Metastatic Breast CancerPhase 2NCT00574236

Phase II Trial of Bortezomib and Doxorubicin in Metastatic Breast Cancer

A Phase 2 study testing PS-341, doxorubicin in people with Metastatic Breast Cancer, run by University of Wisconsin, Madison at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Primary objective is to determine the effectiveness of the combination of bortezomib and doxorubicin in patients with metastatic breast cancer. The trial format is a single arm Phase II design wherein patients are treated with bortezomib IV on days 1, 4, 8, and 11 and with doxorubicin IV on days 1 and 8 of a 21-day… Read more about this study

Who is it for?: Ages 18 years and older, women only
Conditions the study is for: Metastatic Breast Cancer
What is being tested?: PS-341, doxorubicin
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 4 participants
Where: 1 siteUnited States
Study dates: Aug 2006to Oct 2009
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

Cytologically or histologically confirmed metastatic breast cancer
Measurable or evaluable disease
Age > 18, PS 0,1,2
MUGA > 45%
Received one or fewer chemotherapies or investigational regimens for metastatic disease, no limit to the number of prior hormonal therapies. May have had single agent Herceptin and/or Herceptin plus single-agent chemotx.
Must meet designated laboratory criteria within 14 days of enrollment

Who cannot join

Doxorubicin for metatstatic disease.
Pregnant or lactating.
Active infections, no myocardial infarction within 2 months of enrollment.
Investigational drugs within 14 days of enrollment.
Chemotherapy, radiotherapy, hormonal therapy or other investigational therapy within 4 weeks of enrollment.
Neuropathy that is > grade 2.
Active brain mets.
Hypersensitivity to bortezomib, boron, or mannitol.

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Wisconsin Paul P. Carbone Comprehensive Cancer Center
Madison, Wisconsin, 53792

Other trials in United States

About this study

Official title: A Phase II Trial of Bortezomib and Doxorubicin in Metastatic Breast Cancer

Conditions: Metastatic Breast Cancer
Being tested: PS-341, doxorubicin
Medical subject headings: Breast Neoplasms

What participants receive

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

PS-341, doxorubicinDrug
Also called Velcade, Adriamycin
bortezomib:1.3 mg/m2 IVP over 3-5 sec. days 1, 4, 8, 11 of 21 day cycle doxorubicin: 20 mg/m2 IV over 3-5 min. days 1,8 (one hour after bortezomib) of 21 day cycle

Study groups in NCT00574236
Study group	Role	What they receive
A	Experimental	Not described Receives: Drug: PS-341, doxorubicin

What is being measured

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

Overall Response Rate
Determine the clinical efficacy of bortezomib and doxorubicin in patients with metastatic breast cancer. Overall response rate is defined as both complete and partial response per RECIST, where complete response is the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10mm. Partial response is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Progressive disease is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5mm.
Measured: Every two cycles/42 days, up to 7 months

Secondary outcomes (1)

Time to Progression
Number of days to progression, where progression is defined as the number of days from the day of first study drug administration to the day the patient experiences an event of disease progression, or the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions. If a patient has not experienced an event of disease progression, then the patient's data will be censored at the date of the last available evaluation. Progression-free survival will be summarized by medium time to progression.
Measured: Up to one year

Timeline

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

Aug 2006Oct 2009

First posted17 Dec 2007 (estimated)
Study startAug 2006
Primary completionOct 2009
Study completionOct 2009

Why it stopped: no additional funding

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Metastatic Breast CancerStudies of the same condition, open and under way.
More trials run by University of Wisconsin, MadisonThe 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: 4 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00574236
Sponsor's protocol ID: 2004-0130
Other IDs: CO04101, A534260, SMPH/MEDICINE
Status last verified: Apr 2018
First submitted: 13 Dec 2007
Last updated: 13 Dec 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Metastatic Breast Cancer trials

Study at a glance

From the registry record, last updated by the sponsor on 13 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase II Trial of Bortezomib and Doxorubicin in Metastatic Breast Cancer
ClinicalTrials.gov ID: NCT00574236
Acronym / sponsor ID: 2004-0130
Conditions: Metastatic Breast Cancer
Phase: Phase 2
Study type: Interventional
Recruitment status: TerminatedReason stopped: no additional funding
Enrolment: 4 participants (actual)
Lead sponsor: University of Wisconsin, MadisonUniversity, hospital or other
Collaborators: National Cancer Institute (NCI), Millennium Pharmaceuticals, Inc.
Study start: Aug 2006 (actual)
Primary completion: Oct 2009 (actual)
Study completion: Oct 2009 (actual)
First posted: 17 Dec 2007 (estimated)
Results: Posted 20 Apr 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
A	Experimental	Drug: PS-341, doxorubicin

Who may qualify

Ages: 18 years and older
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Cytologically or histologically confirmed metastatic breast cancer
Measurable or evaluable disease
Age > 18, PS 0,1,2
MUGA > 45%
Received one or fewer chemotherapies or investigational regimens for metastatic disease, no limit to the number of prior hormonal therapies. May have had single agent Herceptin and/or Herceptin plus single-agent chemotx.

Key exclusion criteria (8 listed)

Doxorubicin for metatstatic disease.
Pregnant or lactating.
Active infections, no myocardial infarction within 2 months of enrollment.
Investigational drugs within 14 days of enrollment.
Chemotherapy, radiotherapy, hormonal therapy or other investigational therapy within 4 weeks of enrollment.

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
PS-341, doxorubicinAlso: Velcade, Adriamycinbortezomib:1.3 mg/m2 IVP over 3-5 sec. days 1, 4, 8, 11 of 21 day cycle doxorubicin: 20 mg/m2 IV over 3-5 min. days 1,8 (one hour after bortezomib) of 21 day cycle	Drug	A

Primary outcome

Overall Response Rate
Time frame: Every two cycles/42 days, up to 7 months
Determine the clinical efficacy of bortezomib and doxorubicin in patients with metastatic breast cancer. Overall response rate is defined as both complete and partial response per RECIST, where complete response is the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10mm. Partial response is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Progressive disease is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5mm.

1 secondary outcome

Time to Progression
Time frame: Up to one year

Results and safety

Results posted to the registry on 20 Apr 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Bortezomib and Doxorubicin	4	4

Primary outcome: Overall Response Rate

Time frame: Every two cycles/42 days, up to 7 months. Count of participants. Unit: Participants

Measure	Bortezomib and Doxorubicin n = 4
Complete Response	0
Partial Response	1
Progressive Disease	3

Population analysed: Protocol accrued only 4 of 54 subjects, and was ultimately terminated. No data analysis was done.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Adverse event data were collected for 1 year, 9 months.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Bortezomib and Doxorubicin	0 of 4 (0%)	4 of 4 (100%)	0 of 4

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Metastatic Breast Cancer

RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruiting
Augmented-Reality ICG Fluorescence Second-Look for Residual Nodal Disease After Axillary Dissection in Breast Cancer
Breast Cancer, Breast Neoplasms
RecruitingPhase 2
BrAin Metastasis in tripLe Negateive Breast Cancer: IvoneScimab and Trop2 ADC
Triple-Negative Breast Cancer (TNBC), Brain Metastases
RecruitingPhase 1/2
A Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Patients With Metastatic or Locally Advanced Breast Cancer
Metastatic Breast Cancer
RecruitingObservational study
Collection of CSF Samples From Participants With Metastatic Triple Negative Breast Cancer (TNBC) and HER2+ Breast Cancer With no Prior History Nor Active Radiographically Detectable Brain Metastases
Breast Cancer, Breast Carcinoma

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.

James A Stewart, M.D. principal investigator

University of Wisconsin PPC Comprehensive 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 PS-341, doxorubicin in people with Metastatic Breast Cancer, run by University of Wisconsin, Madison 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 6 inclusion and 8 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: stopped early, as of the sponsor's last update on 13 Dec 2019. 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?

Yes. Results are posted in the registry (first posted 20 Apr 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Overall Response Rate (time frame: Every two cycles/42 days, up to 7 months). 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 NCT00574236.

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 Dec 2019.