- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01416558
Nab-paclitaxel in Metastatic Breast Cancer Patients Failing Solvent Based Taxane (Tiffany)
A Multicenter Non-randomized Phase II Study to Evaluate Nab-paclitaxel in Metastatic Brest Cancer Patients Failing a Solvent Based Taxane as (Neo-)Adjuvant Treatment (Tiffany)
Study Overview
Detailed Description
Primary Objective:
To determine overall response rate (ORR) and to exclude that it is 20% or lower.
Secondary Objectives:
- To determine compliance and toxicity of the therapy.
- To determine clinical benefit rate (CBR) in patients with measurable disease.
- To determine duration of response.
- To determine progression-free survival (PFS).
- To determine overall survival.
- To assess biomarkers, e.g. SPARC expression in the tissue of the primary or metastatic tumor.
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
-
Neu-Isenburg, Germany, 63263
- GBG Forschungs GmbH
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Written informed consent for all study procedures according to local regulatory requirements prior to beginning specific protocol procedures.
- Complete baseline documentation must be submitted via the web-based data collection system MedCODES to the GBG Forschungs GmbH.
- Diagnosis of locally advanced or metastatic hormone-sensitive or insensitive, HER2-negative or -positive breast cancer.
- Relapse within ≤ 12 months after completing (last day of last cycle) (neo-) adjuvant chemotherapy.
- Documented relapse of either a measurable or a non-measurable lesion according to the modified RECIST criteria.
- Previous neoadjuvant or adjuvant treatment with a solvent based taxane (paclitaxel or docetaxel) irrespective of dose and duration.
- Prior endocrine treatment for metastatic / advanced disease is allowed.
- Complete radiological and clinical tumor assessment within 4 weeks prior to registration performed as clinically indicated.
- Age ≥ 18 years.
- ECOG Performance Status ≤ 2 (irrespective of restrictions due to breast cancer).
- Laboratory requirements:Absolute neutrophil count (ANC) >= 1.5 x 109/L., Platelets >= 100 x 109/L., Hemoglobin >= 9 g/dL (>= 5.6 mmol/L)., Prothrombin time (PT) or international normalized ratio (INR) <= 1.2x ULN (upper normal limit), Partial thromboplastin time (PTT) <= 1.2x ULN, Total bilirubin < 1.5x ULN, ASAT (SGOT) and ALAT (SGPT) <= 2.5x ULN (concomitant elevations in serum bilirubin and ASAT/ALAT above 1.0x ULN are not permitted), Creatinine clearance >= 50 mL/min), Urine Protein to Creatinine Ratio (UPC) < 1 (if UPC >= 1, then 24-hour urine protein must be < 1 g).
- Normal cardiac function confirmed by ECG.
A female either of: 1) Non-childbearing potential, i.e. physiologically incapable of becoming pregnant because of history of hysterectomy, bilateral oophorectomy (ovariectomy), bilateral tubal ligation or postmenopausal status.
2) Childbearing potential with a negative pregnancy test (urine or serum)within 2 weeks prior to registration, preferably as close to the first dose as possible, and agrees to use adequate contraception.
Acceptable contraceptive methods, when used consistently and in accordance with both the product label and the instructions of the physician, are as follows:
An intrauterine device with a documented failure rate of less than 1% per year, Vasectomised partner who is sterile prior to the female subject's entry and is the sole sexual partner for that female, Complete abstinence from sexual intercourse for 14 days before exposure to the investigational product, through the dosing period, and for at least 21 days after the last dose of investigational product, Double-barrier contraception (condom with spermicidal jelly, foam suppository, or film; diaphragm with spermicide; or male condom and diaphragm with spermicide).
- Female subjects who are lactating should discontinue nursing prior to the first dose of study drug and should refrain from nursing throughout the treatment period and for 14 days following the last dose of study drug.
Exclusion Criteria:
- Known or suspected hypersensitivity reaction to the investigational compounds or incorporated substances.
- (Neo-)adjuvant therapy not containing a solvent based taxane.
- (Neo-)adjuvant therapy with nab-paclitaxel.
- Concurrent hormonal therapy for cancer.
- Life expectancy less than 3 months.
- Pre-existing peripheral neuropathy of > grade 2 (per CTCAE).
- Pre-existing grade 3 or 4 diarrhea.
- Presence of uncontrolled infection.
- Any serious and/or unstable pre-existing medical, psychiatric, or other condition that could interfere with the subject's safety, provision of informed consent, or compliance to study procedures.
- Concurrent specific systemic anti-tumor treatment or treatment with experimental compounds during study treatment.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Overall response rate (ORR)
Time Frame: 3 years
|
3 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Progression-free survival (PFS)
Time Frame: 3 years
|
3 years
|
|
Overall survival (OS)
Time Frame: 3 years
|
3 years
|
|
Duration of response
Time Frame: 3 years
|
3 years
|
|
Toxicity of the therapy
Time Frame: 3 years
|
Number and percent of patients with Adverse Events (any Grade and Grade 3/4).
|
3 years
|
Clinical benefit rate (CBR) in patients with measurable disease
Time Frame: 3 years
|
3 years
|
|
SPARC expression rate of the tissue of the primary and/or metastatic tumor
Time Frame: 3 years
|
3 years
|
|
Compliance of the therapy
Time Frame: 3 years
|
Number and percent of the patients with treatment modifications (dose delay / dose reduction / premature dicontinuation)
|
3 years
|
Collaborators and Investigators
Sponsor
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 (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- GBG 65
- 2011-000075-13 (EUDRACT_NUMBER)
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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