check_circleStudy Completed

Metastatic breast cancer

Bayer Identifier:

91484

ClinicalTrials.gov Identifier:

NCT00555919

EudraCT Number:

2005-005581-36

EU CT Number:

Not Available
ZK 230211 in postmenopausal woman with metastatic breast cancer

Trial purpose

Randomized phase II study to investigate the efficacy, safety and tolerability of ZK 230211 (100 mg vs. 25 mg) as second-line endocrine therapy for postmenopausal women with hormone receptor-positive metastatic breast cancer.Once the cancer has spread beyond the lymph nodes to areas such as e.g. the skin, soft tissues, lung, and liver it is called metastatic breast cancer. Patients who have been diagnosed with metastatic breast cancer that has progressed since their previous cancer treatment and that cannot be removed completely by surgery are eligible to be treated within this trial.Treatment with a new drug called Progesterone Receptor Antagonist ZK 230211 (ZK PRA) targets the progesterone receptor which may be expressed on breast cancer tumour cells. Therefore only patients with this progesterone receptor on their tumour cells can be included in this study.Progesterone receptor antagonists (including onapristone) have already shown efficacy in postmenopausal women with advanced breast cancer (Klijn et al. 2000). This phase II study investigates the efficacy (proof of concept), safety and tolerability of ZK PRA at two dose levels (25 mg and 100 mg) before initiating pivotal phase III trials.

Key Participants Requirements

Sex

Female

Age

18 Years
  • - Postmenopausal women defined as: aged >/= 50 years with amenorrhea for at least 12 months or aged < 50 years with 6 months of spontaneous amenorrhea and follicle stimulating hormone (FSH) level within postmenopausal range (> 40 mIU/ml) or having undergone bilateral oophorectomy
    - Histologically or cytologically confirmed breast cancer
    - Metastatic breast cancer (Stage IV according to UICC - Union Internationale Contre Cancer - criteria, Version 6)
    - Progesterone receptor-positive tumors
    - Patients must be considered candidates for endocrine therapy (no other therapies for breast cancer are required)
    - Disease progression after first-line endocrine therapy for advanced breast cancer (i.e. with tumor remission or stabilization lasting at least 3 months under endocrine therapy)
    - At least one measurable or non-measurable tumor lesion (according to RECIST criteria)
    - WHO Performance status 1
    - Adequate function of major organs and systems:
     -- Hematopoietic:
     --- Hemoglobin: 10 g/dL
     --- Absolute neutrophil count: 1,500/mm3
     --- Platelet count: 100,000/mm3
     -- Hepatic:
     --- Total bilirubin: 1.5 times the upper limit of normal
     --- AST/ALT: 2.5 times the upper limit of normal
     -- Renal: Creatinine: 1.5 times the upper limit of normal
     -- Gynecological: Endometrial thickness (in non-hysterectomized women)  -- No other uncontrolled concurrent illness
    - Adequate recovery from previous surgery, radiation and chemotherapy
    - Written informed consent
  • - Presence of any of the following conditions:
     -- life-threatening metastatic visceral disease (extensive hepatic involvement)
     -- any metastases to the central nervous system (CNS)
     -- pulmonary lymphangitic metastases involving more than 50% of the lung
    - More than one prior endocrine treatment for advanced breast cancer
    - Previous combination of endocrine treatment with any other type of treatment (except chemotherapy), or previous sequential endocrine treatments (if there was disease progression between treatments) are not permitted in this trial.
    - Patients with breast cancer HER-2 positive or with unknown HER-2 status are not eligible.
    - Malignancies or history of prior malignancy other than carcinoma in situ of the cervix or uterus, or basal and squamous cell carcinoma of the skin
    - Intake of CYP3A4 inhibitors less than 2 weeks before start of study treatment
    - A marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a QTc interval >450 milliseconds (ms)
    - A history of additional risk factors for TdP (e.g., heart failure, hypokalemia, family history of Long QT Syndrome)
    - The use of concomitant medications that prolong the QT/QTc interval
    - Other investigational drug therapies less than 4 weeks or at least 5 half-lives before start of study treatment (less than 4 weeks for faslodex and less than 2 weeks for any other endocrine therapy)
    - Expectation that the patient will not be able to complete at least 3 months of therapy
    - Unwillingness or inability to comply with the protocol

Trial summary

Enrollment Goal
68
Trial Dates
March 2008 - March 2011
Phase
Phase 2
Could I Receive a placebo
No
Products
Lonaprisan (Antiprogestin, BAY86-5044)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Hospital Clínico Universitario San CarlosMadrid, 28040, Spain
Completed
Medizinische Universität GrazGraz, 8036, Austria
Completed
SMZ Süd- Kaiser- Franz- Josef- SpitalWien, 1100, Austria
Completed
Klinikum der Eberhard-Karls-Universität TübingenTübingen, 72076, Germany
Completed
IRCCS Ist Clinico HumanitasRozzano, 20089, Italy
Completed
Universität Erlangen-NürnbergErlangen, 91054, Germany
Completed
Centre René GauducheauNantes, 44805, France
Completed
Centre Oscar LambretLille, 59020, France
Completed
Hôpital Tenon - ParisParis, 75020, France
Completed
Nottingham City HospitalNottingham, NG5 1PB, United Kingdom
Completed
SP Szpital Kliniczny nr 2Poznan, 60-569, Poland
Completed
NZOZ ONKO-MEDOlsztyn, 10-226, Poland
Completed
Växjö CentrallasarettVäxjö, 351 85, Sweden
Completed
Länssjukhuset Sundsvall-HärnösandSundsvall, 851 86, Sweden
Completed
Sahlgrenska UniversitetssjukhusetGöteborg, 413 45, Sweden
Completed
Universitätsklinikum InnsbruckInnsbruck, 6020, Austria
Completed
Kantonsspital St. GallenSt. Gallen, 9007, Switzerland
Completed
Klinikum der Christian-Albrechts-UniversitätKiel, 24105, Germany
Completed
Klinikum der Johann Wolfgang Goethe Universität FrankfurtFrankfurt, 60590, Germany
Completed
Landeskrankenhaus SalzburgSalzburg, 5020, Austria
Completed
Klinikum SüdstadtRostock, 18059, Germany
Completed
Centre Val d'Aurelle - MontpellierMONTPELLIER, 34000, France
Completed
Institut Jean Godinot - CRLCCReims, 51056, France
Completed
Centre Léon BérardLYON CEDEX, 69008, France
Completed
Wojewodzkie Centrum OnkologiiGdansk, 80-219, Poland
Completed
Centrum Medyczne "Dojlidy"Bialystok, 15-540, Poland
Completed
Vaasan keskussairaalaVaasa, 65130, Finland
Completed
Turun yliopistollinen keskussairaala, kantasairaalaTurku, FIN-20521, Finland

Primary Outcome

  • To evaluate efficacy (clinical benefit) of two doses of ZK PRA (25 mg and 100 mg) when administered once daily p.o.
    date_rangeTime Frame:
    month 3, month 6
    enhanced_encryption
    Safety Issue:
    no

Secondary Outcome

  • To evaluate safety and tolerability
    date_rangeTime Frame:
    ongoing thoughout the trial
    enhanced_encryption
    Safety Issue:
    yes
  • To evaluate the pharmacokinetics of ZK PRA
    date_rangeTime Frame:
    baseline, month1,2,6
    enhanced_encryption
    Safety Issue:
    no
  • To evaluate the effect of ZK PRA on quality of life (QoL)
    date_rangeTime Frame:
    baseline, month 1,2,3,4,5,6
    enhanced_encryption
    Safety Issue:
    no
  • To perform exploratory analysis of biomarkers
    date_rangeTime Frame:
    baseline, month 1, 3
    enhanced_encryption
    Safety Issue:
    no
  • Progression-free survival (PFS)
    date_rangeTime Frame:
    end of study
    enhanced_encryption
    Safety Issue:
    no
  • Objective response rate (ORR) / Duration of response - in the subset of patients with measurable disease
    date_rangeTime Frame:
    end of study
    enhanced_encryption
    Safety Issue:
    no
  • Duration of Clinical Benefit
    date_rangeTime Frame:
    end of study
    enhanced_encryption
    Safety Issue:
    no
  • Overall Survival (OS)
    date_rangeTime Frame:
    end of study
    enhanced_encryption
    Safety Issue:
    no

Trial design

Randomized phase II study to investigate the efficacy, safety and tolerability of ZK 230211 (25 mg vs. 100 mg) as second-line endocrine therapy for postmenopausal women with hormone receptor-positive metastatic breast cancer
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Randomized
Blinding
Open Label
Assignment
Parallel Assignment
Trial Arms
2

Additional Information

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