Metastatic Breast CancerPhase 2NCT00555919
ZK 230211 in Postmenopausal Woman With Metastatic Breast Cancer
A Phase 2 study testing Lonaprisan (ZK 230211, BAY86-5044) in people with Metastatic Breast Cancer, run by Bayer at 28 sites in 10 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Metastatic Breast Cancer
- What is being tested?
- Lonaprisan (ZK 230211, BAY86-5044)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 28 sitesin 10 countries
- Study dates
- Mar 2008to Mar 2011
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
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- 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
Who cannot join
- 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.
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- 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 locations and contacts
28 sites in 10 countries.
28 sites in 10 countries
France6 sites
Study site
Lille, 59020
Study site
Lyon, 69008
Study site
Montpellier, 34000
Study site
Nantes, 44805
Study site
Paris, 75020
Study site
Reims, 51056
Germany5 sites
Study site
Erlangen, Bavaria, 91054
Study site
Frankfurt am Main, Hesse, 60590
Study site
Kiel, Schleswig-Holstein, 24105
Study site
Rostock, Mecklenburg-Vorpommern, 18059
Study site
Tübingen, Baden-Wurttemberg, 72076
Austria4 sites
Study site
Graz, 8036
Study site
Innsbruck, 6020
Study site
Salzburg, State of Salzburg, 5020
Study site
Vienna, State of Vienna, 1100
Poland4 sites
Study site
Bialystok, 15-540
Study site
Gdansk, 80-219
Study site
Olsztyn, 10-226
Study site
Poznan, 60-569
Sweden3 sites
Study site
Gothenburg, 413 45
Study site
Sundsvall, 851 86
Study site
Vaxjo, 351 85
About this study
Official title: 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
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.
- Conditions
- Metastatic Breast Cancer
- Being tested
- Lonaprisan (ZK 230211, BAY86-5044)
- Keywords
- Metastatic breast cancer stage IV, Metastatic breast cancer, mBC, Stage IV breast cancer, Hormone receptor positive breast cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lonaprisan (ZK 230211, BAY86-5044)Drug
25 mg daily oral treatment
Lonaprisan (ZK 230211, BAY86-5044)Drug
100 mg daily oral treatment
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Not described Receives: Drug: Lonaprisan (ZK 230211, BAY86-5044) |
| Arm 2 | Experimental | Not described Receives: Drug: Lonaprisan (ZK 230211, BAY86-5044) |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate efficacy (clinical benefit) of two doses of ZK PRA (25 mg and 100 mg) when administered once daily p.o.
Measured: month 3, month 6
Secondary outcomes (8)
To evaluate safety and tolerability
Measured: ongoing thoughout the trial
To evaluate the pharmacokinetics of ZK PRA
Measured: baseline, month1,2,6
To evaluate the effect of ZK PRA on quality of life (QoL)
Measured: baseline, month 1,2,3,4,5,6
To perform exploratory analysis of biomarkers
Measured: baseline, month 1, 3
Progression-free survival (PFS)
Measured: end of study
Objective response rate (ORR) / Duration of response - in the subset of patients with measurable disease
Measured: end of study
Duration of Clinical Benefit
Measured: end of study
Overall Survival (OS)
Measured: end of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2007 (estimated)
- Study startMar 2008
- Primary completionApr 2010
- Study completionMar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Metastatic Breast CancerStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00555919
- Sponsor's protocol ID
- 91484
- Other IDs
- 2005-005581-36, 309821, 2005
- Status last verified
- Oct 2014
- First submitted
- 8 Nov 2007
- Last updated
- 10 Oct 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Jonat W, Bachelot T, Ruhstaller T, Kuss I, Reimann U, Robertson JFR. Randomized phase II study of lonaprisan as second-line therapy for progesterone receptor-positive breast cancer. Ann Oncol. 2013 Oct;24(10):2543-2548. doi: 10.1093/annonc/mdt216. Epub 2013 Jun 20.
PubMed 23788750
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT00555919
- Acronym / sponsor ID
- 91484
- Conditions
- Metastatic Breast Cancer
- Keywords
- Metastatic breast cancer stage IV, Metastatic breast cancer, mBC, Stage IV breast cancer, Hormone receptor positive breast cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- Mar 2008
- Primary completion
- Apr 2010 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 9 Nov 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: Lonaprisan (ZK 230211, BAY86-5044) |
| Arm 2 | Experimental | Drug: Lonaprisan (ZK 230211, BAY86-5044) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- 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)
Key exclusion criteria (15 listed)
- Presence of any of the following conditions:
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lonaprisan (ZK 230211, BAY86-5044)25 mg daily oral treatment | Drug | Arm 1 |
| Lonaprisan (ZK 230211, BAY86-5044)100 mg daily oral treatment | Drug | Arm 2 |
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
8 secondary outcomes
To evaluate safety and tolerability
Time frame: ongoing thoughout the trial
To evaluate the pharmacokinetics of ZK PRA
Time frame: baseline, month1,2,6
To evaluate the effect of ZK PRA on quality of life (QoL)
Time frame: baseline, month 1,2,3,4,5,6
To perform exploratory analysis of biomarkers
Time frame: baseline, month 1, 3
Progression-free survival (PFS)
Time frame: end of study
Objective response rate (ORR) / Duration of response - in the subset of patients with measurable disease
Time frame: end of study
Duration of Clinical Benefit
Time frame: end of study
Overall Survival (OS)
Time frame: end of study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2014.
- Background: PubMed 23788750Jonat W, Bachelot T, Ruhstaller T, Kuss I, Reimann U, Robertson JFR. Randomized phase II study of lonaprisan as second-line therapy for progesterone receptor-positive breast cancer. Ann Oncol. 2013 Oct;24(10):2543-2548. doi: 10.1093/annonc/mdt216. Epub 2013 Jun 20.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bayer Study Director study director
Bayer
28 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Lonaprisan (ZK 230211, BAY86-5044) in people with Metastatic Breast Cancer, run by Bayer at 28 sites in 10 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 21 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 28 sites in France, Germany, Austria, Poland, Sweden and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00555919, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2014.