- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01484080
Neoadjuvant Paclitaxel Versus BIBF 1120 Priming Followed by BIBF 1120 Plus Paclitaxel in Early HER-2 Negative Breast Cancer With Proteomic and Dynamic Imaging Correlates
Phase I/II Randomized Clinical Trial of Neoadjuvant Paclitaxel Versus BIBF 1120 Priming Followed by BIBF 1120 Plus Paclitaxel in Early HER-2 Negative Breast Cancer With Proteomic and Dynamic Imaging Correlates
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Locations
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Madrid, Spain, 28033
- MD Anderson Cancer Centre Madrid
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Barcelona
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Hospitalet de Llobregat, Barcelona, Spain, 08907
- Hospital Universitari de Bellvitge
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Madrid
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Fuenlabrada, Madrid, Spain, 28942
- Hospital Universitario de Fuenlabrada
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Signed Informed Consent Form
- Patients ≥18 year-old
- Histological diagnosis of localized breast cancer with primary tumour over 2 cm on its longest diameter (measured by mammography and MRI). Any nodal status is allowed when it is an operable tumour at diagnosis. Multicentricity is allowed.
- HER 2 negative (Inmunohistochemistry - or + over +++; FISH CISH (-); equivalent to HER2/CEP17 copies under 2: HER2 result ++/+++ needs FISH/CISH confirmation.
- Measurable disease with a primary lesion >2 cm. by RECIST v1.1 criteria
- ECOG 0-1
Adequate hematologic, renal and hepatic function, defined by the following laboratory results obtained within 14 days prior to randomization/registration:
- Absolute granulocyte count >1.5 x 109/L
- Absolute platelet count >100 x 109/L
- Hemogobin >10 g/dL
- Serum creatinine >1.5 x UNL or a calculated creatinine clearance >50 ml/min
- Serum bilirubin <1.25 UNL
- AST/ALT <1.5 times UL
- Premenopausal women must be under effective birth control (non-hormone) and continue its use for the duration of the study and even 6 months later.
- For female with childbearing potential, a negative pregnancy test within the prior 7 days to the study enrolment
- Life expectancy >6 months
Exclusion Criteria:
- Metastatic or non-surgical breast cancer (including inflammatory).
- Locally breast cancer with primary lesion under 2 cm. In case of multicentricity, it will not be admitted in the study unless any lesion would be over this length.
- Previous or concurrent treatment of any kind for breast cancer: hormonal agents, conventional cytotoxic drugs, radiation therapy, targeted drugs, bisphosphonates, monoclonal antibodies or surgery. Chemoprevention with tamoxifen or raloxifene is allowed as far as the treatment was interrupted upon diagnosis and at least 4 weeks prior to inclusion. Same criteria for post-menopausal hormonal replacement therapy. Hormonal contraceptives should be discontinued.
- HER-2 positive breast cancer defined as over-expression in Immunochemistry of HER-2 3+ or 2+ with positive FISH/CISH
- Male patients.
- Pregnancy, lactation or breastfeeding.
- Active malignancy at any other side (including contra-lateral synchronous breast cancer) besides non-melanoma skin cancer or ductal/lobular of the breast or cervix in situ carcinoma, colon in situ carcinoma accurately treated as well as any other tumour diagnosis >5 years prior to registration without any sign of progression at present time.
- Concurrent serious medical conditions such as myocardial infarction within 6 months prior to entry, congestive heart failure, unstable angina, active cardiomyopathy, unstable ventricular arrhythmia, uncontrolled hypertension (under NYHA criteria), uncontrolled psychotic disorders, serious active infections, active peptic ulcer disease, psychiatric illness, HIV infection, active hepatitis, COPD or any other medical conditions that might be aggravated by treatment or limit compliance.
- Inability to take oral medication
- History of malabsorption syndrome
- Proven allergy to paclitaxel or BIBF 1120.
- Grade ≥2 peripheral neuropathy.
- Major surgery within 4 weeks of registration (breast cancer surgery regardless of timing is an exclusion criteria).
- Inability to comply with the study and follow-up procedures.
- Anticoagulation therapy (except low-dose heparin and / or wash out with heparin as needed to maintain a permanent intravenous device) or antiplatelet therapy (except for treatment with low doses of aspirin <325 mg per day.
- History of hemorrhagic or thromboembolic event clinically significant in the last 6 months.
- Known hereditary predisposition to bleeding or thrombosis
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Arm I: BIBF1120+Paclitaxel
2 weeks run-in of BIBF 1120 alone followed by paclitaxel + BIBF 1120 combination
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Priming Period: Oral BIBF 1120 will be administered during 2 weeks at the dose determined during the phase-I part that can be combined safely with weekly paclitaxel, on a continuous schedule for 14 days. One week washout is planned before starting the treatment phase. Treatment Phase: Paclitaxel 80 mg/m2 iv on days 1, 8 and 15 + BIBF 1120 recommended dose bid po days 1-21 q 21 days. (BIBF 1120 morning dose is skipped on the paclitaxel administration days). |
Active Comparator: Arm II: Paclitaxel
Paclitaxel monotherapy treatment will start within 2 weeks after randomization.
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Paclitaxel 80 mg/m2 iv on days 1, 8 and 15 q 21 days.
A total of 4 cycles will be administered in both arms.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pathologic complete response
Time Frame: Within 30 days after surgery
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Pathologic complete response defined as the absence of tumor cells assessed on the surgical specimen + residual Ductal Carcinoma In Situ (DCIS) in the breast.
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Within 30 days after surgery
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Determine predicting factors at the phosphoproteomic signature and its correlation with response to BIBF-1120
Time Frame: Baseline and end of priming phase.
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1. Determination of phosphoproteomic signatures in tumor biopsy.
Patients in arm-2 will undergo a baseline biopsy with the aim of establishing a signature predicting response to docetaxel alone, and by comparison with the signature in the arm-1, extracting the signalling nodes implicated in docetaxel response from those implicated in angiogenic blockade response.
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Baseline and end of priming phase.
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Collaborators and Investigators
Collaborators
Investigators
- Study Director: Miguel Ángel Quintela, M.D.,PhD, CNIO
- Principal Investigator: Ramón Colomer, M.D.,PhD, CNIO
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CNIO-BR-01-2010/GEICAM/2010-10
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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