Study 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

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) -- 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

Trial Dates

March 2008 - March 2011

Phase

Phase 2

Could I Receive a placebo

Products

Lonaprisan (Antiprogestin, BAY86-5044)

Accepts Healthy Volunteer

Where to participate

Status	Institution	Location
Completed	Hospital Clínico Universitario San Carlos	Madrid, 28040, Spain
Completed	Medizinische Universität Graz	Graz, 8036, Austria
Completed	SMZ Süd- Kaiser- Franz- Josef- Spital	Wien, 1100, Austria
Completed	Klinikum der Eberhard-Karls-Universität Tübingen	Tübingen, 72076, Germany
Completed	IRCCS Ist Clinico Humanitas	Rozzano, 20089, Italy
Completed	Universität Erlangen-Nürnberg	Erlangen, 91054, Germany
Completed	Centre René Gauducheau	Nantes, 44805, France
Completed	Centre Oscar Lambret	Lille, 59020, France
Completed	Hôpital Tenon - Paris	Paris, 75020, France
Completed	Nottingham City Hospital	Nottingham, NG5 1PB, United Kingdom
Completed	SP Szpital Kliniczny nr 2	Poznan, 60-569, Poland
Completed	NZOZ ONKO-MED	Olsztyn, 10-226, Poland
Completed	Växjö Centrallasarett	Växjö, 351 85, Sweden
Completed	Länssjukhuset Sundsvall-Härnösand	Sundsvall, 851 86, Sweden
Completed	Sahlgrenska Universitetssjukhuset	Göteborg, 413 45, Sweden
Completed	Universitätsklinikum Innsbruck	Innsbruck, 6020, Austria
Completed	Kantonsspital St. Gallen	St. Gallen, 9007, Switzerland
Completed	Klinikum der Christian-Albrechts-Universität	Kiel, 24105, Germany
Completed	Klinikum der Johann Wolfgang Goethe Universität Frankfurt	Frankfurt, 60590, Germany
Completed	Landeskrankenhaus Salzburg	Salzburg, 5020, Austria
Completed	Klinikum Südstadt	Rostock, 18059, Germany
Completed	Centre Val d'Aurelle - Montpellier	MONTPELLIER, 34000, France
Completed	Institut Jean Godinot - CRLCC	Reims, 51056, France
Completed	Centre Léon Bérard	LYON CEDEX, 69008, France
Completed	Wojewodzkie Centrum Onkologii	Gdansk, 80-219, Poland
Completed	Centrum Medyczne "Dojlidy"	Bialystok, 15-540, Poland
Completed	Vaasan keskussairaala	Vaasa, 65130, Finland
Completed	Turun yliopistollinen keskussairaala, kantasairaala	Turku, 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.
Time Frame:
month 3, month 6
Safety Issue:
no

Secondary Outcome

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

Additional Information

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