Breast CancerPhase 1NCT00005886
Tamoxifen Compared With LY353381 in Treating Women With Newly Diagnosed Breast Cancer
A Phase 1 study testing arzoxifene hydrochloride and tamoxifen citrate in people with Breast Cancer, run by University of Kansas Medical Center at 9 sites in United States.
Trial summary
RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using tamoxifen or LY353381 may fight breast cancer by blocking the use of estrogen. PURPOSE: This randomized phase I trial is studying how well tamoxifen works on the biomarkers of the tumor tissue, compared with LY353381, in… Read more about this study
- Who is it for?
- Ages 18 to 120 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- arzoxifene hydrochloride and tamoxifen citrate
- How many people
- Not given
- Where
- 9 sitesUnited States
- Study dates
- Jul 2000to Aug 2002
- Phase
- Phase 1
- 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 120 years
- Women only
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Histologically confirmed noninvasive or small invasive breast cancer
- Low or intermediate grade (ductal carcinoma in situ, T1, or T2) OR
- Estrogen and/or progesterone receptor positive
- Largest mass no greater than 5 cm
- Clustered microcalcifications as only abnormality allowed with no upper size limit
- If no distinction between mass and microcalcifications, size as 1 lesion
- Lumpectomy or mastectomy must be planned for 2-6 weeks from start of study
- No evidence of metastases from any malignancy
- Hormone receptor status:
- Estrogen and progesterone receptor positive (unless low or intermediate grade tumor)
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Sex:
- Female
Menopausal status:
- Postmenopausal by one of the following:
- Prior oophorectomy
- Over age 50 with prior hysterectomy, ovaries remaining
- Uterus and ovaries intact and no menstrual period for more than 3 months
Performance status:
- Not specified
Life expectancy:
- Not specified
Hematopoietic:
- Platelet count greater than 100,000/mm^3
- Hemoglobin greater than 10 g/dL
- Absolute granulocyte count greater than 1,000/mm^3
Hepatic:
- Albumin greater than 3 g/dL
- Bilirubin less than 1.5 mg/dL
- AST less than 100 U/L
- Alkaline phosphatase less than 200 U/L
Renal:
- Creatinine less than 1.5 mg/dL
Cardiovascular:
- No history of deep vein thrombosis
Pulmonary:
- No prior pulmonary embolus
Other:
- Not pregnant or nursing
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- At least 1 year since prior chemotherapy
Endocrine therapy:
- At least 1 year since prior aromatase inhibitors, antiestrogens, or LH agonists/antagonists
- No concurrent hormone replacement therapy or oral contraceptives (from time of randomization)
Radiotherapy:
- Not specified
Surgery:
- See Disease Characteristics
Other:
- No concurrent treatment for other malignancy
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
University of Alabama at Birmingham Comprehensive Cancer Center
Birmingham, Alabama, 35294-3300
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, 44195
Arthur G. James Cancer Hospital - Ohio State University
Columbus, Ohio, 43210-1240
U.S. Oncology Research Inc.
Dallas, Texas, 75246
University of Kansas Medical Center
Kansas City, Kansas, 66160-7357
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, 90095-1781
Loyola University Medical Center
Maywood, Illinois, 60153
Comprehensive Cancer Centers of the Desert
Palm Springs, California, 92262
Kimmel Cancer Center of Thomas Jefferson University - Philadelphia
Philadelphia, Pennsylvania, 19107-5541
About this study
Official title: A Phase IB Randomized Study of an Antiestrogen in Women With Newly Diagnosed Breast Cancer
RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using tamoxifen or LY353381 may fight breast cancer by blocking the use of estrogen.
PURPOSE: This randomized phase I trial is studying how well tamoxifen works on the biomarkers of the tumor tissue, compared with LY353381, in treating women with newly diagnosed breast cancer.
Read the detailed description
OBJECTIVES:
- Determine whether LY353381 hydrochloride or tamoxifen administered in the interval between biopsy and re-excision alters the expression of tissue biomarkers relative to placebo controls in postmenopausal women with newly diagnosed breast cancer.
OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study.
- Phase I: Patients are randomized to receive either oral LY353381 hydrochloride or oral placebo daily.
Upon completion of phase I, all treatment centers begin phase II of the study.
- Phase II: Patients are randomized to receive either oral tamoxifen or oral placebo daily.
Treatment in both phases continues for 2-6 weeks (until scheduled lumpectomy or mastectomy) in the absence of disease progression or unacceptable toxicity.
Patients are followed at 1 and 2 weeks after surgery.
PROJECTED ACCRUAL: A minimum of 120 patients (60 per treatment phase) will be accrued for this study within 18 months.
- Conditions
- Breast Cancer
- Being tested
- arzoxifene hydrochloride, tamoxifen citrate
- Keywords
- stage I breast cancer, stage II breast cancer, ductal breast carcinoma in situ, breast cancer in situ
- Medical subject headings
- Breast Neoplasms, Carcinoma, Intraductal, Noninfiltrating, Breast Carcinoma In Situ
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
arzoxifene hydrochlorideDrug
tamoxifen citrateDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2003 (estimated)
- Study startJul 2000
- Primary completionAug 2002
- Study completionAug 2002
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 Breast CancerStudies of the same condition, open and under way.
- More trials run by University of Kansas Medical CenterThe 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Masking
- Double blind
Sponsor and investigators
- Lead sponsor
- University of Kansas Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Carol J. Fabian, MD, Study chair, University of Kansas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00005886
- Sponsor's protocol ID
- CDR0000067956
- Other IDs
- KUMC-7813-99, KUMC-HSC-7419-98, NCI-P00-0158
- Status last verified
- Jan 2017
- First submitted
- 2 Jun 2000
- Last updated
- 13 Jan 2017
- Results posted
- No
Publications
Fabian CJ, Kimler BF, Anderson J, Tawfik OW, Mayo MS, Burak WE Jr, O'Shaughnessy JA, Albain KS, Hyams DM, Budd GT, Ganz PA, Sauter ER, Beenken SW, Grizzle WE, Fruehauf JP, Arneson DW, Bacus JW, Lagios MD, Johnson KA, Browne D. Breast cancer chemoprevention phase I evaluation of biomarker modulation by arzoxifene, a third generation selective estrogen receptor modulator. Clin Cancer Res. 2004 Aug 15;10(16):5403-17. doi: 10.1158/1078-0432.CCR-04-0171.
PubMed 15328178
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IB Randomized Study of an Antiestrogen in Women With Newly Diagnosed Breast Cancer
- ClinicalTrials.gov ID
- NCT00005886
- Acronym / sponsor ID
- CDR0000067956
- Conditions
- Breast Cancer
- Keywords
- stage I breast cancer, stage II breast cancer, ductal breast carcinoma in situ, breast cancer in situ
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- University of Kansas Medical CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jul 2000
- Primary completion
- Aug 2002 (actual)
- Study completion
- Aug 2002 (actual)
- First posted
- 29 Aug 2003 (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.
RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using tamoxifen or LY353381 may fight breast cancer by blocking the use of estrogen.
PURPOSE: This randomized phase I trial is studying how well tamoxifen works on the biomarkers of the tumor tissue, compared with LY353381, in treating women with newly diagnosed breast cancer.
Detailed description
OBJECTIVES:
- Determine whether LY353381 hydrochloride or tamoxifen administered in the interval between biopsy and re-excision alters the expression of tissue biomarkers relative to placebo controls in postmenopausal women with newly diagnosed breast cancer.
OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study.
- Phase I: Patients are randomized to receive either oral LY353381 hydrochloride or oral placebo daily.
Upon completion of phase I, all treatment centers begin phase II of the study.
- Phase II: Patients are randomized to receive either oral tamoxifen or oral placebo daily.
Treatment in both phases continues for 2-6 weeks (until scheduled lumpectomy or mastectomy) in the absence of disease progression or unacceptable toxicity.
Patients are followed at 1 and 2 weeks after surgery.
PROJECTED ACCRUAL: A minimum of 120 patients (60 per treatment phase) will be accrued for this study within 18 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 120 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| arzoxifene hydrochloride | Drug | – |
| tamoxifen citrate | Drug | – |
Primary outcome
Not reported in the source record.
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 13 Jan 2017.
- Background: PubMed 15328178Fabian CJ, Kimler BF, Anderson J, Tawfik OW, Mayo MS, Burak WE Jr, O'Shaughnessy JA, Albain KS, Hyams DM, Budd GT, Ganz PA, Sauter ER, Beenken SW, Grizzle WE, Fruehauf JP, Arneson DW, Bacus JW, Lagios MD, Johnson KA, Browne D. Breast cancer chemoprevention phase I evaluation of biomarker modulation by arzoxifene, a third generation selective estrogen receptor modulator. Clin Cancer Res. 2004 Aug 15;10(16):5403-17. doi: 10.1158/1078-0432.CCR-04-0171.
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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.
Carol J. Fabian, MD study chair
University of Kansas
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing arzoxifene hydrochloride and tamoxifen citrate in people with Breast Cancer, run by University of Kansas Medical Center at 9 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?
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 13 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00005886, 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 13 Jan 2017.