Breast CancerPhase 2NCT00193076
Combination Gemcitabine, Carboplatin With or Without Trastuzumab in Patients With Metastatic Breast Cancer
A Phase 2 study testing Gemcitabine, Carboplatin and Trastuzumab in people with Breast Cancer, run by SCRI Development Innovations, LLC at 1 site in United States.
Trial summary
Pre-clinical data suggests that combination therapy with gemcitabine and carboplatin is synergistic, and both drugs may be synergistic with trastuzumab. Additionally, recent clinical data suggest that the combination of gemcitabine with platinum is an active regimen in metastatic breast cancer. 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 Trastuzumab
- How many people
- 96 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2003to Oct 2008
- 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
- To be included in this study, you must meet the following criteria:
- Locally advanced or metastatic breast cancer
- Measurable disease as per RECIST criteria
- No prior chemotherapy in the metastatic breast setting
- Prior chemotherapy and/or hormonal therapy for early stage breast cancer
- Adjuvant Herceptin is allowed
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- Prior radiation therapy in either the metastatic or early stage setting
- Patients may have received any number of hormonal therapies
- Age >18 years
- Only women are eligible for the study
- Able to perform activities of daily living with minimal assistance
- Normal organ and bone marrow function
- Patients who will be receiving Trastuzumab must have normal heart function
- Sign a written informed consent document
Who cannot join
- You cannot participate in this study if any of the following apply to you:
- Received prior chemotherapy for metastatic breast cancer
- Known leptomeningeal carcinomatosis
- Uncontrolled brain metastasis
- Uncontrolled intercurrent illness
- Pregnant or lactating
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- History of other non-breast cancer malignancy
- Received prior chemotherapy for early stage breast cancer within 6 months
- Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase II Trial of Combination Gemcitabine, Carboplatin With or Without Trastuzumab in Patients With Metastatic Breast Cancer
Pre-clinical data suggests that combination therapy with gemcitabine and carboplatin is synergistic, and both drugs may be synergistic with trastuzumab. Additionally, recent clinical data suggest that the combination of gemcitabine with platinum is an active regimen in metastatic breast cancer. This study will test the combination of gemcitabine with carboplatin in patients with metastatic breast cancer. Patients with Her2/neu overexpression will be stratified to receive trastuzumab in addition to gemcitabine and carboplatin.
Read the detailed description
Upon determination of eligibility, all patients will receive the following treatment:
Gemcitabine + Carboplatin
- Conditions
- Breast Cancer
- Being tested
- Gemcitabine, Carboplatin, Trastuzumab
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GemcitabineDrug
Gemcitabine
CarboplatinDrug
Carboplatin
TrastuzumabDrug
Trastuzumab
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall response rates
Measured: 18 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2005 (estimated)
- Study startNov 2003
- Primary completionMay 2006
- Study completionOct 2008
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.
- 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- SCRI Development Innovations, LLC
- Sponsor type
- University, hospital or other
- Collaborators
- Eli Lilly and Company, Genentech, Inc.
- Investigators
- Denise A. Yardley, MD, Principal investigator, SCRI Development Innovations, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00193076
- Sponsor's protocol ID
- SCRI BRE 63
- Other IDs
- B9E-US-S324, H3036S
- Status last verified
- May 2011
- First submitted
- 12 Sep 2005
- Last updated
- 3 May 2011
- Results posted
- No
Publications
Yardley DA, Burris HA 3rd, Simons L, Spigel DR, Greco FA, Barton JH, Shipley D, Drosick D, Hainsworth JD. A phase II trial of gemcitabine/carboplatin with or without trastuzumab in the first-line treatment of patients with metastatic breast cancer. Clin Breast Cancer. 2008 Oct;8(5):425-31. doi: 10.3816/CBC.2008.n.051.
PubMed 18952556
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Trial of Combination Gemcitabine, Carboplatin With or Without Trastuzumab in Patients With Metastatic Breast Cancer
- ClinicalTrials.gov ID
- NCT00193076
- Acronym / sponsor ID
- SCRI BRE 63
- Conditions
- Breast Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- SCRI Development Innovations, LLCUniversity, hospital or other
- Collaborators
- Eli Lilly and Company, Genentech, Inc.
- Study start
- Nov 2003
- Primary completion
- May 2006 (actual)
- Study completion
- Oct 2008 (actual)
- First posted
- 19 Sep 2005 (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.
Pre-clinical data suggests that combination therapy with gemcitabine and carboplatin is synergistic, and both drugs may be synergistic with trastuzumab. Additionally, recent clinical data suggest that the combination of gemcitabine with platinum is an active regimen in metastatic breast cancer. This study will test the combination of gemcitabine with carboplatin in patients with metastatic breast cancer. Patients with Her2/neu overexpression will be stratified to receive trastuzumab in addition to gemcitabine and carboplatin.
Detailed description
Upon determination of eligibility, all patients will receive the following treatment:
Gemcitabine + Carboplatin
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Locally advanced or metastatic breast cancer
- Measurable disease as per RECIST criteria
- No prior chemotherapy in the metastatic breast setting
- Prior chemotherapy and/or hormonal therapy for early stage breast cancer
- Adjuvant Herceptin is allowed
Key exclusion criteria (9 listed)
- Received prior chemotherapy for metastatic breast cancer
- Known leptomeningeal carcinomatosis
- Uncontrolled brain metastasis
- Uncontrolled intercurrent illness
- Pregnant or lactating
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 |
|---|---|---|
| GemcitabineGemcitabine | Drug | – |
| CarboplatinCarboplatin | Drug | – |
| TrastuzumabTrastuzumab | Drug | – |
Primary outcome
Overall response rates
Time frame: 18 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 3 May 2011.
- Results publication: PubMed 18952556Yardley DA, Burris HA 3rd, Simons L, Spigel DR, Greco FA, Barton JH, Shipley D, Drosick D, Hainsworth JD. A phase II trial of gemcitabine/carboplatin with or without trastuzumab in the first-line treatment of patients with metastatic breast cancer. Clin Breast Cancer. 2008 Oct;8(5):425-31. doi: 10.3816/CBC.2008.n.051.
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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.
Denise A. Yardley, MD principal investigator
SCRI Development Innovations, LLC
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 Gemcitabine, Carboplatin and Trastuzumab in people with Breast Cancer, run by SCRI Development Innovations, LLC 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 14 inclusion and 9 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 3 May 2011. 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?
Overall response rates (time frame: 18 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 NCT00193076, 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 3 May 2011.