Trial Condition(s):

Metastatic breast cancer

ZK 230211 in postmenopausal woman with metastatic breast cancer

Bayer Identifier:

91484

ClinicalTrials.gov Identifier:

NCT00555919

EudraCT Number:

2005-005581-36

Study Completed

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.

Inclusion Criteria
- 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) </= 10 mm double layer
 -- No other uncontrolled concurrent illness
 - Adequate recovery from previous surgery, radiation and chemotherapy
 - Written informed consent
Exclusion Criteria
- 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
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Phase
2
Could I receive a placebo?
No
Products
Lonaprisan (Antiprogestin, BAY86-5044)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Hospital Clínico Universitario San Carlos

Madrid, Spain, 28040

Status
Completed
 
Locations

Medizinische Universität Graz

Graz, Austria, 8036

Status
Completed
 
Locations

SMZ Süd- Kaiser- Franz- Josef- Spital

Wien, Austria, 1100

Status
Completed
 
Locations

Klinikum der Eberhard-Karls-Universität Tübingen

Tübingen, Germany, 72076

Status
Completed
 
Locations

IRCCS Ist Clinico Humanitas

Rozzano, Italy, 20089

Status
Completed
 
Locations

Universität Erlangen-Nürnberg

Erlangen, Germany, 91054

Status
Completed
 
Locations

Centre René Gauducheau

Nantes, France, 44805

Status
Completed
 
Locations

Centre Oscar Lambret

Lille, France, 59020

Status
Completed
 
Locations

Hôpital Tenon - Paris

Paris, France, 75020

Status
Completed
 
Locations

Nottingham City Hospital

Nottingham, United Kingdom, NG5 1PB

Status
Completed
 
Locations

SP Szpital Kliniczny nr 2

Poznan, Poland, 60-569

Status
Completed
 
Locations

NZOZ ONKO-MED

Olsztyn, Poland, 10-226

Status
Completed
 
Locations

Växjö Centrallasarett

Växjö, Sweden, 351 85

Status
Completed
 
Locations

Länssjukhuset Sundsvall-Härnösand

Sundsvall, Sweden, 851 86

Status
Completed
 
Locations

Sahlgrenska Universitetssjukhuset

Göteborg, Sweden, 413 45

Status
Completed
 
Locations

Universitätsklinikum Innsbruck

Innsbruck, Austria, 6020

Status
Completed
 
Locations

Kantonsspital St. Gallen

St. Gallen, Switzerland, 9007

Status
Completed
 
Locations

Klinikum der Christian-Albrechts-Universität

Kiel, Germany, 24105

Status
Completed
 
Locations

Klinikum der Johann Wolfgang Goethe Universität Frankfurt

Frankfurt, Germany, 60590

Status
Completed
 
Locations

Landeskrankenhaus Salzburg

Salzburg, Austria, 5020

Status
Completed
 
Locations

Klinikum Südstadt

Rostock, Germany, 18059

Status
Completed
 
Locations

Centre Val d'Aurelle - Montpellier

MONTPELLIER, France, 34000

Status
Completed
 
Locations

Institut Jean Godinot - CRLCC

Reims, France, 51056

Status
Completed
 
Locations

Centre Léon Bérard

LYON CEDEX, France, 69008

Status
Completed
 
Locations

Wojewodzkie Centrum Onkologii

Gdansk, Poland, 80-219

Status
Completed
 
Locations

Centrum Medyczne "Dojlidy"

Bialystok, Poland, 15-540

Status
Completed
 
Locations

Vaasan keskussairaala

Vaasa, Finland, 65130

Status
Completed
 
Locations

Turun yliopistollinen keskussairaala, kantasairaala

Turku, Finland, FIN-20521

Status
Completed
 

Trial Design