer
- History of cerebrovascular accident
- History of macular degeneration
- Current use of chemotherapy for benign disease
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Massachusetts General Hospital
Boston, Massachusetts, 02114
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115
About this study
Official title: A Feasibility Study of Tamoxifen Prevention of Breast Cancer in Hodgkin's Disease Survivors
The purpose of this study is determine whether or not tamoxifen reduces the chance of Hodgkin's Disease survivors developing breast cancer.
Read the detailed description
- Patients will receive tamoxifen orally once daily to be taken at home for 1 year. They will be asked to complete a daily drug log to keep track of the pills taken or missed.
- Patients will also be asked to give a blood/DNA sample which will be stored for possible further testing for the presence of cancer related genes that are known nor or discovered in the future.
- Patients will also receive a mammogram that will be reviewed by study officials.
- Side effects will be monitored every 2 months for one year, between visits to the clinic.
- A follow-up visit will be conducted at the 6 month mark and includes a physical exam, blood work, health and wellness surveys)
- A follow-up visit will be performed at the 1 year mark and includes a mammogram, gynecological exam, physical exam, blood work, health and wellness surveys.
- Patients active participation will be for 1 year. However, tamoxifen has been shown to be effective after a 5-year course in other women at increased risk for breast cancer, the patient may decide to stay on tamoxifen for 4 additional years.
- Conditions
- Hodgkin's Disease, Breast Cancer
- Being tested
- Tamoxifen
- Keywords
- Hodgkin's disease, breast cancer prevention, tamoxifen
- Medical subject headings
- Hodgkin Disease, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TamoxifenDrug
Given orally, daily for one year.
| Study group | Role | What they receive |
|---|---|---|
| Tamoxifen | Experimental | Single arm: Tamoxifen 20mg daily Receives: Drug: Tamoxifen |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the feasibility of a randomized trial testing the effectiveness of tamoxifen in reducing the risk of radiogenic breast cancer.
Measured: 2 years
Secondary outcomes (1)
To determine the safety and effect on quality of life in participating women.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2005 (estimated)
- Study startApr 2001
- Primary completionMar 2004
- Study completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hodgkin's DiseaseStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dana-Farber Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Judy E. Garber, MD, Dana-Farber Cancer Institute
- Investigators
- Judy Garber, MD, MPH, Principal investigator, Dana-Farber Cancer InstituteLisa Diller, MD, Principal investigator, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00165308
- Sponsor's protocol ID
- 00-253
- Status last verified
- Jul 2014
- First submitted
- 9 Sep 2005
- Last updated
- 9 Jul 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Boucher AA, Blaes AH. Prophylactic mastectomy: a treatment alternative for Hodgkin survivors? Clin Breast Cancer. 2013 Oct;13(5):307-8. doi: 10.1016/j.clbc.2013.06.001. Epub 2013 Jul 26. No abstract available.
PubMed 23891588
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Feasibility Study of Tamoxifen Prevention of Breast Cancer in Hodgkin's Disease Survivors
- ClinicalTrials.gov ID
- NCT00165308
- Acronym / sponsor ID
- 00-253
- Conditions
- Hodgkin's Disease, Breast Cancer
- Keywords
- Hodgkin's disease, breast cancer prevention, tamoxifen
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Dana-Farber Cancer InstituteUniversity, hospital or other
- Collaborators
- Brigham and Women's Hospital, Massachusetts General Hospital, AstraZeneca
- Study start
- Apr 2001
- Primary completion
- Mar 2004 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 14 Sep 2005 (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 purpose of this study is determine whether or not tamoxifen reduces the chance of Hodgkin's Disease survivors developing breast cancer.
Detailed description
- Patients will receive tamoxifen orally once daily to be taken at home for 1 year. They will be asked to complete a daily drug log to keep track of the pills taken or missed.
- Patients will also be asked to give a blood/DNA sample which will be stored for possible further testing for the presence of cancer related genes that are known nor or discovered in the future.
- Patients will also receive a mammogram that will be reviewed by study officials.
- Side effects will be monitored every 2 months for one year, between visits to the clinic.
- A follow-up visit will be conducted at the 6 month mark and includes a physical exam, blood work, health and wellness surveys)
- A follow-up visit will be performed at the 1 year mark and includes a mammogram, gynecological exam, physical exam, blood work, health and wellness surveys.
- Patients active participation will be for 1 year. However, tamoxifen has been shown to be effective after a 5-year course in other women at increased risk for breast cancer, the patient may decide to stay on tamoxifen for 4 additional years.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tamoxifen | Experimental | Drug: TamoxifenSingle arm: Tamoxifen 20mg daily |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Females diagnosed with Hodgkin's Disease at age < 35 years
- > 5 years from mantle or chest radiation
- Current age > 30 years
- Has completed childbearing
- Willingness to discontinue use of oral contraceptives or other hormonal contraception for duration of the study
Key exclusion criteria (9 listed)
- History of secondary malignancy after Hodgkin's disease, except thyroid cancer of basal cell cancer
- Recurrence of Hodgkin's disease in the 5 years before study entry
- Current participation in any other cancer prevention study
- Current or prior use of tamoxifen
- Current use of coumadin
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TamoxifenGiven orally, daily for one year. | Drug | Tamoxifen |
Primary outcome
To determine the feasibility of a randomized trial testing the effectiveness of tamoxifen in reducing the risk of radiogenic breast cancer.
Time frame: 2 years
1 secondary outcome
To determine the safety and effect on quality of life in participating women.
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2014.
- Derived from this study: PubMed 23891588Boucher AA, Blaes AH. Prophylactic mastectomy: a treatment alternative for Hodgkin survivors? Clin Breast Cancer. 2013 Oct;13(5):307-8. doi: 10.1016/j.clbc.2013.06.001. Epub 2013 Jul 26. No abstract available.
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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.
Judy Garber, MD, MPH principal investigator
Dana-Farber Cancer Institute
Lisa Diller, MD principal investigator
Dana-Farber Cancer Institute
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tamoxifen in people with Hodgkin's Disease and Breast Cancer, run by Dana-Farber Cancer Institute at 2 sites in United States.
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 9 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: finished, as of the sponsor's last update on 9 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
To determine the feasibility of a randomized trial testing the effectiveness of tamoxifen in reducing the risk of radiogenic breast cancer. (time frame: 2 years). 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 NCT00165308, which also lists 1 linked publication.
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 9 Jul 2014.