Breast CancerEarly Phase 1NCT00331630
Abraxane and Lapatinib in Treating Patients With Stage I, Stage II, or Stage III Breast Cancer
A Early Phase 1 study testing lapatinib ditosylate and paclitaxel albumin-stabilized nanoparticle formulation in people with Breast Cancer, run by Northwestern University at 5 sites in United States.
Trial summary
RATIONALE: Drugs used in chemotherapy, such as Abraxane, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Lapatinib may stop the growth of tumor cells by blocking some of the enzymes needed for their growth. 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?
- lapatinib ditosylate and paclitaxel albumin-stabilized nanoparticle formulation
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 5 sitesUnited States
- Study dates
- 4 May 2006to 5 Aug 2010
- Phase
- Early Phase 1
- 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
DISEASE CHARACTERISTICS:
- Histologically confirmed breast cancer
- Clinical stage I-III disease
- Measurable disease defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm with spiral CT scan
- HER2/neu 3+ by immunohistochemistry or positive by fluorescent in situ hybridization
- No known brain metastases
- Hormone receptor status unspecified
PATIENT CHARACTERISTICS:
- Menopausal status not specified
- Male or female
- Life expectancy > 12 weeks
- ECOG performance status (PS) 0-1 OR Karnofsky PS 80-100%
- WBC ≥ 3,000/mm^3
- Absolute neutrophil count ≥ 1,500 mm^3
- Platelet count ≥ 100,000/mm^3
- Total bilirubin normal
- AST and ALT ≤ 2.5 times upper limit of normal
- Creatinine normal OR creatinine clearance ≥ 60 mL/min
- LVEF ≥ 50% as measured by echocardiogram or MUGA scan
- No other malignancy within the past year
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- Able to swallow and retain oral medication
- No history of allergic reactions attributed to compounds of similar chemical or biologic composition to lapatinib
- No ongoing or active infection
- No symptomatic congestive heart failure
- No unstable angina pectoris
- No cardiac arrhythmia
- No psychiatric illness or social situation that would preclude study compliance
- No other uncontrolled illness
- No gastrointestinal (GI) tract disease that would preclude ability to take oral medication
- No malabsorption syndrome
- No requirement for IV alimentation
- No uncontrolled inflammatory GI disease (e.g., Crohn's disease or ulcerative colitis)
PRIOR CONCURRENT THERAPY:
- No prior chemotherapy, immunotherapy, radiotherapy, or hormonal therapy for breast cancer
- No prior treatment with epidermal growth factor receptor targeting therapies
- No prior surgical procedures affecting absorption
- No prior surgery for breast cancer
- At least 14 days since prior and no concurrent CYP3A4 inducers, including any of the following:
- Dexamethasone or dexamethasone equivalent dose ≥ 1.5 mg/day, including any of the following:
- Cortisone (≥ 50 mg/day)
- Hydrocortisone (≥ 40 mg/day)
- Prednisone (≥ 10 mg/day)
- Methylprednisolone (≥ 8 mg/day)
- Phenytoin
- Carbamazepine
- Phenobarbital
- Efavirenz
- Nevirapine
- Rifampin
- Rifabutin
- Rifapentine
- Hypericum perforatum (St. John's wort)
- Modafinil
- At least 7 days since prior and no concurrent CYP3A4 inhibitors, including any of the following:
- Clarithromycin
- Erythromycin
- Troleandomycin
- Delavirdine
- Ritonavir
- Indinavir
- Saquinavir
- Nelfinavir
- Amprenavir
- Lopinavir
- Itraconazole
- Ketoconazole
- Voriconazole
- Fluconazole (doses up to 150 mg/day are permitted)
- Nefazodone
- Fluvoxamine
- Verapamil
- Diltiazem
- Cimetidine
- Aprepitant
- Grapefruit or its juice
- At least 6 months since prior and no concurrent amiodarone
- At least 2 days since prior and no concurrent gastric pH modifiers*, including any of the following:
- Cimetidine
- Ranitidine
- Nizatidine
- Famotidine
- Omeprazole
- Esomeprazole
- Rabeprazole
- Pantoprazole
- Lansoprazole
- NOTE: *Antacids are allowed within 1 hour before and after administration of study drug
- No other concurrent investigational agents
- No other concurrent anticancer therapy, including chemotherapy, radiotherapy, immunotherapy, or antitumor hormonal therapy
- No concurrent herbal (alternative) medicines
- No concurrent combination antiretroviral therapy for HIV-positive patients
- Concurrent bisphosphonates allowed
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Northwestern University, Northwestern Medical Faculty Foundation
Chicago, Illinois, 60611-3013
Hematology-Oncology Associates of Illinois
Chicago, Illinois, 60611
Midwest Center for Hematology/Oncology
Joliet, Illinois, 60432
Joe Arrington Cancer Research and Treatment Center
Lubbock, Texas, 79410-1894
Saint James Hospital and Health Centers Comprehensive Cancer Institute - Olympia Fields
Olympia Fields, Illinois, 60461
About this study
Official title: Pilot Neoadjuvant Trial in Breast Cancer With Combination of ABI-007 (Abraxane) and GW572016 (Lapatinib)
RATIONALE: Drugs used in chemotherapy, such as Abraxane, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Lapatinib may stop the growth of tumor cells by blocking some of the enzymes needed for their growth. Giving Abraxane together with lapatinib may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving Abraxane together with lapatinib works in treating patients with stage I, stage II, or stage III breast cancer.
Read the detailed description
OBJECTIVES:
Primary
- Determine the clinical response rate, as measured by clinical exam and imaging studies, in patients with stage I-III breast cancer treated with neoadjuvant Abraxane in combination with lapatinib.
Secondary
- Determine the pathologic complete response rate in patients treated with this regimen.
- Correlate proliferation (Ki67), apoptosis (cleaved caspase-3), and angiogenesis (vW, CD34) markers, measured before and after treatment, with tumor response in these patients.
- Conduct other correlative studies, including epidermal growth factor receptor (EGFR), HER2/neu, matrix metalloproteinases (MMPs), and transforming growth factor (TGF-β), before and after treatment with this regimen to assess tumor response in these patients.
- Determine the toxicity of this regimen in these patients.
OUTLINE: This is a pilot study. Patients are assigned to 1 of 2 treatment groups.
- Group 1: The first 10 patients receive Abraxane IV over 30 minutes on day 1 and oral lapatinib once daily on days 1-21. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
- Group 2: The next 20 patients receive Abraxane and lapatinib (at a higher dose) as in group 1. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
Patients undergo blood collection and tumor biopsies periodically for correlative biomarker studies.
PROJECTED ACCRUAL: A total of 30 patients will be accrued to this study.
- Conditions
- Breast Cancer
- Being tested
- lapatinib ditosylate, paclitaxel albumin-stabilized nanoparticle formulation
- Keywords
- stage I breast cancer, 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.
lapatinib ditosylateDrug
Also called Tykerb, Tyverb
Oral lapatinib is taken once daily on days 1-21 of each treatment cycle. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
paclitaxel albumin-stabilized nanoparticle formulationDrug
Also called Abraxane, ABI-007
30 patients receive Abraxane IV over 30 minutes on day 1 each of each treatment cycle. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
| Study group | Role | What they receive |
|---|---|---|
| Treatment arm | Experimental | 30 patients receive Abraxane IV over 30 minutes on day 1 and oral lapatinib once daily on days 1-21. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Receives: Drug: lapatinib ditosylate; Drug: paclitaxel albumin-stabilized nanoparticle formulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Response Rate (cRR)
cRR measured by RECIST for target lesions assessed by clinical exam+ mammogram+ ultrasound (US). cRR is defined as number of patients who's best response in any of the assessments (clinical exam/mammogram/US) is CR+PR. Response will be defined as one of the following in either clinical exam, mammogram or US: Complete Response (CR)-Disappearance of all target lesions. Partial Response (PR)>=30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum.
Stable Disease-neither sufficient shrinkage to qualify for Partial disease nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum LD while on study.
Progressive Disease <=20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.
Measured: At Baseline, then before each treatment cycle begins and after 4 cycles of study treatment (1 cycle = 21 days)
Secondary outcomes (6)
Pathologic Complete Response (pCR)
Pathologic Complete Response (pCR) will be assessed by breast biopsy at baseline and after 4 cycles of study treatment (1 cycle = 21 days) and at surgery. This will be defined as the number of patients that show a pCR after surgery. pCR is defined as the absence of histologic evidence of invasive tumor cells in the surgical breast specimen and axillary lymph nodes.
Measured: At baseline, then after 4 cycles of study treatment (1 cycle = 21 days ) and at surgery
Proliferation (Ki67) Measured at Baseline and After Completion of Study Treatment
Correlation of proliferation (Ki67) will be assessed by breast biopsy at baseline and after 4 cycles of study treatment (1 cycle = 21 days). Ki67 scoring was performed based on degree of staining (0= no staining, 1=weak nuclear staining, 2=moderate nuclear staining, 3=strong nuclear staining). Ki67 scores were counted on a maximum of 10 randomly selected x40 high-power fields with an eyepiece grid of 10x10 squares containing representative sections of tumor and calculated as percentage of positively stained cells to total tumor cells (Percent Score method) Ki67 labeling Index (LI) as assessed by counting a maximum of 1,000 malignant cells at x400 magnification.
Measured: At baseline, then after 4 cycles of study treatment (1 cycle = 21 days )
Apoptosis (Cleaved Caspase-3) Measured at Baseline and After Completion of Study Treatment
Apoptosis/cleaved caspase-3 (CC3) will be assessed by breast biopsy at baseline and after 4 cycles of study treatment (1 cycle = 21 days). Scoring was based on the degree of staining (0=more than 90% of tumor cells with no staining, 1= more than 90% of tumor cells have weak staining, 2= more than 90% of tumor cells have moderate staining, 3= more than 90% of tumor cells have strong staining). CC3 scores were counted on a maximum of 10 randomly selected x40 high-power fields with an eyepiece grid of 10x10 squares containing representative sections of tumor and calculated as percentage of positively stained cells to total tumor cells (Percent Score method) CC3 labeling Index (LI) as assessed by counting a maximum of 1,000 malignant cells at x400 magnification.
Measured: At baseline, then after 4 cycles of study treatment (1 cycle = 21 days )
Angiogenesis (vW, CD34) Markers as Measured at Baseline and After Completion of Study Treatment
Angiogenesis (vW, CD34) markers will be assessed by breast biopsy at baseline and after 4 cycles of study treatment (1 cycle = 21 days). Expressions were analyzed by light microscopy in invasive breast cancer regions.
Tumor cells were assigned a score:
0 = no staining
- weak staining less than 1% of tumor cells
- = medium staining in 1-10% of tumor cells/weak staining in less than 1% of tumor cells
- = medium or strong staining in more than 10% of the tumor cells. Capillary density was assessed in breast sections stained for CD34 at a x200 magnification by counting the number of capillaries per field with five fields per slide and results expressed as the average number of capillaries per field.
Measured: At baseline, then after 4 cycles of study treatment (1 cycle = 21 days )
Epidermal Growth Factor Receptor (EGFR), and Matrix Metalloproteinases (MMPs), Measured at Baseline and After Completion of Study Treatment
Epidermal growth factor receptor (EGFR), HER2/neu, matrix metalloproteinases (MMPs), and transforming growth factor (TGF-β) will be assessed by breast biopsy at baseline and after 4 cycles of study treatment (1 cycle = 21 days) with expressions analyzed by light microscopy in invasive breast cancer regions.
MMP2 cytoplasmic staining intensity was assigned a score:
0=no reactivity,
- =1-10% of tumor cells reactive,
- =11-25% of tumor cells reactive,
- = 26-50% of cells reactive,
- = more than 50% of cells reactive
Greater than or equal to 2+ score was considered positive for expression.
EGFR membrane staining was assigned a score:
0 = no staining or faint staining in less than 10% of cells
- = faint incomplete membrane staining in more than 10% of cells
- = weak to moderate complete membrane staining of more than 10% of cells
- = strong complete membrane staining in more than 10% of tumor cells
Measured: At baseline, then after 4 cycles of study treatment (1 cycle = 21 days )
Side Effects From the Combination of Abraxane and Lapatinib
Side effects from the combination of Abraxane and Lapatinib will be assessed using CTCAE 3.0. Side effects that were related to study treatment and grade 3 or higher were collected where:
Grade 1= Mild Grade 2 = Moderate Grade 3 = Severe Grade 4 = Life-threatening Grade 5 = Death
Measured: At baseline, then before the start of each study treatment cycle (1 cycle = 21 days) begins
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2006 (estimated)
- Study start4 May 2006
- Primary completion10 Nov 2006
- Study completion5 Aug 2010
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 Northwestern 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Collaborators
- GlaxoSmithKline, Celgene Corporation
- Responsible party
- Sponsor
- Investigators
- Virginia G. Kaklamani, MD, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00331630
- Sponsor's protocol ID
- NU 05B2
- Other IDs
- NU 05B2, STU00007257
- Status last verified
- Jan 2020
- First submitted
- 30 May 2006
- Last updated
- 6 Mar 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Kaklamani VG, Siziopikou K, Scholtens D, Lacouture M, Gordon J, Uthe R, Meservey C, Hansen N, Khan SA, Jeruss JS, Bethke K, Cianfrocca M, Rosen S, Von Roenn J, Wayne J, Parimi V, Jovanovic B, Gradishar W. Pilot neoadjuvant trial in HER2 positive breast cancer with combination of nab-paclitaxel and lapatinib. Breast Cancer Res Treat. 2012 Apr;132(3):833-42. doi: 10.1007/s10549-011-1411-8. Epub 2011 Feb 27.
PubMed 21359953
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Neoadjuvant Trial in Breast Cancer With Combination of ABI-007 (Abraxane) and GW572016 (Lapatinib)
- ClinicalTrials.gov ID
- NCT00331630
- Acronym / sponsor ID
- NU 05B2
- Conditions
- Breast Cancer
- Keywords
- stage I breast cancer, stage II breast cancer, stage IIIA breast cancer, stage IIIB breast cancer, stage IIIC breast cancer
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Collaborators
- GlaxoSmithKline, Celgene Corporation
- Study start
- 4 May 2006 (actual)
- Primary completion
- 10 Nov 2006 (actual)
- Study completion
- 5 Aug 2010 (actual)
- First posted
- 31 May 2006 (estimated)
- Results
- Posted 6 Mar 2020
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 Abraxane, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Lapatinib may stop the growth of tumor cells by blocking some of the enzymes needed for their growth. Giving Abraxane together with lapatinib may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving Abraxane together with lapatinib works in treating patients with stage I, stage II, or stage III breast cancer.
Detailed description
OBJECTIVES:
Primary
- Determine the clinical response rate, as measured by clinical exam and imaging studies, in patients with stage I-III breast cancer treated with neoadjuvant Abraxane in combination with lapatinib.
Secondary
- Determine the pathologic complete response rate in patients treated with this regimen.
- Correlate proliferation (Ki67), apoptosis (cleaved caspase-3), and angiogenesis (vW, CD34) markers, measured before and after treatment, with tumor response in these patients.
- Conduct other correlative studies, including epidermal growth factor receptor (EGFR), HER2/neu, matrix metalloproteinases (MMPs), and transforming growth factor (TGF-β), before and after treatment with this regimen to assess tumor response in these patients.
- Determine the toxicity of this regimen in these patients.
OUTLINE: This is a pilot study. Patients are assigned to 1 of 2 treatment groups.
- Group 1: The first 10 patients receive Abraxane IV over 30 minutes on day 1 and oral lapatinib once daily on days 1-21. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
- Group 2: The next 20 patients receive Abraxane and lapatinib (at a higher dose) as in group 1. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
Patients undergo blood collection and tumor biopsies periodically for correlative biomarker studies.
PROJECTED ACCRUAL: A total of 30 patients will be accrued to this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment arm | Experimental | Drug: lapatinib ditosylate, Drug: paclitaxel albumin-stabilized nanoparticle formulation30 patients receive Abraxane IV over 30 minutes on day 1 and oral lapatinib once daily on days 1-21. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| lapatinib ditosylateAlso: Tykerb, TyverbOral lapatinib is taken once daily on days 1-21 of each treatment cycle. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. | Drug | Treatment arm |
| paclitaxel albumin-stabilized nanoparticle formulationAlso: Abraxane, ABI-00730 patients receive Abraxane IV over 30 minutes on day 1 each of each treatment cycle. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. | Drug | Treatment arm |
Primary outcome
Clinical Response Rate (cRR)
Time frame: At Baseline, then before each treatment cycle begins and after 4 cycles of study treatment (1 cycle = 21 days)
cRR measured by RECIST for target lesions assessed by clinical exam+ mammogram+ ultrasound (US). cRR is defined as number of patients who's best response in any of the assessments (clinical exam/mammogram/US) is CR+PR. Response will be defined as one of the following in either clinical exam, mammogram or US: Complete Response (CR)-Disappearance of all target lesions. Partial Response (PR)>=30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum. Stable Disease-neither sufficient shrinkage to qualify for Partial disease nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum LD while on study. Progressive Disease <=20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.
6 secondary outcomes
Pathologic Complete Response (pCR)
Time frame: At baseline, then after 4 cycles of study treatment (1 cycle = 21 days ) and at surgery
Proliferation (Ki67) Measured at Baseline and After Completion of Study Treatment
Time frame: At baseline, then after 4 cycles of study treatment (1 cycle = 21 days )
Apoptosis (Cleaved Caspase-3) Measured at Baseline and After Completion of Study Treatment
Time frame: At baseline, then after 4 cycles of study treatment (1 cycle = 21 days )
Angiogenesis (vW, CD34) Markers as Measured at Baseline and After Completion of Study Treatment
Time frame: At baseline, then after 4 cycles of study treatment (1 cycle = 21 days )
Epidermal Growth Factor Receptor (EGFR), and Matrix Metalloproteinases (MMPs), Measured at Baseline and After Completion of Study Treatment
Time frame: At baseline, then after 4 cycles of study treatment (1 cycle = 21 days )
Side Effects From the Combination of Abraxane and Lapatinib
Time frame: At baseline, then before the start of each study treatment cycle (1 cycle = 21 days) begins
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 21359953Kaklamani VG, Siziopikou K, Scholtens D, Lacouture M, Gordon J, Uthe R, Meservey C, Hansen N, Khan SA, Jeruss JS, Bethke K, Cianfrocca M, Rosen S, Von Roenn J, Wayne J, Parimi V, Jovanovic B, Gradishar W. Pilot neoadjuvant trial in HER2 positive breast cancer with combination of nab-paclitaxel and lapatinib. Breast Cancer Res Treat. 2012 Apr;132(3):833-42. doi: 10.1007/s10549-011-1411-8. Epub 2011 Feb 27.
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.
Virginia G. Kaklamani, MD principal investigator
Northwestern University
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing lapatinib ditosylate and paclitaxel albumin-stabilized nanoparticle formulation in people with Breast Cancer, run by Northwestern University at 5 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?
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 6 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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 6 Mar 2020). 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?
Clinical Response Rate (cRR) (time frame: At Baseline, then before each treatment cycle begins and after 4 cycles of study treatment (1 cycle = 21 days)). 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 NCT00331630, 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 6 Mar 2020.