Metastatic Breast CancerPhase 2NCT01423695
Weekly Paclitaxel and Trastuzumab in Metastatic Breast Cancer
A Phase 2 study testing paclitaxel plus trastuzumab in people with Metastatic Breast Cancer, run by WiSP Wissenschaftlicher Service Pharma GmbH at 1 site in Germany.
Trial summary
The 3 weekly combination of trastuzumab and paclitaxel has been approved for the treatment of advanced breast cancer based on a large pivotal study. However, mono and combination chemotherapy trials suggest that weekly paclitaxel has a better therapeutic index, especially in the palliative setting. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Breast Cancer
- What is being tested?
- paclitaxel plus trastuzumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 121 participants
- Where
- 1 siteGermany
- Study dates
- Feb 2001to Dec 2009
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- histologically confirmed metastatic breast cancer overexpressing HER2
- pretreatment with anthracycline in either the adjuvant or palliative setting.
- HER2 positivity was defined as 2+ or 3+ overexpression using the DAKO HercepTest, confirmed by fluorescence in-situ hybridization (FISH) if 2+.
- informed consent
Who cannot join
- more than 1 chemotherapy for advanced disease
- taxane or trastuzumab pretreatment
- brain metastases
- Eastern Cooperative Oncology Group (ECOG) performance status >1
- pregnancy or lactation, childbearing potential without reliable contraception
- clinically significant cardiac disease,
- neutrophils <1500/µl, platelets <75,000/µl
- total bilirubin and creatinine >1.5 × the upper limit of normal
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Weekly Application of Trastuzumab and Paclitaxel in the Treatment of HER2-overexpressing Metastatic Breast Cancer
The 3 weekly combination of trastuzumab and paclitaxel has been approved for the treatment of advanced breast cancer based on a large pivotal study. However, mono and combination chemotherapy trials suggest that weekly paclitaxel has a better therapeutic index, especially in the palliative setting. The present trial examines the efficacy and safety of weekly paclitaxel over a limited duration combined with continued trastuzumab in HER2+ patients.
- Conditions
- Metastatic Breast Cancer
- Being tested
- paclitaxel plus 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.
paclitaxel plus trastuzumabDrug
Weekly paclitaxel (90 mg/m² iv, 12 courses) plus weekly trastuzumab (4mg/kg body weight iv as loading dose, 2 mg/kg iv from week 2 onwards; continued until disease progression)
| Study group | Role | What they receive |
|---|---|---|
| paclitaxel/trastuzumab | Experimental | Single experimental arm in a phase II trial Receives: Drug: paclitaxel plus trastuzumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival
Measured: Patient follow-up on average for 15 months and up to a maximum of 51 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2011 (estimated)
- Study startFeb 2001
- Primary completionDec 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic 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
- 121 participants (actual)
Sponsor and investigators
- Lead sponsor
- WiSP Wissenschaftlicher Service Pharma GmbH
- Sponsor type
- University, hospital or other
- Collaborators
- Bristol-Myers Squibb, Roche Pharma AG
- Responsible party
- Sponsor
- Investigators
- Matthias John, MD, Principal investigator, Oncology Practice, Glauchau
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01423695
- Sponsor's protocol ID
- WISP_RO78
- Status last verified
- Aug 2011
- First submitted
- 25 Aug 2011
- Last updated
- 26 Aug 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Weekly Application of Trastuzumab and Paclitaxel in the Treatment of HER2-overexpressing Metastatic Breast Cancer
- ClinicalTrials.gov ID
- NCT01423695
- Acronym / sponsor ID
- WISP_RO78
- Conditions
- Metastatic Breast Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 121 participants (actual)
- Lead sponsor
- WiSP Wissenschaftlicher Service Pharma GmbHUniversity, hospital or other
- Collaborators
- Bristol-Myers Squibb, Roche Pharma AG
- Study start
- Feb 2001
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 26 Aug 2011 (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 3 weekly combination of trastuzumab and paclitaxel has been approved for the treatment of advanced breast cancer based on a large pivotal study. However, mono and combination chemotherapy trials suggest that weekly paclitaxel has a better therapeutic index, especially in the palliative setting. The present trial examines the efficacy and safety of weekly paclitaxel over a limited duration combined with continued trastuzumab in HER2+ patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| paclitaxel/trastuzumab | Experimental | Drug: paclitaxel plus trastuzumabSingle experimental arm in a phase II trial |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- histologically confirmed metastatic breast cancer overexpressing HER2
- pretreatment with anthracycline in either the adjuvant or palliative setting.
- HER2 positivity was defined as 2+ or 3+ overexpression using the DAKO HercepTest, confirmed by fluorescence in-situ hybridization (FISH) if 2+.
- informed consent
Key exclusion criteria (8 listed)
- more than 1 chemotherapy for advanced disease
- taxane or trastuzumab pretreatment
- brain metastases
- Eastern Cooperative Oncology Group (ECOG) performance status >1
- pregnancy or lactation, childbearing potential without reliable contraception
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 |
|---|---|---|
| paclitaxel plus trastuzumabWeekly paclitaxel (90 mg/m² iv, 12 courses) plus weekly trastuzumab (4mg/kg body weight iv as loading dose, 2 mg/kg iv from week 2 onwards; continued until disease progression) | Drug | paclitaxel/trastuzumab |
Primary outcome
Progression-free survival
Time frame: Patient follow-up on average for 15 months and up to a maximum of 51 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 26 Aug 2011.
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.
Matthias John, MD principal investigator
Oncology Practice, Glauchau
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 paclitaxel plus trastuzumab in people with Metastatic Breast Cancer, run by WiSP Wissenschaftlicher Service Pharma GmbH at 1 site in Germany.
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 4 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: finished, as of the sponsor's last update on 26 Aug 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 Germany. 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?
Progression-free survival (time frame: Patient follow-up on average for 15 months and up to a maximum of 51 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 26 Aug 2011.