Breast CancerPhase 2NCT00944047
Evaluate Trastuzumab Plus Standard Chemotherapy Given Before Surgery in Breast Cancer Patients With Low HER 2 Expression
A Phase 2 study testing nab-paclitaxel, trastuzumab and Doxorubicin in people with Breast Cancer, run by University of Kansas Medical Center at 2 sites in United States.
Trial summary
The purpose of this study is to find out if there is a benefit of adding Herceptin (trastuzumab) to standard chemotherapy in this type of breast cancer. 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?
- nab-paclitaxel, trastuzumab and Doxorubicin
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 2 sitesUnited States
- Study dates
- Jul 2009to Aug 2017
- 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
- Female patient ≥ 18 years of age
- Histologically proven stage II or III adenocarcinoma of the breast
- Must be candidate for neoadjuvant treatment (Tumor size ≥ 2 cm, T2, T3, T4 and/or clinical N1 or N2).
- HER-2/neu 1+ or 2+ by immunohistochemistry
- Must have operable tumor.
- Performance status of 2 or better per SWOG criteria
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- LVEF ≥ 55% by echocardiogram performed within 4 weeks prior to treatment initiation
- If patient of childbearing potential, pregnancy test is negative
- Patients with reproductive potential must use an effective method to avoid pregnancy for the duration of the trial.
- Adequate bone marrow function: ANC > 1500/mm3, platelet count > 100,000/mm3, and hemoglobin > 9 g/dL
- Adequate kidney function: serum creatinine of < 1.5mg/dl and/or creatinine clearance of > 60 mL/min
- Adequate hepatic function: transaminases < 2.5 x upper limit of normal and total bilirubin < 1.5 mg/dL
- Must be informed of the investigational nature of the study and must sign an informed consent in accordance with the institutional rules.
- Pretreatment lab values must be performed within 14 days of patient registration, and other baseline studies (with the exception of mammogram) must be performed within 30 days of patient registration.
Who cannot join
- Patient with metastatic breast cancer.
- Women with tumors that are HER-2 neu 0+ or 3+ by immunohistochemistry
- Women with HER 2 FISH amplified tumors (FISH ratio >2.2)
- Patients who have had prior endocrine therapy for > 4 weeks or chemotherapy for this breast cancer will be excluded.
- Locally advanced, inoperable tumors will be excluded.
- The presence of any other medical or psychiatric disorder that, in the opinion of the treating physician, would contraindicate the use of drugs in this protocol or place the subject at undue risk for treatment complications.
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- History of significant cardiac disease, cardiac risk factors or uncontrolled arrhythmias
- Ejection fraction < 55%
- Pregnancy or lactation
- Patients with inadequate laboratory values (as defined above) are excluded from study.
- Patients with NCI common toxicity criteria (CTC) grade 2 or greater peripheral neuropathy are excluded from study.
- Patients with active infection are excluded from study.
- Patients with concomitant or previous malignancies within the last 5 years, are excluded from the study. Exceptions include: adequately treated basal or squamous cell carcinoma of the skin, carcinoma in situ of the cervix, and ductal carcinoma in situ (DCIS).
- Patients with emotional limitations are excluded from study.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Hays Medical Center
Hays, Kansas, 67601
University of Kansas Medical Center Cancer Center
Kansas City, Kansas, 66205
About this study
Official title: Abraxane and Trastuzumab Followed by Dose Dense Doxorubicin and Cyclophosphamide as Neoadjuvant Therapy in Invasive Breast Cancer With Low HER2 Expression (1+ or 2+ by IHC)
The purpose of this study is to find out if there is a benefit of adding Herceptin (trastuzumab) to standard chemotherapy in this type of breast cancer.
Read the detailed description
Neoadjuvant (primary) chemotherapy refers to chemotherapy given before surgery. Neoadjuvant chemotherapy has a number of potential advantages including increasing the chances for breast preservation at the time of surgery as well as it may improve the local control of the cancer. Several national breast cancer studies have shown that neoadjuvant chemotherapy was equal to chemotherapy given following surgery.
A standard treatment for stage II or Stage III invasive breast cancer with low HER2 expression is combination chemotherapyAdriamycin, Cytoxan,followed by a Taxane: given either before or after surgery), followed by surgery +/- radiation therapy.
The main purpose of chemotherapy however is to reduce the risk of recurrence of cancer and also make surgery more successful. HER2 is a receptor located on the surface of some cells. This receptor plays a role in regulating the growth of the cell, in addition to the growth of tumors. High levels of the HER2 receptor may predict those women who benefit from treatment with agents such as Herceptin that target HER2. Herceptin (Trastuzumab) is a drug that is effective both alone and in combination with standard chemotherapy. There is some data to suggest that patients whose tumors have low expression of the HER2 protein and are normal by FISH may also receive benefit from Herceptin.
- Conditions
- Breast Cancer
- Being tested
- nab-paclitaxel, trastuzumab, Doxorubicin, cyclophosphamide, Growth Factor Support
- Keywords
- invasive breast cancer, HER2, primary breast cancer, neo-adjuvant therapy, Trastuzumab, Nab-paclitaxel
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nab-paclitaxelDrug
Also called Abraxane
100 MG/M2 IV over 30 minutes once a week for 12 weeks
trastuzumabDrug
Also called Herceptin
4 MG loading dose followed by 2 MG/KG every week for a total of 12 weeks
DoxorubicinDrug
Also called Adriamycin
60 MG/M2 every two weeks for a total of 4 cycles
cyclophosphamideDrug
Also called Cytoxan
600 MG/M2 every 2 weeks for 4 cycles (administered with Doxorubicin above)
Growth Factor SupportBiological
- All patients will receive pegfilgrastim 6.0 mg sc on Day #2 of each doxorubicin/cyclophosphamide neoadjuvant treatment cycle.
- Erythropoetic growth factor support for fatigue/anemia will be allowed at the discretion of the treating physician.
SurgeryProcedure or surgery
- After completion of neoadjuvant therapy, patients will proceed with either modified radical mastectomy or lumpectomy.
- All patients with pretreatment lymph node positive disease and positive sentinel lymph node will undergo complete axillary lymph node dissection.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Arm | Experimental | Nab-paclitaxel, trastuzumab, doxorubicin, cyclophosphamide, Growth Factor Support, Surgery Receives: Drug: nab-paclitaxel; Drug: trastuzumab; Drug: Doxorubicin; Drug: cyclophosphamide; Biological: Growth Factor Support; Procedure: Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathologic Complete Response
Measured: 22 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2009 (estimated)
- Study startJul 2009
- Primary completionMay 2014
- Study completionAug 2017
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 Kansas Medical CenterThe 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
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Kansas Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Celgene Corporation
- Responsible party
- Sponsor
- Investigators
- Qamar Khan, MD, Principal investigator, University of Kansas Medical Center Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00944047
- Sponsor's protocol ID
- 11368
- Status last verified
- Mar 2018
- First submitted
- 16 Jul 2009
- Last updated
- 23 Apr 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Abraxane and Trastuzumab Followed by Dose Dense Doxorubicin and Cyclophosphamide as Neoadjuvant Therapy in Invasive Breast Cancer With Low HER2 Expression (1+ or 2+ by IHC)
- ClinicalTrials.gov ID
- NCT00944047
- Acronym / sponsor ID
- 11368
- Conditions
- Breast Cancer
- Keywords
- invasive breast cancer, HER2, primary breast cancer, neo-adjuvant therapy, Trastuzumab, Nab-paclitaxel
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- University of Kansas Medical CenterUniversity, hospital or other
- Collaborators
- Celgene Corporation
- Study start
- Jul 2009
- Primary completion
- May 2014 (actual)
- Study completion
- Aug 2017 (actual)
- First posted
- 22 Jul 2009 (estimated)
- Results
- Posted 23 Apr 2018
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 if there is a benefit of adding Herceptin (trastuzumab) to standard chemotherapy in this type of breast cancer.
Detailed description
Neoadjuvant (primary) chemotherapy refers to chemotherapy given before surgery. Neoadjuvant chemotherapy has a number of potential advantages including increasing the chances for breast preservation at the time of surgery as well as it may improve the local control of the cancer. Several national breast cancer studies have shown that neoadjuvant chemotherapy was equal to chemotherapy given following surgery.
A standard treatment for stage II or Stage III invasive breast cancer with low HER2 expression is combination chemotherapyAdriamycin, Cytoxan,followed by a Taxane: given either before or after surgery), followed by surgery +/- radiation therapy.
The main purpose of chemotherapy however is to reduce the risk of recurrence of cancer and also make surgery more successful. HER2 is a receptor located on the surface of some cells. This receptor plays a role in regulating the growth of the cell, in addition to the growth of tumors. High levels of the HER2 receptor may predict those women who benefit from treatment with agents such as Herceptin that target HER2. Herceptin (Trastuzumab) is a drug that is effective both alone and in combination with standard chemotherapy. There is some data to suggest that patients whose tumors have low expression of the HER2 protein and are normal by FISH may also receive benefit from Herceptin.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention Arm | Experimental | Drug: nab-paclitaxel, Drug: trastuzumab, Drug: Doxorubicin, Drug: cyclophosphamide, Biological: Growth Factor Support, Procedure: SurgeryNab-paclitaxel, trastuzumab, doxorubicin, cyclophosphamide, Growth Factor Support, Surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Female patient ≥ 18 years of age
- Histologically proven stage II or III adenocarcinoma of the breast
- Must be candidate for neoadjuvant treatment (Tumor size ≥ 2 cm, T2, T3, T4 and/or clinical N1 or N2).
- HER-2/neu 1+ or 2+ by immunohistochemistry
- Must have operable tumor.
Key exclusion criteria (14 listed)
- Patient with metastatic breast cancer.
- Women with tumors that are HER-2 neu 0+ or 3+ by immunohistochemistry
- Women with HER 2 FISH amplified tumors (FISH ratio >2.2)
- Patients who have had prior endocrine therapy for > 4 weeks or chemotherapy for this breast cancer will be excluded.
- Locally advanced, inoperable tumors will be excluded.
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 |
|---|---|---|
| nab-paclitaxelAlso: Abraxane100 MG/M2 IV over 30 minutes once a week for 12 weeks | Drug | Intervention Arm |
| trastuzumabAlso: Herceptin4 MG loading dose followed by 2 MG/KG every week for a total of 12 weeks | Drug | Intervention Arm |
| DoxorubicinAlso: Adriamycin60 MG/M2 every two weeks for a total of 4 cycles | Drug | Intervention Arm |
| cyclophosphamideAlso: Cytoxan600 MG/M2 every 2 weeks for 4 cycles (administered with Doxorubicin above) | Drug | Intervention Arm |
| Growth Factor Support* All patients will receive pegfilgrastim 6.0 mg sc on Day #2 of each doxorubicin/cyclophosphamide neoadjuvant treatment cycle. * Erythropoetic growth factor support for fatigue/anemia will be allowed at the discretion of the treating physician. | Biological | Intervention Arm |
| Surgery* After completion of neoadjuvant therapy, patients will proceed with either modified radical mastectomy or lumpectomy. * All patients with pretreatment lymph node positive disease and positive sentinel lymph node will undergo complete axillary lymph node dissection. | Procedure or surgery | Intervention Arm |
Primary outcome
Pathologic Complete Response
Time frame: 22 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2018.
- 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.
Qamar Khan, MD principal investigator
University of Kansas Medical Center Cancer Center
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 nab-paclitaxel, trastuzumab and Doxorubicin in people with Breast Cancer, run by University of Kansas Medical Center 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 14 inclusion and 14 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 23 Apr 2018. 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?
Yes. Results are posted in the registry (first posted 23 Apr 2018). 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?
Pathologic Complete Response (time frame: 22 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 23 Apr 2018.