Breast CancerPhase 2NCT00675259
Phase II NCT (Neoadjuvant Chemotherapy) w/ Weekly Abraxane in Combination With Carboplatin & Bevacizumab in Breast Cancer
A Phase 2 study testing bevacizumab, carboplatin and nab-paclitaxel in people with Breast Cancer, run by Ohio State University Comprehensive Cancer Center at 1 site in United States.
Trial summary
RATIONALE: Drugs used in chemotherapy, such as paclitaxel albumin-stabilized nanoparticle formulation and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. 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?
- bevacizumab, carboplatin and nab-paclitaxel
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2008to Mar 2014
- 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
- Histologically confirmed breast cancer
- Clinically or radiographically measurable residual tumor after core biopsy
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- Age ≥18 yrs
- Absolute neutrophil count ≥ 1,500/mm³
- Hemoglobin ≥ 9 g/dL
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- Platelet count ≥ 100,000/ mm³
- Creatinine ≤ 1.5 times upper limit of normal (ULN)
- Urine protein:creatinine ratio < 1.0
- AST (aspartate aminotransferase) and ALT ≤ 2.5 times ULN
- Alkaline phosphatase ≤ 2.5 times ULN
- Bilirubin normal
- Women of childbearing potential must use effective contraception
- Left ventricular ejection fraction (LVEF) normal by echocardiogram or MUGA
Who cannot join
- No residual tumor after initial biopsy
- Peripheral neuropathy of grade 2 or higher
- HER-2 neu overexpression either by IHC 3+ or FISH+
- No history of any prior treatment of breast cancer.
- No history of unstable angina or myocardial infarction within the past 12 months
- Pregnant or nursing women
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- Anticoagulation therapy within the last 6 months
- History of gastrointestinal bleeding
- Recent hemoptysis
- No known hepatitis B or HIV seropositivity
- No inadequately controlled hypertension, defined as systolic blood pressure (BP) > 150 mm Hg and/or diastolic BP > 100 mm Hg despite antihypertensive medications
- History of hypertensive crisis or hypertensive encephalopathy
- New York Heart Association class II-IV congestive heart failure
- History of stroke or transient ischemic attack at any time
- Significant vascular disease (e.g., aortic aneurysm or aortic dissection)
- No symptomatic peripheral vascular disease
- Evidence of bleeding diathesis or coagulopathy
- Significant traumatic injury within the past 28 days
- History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 6 months
- Serious, non-healing wound, ulcer, or bone fracture
- Known hypersensitivity to any component of bevacizumab
Trial locations and contacts
1 site in 1 country.
United States1 site
Ohio State University Medical Center
Columbus, Ohio, 43210
About this study
Official title: Phase II Trial of Neoadjuvant Chemotherapy [NCT] With Weekly Nanoparticle Albumin-bound Paclitaxel [Nab-paclitaxel; Abraxane®] in Combination With Carboplatin and Bevacizumab in Women With Clinical Stages I-III Breast Cancer
RATIONALE: Drugs used in chemotherapy, such as paclitaxel albumin-stabilized nanoparticle formulation and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some find tumor cells and help kill them or carry tumor-killing substances to them. Others interfere with the ability of tumor cells to grow and spread. Bevacizumab may also stop the growth of breast cancer by blocking blood flow to the tumor. Giving combination chemotherapy together with bevacizumab before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving bevacizumab after surgery may kill any tumor cells that remain after surgery.
PURPOSE: This phase II trial is studying the side effects and how well giving paclitaxel albumin-stabilized nanoparticle formulation and carboplatin together with bevacizumab works in treating women undergoing surgery for stage II or stage III breast cancer.
Read the detailed description
OBJECTIVES:
Primary
- To determine the complete pathological response (pCR) in the breast/axillary lymph nodes in women with stage II or III breast cancer treated with neoadjuvant therapy comprising paclitaxel albumin-stabilized nanoparticle formulation, carboplatin, and bevacizumab followed by surgery and adjuvant bevacizumab.
- To determine the side effects of this regimen in these patients.
Secondary
- To evaluate dynamic contrast-enhanced magnetic resonance imaging in assessing pCR.
- To measure LZTS1 gene expression before and after neoadjuvant therapy to evaluate whether LZTS1 gene expression correlates with pCR.
- To evaluate the feasibility and toxicity of adjuvant bevacizumab when administered for 6 months.
OUTLINE:
- Neoadjuvant therapy: Patients receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes and carboplatin IV over 30 minutes on days 1, 8, and 15 and bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment repeats every 28 days for 5 courses. After completion of course 5, patients receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes and carboplatin IV over 30 minutes on days 1, 8, and 15. Patients then proceed to surgery.
- Surgery: Approximately 4-5 weeks after completion of neoadjuvant therapy, patients undergo definitive surgery (either lumpectomy or mastectomy). Patients with node-positive disease or inflammatory breast cancer at baseline also undergo axillary lymph node dissection. Patients then proceed to adjuvant therapy.
- Adjuvant therapy: Beginning approximately 6 weeks after surgery, patients receive bevacizumab IV over 30-90 minutes once every 3 weeks for 6 months. Patients with hormone receptor-positive disease also receive endocrine therapy. Patients may also receive additional adjuvant chemotherapy or radiotherapy at the discretion of the treating physician.
Patients undergo dynamic contrast-enhanced magnetic resonance imaging at baseline, after course 2 of neoadjuvant therapy, and after completion of neoadjuvant therapy (prior to definitive surgery) for assessment of tumor response. Tumor tissue is collected at baseline and during surgery for correlative laboratory studies. LZST1 gene expression is assessed by immunohistochemistry before and after neoadjuvant therapy.
- Conditions
- Breast Cancer
- Being tested
- bevacizumab, carboplatin, nab-paclitaxel, Surgery, Adjuvant chemotherapy
- Keywords
- stage II breast cancer, stage IIIA breast cancer, stage IIIB breast cancer, stage IIIC 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.
bevacizumabDrug
Also called Avastin
bevacizumab 10 mg/kg on days 1 and 15 administered every 28 days [1 cycle] for 5 cycles
carboplatinDrug
Also called Paraplatin, Paraplatin-AQ
AUC 2 IV on days 1, 8, and 15
nab-paclitaxelDrug
Also called Abraxane
100 mg/M2 IV
SurgeryProcedure or surgery
lumpectomy or mastectomy along with axillary lymph node dissection approximately 4-5 weeks after completion of NCT.
Adjuvant chemotherapyDrug
All hormone receptor positive patients will receive endocrine therapy. All patients will receive 6 months of adjuvant bevacizumab at 15 mg/kg IV every 3 weeks. If using an adjuvant anthracycline-containing regimen then bevacizumab will be administered ≥ 3 weeks after completing the regimen.
| Study group | Role | What they receive |
|---|---|---|
| Neoadjuvant, Surgery, Adjuvant | Experimental | Neoadjuvant chemotherapy : Nab-paclitaxel and carboplatin on days 1, 8, and 15 in combination with bevacizumab on days 1 and 15 administered every 28 days for 5 cycles followed by 1 cycle with Nab-paclitaxel and carboplatin on days 1, 8, and 15. Definitive surgery with either lumpectomy or mastectomy along with axillary lymph node dissection for all pre neo adjuvant chemotherapy node-positive patients approximately 4-5 weeks after the completion of NCT. Use of additional adjuvant chemotherapy and/or radiation therapy depends upon the treating physicians' judgment. Radiation therapy should begin no sooner than 6 weeks after breast cancer surgery. All hormone receptor positive patients will receive endocrine therapy. All patients will receive 6 months of adjuvant bevacizumab every 3 weeks. If using an adjuvant anthracycline-containing regimen then bevacizumab will be administered ≥ 3 weeks after completing the regimen. Receives: Drug: bevacizumab; Drug: carboplatin; Drug: nab-paclitaxel; Procedure: Surgery; Drug: Adjuvant chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients With Pathologic Complete Response (pCR)
pCR was defined as the absence of viable invasive tumor cells in the surgical breast specimen and axillary lymph nodes.
Measured: every 4 weeks
Side Effects of Weekly Nab-paclitaxel, Carboplatin and Bevacizumab
Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events, version 3.0
Measured: Up to 4 weeks
Secondary outcomes (2)
Evaluation of Dynamic Contrast-enhanced Magnetic Resonance Imaging in Assessing pCR at Baseline and After 2 Cycles of Neoadjuvant Therapy
Relative angiogenic volume (AV) was defined as the ratio of AV to the geometric volume of the tumor in the breast.
Measured: after 2 cycles of therapy
Overall Expression of LZTS1 Before and After Neoadjuvant Therapy as Assessed by Immunohistochemistry
LZTS1 expression in breast cancer cells collected prior to NCT
Measured: prior to surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2008 (estimated)
- Study startJul 2008
- Primary completionMay 2011
- Study completionMar 2014
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 Ohio State University Comprehensive Cancer 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
- 33 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Celgene Corporation, Genentech, Inc.
- Responsible party
- Sponsor
- Investigators
- Ewa Mrozek, MD, Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00675259
- Sponsor's protocol ID
- OSU-07074
- Other IDs
- NCI-2011-03188
- Status last verified
- Jun 2018
- First submitted
- 8 May 2008
- Last updated
- 24 Jul 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Mrozek E, Layman R, Ramaswamy B, Lustberg M, Vecchione A, Knopp MV, Shapiro CL. Phase II trial of neoadjuvant weekly nanoparticle albumin-bound paclitaxel, carboplatin, and biweekly bevacizumab therapy in women with clinical stage II or III HER2-negative breast cancer. Clin Breast Cancer. 2014 Aug;14(4):228-34. doi: 10.1016/j.clbc.2014.02.005. Epub 2014 Feb 20.
PubMed 24703985
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Trial of Neoadjuvant Chemotherapy [NCT] With Weekly Nanoparticle Albumin-bound Paclitaxel [Nab-paclitaxel; Abraxane®] in Combination With Carboplatin and Bevacizumab in Women With Clinical Stages I-III Breast Cancer
- ClinicalTrials.gov ID
- NCT00675259
- Acronym / sponsor ID
- OSU-07074
- Conditions
- Breast Cancer
- Keywords
- stage II breast cancer, stage IIIA breast cancer, stage IIIB breast cancer, stage IIIC breast cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Ohio State University Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- Celgene Corporation, Genentech, Inc.
- Study start
- Jul 2008
- Primary completion
- May 2011 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 9 May 2008 (estimated)
- Results
- Posted 24 Aug 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Drugs used in chemotherapy, such as paclitaxel albumin-stabilized nanoparticle formulation and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some find tumor cells and help kill them or carry tumor-killing substances to them. Others interfere with the ability of tumor cells to grow and spread. Bevacizumab may also stop the growth of breast cancer by blocking blood flow to the tumor. Giving combination chemotherapy together with bevacizumab before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving bevacizumab after surgery may kill any tumor cells that remain after surgery.
PURPOSE: This phase II trial is studying the side effects and how well giving paclitaxel albumin-stabilized nanoparticle formulation and carboplatin together with bevacizumab works in treating women undergoing surgery for stage II or stage III breast cancer.
Detailed description
OBJECTIVES:
Primary
- To determine the complete pathological response (pCR) in the breast/axillary lymph nodes in women with stage II or III breast cancer treated with neoadjuvant therapy comprising paclitaxel albumin-stabilized nanoparticle formulation, carboplatin, and bevacizumab followed by surgery and adjuvant bevacizumab.
- To determine the side effects of this regimen in these patients.
Secondary
- To evaluate dynamic contrast-enhanced magnetic resonance imaging in assessing pCR.
- To measure LZTS1 gene expression before and after neoadjuvant therapy to evaluate whether LZTS1 gene expression correlates with pCR.
- To evaluate the feasibility and toxicity of adjuvant bevacizumab when administered for 6 months.
OUTLINE:
- Neoadjuvant therapy: Patients receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes and carboplatin IV over 30 minutes on days 1, 8, and 15 and bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment repeats every 28 days for 5 courses. After completion of course 5, patients receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes and carboplatin IV over 30 minutes on days 1, 8, and 15. Patients then proceed to surgery.
- Surgery: Approximately 4-5 weeks after completion of neoadjuvant therapy, patients undergo definitive surgery (either lumpectomy or mastectomy). Patients with node-positive disease or inflammatory breast cancer at baseline also undergo axillary lymph node dissection. Patients then proceed to adjuvant therapy.
- Adjuvant therapy: Beginning approximately 6 weeks after surgery, patients receive bevacizumab IV over 30-90 minutes once every 3 weeks for 6 months. Patients with hormone receptor-positive disease also receive endocrine therapy. Patients may also receive additional adjuvant chemotherapy or radiotherapy at the discretion of the treating physician.
Patients undergo dynamic contrast-enhanced magnetic resonance imaging at baseline, after course 2 of neoadjuvant therapy, and after completion of neoadjuvant therapy (prior to definitive surgery) for assessment of tumor response. Tumor tissue is collected at baseline and during surgery for correlative laboratory studies. LZST1 gene expression is assessed by immunohistochemistry before and after neoadjuvant therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Neoadjuvant, Surgery, Adjuvant | Experimental | Drug: bevacizumab, Drug: carboplatin, Drug: nab-paclitaxel, Procedure: Surgery, Drug: Adjuvant chemotherapyNeoadjuvant chemotherapy : Nab-paclitaxel and carboplatin on days 1, 8, and 15 in combination with bevacizumab on days 1 and 15 administered every 28 days for 5 cycles followed by 1 cycle with Nab-paclitaxel and carboplatin on days 1, 8, and 15. Definitive surgery with either lumpectomy or mastectomy along with axillary lymph node dissection for all pre neo adjuvant chemotherapy node-positive patients approximately 4-5 weeks after the completion of NCT. Use of additional adjuvant chemotherapy and/or radiation therapy depends upon the treating physicians' judgment. Radiation therapy should begin no sooner than 6 weeks after breast cancer surgery. All hormone receptor positive patients will receive endocrine therapy. All patients will receive 6 months of adjuvant bevacizumab every 3 weeks. If using an adjuvant anthracycline-containing regimen then bevacizumab will be administered ≥ 3 weeks after completing the regimen. |
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)
- Histologically confirmed breast cancer
- Clinically or radiographically measurable residual tumor after core biopsy
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- Age ≥18 yrs
- Absolute neutrophil count ≥ 1,500/mm³
Key exclusion criteria (21 listed)
- No residual tumor after initial biopsy
- Peripheral neuropathy of grade 2 or higher
- HER-2 neu overexpression either by IHC 3+ or FISH+
- No history of any prior treatment of breast cancer.
- No history of unstable angina or myocardial infarction within the past 12 months
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 |
|---|---|---|
| bevacizumabAlso: Avastinbevacizumab 10 mg/kg on days 1 and 15 administered every 28 days [1 cycle] for 5 cycles | Drug | Neoadjuvant, Surgery, Adjuvant |
| carboplatinAlso: Paraplatin, Paraplatin-AQAUC 2 IV on days 1, 8, and 15 | Drug | Neoadjuvant, Surgery, Adjuvant |
| nab-paclitaxelAlso: Abraxane100 mg/M2 IV | Drug | Neoadjuvant, Surgery, Adjuvant |
| Surgerylumpectomy or mastectomy along with axillary lymph node dissection approximately 4-5 weeks after completion of NCT. | Procedure or surgery | Neoadjuvant, Surgery, Adjuvant |
| Adjuvant chemotherapyAll hormone receptor positive patients will receive endocrine therapy. All patients will receive 6 months of adjuvant bevacizumab at 15 mg/kg IV every 3 weeks. If using an adjuvant anthracycline-containing regimen then bevacizumab will be administered ≥ 3 weeks after completing the regimen. | Drug | Neoadjuvant, Surgery, Adjuvant |
Primary outcome
Number of Patients With Pathologic Complete Response (pCR)
Time frame: every 4 weeks
pCR was defined as the absence of viable invasive tumor cells in the surgical breast specimen and axillary lymph nodes.
Side Effects of Weekly Nab-paclitaxel, Carboplatin and Bevacizumab
Time frame: Up to 4 weeks
Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events, version 3.0
2 secondary outcomes
Evaluation of Dynamic Contrast-enhanced Magnetic Resonance Imaging in Assessing pCR at Baseline and After 2 Cycles of Neoadjuvant Therapy
Time frame: after 2 cycles of therapy
Overall Expression of LZTS1 Before and After Neoadjuvant Therapy as Assessed by Immunohistochemistry
Time frame: prior to surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 24703985Mrozek E, Layman R, Ramaswamy B, Lustberg M, Vecchione A, Knopp MV, Shapiro CL. Phase II trial of neoadjuvant weekly nanoparticle albumin-bound paclitaxel, carboplatin, and biweekly bevacizumab therapy in women with clinical stage II or III HER2-negative breast cancer. Clin Breast Cancer. 2014 Aug;14(4):228-34. doi: 10.1016/j.clbc.2014.02.005. Epub 2014 Feb 20.
- JameslineLink provided by the sponsor.
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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.
Ewa Mrozek, MD principal investigator
Ohio State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing bevacizumab, carboplatin and nab-paclitaxel in people with Breast Cancer, run by Ohio State University Comprehensive Cancer Center at 1 site 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 21 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 24 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 24 Aug 2016). 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 Patients With Pathologic Complete Response (pCR) (time frame: every 4 weeks). The study lists 2 primary outcomes in all. 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 NCT00675259, 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 24 Jul 2018.