Breast CancerPhase 2NCT00232479
Dose Dense Carboplatin, Taxotere and Herceptin As Primary Systemic Therapy in Breast Cancer
A Phase 2 study testing trastuzumab, docetaxel and carboplatin in dose dense regimen in people with Breast Cancer, run by University of Miami at 1 site in United States.
Trial summary
Dose dense therapy has been shown to increase survival in the adjuvant setting of breast cancer. It is unknown if dose dense therapy will improve survival in tumors that express her-2. 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?
- trastuzumab, docetaxel and carboplatin in dose dense regimen
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2005to Jun 2008
- 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
- HER-2 overexpressing breast cancer
- Clinical stage 2-3B
- Normal ejection fraction
Who cannot join
- Metastatic disease
- Low ejection fraction
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase II Study of Dose Dense Carboplatin and Taxotere With Herceptin As Primary Systemic Therapy in Breast Cancer
Dose dense therapy has been shown to increase survival in the adjuvant setting of breast cancer. It is unknown if dose dense therapy will improve survival in tumors that express her-2. This study evaluates a neoadjuvant regimen containing carboplatin, taxotere and herceptin when used in a dose dense manner in patients with large breast cancers. The endpoint of pathologic complete response is used as a surrogate marker for survival.
Read the detailed description
Dose dense therapy has been shown to increase survival in the adjuvant setting of breast cancer. It is unknown if dose dense therapy will improve survival in tumors that express her-2. This study evaluates a neoadjuvant regimen containing carboplatin, taxotere and herceptin when used in a dose dense manner in patients with large breast cancers. The endpoint of pathologic complete response is used as a surrogate marker for survival.Safety and tolerability assessed by number of grade 4 toxicities and hospitalizations
- Conditions
- Breast Cancer
- Being tested
- trastuzumab, docetaxel and carboplatin in dose dense regimen
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
trastuzumab, docetaxel and carboplatin in dose dense regimenDrug
Also called herceptin, taxotere and carboplatin
trastuzumab 4 mg/kg day 1 and then 2 mg/kg/week x 11, carboplatin 6 mg AUC Day 1, 15, 29, 43, docetaxel 75 mg/meter squared Days 1, 15, 29, 43, neulasta 6 mg Day 2, 16, 30, 44
| Study group | Role | What they receive |
|---|---|---|
| arm 1 | Experimental | single arm study evaluating the efficacy of neoadjuvant taxotere, herceptin and carboplatin given in a dose dense fashion Receives: Drug: trastuzumab, docetaxel and carboplatin in dose dense regimen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients With Pathologic Complete Response (pCR)
pCR is defined as the absence of invasive tumor from the surgical specimen of breast and axilla which is obtained after the chemotherapy regimen has been delivered.
Measured: determined at the time of surgery which is approximately 16 weeks from the beginning of treatment
Secondary outcomes (1)
Safety and Tolerability
the number of patients with grade 4 (severe) toxicities and or hospitalizations were measured to assess safety and tolerability
Measured: from the first dose of chemotherapy until surgery which was approximately 16 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2005 (estimated)
- Study startSep 2005
- Primary completionMay 2008
- Study completionJun 2008
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 Breast CancerStudies of the same condition, open and under way.
- More trials run by University of MiamiThe 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
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Collaborators
- Aventis Pharmaceuticals
- Responsible party
- Principal investigator, Judith Hurley, University of Miami
- Investigators
- Judith Hurley, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00232479
- Sponsor's protocol ID
- SCCC 2004-064
- Status last verified
- Jul 2012
- First submitted
- 30 Sep 2005
- Last updated
- 21 Aug 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Dose Dense Carboplatin and Taxotere With Herceptin As Primary Systemic Therapy in Breast Cancer
- ClinicalTrials.gov ID
- NCT00232479
- Acronym / sponsor ID
- SCCC 2004-064
- Conditions
- Breast Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Collaborators
- Aventis Pharmaceuticals
- Study start
- Sep 2005
- Primary completion
- May 2008 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 4 Oct 2005 (estimated)
- Results
- Posted 21 Aug 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Dose dense therapy has been shown to increase survival in the adjuvant setting of breast cancer. It is unknown if dose dense therapy will improve survival in tumors that express her-2. This study evaluates a neoadjuvant regimen containing carboplatin, taxotere and herceptin when used in a dose dense manner in patients with large breast cancers. The endpoint of pathologic complete response is used as a surrogate marker for survival.
Detailed description
Dose dense therapy has been shown to increase survival in the adjuvant setting of breast cancer. It is unknown if dose dense therapy will improve survival in tumors that express her-2. This study evaluates a neoadjuvant regimen containing carboplatin, taxotere and herceptin when used in a dose dense manner in patients with large breast cancers. The endpoint of pathologic complete response is used as a surrogate marker for survival.Safety and tolerability assessed by number of grade 4 toxicities and hospitalizations
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| arm 1 | Experimental | Drug: trastuzumab, docetaxel and carboplatin in dose dense regimensingle arm study evaluating the efficacy of neoadjuvant taxotere, herceptin and carboplatin given in a dose dense fashion |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- HER-2 overexpressing breast cancer
- Clinical stage 2-3B
- Normal ejection fraction
Key exclusion criteria (2 listed)
- Metastatic disease
- Low ejection fraction
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 |
|---|---|---|
| trastuzumab, docetaxel and carboplatin in dose dense regimenAlso: herceptin, taxotere and carboplatintrastuzumab 4 mg/kg day 1 and then 2 mg/kg/week x 11, carboplatin 6 mg AUC Day 1, 15, 29, 43, docetaxel 75 mg/meter squared Days 1, 15, 29, 43, neulasta 6 mg Day 2, 16, 30, 44 | Drug | arm 1 |
Primary outcome
Number of Patients With Pathologic Complete Response (pCR)
Time frame: determined at the time of surgery which is approximately 16 weeks from the beginning of treatment
pCR is defined as the absence of invasive tumor from the surgical specimen of breast and axilla which is obtained after the chemotherapy regimen has been delivered.
1 secondary outcome
Safety and Tolerability
Time frame: from the first dose of chemotherapy until surgery which was approximately 16 weeks.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Judith Hurley principal investigator
University of Miami
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 trastuzumab, docetaxel and carboplatin in dose dense regimen in people with Breast Cancer, run by University of Miami 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 3 inclusion and 2 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 21 Aug 2012. 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 21 Aug 2012). 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?
Number of Patients With Pathologic Complete Response (pCR) (time frame: determined at the time of surgery which is approximately 16 weeks from the beginning of treatment). 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 21 Aug 2012.