Breast CancerPhase 2NCT00503750
Phase II Neoadjuvant Trial of Trastuzumab in Combination With Dose-Dense ABI-007 (Abraxane™)
A Phase 2 study testing Pre operativeTrastuzumab, ABI-007 (Abraxane) and Vinorelbine in people with Breast Cancer, run by Emory University at 2 sites in United States.
Trial summary
This is a phase II one arm study. Patients with HER2 (Human Epidermal Growth Factor Receptor 2)positive early stage breast cancer will receive ABI-007 and vinorelbine in combination with trastuzumab before having breast 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?
- Pre operativeTrastuzumab, ABI-007 (Abraxane) and Vinorelbine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 2 sitesUnited States
- Study dates
- Apr 2008to Jul 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
- Histologically or cytologically confirmed invasive breast carcinoma.
- Early stage breast cancer - stage I (tumor size greater than 1 cm), II and IIA.
- 3+ HER2 overexpression by IHC or 2+ HER2 overexpression and FISH positivity.
- Patients must have measurable disease as defined by palpable lesion with both diameters greater than or equal to 1 cm measurable with caliper and/or a positive mammogram or ultrasound with at least one dimension greater than or equal to 1 cm. Bilateral mammogram and clip placement is required for study entry. Baseline measurements of the indicator lesions must be recorded on the patient registration form. To be valid for baseline, the measurements must have been made within the 14 days (4-6 weeks for x-rays and scans) immediately preceding patient's entry in study.
- ECOG performance status 0 to 2 within 14 days of study entry.
- Normal (greater than 50%) left ventricular ejection fraction (LVEF) by MUGA scan or echocardiography.
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- Must be 18 years of age or older.
- Women or men of childbearing potential must use a reliable and appropriate contraceptive method. Postmenopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential.
- Final eligibility for a clinical trial is determined by the health professionals conducting the trial.
Who cannot join
- Evidence of disease outside the breast or chest wall, except ipsilateral axillary lymph nodes.
- Prior chemotherapy, hormonal therapy, biologic therapy or radiation therapy for breast cancer. Patients with history of DCIS are eligible if they were treated with surgery alone.
- Medical, psychological, or surgical condition which the investigator feels might compromise study participation.
- Pregnant or lactating women are not eligible.
- Patients with history of previous or current malignancy at other sites with the exception of adequately treated carcinoma in situ of the cervix or basal or squamous cell carcinoma of the skin. Patients with a history of other malignancies who remain disease free for greater than five years are eligible.
- Evidence of sensory and/or peripheral neuropathy.
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- Serious, uncontrolled, concurrent infections.
- Major surgery within 4 weeks of the start of study treatment without complete recovery.
- Final eligibility for a clinical trial is determined by the health professionals conducting the trial.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Piedmont Hospital Research Institute
Atlanta, Georgia, 30309
Emory University Winship Cancer Institute
Atlanta, Georgia, 30322
About this study
Official title: Phase II Neoadjuvant Trial of Trastuzumab in Combination With Dose-Dense ABI-007 (Abraxane™) Followed by Vinorelbine for HER2 Overexpressing Early Stage Breast Cancer
This is a phase II one arm study. Patients with HER2 (Human Epidermal Growth Factor Receptor 2)positive early stage breast cancer will receive ABI-007 and vinorelbine in combination with trastuzumab before having breast surgery.
Read the detailed description
This is a phase II one arm study. Patients with HER2(Human Epidermal Growth Factor Receptor 2) positive early stage breast cancer will receive ABI-007 and vinorelbine in combination with trastuzumab before having breast surgery.
Approximately 50 patients will take part at multi-sites with potentially 20 patients participating at the Emory Winship Cancer Institute, Grady Memorial Hospital, and Emory Crawford Long Hospital in Atlanta, Georgia.
- Conditions
- Breast Cancer
- Being tested
- Pre operativeTrastuzumab, ABI-007 (Abraxane), Vinorelbine
- Keywords
- 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.
Pre operativeTrastuzumabDrug
Trastuzumab one-time loading dose of 4 mg/kg as 90 minute infusion, followed by 20 weekly treatments at 2 mg/kg as 30 minute infusion.
As per standard treatment of HER2-positive breast cancers, patients will continue to receive trastuzumab every 3 weeks at 6 mg/kg beginning week 21 through week 52.
ABI-007 (Abraxane)Drug
ABI-007 will be administered every 2 weeks at a dose of 260mg/m2 as 30 minute infusion on the same days as trastuzumab for a total of 4 cycles (weeks 1 -8).
VinorelbineDrug
Beginning week 9, patients will then receive weekly vinorelbine at a dose of 25mg/m2 for 12 weeks on the same day as trastuzumab for a total of 4 cycles (weeks 9-20).
| Study group | Role | What they receive |
|---|---|---|
| Trastuzumab and Abraxane followed Trastuzumab and Vinorelbine | Active comparator | Patients will be treated sequentially with preoperative trastuzumab and dose-dense ABI-007 followed by trastuzumab in combination with vinorelbine. Trastuzumab will be administered as a one-time loading dose of 4 mg/kg as a 90 minute infusion, followed by 20 weekly treatments at 2 mg/kg as a 30 minute infusion. ABI-007 will be administered every 2 weeks at a dose of 260mg/m2 as 30 minute infusion on the same days as trastuzumab for a total of 4 cycles (weeks 1 -8). Growth factor support with pegfilgrastim (Neulasta®) is required 24 to 48 hours following completion of each cycle of ABI-007. Beginning week 9, patients will then receive weekly vinorelbine at a dose of 25mg/m2 for 12 weeks on the same day as trastuzumab for a total of 4 cycles (weeks 9-20). As per standard treatment of HER2-positive breast cancers, patients will continue to receive trastuzumab every 3 weeks at 6 mg/kg beginning week 21 through week 52. Receives: Drug: Pre operativeTrastuzumab; Drug: ABI-007 (Abraxane); Drug: Vinorelbine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Complete Pathologic Response.
Pathologic complete response (pCR): Absence of invasive breast cancer in the breast (mastectomy or lumpectomy) specimen at the time of definitive surgery. Presence of in situ cancer alone will be considered a pCR.
Although clinical examination is the primary method of determining response, radiologic assessments (mammogram, ultrasound ± MRI) may be used to confirm response/non-response.
Measured: assess at 8 weeks
Secondary outcomes (1)
Number of Participants Who Had Complete Clinical Resposnse, Partial Response and Stable Disease.
Complete clinical response (CCR): complete disappearance of all measurable malignant disease. No new malignant lesion, disease-related symptoms or evidence of non-evaluable disease.
Partial response (PR): Reduction by at least 50% of the sum of the products of the longest perpendicular diameters of all measurable lesions.
Stable disease (SD): For bidimensionally measurable disease, no decrease or <25% increase in the sum of the products of the longest perpendicular diameters of all measurable lesions.
Measured: clinic examination every 2 weeks, evaluated every 3 months for 2 years post-op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2007 (estimated)
- Study startApr 2008
- Primary completionJul 2011
- Study completionJul 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.
- More trials run by Emory UniversityThe 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
- Single group
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ruth O'Regan, Emory University
- Investigators
- Ruth O'Regan, MD, Principal investigator, Emory University Winship Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00503750
- Sponsor's protocol ID
- 0495-2006
- Status last verified
- Jun 2012
- First submitted
- 17 Jul 2007
- Last updated
- 25 Jun 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Neoadjuvant Trial of Trastuzumab in Combination With Dose-Dense ABI-007 (Abraxane™) Followed by Vinorelbine for HER2 Overexpressing Early Stage Breast Cancer
- ClinicalTrials.gov ID
- NCT00503750
- Acronym / sponsor ID
- 0495-2006
- Conditions
- Breast Cancer
- Keywords
- Breast Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Study start
- Apr 2008
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 19 Jul 2007 (estimated)
- Results
- Posted 14 Jun 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a phase II one arm study. Patients with HER2 (Human Epidermal Growth Factor Receptor 2)positive early stage breast cancer will receive ABI-007 and vinorelbine in combination with trastuzumab before having breast surgery.
Detailed description
This is a phase II one arm study. Patients with HER2(Human Epidermal Growth Factor Receptor 2) positive early stage breast cancer will receive ABI-007 and vinorelbine in combination with trastuzumab before having breast surgery.
Approximately 50 patients will take part at multi-sites with potentially 20 patients participating at the Emory Winship Cancer Institute, Grady Memorial Hospital, and Emory Crawford Long Hospital in Atlanta, Georgia.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Trastuzumab and Abraxane followed Trastuzumab and Vinorelbine | Active comparator | Drug: Pre operativeTrastuzumab, Drug: ABI-007 (Abraxane), Drug: VinorelbinePatients will be treated sequentially with preoperative trastuzumab and dose-dense ABI-007 followed by trastuzumab in combination with vinorelbine. Trastuzumab will be administered as a one-time loading dose of 4 mg/kg as a 90 minute infusion, followed by 20 weekly treatments at 2 mg/kg as a 30 minute infusion. ABI-007 will be administered every 2 weeks at a dose of 260mg/m2 as 30 minute infusion on the same days as trastuzumab for a total of 4 cycles (weeks 1 -8). Growth factor support with pegfilgrastim (Neulasta®) is required 24 to 48 hours following completion of each cycle of ABI-007. Beginning week 9, patients will then receive weekly vinorelbine at a dose of 25mg/m2 for 12 weeks on the same day as trastuzumab for a total of 4 cycles (weeks 9-20). As per standard treatment of HER2-positive breast cancers, patients will continue to receive trastuzumab every 3 weeks at 6 mg/kg beginning week 21 through week 52. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Histologically or cytologically confirmed invasive breast carcinoma.
- Early stage breast cancer - stage I (tumor size greater than 1 cm), II and IIA.
- 3+ HER2 overexpression by IHC or 2+ HER2 overexpression and FISH positivity.
- Patients must have measurable disease as defined by palpable lesion with both diameters greater than or equal to 1 cm measurable with caliper and/or a positive mammogram or ultrasound with at least one dimension greater than or equal to 1 cm. Bilateral mammogram and clip placement is required for study entry. Baseline measurements of the indicator lesions must be recorded on the patient registration form. To be valid for baseline, the measurements must have been made within the 14 days (4-6 weeks for x-rays and scans) immediately preceding patient's entry in study.
- ECOG performance status 0 to 2 within 14 days of study entry.
Key exclusion criteria (9 listed)
- Evidence of disease outside the breast or chest wall, except ipsilateral axillary lymph nodes.
- Prior chemotherapy, hormonal therapy, biologic therapy or radiation therapy for breast cancer. Patients with history of DCIS are eligible if they were treated with surgery alone.
- Medical, psychological, or surgical condition which the investigator feels might compromise study participation.
- Pregnant or lactating women are not eligible.
- Patients with history of previous or current malignancy at other sites with the exception of adequately treated carcinoma in situ of the cervix or basal or squamous cell carcinoma of the skin. Patients with a history of other malignancies who remain disease free for greater than five years are eligible.
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 |
|---|---|---|
| Pre operativeTrastuzumabTrastuzumab one-time loading dose of 4 mg/kg as 90 minute infusion, followed by 20 weekly treatments at 2 mg/kg as 30 minute infusion. As per standard treatment of HER2-positive breast cancers, patients will continue to receive trastuzumab every 3 weeks at 6 mg/kg beginning week 21 through week 52. | Drug | Trastuzumab and Abraxane followed Trastuzumab and Vinorelbine |
| ABI-007 (Abraxane)ABI-007 will be administered every 2 weeks at a dose of 260mg/m2 as 30 minute infusion on the same days as trastuzumab for a total of 4 cycles (weeks 1 -8). | Drug | Trastuzumab and Abraxane followed Trastuzumab and Vinorelbine |
| VinorelbineBeginning week 9, patients will then receive weekly vinorelbine at a dose of 25mg/m2 for 12 weeks on the same day as trastuzumab for a total of 4 cycles (weeks 9-20). | Drug | Trastuzumab and Abraxane followed Trastuzumab and Vinorelbine |
Primary outcome
Number of Participants With Complete Pathologic Response.
Time frame: assess at 8 weeks
Pathologic complete response (pCR): Absence of invasive breast cancer in the breast (mastectomy or lumpectomy) specimen at the time of definitive surgery. Presence of in situ cancer alone will be considered a pCR. Although clinical examination is the primary method of determining response, radiologic assessments (mammogram, ultrasound ± MRI) may be used to confirm response/non-response.
1 secondary outcome
Number of Participants Who Had Complete Clinical Resposnse, Partial Response and Stable Disease.
Time frame: clinic examination every 2 weeks, evaluated every 3 months for 2 years post-op
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2012.
- 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.
Ruth O'Regan, MD principal investigator
Emory University Winship 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 Pre operativeTrastuzumab, ABI-007 (Abraxane) and Vinorelbine in people with Breast Cancer, run by Emory University 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 9 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 25 Jun 2012. 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 14 Jun 2012). 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?
Number of Participants With Complete Pathologic Response. (time frame: assess at 8 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 25 Jun 2012.