Metastatic Breast CancerPhase 2NCT00615940
Combination of Oral WX-671 Plus Capecitabine vs. Capecitabine Monotherapy in First-line Her2-negative Metastatic Breast Cancer
A Phase 2 study testing WX-671 in people with Metastatic Breast Cancer, run by Heidelberg Pharma AG at 20 sites in 5 countries.
Trial summary
This randomized, double-blind, placebo controlled phase II trial is studying how well capecitabine works when given in combination with WX-671 or when given alone in treating patients receiving first-line therapy for her2negative metastatic breast cancer. 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?
- WX-671
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 132 participants
- Where
- 20 sitesin 5 countries
- Study dates
- Jul 2008to Apr 2012
- 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
- Females aged ≥ 18 years
- Patients appropriate for palliative first-line, mono chemotherapy with capecitabine
- Histological or cytological confirmed, non-inflammatory metastatic breast cancer
- Availability of paraffin-embedded tumor tissue from the primary resection or biopsy of a metastatic lesion.
- HER2-negative breast cancer
- Complete staging within 2 weeks prior to randomization (4 weeks for bone scan).
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- Radiologically confirmed disease
- ECOG performance status of ≤ 2
- Ability to understand and willingness to voluntarily sign and date a written informed consent form before screening
- Negative pregnancy test (urine or serum) within 3 days before first study drug for women of childbearing potential. Use of effective contraception during the study and for 3 months after stopping study drug treatment.
- Normal organ and marrow function as defined by laboratory parameters (obtained within the screening period) within the following limits:
- neutrophils >= 1.5 x 109/L;
- platelets >= 100 x 109/L;
- hemoglobin >= 9.0 g/dL (5.6 mmol/L).
- total bilirubin <= 1.5 x upper limit of normal (ULN);
- aspartate aminotransferase (AST)/ALT <= 2.5 x ULN (< 5.0 x ULN for patients with liver metastases);
- serum creatinine <= 2 x ULN, or calculated creatinine clearance >45 mL/min according to Cockroft and Gault formula).
Who cannot join
- Endocrine therapy completed within 2 weeks before the start of treatment (i.e. previous hormone therapy is allowed provided that there is a washout period of 2 weeks).
- Prior chemotherapy or biologic therapy for metastatic disease.
- Major surgery within 4 weeks prior to the start of treatment.
- Other anti-cancer treatment (e.g. hormones) within 2 weeks before the start of treatment.
- Treatment within 12 months with adjuvant 5-FU containing chemotherapy (regarded as indicating 5-FU resistance) and/or prior capecitabine therapy.
- Radiation therapy. Palliative radiation of stable, non-target lesions more than 2 weeks before the start of treatment is allowed, provided patients have recovered from the radiation side-effects.
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- History of or radiological evidence of brain metastasis including previously treated, resected or asymptomatic brain lesions or leptomeningeal involvement.
- Active seizure disorder or history of cerebrovascular accident (CVA) or transient ischemic (TI) attack within the past 12 months.
- History of other malignancy within the last 3 years except for surgically cured non-melanoma skin cancer or cervical carcinoma in situ.
- Active cardiac disease e.g. unstable angina, congestive heart failure, myocardial infarction (MI) within the preceding 6 months.
- Any medical condition prohibiting standard imaging procedures
- Pregnant or breast-feeding.
- Any unrelated illness, e.g. active infection requiring parenteral antibiotics, inflammation, medical condition or laboratory abnormalities, which in the judgment of the investigator might significantly affect patients' study participation.
- Any surgical or medical condition that might significantly alter the absorption, distribution, metabolism or excretion of either study drug.
- Known hepatitis B/C or HIV (human immunodeficiency virus) infection.
Trial locations and contacts
20 sites in 5 countries.
20 sites in 5 countries
Germany7 sites
Gemeinschaftspraxis Dr. Brudler, Dr. Heinrich, Dr. Bangerter
Augsburg, 86150
Klinik und Poliklinik für Frauenheilkunde und Geburtshilfe, Uniklinik Köln
Cologne
Universitätsklinikum Essen, Innere Klinik und Poliklinik (Tumorforschung)
Essen, 45147
Uniklinik Frankfurt, Zentrum der Frauenheilkunde und Geburtshilfe
Frankfurt am Main, 60590
Universitätsklinikum der Martin-Luther-Universität Halle-Wittenberg, Poliklinik Gynäkologie
Halle, 06120
Bethesda KH
Mönchengladbach, 41061
Department of Obstetrics and Gynecology, Technical University
Munich, 81675
Israel4 sites
Davidof Center, Rabin Medical Center, Department of Oncology
Petah Tikva, 49100
Kaplan Medical Center, Department of Oncolocy
Rehovot, 76100
Sheba Medical Center, Department of Oncology
Tel HaShomer, 52621
Assaf Harofeh medical center, Department of Oncology
Tsrifin, 70300
United States3 sites
Universitys Hospital Case Medical Center
Cleveland, Ohio, 44106
Montefiore Medical Center Weiler Division Department
New York, New York, 10461
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
Belgium3 sites
AZ Klina, Oncology Department
Brasschaat, 2930
Institut Jules Bordet Oncologie Médicale
Brussels, 1000
CHU de Liège, Domaine Universitaire de Sart-Tilman, Oncology Department
Liège, 4000
Brazil3 sites
Irmandade de Misericórdia da Santa Casa de Porto Alegre
Porto Alegre, 9005
Instituto Nacional do Câncer - INCA
Rio de Janeiro, 20560
Instituto Brasileiro de Controle do Câncer - IBCC
São Paulo, 03102
About this study
Official title: A Phase 2, Two-arm, Double-blind, Multi-center, Randomized Study of the Combination of Oral WX-671 Plus Capecitabine vs. Capecitabine Monotherapy in First-line Her2-negative Metastatic Breast Cancer
This randomized, double-blind, placebo controlled phase II trial is studying how well capecitabine works when given in combination with WX-671 or when given alone in treating patients receiving first-line therapy for her2negative metastatic breast cancer.
- Conditions
- Metastatic Breast Cancer
- Being tested
- WX-671, placebo
- Keywords
- HER2negative
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WX-671Drug
capsules taken per os once daily until progression or toxicity
placeboDrug
capsule taken per os once daily until progression or toxicity
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Capecitabine, 1000 mg/m2, twice daily by mouth, on Days 1 to 14, followed by a 7 day rest in each 21 day cycle given in combination with WX-671 once daily by mouth, Days 1-21 inclusive. Receives: Drug: WX-671 |
| 2 | Experimental | Capecitabine, 1000 mg/m2, twice daily by mouth, on Days 1 to 14, followed by a 7 day rest in each 21 day cycle given in combination with placebo once daily by mouth, Days 1-21 inclusive. Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy in terms of progression-free survival (PFS)
Measured: disease staging with CT/MRI/bone scans at regular intervals
Secondary outcomes (1)
Secondary endpoints are objective response rate (ORR), overall survival, safety and pharmacokinetics.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2008 (estimated)
- Study startJul 2008
- Primary completionDec 2011
- Study completionApr 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Breast CancerStudies of the same condition, open and under way.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 132 participants (actual)
Sponsor and investigators
- Lead sponsor
- Heidelberg Pharma AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- U.S. Army Medical Research and Development Command
- Responsible party
- Sponsor
- Investigators
- Lori Goldstein, MD, Principal investigator, Dept. of Medical Oncology, Division of Medical Science, Fox Chase Cancer Center, 7701 Burholme Avenue, Philadelphia, Pennsylvania 19111, USANadia Harbeck, MD, Principal investigator, Klinik und Poliklinik für Frauenheilkunde und Geburtshilfe, Uniklinik Köln
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00615940
- Sponsor's protocol ID
- WX/60-006
- Status last verified
- Jan 2014
- First submitted
- 1 Feb 2008
- Last updated
- 28 Feb 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Two-arm, Double-blind, Multi-center, Randomized Study of the Combination of Oral WX-671 Plus Capecitabine vs. Capecitabine Monotherapy in First-line Her2-negative Metastatic Breast Cancer
- ClinicalTrials.gov ID
- NCT00615940
- Acronym / sponsor ID
- WX/60-006
- Conditions
- Metastatic Breast Cancer
- Keywords
- HER2negative
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 132 participants (actual)
- Lead sponsor
- Heidelberg Pharma AGIndustry (pharma, biotech, devices)
- Collaborators
- U.S. Army Medical Research and Development Command
- Study start
- Jul 2008
- Primary completion
- Dec 2011 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 14 Feb 2008 (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.
This randomized, double-blind, placebo controlled phase II trial is studying how well capecitabine works when given in combination with WX-671 or when given alone in treating patients receiving first-line therapy for her2negative metastatic breast cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: WX-671Capecitabine, 1000 mg/m2, twice daily by mouth, on Days 1 to 14, followed by a 7 day rest in each 21 day cycle given in combination with WX-671 once daily by mouth, Days 1-21 inclusive. |
| 2 | Experimental | Drug: placeboCapecitabine, 1000 mg/m2, twice daily by mouth, on Days 1 to 14, followed by a 7 day rest in each 21 day cycle given in combination with placebo once daily by mouth, Days 1-21 inclusive. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Females aged ≥ 18 years
- Patients appropriate for palliative first-line, mono chemotherapy with capecitabine
- Histological or cytological confirmed, non-inflammatory metastatic breast cancer
- Availability of paraffin-embedded tumor tissue from the primary resection or biopsy of a metastatic lesion.
- HER2-negative breast cancer
Key exclusion criteria (15 listed)
- Endocrine therapy completed within 2 weeks before the start of treatment (i.e. previous hormone therapy is allowed provided that there is a washout period of 2 weeks).
- Prior chemotherapy or biologic therapy for metastatic disease.
- Major surgery within 4 weeks prior to the start of treatment.
- Other anti-cancer treatment (e.g. hormones) within 2 weeks before the start of treatment.
- Treatment within 12 months with adjuvant 5-FU containing chemotherapy (regarded as indicating 5-FU resistance) and/or prior capecitabine therapy.
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 |
|---|---|---|
| WX-671capsules taken per os once daily until progression or toxicity | Drug | 1 |
| placebocapsule taken per os once daily until progression or toxicity | Drug | 2 |
Primary outcome
Efficacy in terms of progression-free survival (PFS)
Time frame: disease staging with CT/MRI/bone scans at regular intervals
1 secondary outcome
Secondary endpoints are objective response rate (ORR), overall survival, safety and pharmacokinetics.
Time frame: 2 years
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 28 Feb 2014.
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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.
Lori Goldstein, MD principal investigator
Dept. of Medical Oncology, Division of Medical Science, Fox Chase Cancer Center, 7701 Burholme Avenue, Philadelphia, Pennsylvania 19111, USA
Nadia Harbeck, MD principal investigator
Klinik und Poliklinik für Frauenheilkunde und Geburtshilfe, Uniklinik Köln
20 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing WX-671 in people with Metastatic Breast Cancer, run by Heidelberg Pharma AG at 20 sites in 5 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 17 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 28 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in Germany, Israel, United States, Belgium, Brazil. 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?
Efficacy in terms of progression-free survival (PFS) (time frame: disease staging with CT/MRI/bone scans at regular intervals). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Feb 2014.