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Breast CancerPhase 2NCT00295100

Tamoxifen-MRI Study

A Phase 2 study testing Tamoxifen in people with Breast Cancer, run by University of Pennsylvania at 7 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The project is a double blind, randomized, placebo-controlled phase II chemoprevention trial. Study participants will be randomly assigned to receive either tamoxifen or placebo for one year. Participants will subsequently be followed for one year off of medication. Read more about this study

Who is it for?
Ages 25 to 45 years, women onlyHealthy volunteers can take part
Conditions the study is for
Breast Cancer
What is being tested?
Tamoxifen
How many people
78 participants
Where
7 sitesin 2 countries
Study dates
Sep 2000to Jul 2006
Phase
Phase 2
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 25 to 45 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Study participants will include healthy pre-menopausal women, ages 25 to 45 who meet all of the following eligibility criteria:
  • Signed and dated informed consent documents (2) for the study in accordance with all applicable Federal, State and Institutional regulations
  • Lifetime breast cancer risk >20% based on the Gail model, the Claus model, a known familial breast cancer susceptibility mutation, a predicted probability of a BRCA1/2 mutation > 25 % by the Couch model or diagnosis of LCIS or DCIS, or > 20 Gy of external beam radiation delivered to the chest wall.
  • Regular monthly menstrual periods or pre-menopausal defined as cycle occurring every 21 - 35 days
  • Negative serum pregnancy test
  • Prior tubal ligation or willingness to use a non-hormonal barrier method of contraception for two (2) years
  • Prior to randomization, all baseline radiology test results (mammogram, MRI and biopsy, if applicable) must be reviewed to confirm absence of invasive cancer.

Who cannot join

  • Study participants will be excluded if any of the following conditions occur:
  • Absence of or irregular menstrual periods. Irregular menstrual period defined as menstrual cycle occurring < 21 days or > 35 days within the last six months or serum LH > 45.
  • Oral contraceptive or other hormonal treatment within 3 months of study entry. The participant will be considered deferred for 3 months if she agrees to discontinue use of oral contraceptive pills or other hormonal treatment.
  • History or evidence of any malignancy
  • Use of the following concurrent medications: Anticoagulant therapy (e.g. coumarin containing agents and lovanox), estrogens (including Estring), progestins, androgens, or ovarian steroid hormones.
  • Concurrent serious medical illness including:
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  • Uncontrolled Diabetes Mellitus (defined as HgA1C > 9.0 %)
  • Uncontrolled hypertension (defined as systolic >180 or diastolic >110 on average of 2 or more readings taken at each of 2 or more visits after initial visit.)
  • Thromboembolic disease (DVT or PE)
  • Cerebrovascular disease (CVA or TIA)
  • Liver disease (AST and/or ALT > 2 X normal)
  • Renal disease (BUN > 30 mg/dl or Creatinine.>2.0 mg/dl)
  • Pregnant or breast feeding
  • Breast implants
  • Prophylactic mastectomy
  • Bilateral oophorectomy (TAH without BSO is permitted)
  • Greater than 3 months of prior participation in a chemoprevention trial or participation in a chemoprevention trial within the last 6 months
  • Prior treatment with tamoxifen for > 3 months duration at any time in the past
  • Prior treatment with Raloxifene for > 3 months duration at any time in the past
  • Contraindications to MRI: presence of implanted metal including pacemaker, ferromagnetic aneurysm clip, other ferromagnetic implant
  • Refusal to undergo MRI
  • Deferral Criteria:
  • Study participants will be deferred from the study for the time period stated if any of the following conditions occur.
  • If a participant has been treated with tamoxifen for less than 3 months, within the last 6 months, she will be deferred for six (6) months from the date of last dose.
  • If a participant has been treated with Raloxifene for less than 3 months, within the last 6 months, she will be deferred for six (6) months from the date of last dose.
  • If a participant is pregnant or breast feeding she will be deferred for six (6) months from the end of pregnancy or breast-feeding. At that time, eligibility status will be re-evaluated.
  • The participant will be considered deferred for three (3) months if she agrees to discontinue use of oral contraceptive pills, has used "emergency contraceptive pill" (ECP or morning after pill) or other hormonal treatment.
  • If the participant has had an open breast biopsy within the last two months or there is a clinical indication for an open breast biopsy, pathology results must be reviewed. If PATHOLOGY is NEGATIVE for invasive cancer, she will be deferred for two (2) months from the date of her last biopsy.

Trial locations and contacts

7 sites in 2 countries.

7 sites in 2 countries

United States6 sites

  • Dana Farber Cancer Institute

    Boston, Massachusetts, 02115

  • Wayne State University

    Detroit, Michigan, 48201

  • UCLA Medical Center

    Los Angeles, California, 90095

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

  • Fox Chase Cancer Center

    Philadelphia, Pennsylvania, 19111

  • Mayo Clinic

    Rochester, Minnesota, 55905

Other trials in United States

Italy1 site

  • European Institute of Oncology

    Milan

Other trials in Italy

About this study

Official title: Cancer Risk and Biomarkers of Tamoxifen Chemoprevention

The project is a double blind, randomized, placebo-controlled phase II chemoprevention trial. Study participants will be randomly assigned to receive either tamoxifen or placebo for one year. Participants will subsequently be followed for one year off of medication. The primary objective is to evaluate the effectiveness of tamoxifen in reducing breast density by mammogram.

Read the detailed description

The project is a double blind, randomized, placebo-controlled phase II chemoprevention trial.

The study outcomes will be biological markers, rather than cancer incidence or mortality. Eligible study subjects will be women, between the ages 25-45, whose calculated lifetime breast cancer risk is > 20% (25% by the Couch model).

Study participants will be randomly assigned to receive either tamoxifen or placebo for one year. Participants will subsequently be followed for one year off of medication.

The primary objective is to evaluate the effectiveness of tamoxifen in reducing breast density by mammogram. Mammographic density has been correlated with breast cancer risk and reduced breast density may have the added benefit of improving the sensitivity of breast cancer screening in young women. Breast density will be employed as a marker of progression-related - proliferative - mechanisms of carcinogenesis.

Secondary study outcomes will include estrogen ratios (catechol estrogen/estradiol), and markers of oxidative DNA damage in peripheral blood and urine (markers of progression-related - mutational - events in carcinogenesis). The responsiveness of these outcomes will suggest the mechanisms through which tamoxifen exerts its preventive effect. Persistence of the markers after one year of treatment may also provide early information about the anticipated duration of the tamoxifen effect.

Conditions
Breast Cancer
Being tested
Tamoxifen
Keywords
Tamoxifen, Prevention, Breast Cancer, MRI
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TamoxifenDrug

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Breast Density

Secondary outcomes (1)

  1. Biomarkers

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Feb 2006 (estimated)
  2. Study startSep 2000
  3. Study completionJul 2006

Resources

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 2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Crossover
Masking
Double blind
Enrolment
78 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00295100
Sponsor's protocol ID
278100
Other IDs
UPC 2100
Status last verified
Jun 2007
First submitted
20 Feb 2006
Last updated
21 Jun 2007
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Tamoxifen in people with Breast Cancer, run by University of Pennsylvania at 7 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 7 inclusion and 28 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 21 Jun 2007. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in United States, Italy. 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.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

Breast Density. 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 NCT00295100.

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 21 Jun 2007.

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