Breast CancerPhase 2NCT00136539
Neoadjuvant Therapy With Herceptin and Taxol for Breast Cancer
A Phase 2 study testing Herceptin, Taxol and Adriamycin in people with Breast Cancer, run by Harold J. Burstein, MD, PhD at 2 sites in United States.
Trial summary
The purpose of this study is to determine the effectiveness and safety of administering Herceptin in combination with Taxol (paclitaxel) in the treatment of women with HER2-positive, early stage breast cancer prior to surgery. 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, Taxol and Adriamycin
- Type of treatment
- Injection or infusion
- How many people
- 41 participants
- Where
- 2 sitesUnited States
- Study dates
- Mar 1999to Mar 2012
- 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
- Patients must have Stage II or III histologically diagnosed breast cancer
- Primary invasive breast cancers that overexpress the HER2/neu oncogene
- Age older than 18 years
- Eastern Cooperative Oncology Group (ECOG) performance status of < 1
- White blood cell (WBC) > 4000/mm3
- Platelet count > 100,000/mm3
Show all 10Show fewer
- Bilirubin < 1 x upper limit of normal (ULN)
- SGOT < 1 x ULN
- Creatinine < 1.5mg/dl
- Normal cardiac function and electrocardiogram (EKG) showing absence of ischemic changes or ventricular hypertrophy
Who cannot join
- Excisional biopsy, sentinel node dissection or axillary node dissection.
- Prior history of breast cancer unless: diagnosed at least 2 years ago, present cancer is not in a previously irradiated breast, no prior therapy with anthracycline or taxane, no prior high-dose chemotherapy with stem cell or bone marrow transplant.
- Pregnant or breast-feeding women
- Uncontrolled infection
- Active or severe cardiovascular or pulmonary disease
- Peripheral neuropathy of any etiology that exceeds grade 1
- Prior history of malignancy treated without curative intent
- Uncontrolled diabetes
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115
Massachusetts General Hospital
Boston, Massachusetts, 02115
About this study
Official title: Neoadjuvant Therapy With Herceptin and Taxol for Stage II/III Breast Cancer
The purpose of this study is to determine the effectiveness and safety of administering Herceptin in combination with Taxol (paclitaxel) in the treatment of women with HER2-positive, early stage breast cancer prior to surgery.
Read the detailed description
Patients will receive Herceptin intravenously once weekly for 12 weeks, and Taxol intravenously every 3 weeks (week 1, week 4, week 7 and week 10).
After 12 weeks of treatment, breast surgery will be performed (either a lumpectomy or a mastectomy).
Once patients have recovered from the surgery, they will receive adriamycin and cytoxan every 3 weeks for 4 cycles (12 weeks total).
After Herceptin and Taxol therapy, tumor assessment will be performed along with an echocardiogram and mammogram.
At the time of surgery, re-assessment of the tumor will be done.
Blood work will be performed on day one of each chemotherapy cycle.
- Conditions
- Breast Cancer
- Being tested
- Herceptin, Taxol, Adriamycin, Cytoxan
- Keywords
- Breast Cancer, Early Stage Breast Cancer, HER2-positive, HER2-positive breast cancer, Herceptin, Taxol, Stage II Breast Cancer, Stage III 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
Given intravenously once weekly for 12 weeks prior to surgery.
TaxolDrug
Given intravenously every 3 weeks (weeks 1, 4, 7, and 10) before surgery.
AdriamycinDrug
Given every three weeks for 12 weeks after surgery.
CytoxanDrug
Given every three weeks for 12 weeks after surgery.
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the response of HER2-positive breast cancer to treatment with Herceptin and Taxol prior to surgery
Secondary outcomes (1)
To examine the safety of Herceptin and Taxol therapy followed by surgery and chemotherapy
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2005 (estimated)
- Study startMar 1999
- Primary completionNov 2006
- Study completionMar 2012
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.
- 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
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Harold J. Burstein, MD, PhD
- Sponsor type
- University, hospital or other
- Collaborators
- Dana-Farber Cancer Institute, Genentech, Inc., Bristol-Myers Squibb, Massachusetts General Hospital, Beth Israel Deaconess Medical Center, Harvard Vanguard Medical Associates, Brigham and Women's Hospital
- Responsible party
- Sponsor-investigator, Harold J. Burstein, MD, PhD, Dana-Farber Cancer Institute
- Investigators
- Harold Burstein, MD, PhD, Principal investigator, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00136539
- Sponsor's protocol ID
- 98-222
- Status last verified
- Feb 2013
- First submitted
- 26 Aug 2005
- Last updated
- 18 Feb 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neoadjuvant Therapy With Herceptin and Taxol for Stage II/III Breast Cancer
- ClinicalTrials.gov ID
- NCT00136539
- Acronym / sponsor ID
- 98-222
- Conditions
- Breast Cancer
- Keywords
- Breast Cancer, Early Stage Breast Cancer, HER2-positive, HER2-positive breast cancer, Herceptin, Taxol, Stage II Breast Cancer, Stage III Breast Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Harold J. Burstein, MD, PhDUniversity, hospital or other
- Collaborators
- Dana-Farber Cancer Institute, Genentech, Inc., Bristol-Myers Squibb, Massachusetts General Hospital, Beth Israel Deaconess Medical Center, Harvard Vanguard Medical Associates, Brigham and Women's Hospital
- Study start
- Mar 1999
- Primary completion
- Nov 2006 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 29 Aug 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 determine the effectiveness and safety of administering Herceptin in combination with Taxol (paclitaxel) in the treatment of women with HER2-positive, early stage breast cancer prior to surgery.
Detailed description
Patients will receive Herceptin intravenously once weekly for 12 weeks, and Taxol intravenously every 3 weeks (week 1, week 4, week 7 and week 10).
After 12 weeks of treatment, breast surgery will be performed (either a lumpectomy or a mastectomy).
Once patients have recovered from the surgery, they will receive adriamycin and cytoxan every 3 weeks for 4 cycles (12 weeks total).
After Herceptin and Taxol therapy, tumor assessment will be performed along with an echocardiogram and mammogram.
At the time of surgery, re-assessment of the tumor will be done.
Blood work will be performed on day one of each chemotherapy cycle.
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
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Patients must have Stage II or III histologically diagnosed breast cancer
- Primary invasive breast cancers that overexpress the HER2/neu oncogene
- Age older than 18 years
- Eastern Cooperative Oncology Group (ECOG) performance status of < 1
- White blood cell (WBC) > 4000/mm3
Key exclusion criteria (8 listed)
- Excisional biopsy, sentinel node dissection or axillary node dissection.
- Prior history of breast cancer unless: diagnosed at least 2 years ago, present cancer is not in a previously irradiated breast, no prior therapy with anthracycline or taxane, no prior high-dose chemotherapy with stem cell or bone marrow transplant.
- Pregnant or breast-feeding women
- Uncontrolled infection
- 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 |
|---|---|---|
| HerceptinGiven intravenously once weekly for 12 weeks prior to surgery. | Drug | – |
| TaxolGiven intravenously every 3 weeks (weeks 1, 4, 7, and 10) before surgery. | Drug | – |
| AdriamycinGiven every three weeks for 12 weeks after surgery. | Drug | – |
| CytoxanGiven every three weeks for 12 weeks after surgery. | Drug | – |
Primary outcome
To determine the response of HER2-positive breast cancer to treatment with Herceptin and Taxol prior to surgery
1 secondary outcome
To examine the safety of Herceptin and Taxol therapy followed by surgery and chemotherapy
Time frame: 3 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 18 Feb 2013.
Related trials for Breast Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
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.
Harold Burstein, MD, PhD principal investigator
Dana-Farber Cancer Institute
2 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, Taxol and Adriamycin in people with Breast Cancer, run by Harold J. Burstein, MD, PhD at 2 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 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 18 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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 determine the response of HER2-positive breast cancer to treatment with Herceptin and Taxol prior to surgery. 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 18 Feb 2013.