Breast CancerPhase 2NCT00093145
Study of Albumin-bound Paclitaxel (Abraxane) in Combination With Carboplatin and Herceptin in Patients With Advanced Breast Cancer
A Phase 2 study testing Albumin-bound paclitaxel, Carboplatin and Herceptin® in people with Breast Cancer, run by Celgene at 14 sites in United States.
Trial summary
This trial will treat patients with advanced breast cancer with a new anti-cancer medicine used in combination with two existing anti-cancer medications: Albumin-bound paclitaxel (ABI-007), Carboplatin and Herceptin. 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?
- Albumin-bound paclitaxel, Carboplatin and Herceptin®
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 14 sitesUnited States
- Study dates
- 1 Jun 2004to 1 Oct 2008
- 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
- Confirmed adenocarcinoma of the breast
- Tumor shows 3+ overexpression of the human epidermal growth factor receptor 2 (HER-2)/proto-oncogene by immunohistochemistry assay, or is fluorescence in situ hybridization (FISH)+
- Stage IV disease
- Measurable disease
- At least 3 weeks since prior cytotoxic chemotherapy
- At least 4 weeks since radiotherapy with full recovery
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- At least 4 weeks since major surgery with full recovery
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- At least 18 years old
- Absolute neutrophil count (ANC) at least 1.5 x 10^9 cells/L
- Platelets at least 100 x 10^9 cells/L
- Hemoglobin at least 9 g/dL
- Aspartame aminotransferase (AST), alanine aminotransferase (ALT) less than 2.5X upper limit normal
- Alkaline Phosphatase less than 1.5X upper limit normal
- Creatinine less than 1.5 gm/dL
- Normal left ventricular ejection fraction
- Negative pregnancy test
- Agree to use method to avoid pregnancy
- Informed Consent is obtained
Who cannot join
- Up to one regimen of prior neo-adjuvant or adjuvant chemotherapy is allowed. One year since Taxane and Herceptin treatment.
- Cumulative life-time dose of doxorubicin is greater than 360 mg/m^2
- Concurrent immunotherapy or hormonal therapy
- Parenchymal brain metastases, if present, must be documented to be clinically and radiographically stable for at least 6 months after treatment
- Serious intercurrent medical or psychiatric illness, including serious active infection
- History of congestive heart failure
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- History of other malignancy within the last 5 years which could affect the diagnosis or assessment of breast cancer
- Patients who have received an investigational drug within the previous 3 weeks
- Patient is currently enrolled in another clinical study receiving investigational therapies
- Pregnant or nursing women
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
United States14 sites
Gerogia Cancer Specialist
Atlanta, Georgia, 30341
Southwest Regional Cancer Center
Austin, Texas, 78705
Florida Cancer Institute
Hudson, Florida, 34667
Breastlink Med Group
Long Beach, California, 90806
Memorial Sloan-Kettering Cancer Center
New York, New York, 10021
University of Pittsburgh Medical Center Magee Womens Hospital
Pittsburgh, Pennsylvania, 15213
Rhode Island Hospital
Providence, Rhode Island, 02903
Maine Center for Cancer Medicine and Blood Disorders
Scarborough, Maine, 04074
Swedish Medical Center Cancer Institute Research
Seattle, Washington, 98104
Gulf Coast Oncology Associates
St. Petersburg, Florida, 33705
Hematology/Oncology P.C. Carl & Dorothy Bennet Cancer Center
Stamford, Connecticut, 06902
Washington Hospital Center
Washington D.C., District of Columbia, 20010
Lombardi Cancer Center Georgetown University Hospital
Washington D.C., District of Columbia, 2007
Palm Beach Cancer Institute
West Palm Beach, Florida, 33401
About this study
Official title: A Phase II Study of Weekly Dose-Dense Nanoparticle Paclitaxel (ABI-007), Carboplatin With Herceptin® As First-Line Therapy of Advanced HER-2 Positive Breast Cancer
This trial will treat patients with advanced breast cancer with a new anti-cancer medicine used in combination with two existing anti-cancer medications: Albumin-bound paclitaxel (ABI-007), Carboplatin and Herceptin. Participants will be given the combination therapy on a weekly basis and may continue on therapy as long as their condition improves and drug toxicity is tolerated.
- Conditions
- Breast Cancer
- Being tested
- Albumin-bound paclitaxel, Carboplatin, Herceptin®
- Keywords
- Advanced 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.
Albumin-bound paclitaxelDrug
Also called ABI-007, ABRAXANE®
Administered by intravenous infusion.
CarboplatinDrug
Also called Paraplatin®
Carboplatin dose was calculated using a modified Calvert formula (creatinine clearance was substituted for GFR): Total dose (mg) = (target AUC) x (creatinine clearance + 25). Note: AUC = 6 was initially targeted, but could be decreased due to toxicity.
Herceptin®Drug
Also called Trastuzumab
Administered by IV infusion
| Study group | Role | What they receive |
|---|---|---|
| Albumin-bound paclitaxel, Carboplatin + Herceptin | Experimental | Participants received albumin-bound paclitaxel, 100 mg/m^2 weekly every 3 out of 4 weeks, carboplatin at an area under the curve (AUC) = 6 every 4 weeks and Herceptin weekly, 4 mg/kg the first week and 2 mg/kg on all subsequent weeks by intravenous (IV) infusion for up to 6 cycles in the absence of disease progression or intolerable toxicity. Participants could continue treatment with chemotherapy beyond 6 cycles at the discretion of the investigator, but Herceptin therapy was to continue to be administered weekly (2 mg/kg) until intercurrent illness, disease progression, unacceptable toxicity, patient withdrawal or administration of any non-protocol anti-cancer treatment. Receives: Drug: Albumin-bound paclitaxel; Drug: Carboplatin; Drug: Herceptin® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Who Achieved an Objective Confirmed Complete or Partial Overall Response
Percentage of participants who achieved an objective confirmed complete or partial overall response based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0. A complete response (CR) is the disappearance of all known disease and no new sites or disease related symptoms confirmed at least 4 weeks after initial documentation. A partial response (PR) is at least a 30% decrease in the sum of the longest diameters of target lesions, taking as a reference the baseline sum of the longest diameters confirmed at least 4 weeks after initial documentation. PR is also recorded when all measurable disease has completely disappeared, but a non-measurable component (i.e., ascites) is still present but not progressing, or with the persistence of one or more non-target lesions and/or the maintenance of tumor marker level above the normal limits.
Measured: Objective response was evaluated every 2 cycles, up to a maximum of 39 cycles (approximately 39 months)
Secondary outcomes (5)
Percentage of Participants With a Total Response
Total response was defined as the percentage of participants with stable disease (SD) for ≥ 16 weeks or complete or partial overall response. Stable disease was defined as neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease. Progressive disease is at least a 20% increase in the sum of the longest diameters of target lesions, taking as reference the smallest sum of the longest diameters recorded since the treatment started; or the appearance of one or more new lesions; or the unequivocal progression of a non-target lesion.
Measured: Evaluated every 2 cycles, up to a maximum of 39 cycles.
Time to Disease Progression
Time to disease progression was measured from the date of first dose of study drug to the start of disease progression. Patients who did not have disease progression at the end of follow-up were censored at the last known time that the patient was evaluated for progression. Progression is at least a 20% increase in the sum of the longest diameters of target lesions, taking as reference the smallest sum of the longest diameters recorded since the treatment started; or the appearance of one or more new lesions; or the unequivocal progression of a non-target lesion. Time to disease progression was summarized using Kaplan-Meier methods.
Measured: Assessed every 2 cycles, up to a maximum of 39 cycles.
Duration of Response
Duration of response was evaluated by measuring progression-free survival for participants with a complete response or partial response. Progression-free survival was defined as the time from the first dose of study drug to the start of progression or patient death (whichever occurred first). Participants who did not have progression or were still alive were censored at the last known time the patient was progression free. Patients that initiated other anticancer therapy prior to progression were censored at the time when new anticancer therapy was initiated. Progression is at least a 20% increase in the sum of the longest diameters of target lesions, taking as reference the smallest sum of the longest diameters recorded since the treatment started; or the appearance of one or more new lesions; or the unequivocal progression of a non-target lesion.
Measured: Assessed every 2 cycles, up to a maximum of 39 cycles.
Overall Patient Survival
Overall survival was defined as the time from the day of randomization to patient death (due to any cause), as assessed by post study follow-up on a monthly basis for 3 months and every 3 months. Participants still alive were censored at the last known time that the patient was alive. Patient survival was estimated using Kaplan-Meier methods.
Measured: From Day 1 until approximately 44 months.
Number of Participants With Adverse Events (AEs)
A Treatment-emergent AE was any AE that began or worsened after the start of study drug through 30 days after the last dose of study drug or end of study whichever is later. A treatment related toxicity was one considered by the investigator to be possibly, probably or definitely related to study drug. AEs were graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events v3.0 (CTCAE) on the following scale: Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = life-threatening, Grade 5 = death. A serious adverse event (SAE) is any untoward medical occurrence at any dose that: is fatal or life-threatening; results in persistent or significant disability or incapacity; requires or prolongs in-patient hospitalization; is a congenital anomaly/birth defect in the offspring of a patient; and conditions not included in the above that may jeopardize the patient or may require intervention to prevent one of the outcomes listed above
Measured: Day 1 up to 39 cycles
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2004 (estimated)
- Study start1 Jun 2004
- Primary completion1 Oct 2008
- Study completion1 Oct 2008
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by CelgeneThe 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
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Celgene
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Andrew Seidman, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00093145
- Sponsor's protocol ID
- CA016
- Status last verified
- Nov 2019
- First submitted
- 4 Oct 2004
- Last updated
- 25 Nov 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Conlin AK, Seidman AD, Bach A, Lake D, Dickler M, D'Andrea G, Traina T, Danso M, Brufsky AM, Saleh M, Clawson A, Hudis CA. Phase II trial of weekly nanoparticle albumin-bound paclitaxel with carboplatin and trastuzumab as first-line therapy for women with HER2-overexpressing metastatic breast cancer. Clin Breast Cancer. 2010 Aug 1;10(4):281-7. doi: 10.3816/CBC.2010.n.036.
PubMed 20705560
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Weekly Dose-Dense Nanoparticle Paclitaxel (ABI-007), Carboplatin With Herceptin® As First-Line Therapy of Advanced HER-2 Positive Breast Cancer
- ClinicalTrials.gov ID
- NCT00093145
- Acronym / sponsor ID
- CA016
- Conditions
- Breast Cancer
- Keywords
- Advanced Breast Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- CelgeneIndustry (pharma, biotech, devices)
- Study start
- 1 Jun 2004 (actual)
- Primary completion
- 1 Oct 2008 (actual)
- Study completion
- 1 Oct 2008 (actual)
- First posted
- 5 Oct 2004 (estimated)
- Results
- Posted 17 Jul 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This trial will treat patients with advanced breast cancer with a new anti-cancer medicine used in combination with two existing anti-cancer medications: Albumin-bound paclitaxel (ABI-007), Carboplatin and Herceptin. Participants will be given the combination therapy on a weekly basis and may continue on therapy as long as their condition improves and drug toxicity is tolerated.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Albumin-bound paclitaxel, Carboplatin + Herceptin | Experimental | Drug: Albumin-bound paclitaxel, Drug: Carboplatin, Drug: Herceptin®Participants received albumin-bound paclitaxel, 100 mg/m^2 weekly every 3 out of 4 weeks, carboplatin at an area under the curve (AUC) = 6 every 4 weeks and Herceptin weekly, 4 mg/kg the first week and 2 mg/kg on all subsequent weeks by intravenous (IV) infusion for up to 6 cycles in the absence of disease progression or intolerable toxicity. Participants could continue treatment with chemotherapy beyond 6 cycles at the discretion of the investigator, but Herceptin therapy was to continue to be administered weekly (2 mg/kg) until intercurrent illness, disease progression, unacceptable toxicity, patient withdrawal or administration of any non-protocol anti-cancer treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Confirmed adenocarcinoma of the breast
- Tumor shows 3+ overexpression of the human epidermal growth factor receptor 2 (HER-2)/proto-oncogene by immunohistochemistry assay, or is fluorescence in situ hybridization (FISH)+
- Stage IV disease
- Measurable disease
- At least 3 weeks since prior cytotoxic chemotherapy
Key exclusion criteria (10 listed)
- Up to one regimen of prior neo-adjuvant or adjuvant chemotherapy is allowed. One year since Taxane and Herceptin treatment.
- Cumulative life-time dose of doxorubicin is greater than 360 mg/m^2
- Concurrent immunotherapy or hormonal therapy
- Parenchymal brain metastases, if present, must be documented to be clinically and radiographically stable for at least 6 months after treatment
- Serious intercurrent medical or psychiatric illness, including serious active infection
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 |
|---|---|---|
| Albumin-bound paclitaxelAlso: ABI-007, ABRAXANE®Administered by intravenous infusion. | Drug | Albumin-bound paclitaxel, Carboplatin + Herceptin |
| CarboplatinAlso: Paraplatin®Carboplatin dose was calculated using a modified Calvert formula (creatinine clearance was substituted for GFR): Total dose (mg) = (target AUC) x (creatinine clearance + 25). Note: AUC = 6 was initially targeted, but could be decreased due to toxicity. | Drug | Albumin-bound paclitaxel, Carboplatin + Herceptin |
| Herceptin®Also: TrastuzumabAdministered by IV infusion | Drug | Albumin-bound paclitaxel, Carboplatin + Herceptin |
Primary outcome
Percentage of Participants Who Achieved an Objective Confirmed Complete or Partial Overall Response
Time frame: Objective response was evaluated every 2 cycles, up to a maximum of 39 cycles (approximately 39 months)
Percentage of participants who achieved an objective confirmed complete or partial overall response based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0. A complete response (CR) is the disappearance of all known disease and no new sites or disease related symptoms confirmed at least 4 weeks after initial documentation. A partial response (PR) is at least a 30% decrease in the sum of the longest diameters of target lesions, taking as a reference the baseline sum of the longest diameters confirmed at least 4 weeks after initial documentation. PR is also recorded when all measurable disease has completely disappeared, but a non-measurable component (i.e., ascites) is still present but not progressing, or with the persistence of one or more non-target lesions and/or the maintenance of tumor marker level above the normal limits.
5 secondary outcomes
Percentage of Participants With a Total Response
Time frame: Evaluated every 2 cycles, up to a maximum of 39 cycles.
Time to Disease Progression
Time frame: Assessed every 2 cycles, up to a maximum of 39 cycles.
Duration of Response
Time frame: Assessed every 2 cycles, up to a maximum of 39 cycles.
Overall Patient Survival
Time frame: From Day 1 until approximately 44 months.
Number of Participants With Adverse Events (AEs)
Time frame: Day 1 up to 39 cycles
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 20705560Conlin AK, Seidman AD, Bach A, Lake D, Dickler M, D'Andrea G, Traina T, Danso M, Brufsky AM, Saleh M, Clawson A, Hudis CA. Phase II trial of weekly nanoparticle albumin-bound paclitaxel with carboplatin and trastuzumab as first-line therapy for women with HER2-overexpressing metastatic breast cancer. Clin Breast Cancer. 2010 Aug 1;10(4):281-7. doi: 10.3816/CBC.2010.n.036.
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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.
Andrew Seidman, MD principal investigator
Memorial Sloan Kettering Cancer Center
14 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 Albumin-bound paclitaxel, Carboplatin and Herceptin® in people with Breast Cancer, run by Celgene at 14 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 19 inclusion and 10 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 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 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 17 Jul 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?
Percentage of Participants Who Achieved an Objective Confirmed Complete or Partial Overall Response (time frame: Objective response was evaluated every 2 cycles, up to a maximum of 39 cycles (approximately 39 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00093145, which also lists 1 linked publication.
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 Nov 2019.