Recurrent Breast CancerPhase 2NCT00025584
PS-341 in Treating Women With Metastatic Breast Cancer
A Phase 2 study testing bortezomib and laboratory biomarker analysis in people with Recurrent Breast Cancer and Stage IV Breast Cancer, run by National Cancer Institute (NCI) at 1 site in United States.
Trial summary
PS-341 may stop the growth of tumor cells by blocking the enzymes necessary for cancer cell growth. Phase II trial to study the effectiveness of PS-341 in treating women who have metastatic breast cancer Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Recurrent Breast Cancer, Stage IV Breast Cancer
- What is being tested?
- bortezomib and laboratory biomarker analysis
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2001to Aug 2004
- 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
Who may be able to join
- Histologically or cytologically confirmed invasive breast cancer
- Clinical and/or radiological evidence of stage IV disease
- Relapsed or resistant disease within 6-12 months after completion of prior chemotherapy with doxorubicin or epirubicin and/or paclitaxel or docetaxel foradvanced disease or in the adjuvant setting
- At least 1 unidimensionally measurable lesion
- At least 20 mm by conventional techniques
- At least 10 mm by spiral CT scan
Show all 48Show fewer
- No bone metastases as only measurable site
- Pleural or peritoneal effusions not acceptable as measurable disease
- No known brain metastases
- Hormone receptor status:
- Estrogen receptor-negative
- Estrogen receptor-positive
- Female
- Performance status - ECOG 0-2
- Performance status - Karnofsky 60-100%
- More than 12 weeks
- WBC at least 3,000/mm^3
- Absolute neutrophil count at least 1,500/mm^3
- Platelet count at least 100,000/mm^3
- Bilirubin normal
- AST or ALT no greater than 2.5 times upper limit of normal
- Creatinine normal
- Creatinine clearance at least 60 mL/min
- No acute ischemia or significant conduction abnormality by EKG
- No symptomatic congestive heart failure
- No unstable angina pectoris
- No cardiac arrhythmia
- LVEF greater than 50%
- No uncontrolled concurrent illness
- No psychiatric illness or social situation that would preclude study
- No ongoing or active infection
- No prior allergic reaction(s) to compounds of similar chemical or biologic composition to PS-341
- No other malignancy within the past 5 years except carcinoma in situ of the cervix or basal cell skin cancer
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective barrier-method contraception
- See Chemotherapy
- See Disease Characteristics
- No more than 1 prior chemotherapy regimen for metastatic disease
- High-dose regimen or bone marrow transplantation considered 1 prior regimen
- At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered
- Prior hormonal therapy for metastatic disease or in adjuvant setting allowed
- Prior localized radiotherapy allowed if it does not influence the signal evaluable lesion
- At least 4 weeks since prior radiotherapy and recovered
- At least 2 weeks since prior minor surgery and recovered
- At least 4 weeks since prior major surgery and recovered
- No other concurrent investigational agent
- No other concurrent investigational or commercial agents or therapies to treat this malignancy
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase II Trial Of PS-341 In Metastatic Breast Cancer
PS-341 may stop the growth of tumor cells by blocking the enzymes necessary for cancer cell growth. Phase II trial to study the effectiveness of PS-341 in treating women who have metastatic breast cancer
Read the detailed description
PRIMARY OBJECTIVES:
- Determine the efficacy of PS-341, in terms of response rate, in women with metastatic breast cancer.
SECONDARY OBJECTIVES:
- Determine the clinical activity of this drug, in terms of progression-free survival, in these women.
II. Determine the toxicity profile and tolerability of this drug in these women.
III. Determine the pharmacodynamics of this drug in these women.
OUTLINE:
Patients receive PS-341 IV over 3-5 seconds twice weekly on weeks 1 and 2. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
PROJECTED ACCRUAL: A maximum of 12-35 patients will be accrued for this study within 9-12 months.
- Conditions
- Recurrent Breast Cancer, Stage IV Breast Cancer
- Being tested
- bortezomib, laboratory biomarker analysis
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bortezomibDrug
Also called LDP 341, MLN341, VELCADE
Given IV
laboratory biomarker analysisOther
Correlative studies
| Study group | Role | What they receive |
|---|---|---|
| Treatment (bortezomib) | Experimental | Patients receive PS-341 IV over 3-5 seconds twice weekly on weeks 1 and 2. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity. Receives: Drug: bortezomib; Other: laboratory biomarker analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective tumor response (CR + PR)
The agent would be of definite interest for further investigation if the associated response rate is at least 30% (p1), and would not be of further interest if the response rate is below 10% (p0).
Measured: Up to 24 months
Secondary outcomes (4)
Time to progression
Will be reported using the Kaplan-Meier method with 95% confidence intervals indicated.
Measured: Up to 3 years
Overall survival
Will be reported using the Kaplan-Meier method with 95% confidence intervals indicated.
Measured: Up to 3 years
Correlation between variations in the serum levels of adhesion molecules and angiogenic factors
Will be evaluated and descriptive analysis will be performed.
Measured: Up to 24 months
Tissue markers of biological activity
Will be described in case of lesions amenable to tissue biopsy. The plasma pharmacodynamics of PS-341 as measured by the 20S-proteosome assay, will be used to measured the biological activity of the drug and correlated with response to treatment and variations in biomarkers.
Measured: Up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2003 (estimated)
- Study startAug 2001
- Primary completionAug 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent Breast CancerStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Massimo Cristofanilli, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00025584
- Sponsor's protocol ID
- NCI-2012-02422
- Other IDs
- ID00-308, N01CM17003, CDR0000068976
- Status last verified
- Jan 2013
- First submitted
- 11 Oct 2001
- Last updated
- 23 Jan 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Trial Of PS-341 In Metastatic Breast Cancer
- ClinicalTrials.gov ID
- NCT00025584
- Acronym / sponsor ID
- NCI-2012-02422
- Conditions
- Recurrent Breast Cancer, Stage IV Breast Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- Aug 2001
- Primary completion
- Aug 2004 (actual)
- First posted
- 27 Jan 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.
PS-341 may stop the growth of tumor cells by blocking the enzymes necessary for cancer cell growth. Phase II trial to study the effectiveness of PS-341 in treating women who have metastatic breast cancer
Detailed description
PRIMARY OBJECTIVES:
- Determine the efficacy of PS-341, in terms of response rate, in women with metastatic breast cancer.
SECONDARY OBJECTIVES:
- Determine the clinical activity of this drug, in terms of progression-free survival, in these women.
II. Determine the toxicity profile and tolerability of this drug in these women.
III. Determine the pharmacodynamics of this drug in these women.
OUTLINE:
Patients receive PS-341 IV over 3-5 seconds twice weekly on weeks 1 and 2. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
PROJECTED ACCRUAL: A maximum of 12-35 patients will be accrued for this study within 9-12 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment (bortezomib) | Experimental | Drug: bortezomib, Other: laboratory biomarker analysisPatients receive PS-341 IV over 3-5 seconds twice weekly on weeks 1 and 2. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (48 listed)
- Histologically or cytologically confirmed invasive breast cancer
- Relapsed or resistant disease within 6-12 months after completion of prior chemotherapy with doxorubicin or epirubicin and/or paclitaxel or docetaxel foradvanced disease or in the adjuvant setting
- At least 1 unidimensionally measurable lesion
- No known brain metastases
- Hormone receptor status:
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| bortezomibAlso: LDP 341, MLN341, VELCADEGiven IV | Drug | Treatment (bortezomib) |
| laboratory biomarker analysisCorrelative studies | Other | Treatment (bortezomib) |
Primary outcome
Objective tumor response (CR + PR)
Time frame: Up to 24 months
The agent would be of definite interest for further investigation if the associated response rate is at least 30% (p1), and would not be of further interest if the response rate is below 10% (p0).
4 secondary outcomes
Time to progression
Time frame: Up to 3 years
Overall survival
Time frame: Up to 3 years
Correlation between variations in the serum levels of adhesion molecules and angiogenic factors
Time frame: Up to 24 months
Tissue markers of biological activity
Time frame: Up to 24 months
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 23 Jan 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.
Massimo Cristofanilli principal investigator
M.D. Anderson 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 bortezomib and laboratory biomarker analysis in people with Recurrent Breast Cancer and Stage IV Breast Cancer, run by National Cancer Institute (NCI) 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?
The sponsor lists 48 inclusion and 0 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 23 Jan 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.
What does the primary outcome measure?
Objective tumor response (CR + PR) (time frame: Up to 24 months). It is what the study was designed to measure, not a finding.
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 23 Jan 2013.