Breast CancerPhase 2NCT00148668
Preoperative Herceptin/Navelbine Versus Taxotere/Carboplatin/Herceptin in HER-2 Positive Breast Cancer
A Phase 2 study testing Herceptin, Navelbine and Taxotere in people with Breast Cancer, run by Eric Winer, MD at 4 sites in United States.
Trial summary
The purpose of this study is to find out what effects the preoperative combination therapies of herceptin/navelbine or herceptin/taxotere/carboplatin will have on patients with early stage HER-2 positive breast cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Herceptin, Navelbine and Taxotere
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 81 participants
- Where
- 4 sitesUnited States
- Study dates
- Dec 2003to Aug 2011
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with stage II or III breast cancer
- HER-2 positive tumors
- Older than 18 years of age
- Eastern Cooperative Oncology Group (ECOG) Performance Status of greater or equal to 1.
- ANC > 1,500/mm3
- Hemoglobin > 9gm/dl
Show all 10Show fewer
- Platelets > 100,000mm3
- Creatinine < 2mg/dl
- Glucose < 200mg/dl
- Bilirubin < 1.5 x ULN
Who cannot join
- Previous treatment with herceptin, taxanes, doxorubicin or other anthracycline-type therapy, navelbine, or platinum-based therapy.
- Pregnant or breast-feeding women
- Serious illness, or medical or psychiatric condition
- Uncontrolled infections
- Active or severe cardiovascular or pulmonary disease
- Patients with left ventricular ejection fraction < 50%
Show all 9Show fewer
- Peripheral neuropathy of any etiology that exceeds grade 1
- Prior history of malignancy
- Uncontrolled diabetes
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02115
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115
Massachusetts General Hospital
Boston, Massachusetts, 02115
Yale Cancer Center
New Haven, Connecticut, 06520
About this study
Official title: A Randomized Phase II Study of Preoperative Herceptin/Navelbine Versus Taxotere/Carboplatin/Herceptin in Early Stage, HER-2 Positive Breast Cancer
The purpose of this study is to find out what effects the preoperative combination therapies of herceptin/navelbine or herceptin/taxotere/carboplatin will have on patients with early stage HER-2 positive breast cancer.
Read the detailed description
Before starting treatment, a clip will be placed via catheter into the tumor bed, so the surgeon can locate the site of the tumor. During clip placement, tissue biopsy will be taken of the tumor. One to two weeks after the first dose of herceptin another biopsy will be performed.
Patients will be placed into one of 2 arms.
- Arm 1 receives 12 weeks of herceptin and navelbine. Arm 2 receives 4 cycles of taxotere/carboplatin/herceptin.
- Arm 2 participants will also receive neulasta (growth factor support) on day 2 of each cycle.
Phase A of Arm 1 is one dose of herceptin followed by an MRI of the affected breast and a second biopsy 1-2 weeks following this dose. Phase B of Arm 1 begins on week 3 and ends on week 14 and involves weekly injections of herceptin and navelbine. Surgery will take place a minimum of 3 weeks after the patients last dose of herceptin and navelbine.
Phase A of Arm 2 is one dose of herceptin followed by an MRI of the affected breast and second biopsy 1-2 weeks following this dose. Phase B of Arm 2 begins on week 3 and ends on week 14 and involves herceptin weekly, taxotere and carboplatin every 3 weeks. Surgery will take place a minimum of 3 weeks after the patients last dose of herceptin, taxotere and carboplatin.
Blood tests will be performed every 3 weeks during pre-operative treatment and every 6 months after surgery.
- Conditions
- Breast Cancer
- Being tested
- Herceptin, Navelbine, Taxotere, Carboplatin
- Keywords
- HER-2 Positive Breast Cancer, herceptin, navelbine, taxotere, carboplatin, Early stage Breast Cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HerceptinDrug
Also called Trastuzumab
One dose given followed by an MRI, then weekly injections beginning week 3 and ending week 14.
NavelbineDrug
Also called vinorelbine
Weekly injections given starting week 3 and ending week 14
TaxotereDrug
Also called docetaxel
Given every three weeks starting week 3 and ending on week 14
CarboplatinDrug
Also called paraplatin
Given every three weeks starting week 3 and ending on week 14
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Active comparator | Herceptin/navelbine Receives: Drug: Herceptin; Drug: Navelbine |
| Arm 2 | Active comparator | Taxotere/carboplatin/herceptin Receives: Drug: Herceptin; Drug: Taxotere; Drug: Carboplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathological Complete Response After Preoperative Therapy With Herceptin/Navelbine Versus Taxotere/Carboplatin/Herceptin in Patients With HER-2 Positive Early Breast Cancer
Pathological Complete Response is defined as the complete disappearance of invasive tumor in the breast at the time of surgery
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2005 (estimated)
- Study startDec 2003
- Primary completionJan 2009
- Study completionAug 2011
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.
- 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eric Winer, MD
- Sponsor type
- University, hospital or other
- Collaborators
- Dana-Farber Cancer Institute, Brigham and Women's Hospital, Massachusetts General Hospital, Beth Israel Deaconess Medical Center, Yale University
- Responsible party
- Sponsor-investigator, Eric Winer, MD, Dana-Farber Cancer Institute
- Investigators
- Eric Winer, MD, Principal investigator, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00148668
- Sponsor's protocol ID
- 03-311
- Status last verified
- Mar 2013
- First submitted
- 7 Sep 2005
- Last updated
- 9 Apr 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Phase II Study of Preoperative Herceptin/Navelbine Versus Taxotere/Carboplatin/Herceptin in Early Stage, HER-2 Positive Breast Cancer
- ClinicalTrials.gov ID
- NCT00148668
- Acronym / sponsor ID
- 03-311
- Conditions
- Breast Cancer
- Keywords
- HER-2 Positive Breast Cancer, herceptin, navelbine, taxotere, carboplatin, Early stage Breast Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- Eric Winer, MDUniversity, hospital or other
- Collaborators
- Dana-Farber Cancer Institute, Brigham and Women's Hospital, Massachusetts General Hospital, Beth Israel Deaconess Medical Center, Yale University
- Study start
- Dec 2003
- Primary completion
- Jan 2009 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 8 Sep 2005 (estimated)
- Results
- Posted 25 Jan 2013
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 study is to find out what effects the preoperative combination therapies of herceptin/navelbine or herceptin/taxotere/carboplatin will have on patients with early stage HER-2 positive breast cancer.
Detailed description
Before starting treatment, a clip will be placed via catheter into the tumor bed, so the surgeon can locate the site of the tumor. During clip placement, tissue biopsy will be taken of the tumor. One to two weeks after the first dose of herceptin another biopsy will be performed.
Patients will be placed into one of 2 arms.
- Arm 1 receives 12 weeks of herceptin and navelbine. Arm 2 receives 4 cycles of taxotere/carboplatin/herceptin.
- Arm 2 participants will also receive neulasta (growth factor support) on day 2 of each cycle.
Phase A of Arm 1 is one dose of herceptin followed by an MRI of the affected breast and a second biopsy 1-2 weeks following this dose. Phase B of Arm 1 begins on week 3 and ends on week 14 and involves weekly injections of herceptin and navelbine. Surgery will take place a minimum of 3 weeks after the patients last dose of herceptin and navelbine.
Phase A of Arm 2 is one dose of herceptin followed by an MRI of the affected breast and second biopsy 1-2 weeks following this dose. Phase B of Arm 2 begins on week 3 and ends on week 14 and involves herceptin weekly, taxotere and carboplatin every 3 weeks. Surgery will take place a minimum of 3 weeks after the patients last dose of herceptin, taxotere and carboplatin.
Blood tests will be performed every 3 weeks during pre-operative treatment and every 6 months after surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Active comparator | Drug: Herceptin, Drug: NavelbineHerceptin/navelbine |
| Arm 2 | Active comparator | Drug: Herceptin, Drug: Taxotere, Drug: CarboplatinTaxotere/carboplatin/herceptin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Patients with stage II or III breast cancer
- HER-2 positive tumors
- Older than 18 years of age
- Eastern Cooperative Oncology Group (ECOG) Performance Status of greater or equal to 1.
- ANC > 1,500/mm3
Key exclusion criteria (9 listed)
- Previous treatment with herceptin, taxanes, doxorubicin or other anthracycline-type therapy, navelbine, or platinum-based therapy.
- Pregnant or breast-feeding women
- Serious illness, or medical or psychiatric condition
- Uncontrolled infections
- Active or severe cardiovascular or pulmonary disease
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 |
|---|---|---|
| HerceptinAlso: TrastuzumabOne dose given followed by an MRI, then weekly injections beginning week 3 and ending week 14. | Drug | Arm 1, Arm 2 |
| NavelbineAlso: vinorelbineWeekly injections given starting week 3 and ending week 14 | Drug | Arm 1 |
| TaxotereAlso: docetaxelGiven every three weeks starting week 3 and ending on week 14 | Drug | Arm 2 |
| CarboplatinAlso: paraplatinGiven every three weeks starting week 3 and ending on week 14 | Drug | Arm 2 |
Primary outcome
Pathological Complete Response After Preoperative Therapy With Herceptin/Navelbine Versus Taxotere/Carboplatin/Herceptin in Patients With HER-2 Positive Early Breast Cancer
Time frame: 12 weeks
Pathological Complete Response is defined as the complete disappearance of invasive tumor in the breast at the time of surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2013.
- 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.
Eric Winer, MD principal investigator
Dana-Farber Cancer Institute
4 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 Herceptin, Navelbine and Taxotere in people with Breast Cancer, run by Eric Winer, MD at 4 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 10 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 9 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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?
Yes. Results are posted in the registry (first posted 25 Jan 2013). 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?
Pathological Complete Response After Preoperative Therapy With Herceptin/Navelbine Versus Taxotere/Carboplatin/Herceptin in Patients With HER-2 Positive Early Breast Cancer (time frame: 12 weeks). 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 9 Apr 2013.