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Studien: AGMT_MBC-10 |  AGMT_Sportstudie |  MBC 5 |  02/89 |  01/89 |  CaelNav 1st Line |  GemVin 2nd Line |  Vin Mono |  GemVin 1st Line |  CaelMono 2nd Line |  AGMT MBC-6 | 

 


AGMT_MBC-10

Coordinating Investigator: Prof. Dr. Richard Greil / PROTOCOL CONTACT: Dr. Rinnerthaler, Dr. Gampenrieder
Fallzahl: 54
Start: Q2 2016 | Ende: Q2 2019
Status: recruiting


Ixazomib (MLN9708) in combination with carboplatin in pretreated women with advanced triple negative breast cancer (CARIXA)

Studiendesign

Subjects meeting all inclusion criteria will be enrolled receiving ixazomib on days 1, 8, and 15 in combination with carboplatin on days 1, 8, and 15. Cycles will be repeated every four weeks.

Phase I:
The phase I part of this study uses an alternate dose escalation accelerated titration design. In the accelerated dose-escalation phase a single-patient cohort per dose level will be enrolled, until one dose limiting toxicity (DLT) or 2 moderate toxicities are observed during cycle 1, or until dose level 4 is reached. At this dose level the cohort is expanded to three patients and dose escalation reverts to a conventional 3+3 escalation design.
DLTs are defined as inability to deliver the drug combination of ixazomib and carboplatin due to drug related toxicity :
• grade 3 or 4 non-hematologic toxicity excluding alopecia
• polyneuropathy greater or equal grade 3
• neutropenia grade 4 for more than 7 days
• neutropenia grade 4 with fever greater than 38.5C
• thrombocytopenia grade 4
• thrombocytopenia grade 3 with bleeding
Moderate toxicities are defined as:
• any grade 2 non-hematologic toxicity excluding alopecia
• any grade 3 hematologic toxicity
The maximum-administered dose (MAD) is defined as the dose at which DLT occur in at least two of six patients treated at that dose level. The dose just below the MAD is considered the maximum-tolerated dose (MTD), providing that DLT is observed in fewer than two of six treated patients (or fewer than one third if more than six patients will be treated) at that dose level. Determination of MAD and MTD is based on DLT observed during the first treatment cycle.

Phase II:
After establishing MTD in phase I, accrual continues to evaluate the efficacy and safety of the combination. A total of 35 patients will be included (patients enrolled in the phase I part within the conventional dose escalation phase at the dose level considered as the MTD may be included).

All subjects will continue on study drugs until disease progression, unacceptable toxicity or treatment discontinuation for any other reason.

Studienziele

Primary endpoints
• Phase I: Determination of maximum tolerated dose (MTD) and dose-limiting toxicities (DLTs)
• Phase II: Overall response rate (ORR)

Secondary endpoints
• Safety profile
• Overall response rate
• Clinical benefit rate
• Progression-free survival (PFS)
• Quality of Life (EORTC QLQ-C3)

Einschlusskriterien (Auszug)

Each patient must meet all of the following inclusion criteria to be enrolled in the study:
• Signed informed consent prior to any study-specific procedure
• Female patients, age ≥ 18 years
• Women of childbearing potential must have a negative pregnancy test at screening and must use effective contraception during the study and for a period of 90 days following the last administration of study drug
• Metastatic or locally advanced (without curative loco-regional treatment options with curative intention) adenocarcinoma of the breast, histologically confirmed
• Triple negative subtype defined as the absence of staining for estrogen receptor (IHC <1%), progesterone receptor (IHC <1%) and HER2/neu (IHC 1+ or ISH ratio of < 2.0 between Her2 gene copy number and centromere of chromosome 17 or a copy number of 4 or less)
• At least one prior line of chemotherapy for metastatic or locally advanced disease or disease progression within 12 months of completion of adjuvant chemotherapy
• Documented disease progression
• At least one measurable lesion according to RECIST 1.1 criteria
• Life expectancy of at least 12 weeks
• Performance status ECOG 0-2
• Adequate left ventricular ejection fraction at baseline, defined as LVEF ≥ 50% by either echocardiogram or MUGA
• Peripheral neuropathy NCI CTCAE grade ≤ 1 or grade 2 if no pain on clinical examination
• Adequate hematological, liver and renal function

Öffentliche Downloads

AGMT_MBC-10 Poster
Poster am OeGHO 2017



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AGMT_Sportstudie

Coordinating Investigator: Prim. Univ.-Prof. Dr. Richard Greil
Fallzahl: 80
Start: Q1 2011 | Ende: Q3 2014
Status: completed


Randomized trial of exercise training in postmenopausal patients with hormone-receptor positive breast cancer undergoing treatment with aromatase inhibitors

Studiendesign

This is a randomized trial. It will start at one site, but after enrolment of the first 10 patients, other eligible sites can participate.

All patients will be screened for their physical ability to complete the interventional exercise program. Only patients capable and willing to take part in this study and meeting all inclusion and exclusion criteria will be randomized. Randomization will be stratified according to BMI. All patients are to receive identical counseling for ideal nutritional / life-style / physical activity.

Patients randomized to Arm 2 will additionally undergo a controlled and observed program of physical activity for a period of 6 months. Thereafter the patients are expected to adhere to a comparable; unobserved exercise program at home.

Patients will be followed-up routinely according to the stage of their disease and medical needs. Apart from examinations in the screening phase and after 1 year as well as assessment of laboratory parameters at 3, 6 and 9 months, no additional visits outside of routine visits will be required for study participants.

Patients in Arm-2 will additionally be required to adhere to the time points of the con-trolled/observed physical activity schedule.

Studienziele

Primary objective
The primary objective of the study is the individual maximum power output in watt (Pmax) on a bicycle ergometer after 6 months of controlled or unobserved physical activity.

Secondary objectives
• Determination of feasibility of achieving 12 MET/week on an outpatient basis
• Determination of adherence/compliance of patients to
• nutritional / lifestyle / physical activity counseling in Arm 1;
• nutritional and lifestyle counseling in Arm 2
• observed physical activity on an outpatient basis in Arm 2
• continued uncontrolled/unobserved physical activity after the controlled pe-riod of 6 months
• Evaluation of the influence of controlled/observed physical activity versus lifestyle counseling only on:
• Fitness level (as measured by watt/kg at the anaerobic threshold and maximal, symptom-limited excertion
• Quality of Life (as assessed by EORTC QLQ C30 plus BR-23); Life style changes; Sports habit changes
• Rate of infections; Weight; BMI; Body fat percentage (as measured by caliper; Laboratory parameters
• Time to retreatment, relapse rate and OS in the long run


Einschlusskriterien (Auszug)

• Signed informed consent
• Postmenopausal women with hormone Rec.pos. breast cancer, who are treated with aromatase inhibitors
• Patients must be able and willing to fill out repeated questionnaires on QOL.
• on lifestyle and sports habits, as well as to adhere to the physical activity program
• Patients must fulfill all screening criteria
• ECOG performance status <= 2
• all age groups



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MBC 5

Coordinating Investigator: Prof. Dr. Richard Greil
Fallzahl: 30
Start: Q1 2009 | Ende: Q2 2012
Status: completed


Lapatinib plus Caelyx in patients with advanced or metastatic breast cancer following failure of Trastuzumab therapy – a Phase II study

Studiendesign

This is a non-randomized, multicenter, open-label, single-arm Phase II study in patients with previously treated metastatic breast cancer. Eligible patients may have no more than 1 line of palliative treatment, however prior therapies must include trastuzumab containing regimens in the adjuvant or metastatic setting

Studienziele

Primary Endpoint: to determine the efficacy of a Lapatinib plus Caelyx combination regimen in the treatment of advanced metastatic breast cancer, in terms of overall response rates

Secondary Endpoint: overall survival, progression free survival, clinical benefit, to evaluate Quality of Life (QoL)

Einschlusskriterien (Auszug)

• Female patients, age ≥ 18 years.
• Advanced or metastatic breast cancer, histologically confirmed
• Documented HER2 overexpression
• At least one measurable lesion according to RECIST criteria.
• Documented disease progression
• Patients that are progredient after Trastuzumab therapy (paliativ or adjuvant)
• Life expectancy of at least 12 weeks
• Performance status 0-1
• Adequate hematology, liver and renal function



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02/89

Coordinating Investigator:
Fallzahl:
Start: | Ende:
Status: geschlossen


Risikoadaptierte sequentielle Chemotherapie (+/- Erhaltungstherapie) beim metastasierenden Mammakarzinom unter besonderer Berücksichtigung der Lebensqualität. Kontinuierliche versus intermittierende Chemotherapie bei Patientinnen mit Low Risk.



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01/89

Coordinating Investigator:
Fallzahl:
Start: | Ende:
Status: geschlossen


Risikoadaptierte sequentielle Chemotherapie (+/- Erhaltungstherapie) beim metastasierenden Mammakarzinom unter besonderer Berücksichtigung der Lebensqualität. Kontinuierliche versus intermittierende Chemotherapie bei Patientinnen mit High Risk.



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CaelNav 1st Line

Coordinating Investigator: OA Dr. Brigitte Mlineritsch
Fallzahl: 50
Start: Q4 2002 | Ende: Q2 2004
Status: geschlossen


Phase II Study of CAELYX®/Navelbine® as first line Chemotherapy in Metastatic Breast Cancer in Elderly Patients

Studienziele

Primärer Endpunkt: Response rate
Sekundäre Endpunkte: Progression free survival, time to progression and overall survival, toxicity and quality of life

Einschlusskriterien (Auszug)

Chemotherapeutisch unbehandelte metastasierte Mammakarzinome
60 Jahre oder älter



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GemVin 2nd Line

Coordinating Investigator: OA Dr. Renate Schaberl-Moser
Fallzahl: 35
Start: Q3 1999 | Ende: Q1 2002
Status: geschlossen


Gemcitabine/Vinorelbin als Second Line Chemotherapie beim fortgeschrittenen Mammakarzinom

Studienziele

Primärer Endpunkt: Remissionsrate
Sekundäre Endpunkte :Zeit zur Progression; Überleben; Toxizität; Lebensqualität

Einschlusskriterien (Auszug)

Metastasiertes Mammakarzinom, Versagen auf 1st line Therapie



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Vin Mono

Coordinating Investigator: OA Dr. Brigitte Mlineritsch
Fallzahl: 57
Start: Q1 1991 | Ende: Q1 1994
Status: geschlossen


Vinorelbine in der Behandlung des metastasierenden Mammakarzinoms

Studienziele

Ermittlung der Remissionsrate
Evaluierung der Toxizität einer Vinorelbine-Monotherapie

Einschlusskriterien (Auszug)

Histologisch bestätigtes metastasierendes Mammakarzinom
Messbarer Tumor
Letzte Chemo- oder Hormontherapie mindestens 4 Wochen zurückliegend und bestehende PD
1st Line Patienten mit Vorbehandlung



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GemVin 1st Line

Coordinating Investigator:
Fallzahl:
Start: | Ende:
Status: geschlossen


Gemcitabine/ Vinorelbine als First Line Chemotherapie beim fortgeschrittenen Mammakarzinom



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CaelMono 2nd Line

Coordinating Investigator: OA Dr. Brigitte Mlineritsch
Fallzahl: 30
Start: | Ende:
Status: geschlossen


Phase II Studie zur Bewertung von Caelyx Monotherapie (Pegyliertes liposomales Doxorubicin-HCl)beim metastasierten Mammakarzinom nach Versagen einer First-Line Therapie

Studienziele

Remmissionsrate und Evaluierung der Toxizität der pegylierten liposomalen Form des Doxorubicins

Einschlusskriterien (Auszug)

Histologisch bestätigtes metastatsierendes Mammakarzinom
Vorherige palliative Chemotherapie ohne Anthracycline



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AGMT MBC-6

Coordinating Investigator: Prim. Univ. Prof. Dr. R. Greil
Fallzahl: 40
Start: 06.08.2013 | Ende: 31.08.2016
Status: active, not recruiting


Capecitabine in combination with Bendamustine in women with pretreated locally advanced or metastatic Her2-negative breast cancer, a Phase II Trial

Studiendesign

This is a non-randomized, multicenter, open-label, single-arm Phase II study in pretreated patients with Her2-negative advanced breast cancer. Prior therapies must include anthracyclines and/or taxans in the adjuvant or metastatic setting. Following a two-stage design efficacy and safety of bendamustine and capecitabine will be evaluated following recruitment of the first 20 patients. Upon favorable results a further 20 patients will be recruited to reach the target population of 40 evaluable patients.


Studienziele

Primary objective:
The efficacy of a capecitabine plus bendamustine combination regimen in the treatment of Her2-negative advanced metastatic breast cancer.
Secondary objectives:
• To determine the safety profile of a combination with capecitabine and bendamustine in terms of qualitative and quantitative toxicities from first study treatment dose until completion of study treatment due to progression or for any other reason.
• To evaluate the study population with respect to the following: clinical benefit (CR, PR or stable disease for at least 24 weeks), progression free survival (from treatment start until progression or death from any cause) and explorative the overall survival (from treatment start until death from any cause).
• To evaluate Quality of Life (QoL) status within the study population is captured using the EORTC QLQ-C30 standard questionnaire
• Predefined subgroup analysis of triple-negative patients and hormone receptor positive patients in terms of response

Einschlusskriterien (Auszug)

• Signed informed consent
• Female patients, age ≥ 18 years (women of childbearing potential must have a negative pregnancy test at screening and must use effective contraception)
• Advanced or metastatic Her2-negative breast cancer, histologically confirmed
• At least one measurable lesion according to RECIST criteria (Version 1.1)
• Documented disease progression
• Patients with progression after anthracycline and/or taxane treatment (palliative or adjuvant)
• Life expectancy of at least 12 weeks
• Performance status 0-2
• Adequate hematology, liver and renal function:
o Hematologic:
o ANC (absolute neutrophil count) ≥ 1.5 x 109/L
o Hemoglobin ≥ 9 g/dL
o Platelets ≥ 100 x 109/L
o Liver Function:
o Albumin ≥ 2.5 g/dL
o Serum bilirubin ≤ 2 mg/dL
o AST and ALT ≤ 3 x ULN without liver metastases
≤ 5 x ULN if documented liver metastases
o Renal Function:
o Serum Creatinine ≤ 1.5 mg/dL OR Calculated Creatinine Clearance ≥ 40 mL/min

Öffentliche Downloads

MBC-6 Folder
Kurzbeschreibung der MBC-6 Studie



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