Breast CancerPhase 2NCT00148681
Preoperative Herceptin and Navelbine for Breast Cancer
A Phase 2 study testing Herceptin, Navelbine and Doxorubicin in people with Breast Cancer and Stage II Breast Cancer, run by Dana-Farber Cancer Institute at 3 sites in United States.
Trial summary
The purpose of this study is to find out what effects the preoperative combination therapy of herceptin and navelbine have on 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, Stage II Breast Cancer, Stage III Breast Cancer
- What is being tested?
- Herceptin, Navelbine and Doxorubicin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 3 sitesUnited States
- Study dates
- May 2001to May 2003
- 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
- EGOG performance status of 0-1
- HER2 overexpressing (IHC 3+ or FISH +)
- Stage II or III breast cancer. Clinical T1N1M) and inflammatory (T4) breast cancer are eligible
- Patients with metastatic breast cancer (Stage IV) which is limited to supraclavicular and/or infraclavicular node positivity are eligible
- 18 years of age or older
Who cannot join
- Prior therapy with herceptin, paclitaxel or other taxane, doxorubicin or other anthracycline-type chemotherapy, navelbine
- Pregnant or lactating women
- Uncontrolled infections, including AIDS
- History or symptoms diagnostic of systemic connective tissue or inflammatory disease
- Active or severe cardiovascular or pulmonary disease, including recent myocardial infarction or deep-venous thrombosis/pulmonary embolism, congestive heart failure, uncontrolled hypertension, or steroid-dependent asthma.
- Left ventricular ejection fraction < 50%
Show all 9Show fewer
- Peripheral neuropathy of any etiology that exceeds grade 1
- Prior history of malignancy treated without curative intent
- Uncontrolled diabetes
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Massachusetts General Hospital
Boston, Massachusetts, 02114
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Dana-Farber Cancer Center
Boston, Massachusetts, 02215
About this study
Official title: Preoperative Herceptin and Navelbine in Early Stage, HER-2 Positive Breast Cancer
The purpose of this study is to find out what effects the preoperative combination therapy of herceptin and navelbine have on HER-2 positive breast cancer.
Read the detailed description
- As part of the patients pre-treatment evaluation, a clip will be placed within the tumor bed so that the surgeon can find it at the time of surgery. Four biopsies of the tumor will be obtained at the time of the clip placement for further testing at a later date.
- Depending upon the patient's risk level (as assessed by the treating physician), they will be treated similarly to one of two regimens. The first 8 months of both regimens are the same consisting of 12 weeks of herceptin and navelbine, followed by surgery and then 4 cycles of adriamycin and cytoxan. The treatment following these 8 months will depend upon the health risk to the patient and will be determined by both the patient and treating physician.
- Group 1: Lower Risk Regimen: Patients in this group will receive 3 phases of treatment. In Phase A they will receive Navelbine and Herceptin intravenously every week for 12 weeks. Upon completion of this therapy they will undergo surgery to remove the tumor. Following surgery there will be a 6 week recovery period where no treatment will be received. In Phase B, patients will receive adriamycin (doxorubicin) and cytoxan (cyclophosphamide) intravenously every 3 weeks for 12 weeks, for a total of 4 cycles. Patients then may or may not receive Phase C (depending upon physicians discretion), during which they will receive herceptin intravenously every 3 weeks for 40 weeks. If the physician decides that the patient needs radiation therapy, it will commence after the completion of adriamycin and cytoxan.
- Group 2: Higher Risk Regimen: Patients in this group will undergo four different phases of treatment. Phase A is identical to that of Group 1 (herceptin and navelbine for 12 weeks followed by surgery) as is Phase B (adriamycin and cytoxan every 3 weeks for 12 weeks for a total of 4 cycles). Phase C will consist of paclitaxel and herceptin weekly for a total of 12 weeks. If the physician decides that radiation therapy should be performed, it will commence within 6 weeks of the last dose of paclitaxel and herceptin. In Phase D, patients will receive herceptin intravenously every three weeks for 28 weeks.
- The following procedures and tests will be performed during this study: During Phase A: Every week: blood work; Every 3 weeks: physical exam, tumor assessment and bloodwork. During Phase B: Every 3 weeks; physical exam and blood work. At the start of Phase B and C: physical exam, EKG, MUGA scan or echocardiogram and bloodwork. During Phase C: Every 3 weeks for High risk patients and every 3 months for low risk patients; physical exam and blood work. End of Phase C: MUGA scan or echocardiogram. Phase C and D: every 3 months; physical exam, EGK, MUGA scan or echocardiogram and bloodwork.
- At the end of the study patients will undergo a physical exam, EKG, MUGA scan or echocardiogram and bloodwork.
- Being tested
- Herceptin, Navelbine, Doxorubicin, Cyclophosphamide, Paclitaxel
- Keywords
- HER-2 Positive breast cancer, herceptin, navelbine
- 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
Intravenously every week for 12 weeks (weeks 1-12) Intravenously every three weeks for 40 weeks (weeks 32-72)
NavelbineDrug
Intravenously every week for 12 weeks
DoxorubicinDrug
Also called adriamycin
Every 3 weeks for 12 weeks
CyclophosphamideDrug
Also called Cytoxan
Intravenously every 3 weeks for 12 weeks
PaclitaxelDrug
Also called Taxol
Weekly for 12 weeks (or a similar schedule)
| Study group | Role | What they receive |
|---|---|---|
| Lower Risk Regimen | Experimental | Not described Receives: Drug: Herceptin; Drug: Navelbine; Drug: Doxorubicin; Drug: Cyclophosphamide |
| Higher Risk Regimen | Experimental | Not described Receives: Drug: Herceptin; Drug: Navelbine; Drug: Doxorubicin; Drug: Cyclophosphamide; Drug: Paclitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the complete response rate after preoperative herceptin and navelbine in HER-2 positive breast cancer.
Measured: 2 years
Secondary outcomes (1)
To determine the safety of herceptin and navelbine in this patient population (either high risk or low risk).
Measured: 2 years
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 startMay 2001
- Primary completionMay 2003
- Study completionMay 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Dana-Farber Cancer InstituteThe 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dana-Farber Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Massachusetts General Hospital, Beth Israel Deaconess Medical Center, Brigham and Women's Hospital
- Responsible party
- Principal investigator, Eric P Winer, MD, Dana-Farber Cancer Institute
- Investigators
- Eric Winer, MD, Principal investigator, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00148681
- Sponsor's protocol ID
- 00-273
- Status last verified
- Jan 2019
- First submitted
- 7 Sep 2005
- Last updated
- 15 Jan 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoperative Herceptin and Navelbine in Early Stage, HER-2 Positive Breast Cancer
- ClinicalTrials.gov ID
- NCT00148681
- Acronym / sponsor ID
- 00-273
- Keywords
- HER-2 Positive breast cancer, herceptin, navelbine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Dana-Farber Cancer InstituteUniversity, hospital or other
- Collaborators
- Massachusetts General Hospital, Beth Israel Deaconess Medical Center, Brigham and Women's Hospital
- Study start
- May 2001
- Primary completion
- May 2003 (actual)
- Study completion
- May 2003 (actual)
- First posted
- 8 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.
The purpose of this study is to find out what effects the preoperative combination therapy of herceptin and navelbine have on HER-2 positive breast cancer.
Detailed description
- As part of the patients pre-treatment evaluation, a clip will be placed within the tumor bed so that the surgeon can find it at the time of surgery. Four biopsies of the tumor will be obtained at the time of the clip placement for further testing at a later date.
- Depending upon the patient's risk level (as assessed by the treating physician), they will be treated similarly to one of two regimens. The first 8 months of both regimens are the same consisting of 12 weeks of herceptin and navelbine, followed by surgery and then 4 cycles of adriamycin and cytoxan. The treatment following these 8 months will depend upon the health risk to the patient and will be determined by both the patient and treating physician.
- Group 1: Lower Risk Regimen: Patients in this group will receive 3 phases of treatment. In Phase A they will receive Navelbine and Herceptin intravenously every week for 12 weeks. Upon completion of this therapy they will undergo surgery to remove the tumor. Following surgery there will be a 6 week recovery period where no treatment will be received. In Phase B, patients will receive adriamycin (doxorubicin) and cytoxan (cyclophosphamide) intravenously every 3 weeks for 12 weeks, for a total of 4 cycles. Patients then may or may not receive Phase C (depending upon physicians discretion), during which they will receive herceptin intravenously every 3 weeks for 40 weeks. If the physician decides that the patient needs radiation therapy, it will commence after the completion of adriamycin and cytoxan.
- Group 2: Higher Risk Regimen: Patients in this group will undergo four different phases of treatment. Phase A is identical to that of Group 1 (herceptin and navelbine for 12 weeks followed by surgery) as is Phase B (adriamycin and cytoxan every 3 weeks for 12 weeks for a total of 4 cycles). Phase C will consist of paclitaxel and herceptin weekly for a total of 12 weeks. If the physician decides that radiation therapy should be performed, it will commence within 6 weeks of the last dose of paclitaxel and herceptin. In Phase D, patients will receive herceptin intravenously every three weeks for 28 weeks.
- The following procedures and tests will be performed during this study: During Phase A: Every week: blood work; Every 3 weeks: physical exam, tumor assessment and bloodwork. During Phase B: Every 3 weeks; physical exam and blood work. At the start of Phase B and C: physical exam, EKG, MUGA scan or echocardiogram and bloodwork. During Phase C: Every 3 weeks for High risk patients and every 3 months for low risk patients; physical exam and blood work. End of Phase C: MUGA scan or echocardiogram. Phase C and D: every 3 months; physical exam, EGK, MUGA scan or echocardiogram and bloodwork.
- At the end of the study patients will undergo a physical exam, EKG, MUGA scan or echocardiogram and bloodwork.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lower Risk Regimen | Experimental | Drug: Herceptin, Drug: Navelbine, Drug: Doxorubicin, Drug: Cyclophosphamide |
| Higher Risk Regimen | Experimental | Drug: Herceptin, Drug: Navelbine, Drug: Doxorubicin, Drug: Cyclophosphamide, Drug: Paclitaxel |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- EGOG performance status of 0-1
- HER2 overexpressing (IHC 3+ or FISH +)
- Stage II or III breast cancer. Clinical T1N1M) and inflammatory (T4) breast cancer are eligible
- Patients with metastatic breast cancer (Stage IV) which is limited to supraclavicular and/or infraclavicular node positivity are eligible
- 18 years of age or older
Key exclusion criteria (9 listed)
- Prior therapy with herceptin, paclitaxel or other taxane, doxorubicin or other anthracycline-type chemotherapy, navelbine
- Pregnant or lactating women
- Uncontrolled infections, including AIDS
- History or symptoms diagnostic of systemic connective tissue or inflammatory disease
- Active or severe cardiovascular or pulmonary disease, including recent myocardial infarction or deep-venous thrombosis/pulmonary embolism, congestive heart failure, uncontrolled hypertension, or steroid-dependent asthma.
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 |
|---|---|---|
| HerceptinIntravenously every week for 12 weeks (weeks 1-12) Intravenously every three weeks for 40 weeks (weeks 32-72) | Drug | Higher Risk Regimen, Lower Risk Regimen |
| NavelbineIntravenously every week for 12 weeks | Drug | Higher Risk Regimen, Lower Risk Regimen |
| DoxorubicinAlso: adriamycinEvery 3 weeks for 12 weeks | Drug | Higher Risk Regimen, Lower Risk Regimen |
| CyclophosphamideAlso: CytoxanIntravenously every 3 weeks for 12 weeks | Drug | Higher Risk Regimen, Lower Risk Regimen |
| PaclitaxelAlso: TaxolWeekly for 12 weeks (or a similar schedule) | Drug | Higher Risk Regimen |
Primary outcome
To assess the complete response rate after preoperative herceptin and navelbine in HER-2 positive breast cancer.
Time frame: 2 years
1 secondary outcome
To determine the safety of herceptin and navelbine in this patient population (either high risk or low risk).
Time frame: 2 years
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 15 Jan 2019.
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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
3 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 Doxorubicin in people with Breast Cancer and Stage II Breast Cancer, run by Dana-Farber Cancer Institute at 3 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 5 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 15 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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?
To assess the complete response rate after preoperative herceptin and navelbine in HER-2 positive breast cancer. (time frame: 2 years). 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 15 Jan 2019.