Nab-paclitaxel in Metastatic Breast Cancer Patients Failing Solvent Based Taxane (Tiffany)
This study has been terminated.
(Study was terminated because of extrem low recruitment)
Information provided by (Responsible Party):
German Breast Group
First received: August 11, 2011
Last updated: May 21, 2013
Last verified: May 2013
Nab-paclitaxel has demonstrated to be an active agent in breast cancer and probably a less toxic alternative to solvent based taxanes. It is indicated in metastatic breast cancer after failure of anthracyclines. However, most patients receive anthracyclines as well as taxanes as part of their (neo-)adjuvant therapy. There is currently no standard treatment for patients with an early relapse (<12 months) after a taxane containing (neo-)adjuvant therapy. Nab-paclitaxel, a novel nano-particle encapsulated paclitaxel is expected to have only limited cross-resistant to solvent-based taxanes and might therefore be indicated in this setting.
Metastatic Breast Cancer
||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||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)
Primary Outcome Measures:
- Overall response rate (ORR) [ Time Frame: 3 years ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
| Estimated Enrollment:
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||October 2012 (Final data collection date for primary outcome measure)
Nab-Paclitaxel 125 mg/m2 i.v. over 30 min. weekly in 5 out of 6 weeks
Given until progression, unacceptable toxicity, patient's request or withdrawal from Study
Other Name: Abraxane, EU/1/07/428/001
To determine overall response rate (ORR) and to exclude that it is 20% or lower.
- 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.
|Ages Eligible for Study:
||18 Years and older (Adult, Senior)
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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.
- 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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01416558
|GBG Forschungs GmbH
|Neu-Isenburg, Germany, 63263 |
German Breast Group
||German Breast Group
History of Changes
|Other Study ID Numbers:
|Study First Received:
||August 11, 2011
||May 21, 2013
||Germany: Federal Institute for Drugs and Medical Devices
Keywords provided by German Breast Group:
German Breast Group
GBG Forschungs GmbH
Metastatic Breast Cancer
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on July 26, 2016
Neoplasms by Site
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Molecular Mechanisms of Pharmacological Action