Breast CancerPhase 2NCT00003428
Hormone Therapy in Treating Women With Breast Cancer
A Phase 2 study testing arzoxifene hydrochloride in people with Breast Cancer, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
Trial summary
RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using arzoxifene hydrochloride may fight breast cancer by blocking the use of estrogen by the tumor cells. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- arzoxifene hydrochloride
- How many people
- 114 participants
- Where
- 1 siteUnited States
- Study dates
- May 1998to Jun 2001
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS: Histologically proven locally advanced or metastatic breast cancer and meeting one of the following criteria: No prior systemic therapy OR Relapsed more than 12 months after stopping adjuvant tamoxifen (tamoxifen- sensitive) OR Relapsed while receiving adjuvant tamoxifen for more than 12 months (tamoxifen-refractory) OR Disease progression while receiving tamoxifen as first-line treatment for metastatic breast cancer (tamoxifen-refractory) Evaluable or bidimensionally measurable disease No rapid disease progression requiring chemotherapy Brain metastases allowed if stable for at least 6 months after surgery or radiotherapy, with no increase in corticosteroids Hormone receptor status: Estrogen receptor positive AND/OR Progesterone receptor positive OR Unknown status allowed if over 50 years old
PATIENT CHARACTERISTICS: Age: 18 and over Sex: Female Menopausal status: Not specified Performance status: ECOG 0-1 Life expectancy: At least 24 weeks Hematopoietic: Granulocyte count at least 1500/mm3 Platelet count at least 100,000/mm3 Hemoglobin at least 9 g/dL, transfusion independent Hepatic: Bilirubin no greater than 1.5 times normal PT/PTT no greater than 1.25 times upper limit of normal (ULN) ALT/AST no greater than 2.5 times ULN Renal: Creatinine less than 1.5 times ULN Calcium no greater than 11 mg/dL No hypercalcemia Other: Not pregnant or nursing Fertile patients must use approved nonhormonal contraceptive during and for 3 months after study No known predisposition to thromboembolic disorder At least 5 years since other primary malignancy except: Adequately treated nonmelanomatous skin cancer Carcinoma in situ of the cervix No serious concurrent systemic disorders incompatible with study
PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent immunotherapy Concurrent hematopoietic growth factor allowed Chemotherapy: No prior chemotherapy for metastatic breast cancer No concurrent chemotherapy Endocrine therapy: No prior hormonal therapy for metastatic breast cancer (except tamoxifen) No concurrent supplemental estrogen or progesterone At least 3 weeks since prior estrogen replacement therapy No other concurrent hormone therapy Radiotherapy: At least 2 weeks since prior radiotherapy Surgery: Not specified Other: At least 4 weeks since prior use of other investigational agents Concurrent bisphosphonate therapy allowed No other concurrent investigational agent
Trial locations and contacts
1 site in 1 country.
United States1 site
Memorial Sloan-Kettering Cancer Center
New York, New York, 10021
About this study
Official title: Phase II Randomized Double-Blind Evaluation of Two Dose Levels of LY353381 Hydrochloride Administered to Women With Locally Advanced or Metastatic Breast Cancer
RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using arzoxifene hydrochloride may fight breast cancer by blocking the use of estrogen by the tumor cells.
PURPOSE: This randomized phase II trial is comparing two different doses of arzoxifene hydrochloride to see how well it works in treating women with advanced or metastatic breast cancer.
Read the detailed description
OBJECTIVES: I. Compare the response rate or clinical benefit rate in patients with locally advanced or metastatic breast cancer treated with 1 of 2 different doses of arzoxifene hydrochloride. II. Compare the response rates and clinical benefit rates for patients with tamoxifen-sensitive versus tamoxifen-refractory disease. III. Compare the degree of toxicity between the 2 doses of arzoxifene hydrochloride in these patients. IV. Compare the quality of life and survival of these patients receiving high versus low dose arzoxifene hydrochloride. V. Determine the time to progressive disease, time to treatment failure, and response duration of this treatment in these patients. VII. Measure changes in serum estradiol, follicle stimulating hormone, luteinizing hormone, and sex hormone binding globulin in these patients during treatment.
OUTLINE: This is a randomized, double blind study. Patients are stratified according to number of metastatic sites (less than 3 vs 3 or more), tamoxifen sensitivity (sensitive vs refractory), and degree of estrogen receptor positivity (high vs low vs unknown). Patients are randomized to receive 1 of 2 doses of arzoxifene hydrochloride. Patients receive arzoxifene hydrochloride orally once daily for 12 weeks. Treatment continues in the absence of toxicity and disease progression. Quality of life is assessed before, during, and at the completion of the study. Patients are followed every 4 weeks for 12 weeks, at 30 days after the last treatment, and every 2-3 months after the last treatment.
PROJECTED ACCRUAL: This study will accrue 104-114 patients.
- Conditions
- Breast Cancer
- Being tested
- arzoxifene hydrochloride
- Keywords
- stage IV breast cancer, recurrent breast cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
arzoxifene hydrochlorideDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2004 (estimated)
- Study startMay 1998
- Primary completionJun 2001
- Study completionJun 2001
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Enrolment
- 114 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Clifford A. Hudis, MD, Study chair, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00003428
- Sponsor's protocol ID
- 98-038
- Other IDs
- CDR0000066453, LILLY-H4Z-MC-JWWD(a), NCI-G98-1451
- Status last verified
- Jun 2013
- First submitted
- 1 Nov 1999
- Last updated
- 24 Jun 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Randomized Double-Blind Evaluation of Two Dose Levels of LY353381 Hydrochloride Administered to Women With Locally Advanced or Metastatic Breast Cancer
- ClinicalTrials.gov ID
- NCT00003428
- Acronym / sponsor ID
- 98-038
- Conditions
- Breast Cancer
- Keywords
- stage IV breast cancer, recurrent breast cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 114 participants (estimated)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- May 1998
- Primary completion
- Jun 2001 (actual)
- Study completion
- Jun 2001 (actual)
- First posted
- 13 Sep 2004 (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 arzoxifene hydrochloride may fight breast cancer by blocking the use of estrogen by the tumor cells.
PURPOSE: This randomized phase II trial is comparing two different doses of arzoxifene hydrochloride to see how well it works in treating women with advanced or metastatic breast cancer.
Detailed description
OBJECTIVES: I. Compare the response rate or clinical benefit rate in patients with locally advanced or metastatic breast cancer treated with 1 of 2 different doses of arzoxifene hydrochloride. II. Compare the response rates and clinical benefit rates for patients with tamoxifen-sensitive versus tamoxifen-refractory disease. III. Compare the degree of toxicity between the 2 doses of arzoxifene hydrochloride in these patients. IV. Compare the quality of life and survival of these patients receiving high versus low dose arzoxifene hydrochloride. V. Determine the time to progressive disease, time to treatment failure, and response duration of this treatment in these patients. VII. Measure changes in serum estradiol, follicle stimulating hormone, luteinizing hormone, and sex hormone binding globulin in these patients during treatment.
OUTLINE: This is a randomized, double blind study. Patients are stratified according to number of metastatic sites (less than 3 vs 3 or more), tamoxifen sensitivity (sensitive vs refractory), and degree of estrogen receptor positivity (high vs low vs unknown). Patients are randomized to receive 1 of 2 doses of arzoxifene hydrochloride. Patients receive arzoxifene hydrochloride orally once daily for 12 weeks. Treatment continues in the absence of toxicity and disease progression. Quality of life is assessed before, during, and at the completion of the study. Patients are followed every 4 weeks for 12 weeks, at 30 days after the last treatment, and every 2-3 months after the last treatment.
PROJECTED ACCRUAL: This study will accrue 104-114 patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
Who may qualify
- Ages
- 18 years and older
- 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 | – |
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 24 Jun 2013.
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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.
Clifford A. Hudis, MD study chair
Memorial Sloan Kettering Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing arzoxifene hydrochloride in people with Breast Cancer, run by Memorial Sloan Kettering Cancer Center at 1 site 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 24 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 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.
Where can I read the original study information?
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 24 Jun 2013.