Breast CancerPhase 2NCT00540358
A Phase 2 Trial of Standard Chemotherapy, With or Without BSI-201, in Patients With Triple Negative Metastatic Breast Cancer
A Phase 2 study testing gemcitabine/carboplatin and iniparib in people with Breast Cancer, run by Sanofi at 18 sites in United States.
Trial summary
The purpose of this clinical trial was to determine whether combining iniparib (BSI-201) with standard chemotherapy in estrogen receptor (ER)-negative, progesterone receptor (PR)-negative, and human epidermal growth factor receptor 2 (HER2) negative metastatic breast cancer patients improve clinical benefit compared… 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?
- gemcitabine/carboplatin and iniparib
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 123 participants
- Where
- 18 sitesUnited States
- Study dates
- Oct 2007to Jun 2010
- 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
- At least 18 years of age;
- Metastatic breast cancer (Stage IV) with measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) criteria;
- 0-2 prior chemotherapy regimens in the metastatic setting;
- Histologically documented (either primary or metastatic site) breast cancer that was ER-negative, PR-negative, and HER-2 nonoverexpressing by immunohistochemistry (0,1) or non-gene amplification by fluorescence in situ hybridization (FISH);
- Completion of prior chemotherapy at least 2 weeks prior to trial entry and recovery from toxicity of prior chemotherapy;
- Radiation therapy must have been completed at least 2 weeks prior to trial entry, and radiated lesions may not have served as measurable disease;
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- Patient may have had central nervous system (CNS) metastases if he/she did not require steroids, whole brain radiation therapy (XRT), gamma/cyber knife, and brain metastases were clinically stable without symptomatic progression;
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1;
- Adequate organ function defined as: absolute neutrophil count (ANC)≥1,500/mm3, platelets ≥100,000/mm3, creatinine clearance >50mL/min, ALT and AST <2.5 x upper limit of normal (ULN) (or <5 x ULN in case of liver metastases); total bilirubin <1.5 mg/dL.
- Tissue block (primary or metastatic) available for PARP and PG studies was recommended, although its absence did not exclude subjects from participating;
- Woman of child bearing potential must have had documented negative pregnancy test within two weeks of trial entry and agreed to acceptable birth control during the duration of the trial therapy;
- Signed, IRB approved written informed consent.
Who cannot join
- Lesions identifiable only by positron emission tomography (PET);
- Prior treatment with gemcitabine, carboplatin, cisplatin or iniparib;
- Major medical conditions that might have affected trial participation (uncontrolled pulmonary, renal, or hepatic dysfunction, uncontrolled infection);
- Significant history of uncontrolled cardiac disease; i.e. uncontrolled hypertension, unstable angina, recent myocardial infarction (within prior 6 months), uncontrolled congestive heart failure, and cardiomyopathy that was either symptomatic or asymptomatic but with decreased ejection fraction <45%;
- Other significant comorbid condition which the investigator felt might compromise effective and safe participation in the trial;
- Patient enrolled in another investigational device or drug trial, or was receiving other investigational agents;
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- Concurrent or prior (within 7 days of trial day 1) anticoagulation therapy (low dose for port maintenance allowed);
- Concurrent radiation therapy was not permitted throughout the course of the trial;
- Inability to comply with the requirements of the trial;
- Pregnant or lactating woman;
- Leptomeningeal disease or brain metastases requiring steroids or other therapeutic intervention.
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
United States18 sites
Research Site
Bedford, Texas
Research Site
Birmingham, Alabama
Research Site
Dallas, Texas
Research Site
Denver, Colorado
Research Site
El Paso, Texas
Research Site
Fairfax, Virginia
Research Site
Fort Worth, Texas
Research Site
Henderson, Nevada
Research Site
Hooksett, New Hampshire
Research Site
Houston, Texas
Research Site
Indianapolis, Indiana
Research Site
Ocoee, Florida
Research Site
Overland Park, Kansas
Research Site
Raleigh, North Carolina
Research Site
Torrington, Connecticut
Research Site
Tyler, Texas
Research Site
Vancouver, Washington
Research Site
Yakima, Washington
About this study
Official title: A Phase 2, Multi-center, Open-Label, Randomized Trial of Gemcitabine/ Carboplatin, With or Without BSI-201, in Patients With ER, PR and HER2-negative Metastatic Breast Cancer
The purpose of this clinical trial was to determine whether combining iniparib (BSI-201) with standard chemotherapy in estrogen receptor (ER)-negative, progesterone receptor (PR)-negative, and human epidermal growth factor receptor 2 (HER2) negative metastatic breast cancer patients improve clinical benefit compared to treatment with standard chemotherapy alone.
Based on data generated by BiPar/Sanofi, it was concluded that iniparib does not possess characteristics typical of the poly (ADP-ribose) polymerase (PARP) inhibitor class. The exact mechanism has not yet been fully elucidated, however based on experiments on tumor cells performed in the laboratory, iniparib is a novel investigational anti-cancer agent that induces gamma-H2AX (a marker of DNA damage) in tumor cell lines, induces cell cycle arrest in the G2/M phase in tumor cell lines, and potentiates the cell cycle effects of DNA damaging modalities in tumor cell lines. Investigations into potential targets of iniparib and its metabolites are ongoing.
Read the detailed description
Patients were treated until disease progression, unacceptable toxicity, Investigator's decision to discontinue, or withdrawal of consent. After treatment discontinuation, all patients were evaluated every 90 days after last dose of gemcitabine/carboplatin with or without iniparib, for up to 3 years or death or end of study, which ever occurred first.
- Conditions
- Breast Cancer
- Being tested
- gemcitabine/carboplatin, iniparib
- Keywords
- Triple negative breast cancer
- Medical subject headings
- Breast Neoplasms, Triple Negative Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
gemcitabine/carboplatinDrug
Gemcitabine and carboplatin administered according to instructions in the package inserts.
iniparibDrug
Also called BSI-201, SAR240550
Body weight adjusted dose
1 hour intravenous infusion
| Study group | Role | What they receive |
|---|---|---|
| Arm G/C | Active comparator | Standard chemotherapy with gemcitabine/carboplatin on Days 1 and 8 of 21-day cycle(s) Receives: Drug: gemcitabine/carboplatin |
| Arm G/C/I | Experimental | Standard chemotherapy with gemcitabine/carboplatin on Days 1 and 8, plus iniparib on Days 1, 4, 8, and 11 of 21-day cycle(s) Receives: Drug: gemcitabine/carboplatin; Drug: iniparib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical benefit rate
Clinical benefit rate was defined as the percentage of patients with complete response, partial response or stable disease ≥6 months.
Measured: until cut-off date established so that all patients were evaluable for primary outcome measure
Secondary outcomes (2)
Objective response rate
Objective response rate was defined as the percentage of patients with confirmed partial response or complete response
Measured: until cut-off date established so that all patients were evaluable for primary outcome measure
Progression-free survival
Progression-free survival was defined as the time interval from the date of randomization to the date of disease progression or the date of death due to any cause, whichever came first.
Measured: until cut-off date established so that all patients were evaluable for primary outcome measure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2007 (estimated)
- Study startOct 2007
- Primary completionNov 2009
- Study completionJun 2010
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 SanofiThe 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
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 123 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- BiPar Sciences
- Responsible party
- Sponsor
- Investigators
- Clinical Sciences & Operations, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00540358
- Sponsor's protocol ID
- TCD11485
- Other IDs
- 20070102
- Status last verified
- Dec 2012
- First submitted
- 4 Oct 2007
- Last updated
- 28 Dec 2012
- Results posted
- No
- Data monitoring committee
- No
- Expanded access
- Available
Publications
O'Shaughnessy J, Osborne C, Pippen JE, Yoffe M, Patt D, Rocha C, Koo IC, Sherman BM, Bradley C. Iniparib plus chemotherapy in metastatic triple-negative breast cancer. N Engl J Med. 2011 Jan 20;364(3):205-14. doi: 10.1056/NEJMoa1011418. Epub 2011 Jan 5.
PubMed 21208101
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Multi-center, Open-Label, Randomized Trial of Gemcitabine/ Carboplatin, With or Without BSI-201, in Patients With ER, PR and HER2-negative Metastatic Breast Cancer
- ClinicalTrials.gov ID
- NCT00540358
- Acronym / sponsor ID
- TCD11485
- Conditions
- Breast Cancer
- Keywords
- Triple negative breast cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 123 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Collaborators
- BiPar Sciences
- Study start
- Oct 2007
- Primary completion
- Nov 2009 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 8 Oct 2007 (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.
The purpose of this clinical trial was to determine whether combining iniparib (BSI-201) with standard chemotherapy in estrogen receptor (ER)-negative, progesterone receptor (PR)-negative, and human epidermal growth factor receptor 2 (HER2) negative metastatic breast cancer patients improve clinical benefit compared to treatment with standard chemotherapy alone.
Based on data generated by BiPar/Sanofi, it was concluded that iniparib does not possess characteristics typical of the poly (ADP-ribose) polymerase (PARP) inhibitor class. The exact mechanism has not yet been fully elucidated, however based on experiments on tumor cells performed in the laboratory, iniparib is a novel investigational anti-cancer agent that induces gamma-H2AX (a marker of DNA damage) in tumor cell lines, induces cell cycle arrest in the G2/M phase in tumor cell lines, and potentiates the cell cycle effects of DNA damaging modalities in tumor cell lines. Investigations into potential targets of iniparib and its metabolites are ongoing.
Detailed description
Patients were treated until disease progression, unacceptable toxicity, Investigator's decision to discontinue, or withdrawal of consent. After treatment discontinuation, all patients were evaluated every 90 days after last dose of gemcitabine/carboplatin with or without iniparib, for up to 3 years or death or end of study, which ever occurred first.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm G/C | Active comparator | Drug: gemcitabine/carboplatinStandard chemotherapy with gemcitabine/carboplatin on Days 1 and 8 of 21-day cycle(s) |
| Arm G/C/I | Experimental | Drug: gemcitabine/carboplatin, Drug: iniparibStandard chemotherapy with gemcitabine/carboplatin on Days 1 and 8, plus iniparib on Days 1, 4, 8, and 11 of 21-day cycle(s) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- At least 18 years of age;
- Metastatic breast cancer (Stage IV) with measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) criteria;
- 0-2 prior chemotherapy regimens in the metastatic setting;
- Histologically documented (either primary or metastatic site) breast cancer that was ER-negative, PR-negative, and HER-2 nonoverexpressing by immunohistochemistry (0,1) or non-gene amplification by fluorescence in situ hybridization (FISH);
- Completion of prior chemotherapy at least 2 weeks prior to trial entry and recovery from toxicity of prior chemotherapy;
Key exclusion criteria (11 listed)
- Lesions identifiable only by positron emission tomography (PET);
- Prior treatment with gemcitabine, carboplatin, cisplatin or iniparib;
- Major medical conditions that might have affected trial participation (uncontrolled pulmonary, renal, or hepatic dysfunction, uncontrolled infection);
- Significant history of uncontrolled cardiac disease; i.e. uncontrolled hypertension, unstable angina, recent myocardial infarction (within prior 6 months), uncontrolled congestive heart failure, and cardiomyopathy that was either symptomatic or asymptomatic but with decreased ejection fraction <45%;
- Other significant comorbid condition which the investigator felt might compromise effective and safe participation in the trial;
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 |
|---|---|---|
| gemcitabine/carboplatinGemcitabine and carboplatin administered according to instructions in the package inserts. | Drug | Arm G/C, Arm G/C/I |
| iniparibAlso: BSI-201, SAR240550Body weight adjusted dose 1 hour intravenous infusion | Drug | Arm G/C/I |
Primary outcome
Clinical benefit rate
Time frame: until cut-off date established so that all patients were evaluable for primary outcome measure
Clinical benefit rate was defined as the percentage of patients with complete response, partial response or stable disease ≥6 months.
2 secondary outcomes
Objective response rate
Time frame: until cut-off date established so that all patients were evaluable for primary outcome measure
Progression-free survival
Time frame: until cut-off date established so that all patients were evaluable for primary outcome measure
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 28 Dec 2012.
- Results publication: PubMed 21208101O'Shaughnessy J, Osborne C, Pippen JE, Yoffe M, Patt D, Rocha C, Koo IC, Sherman BM, Bradley C. Iniparib plus chemotherapy in metastatic triple-negative breast cancer. N Engl J Med. 2011 Jan 20;364(3):205-14. doi: 10.1056/NEJMoa1011418. Epub 2011 Jan 5.
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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.
Clinical Sciences & Operations study director
Sanofi
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing gemcitabine/carboplatin and iniparib in people with Breast Cancer, run by Sanofi at 18 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?
The sponsor lists 12 inclusion and 11 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 28 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 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 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?
Clinical benefit rate (time frame: until cut-off date established so that all patients were evaluable for primary outcome measure). 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 NCT00540358, 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 28 Dec 2012.