Metastatic Breast CancerPhase 2NCT00165880
An Open-label, Randomized, Phase II Study of the Efficacy and Safety of Indisulam (E7070) in Combination With Capecitabine
A Phase 2 study testing E7070 in people with Metastatic Breast Cancer, run by Eisai Limited at 33 sites in 5 countries.
Trial summary
The overall purpose of this study is to compare the efficacy, safety and tolerability of indisulam in combination with capecitabine (IC) versus capecitabine (C) monotherapy in patients with metastatic breast cancer who have previously been treated with an anthracycline and a taxane. 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?
- E7070
- How many people
- 62 participants
- Where
- 33 sitesin 5 countries
- Study dates
- Dec 2004to Sep 2007
- 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
- Ambulant female patients with metastatic breast cancer who have been treated previously with an anthracycline and a taxane will be enrolled.
- Patients must fulfill the following criteria to be included in the study:
- Histologically or cytologically confirmed breast cancer with at least one --- metastatic uni-dimensionally measurable lesion according to RECIST criteria (the following do not qualify as measurable lesions: bone, leptomeningeal disease, ascites, pleural/pericardial effusion, lymphangitis cutis/pulmonis, abdominal masses that are not confirmed and followed by imaging techniques, and cystic lesions).
- Prior treatment with an anthracycline and a taxane.
- All previous treatment (including surgery and radiotherapy) must have been completed at least 4 weeks prior to study entry and any acute toxicities must have resolved.
- Age >= 18 years.
- Karnofsky performance status of >= 70%.
- Written informed consent to participate in the study.
Who cannot join
- Patients with the following characteristics will not be included in the study:
- Previously received greater than two prior chemotherapy regimens for metastatic breast cancer.
- Previously received greater than three prior chemotherapy regimens in total (including neo-adjuvant and adjuvant regimens) for breast cancer.
- Primary diagnosis of inflammatory breast cancer, confirmed by histology or cytology.
- Untreated brain metastases (patients who have been treated for CNS metastases must be asymptomatic and radiologically stable for 3 months prior to entry). Patients must not have clinical symptoms from brain metastases and must not be taking corticosteroids for the treatment of brain metastases. Patients must not have leptomeningeal metastases.
- Concurrent or previous malignancy of a different tumor type within five years of starting the study except for adequately treated non-melanoma skin cancer or cervical intraepithelial neoplasia.
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- Any of the following laboratory parameters:
- hemoglobin <10 g/dl;
- neutrophils <1.5 x 109/L;
- platelets <100 x 109/L;
- serum bilirubin >25 µmol/l (1.5 mg/dl);
- other liver parameters >2.5 x upper normal limit (ULN) (> 5 x upper normal limit in the presence of hepatic metastases);
- serum creatinine >1.5 x ULN;
- serum calcium (corrected for albumin) >=11.5 mg/dl.
- Uncontrolled infections.
- Clinically significant cardiac impairment or unstable ischemic heart disease including a myocardial infarction within six months of study start.
- Malabsorption syndrome or other condition which may affect drug absorption.
- History of hypersensitivity to sulfonamides.
- Prior severe or unexpected reaction to fluoropyrimidine therapy (which may be explained by dihydropyrimidine dehydrogenase deficiency or hypersensitivity to 5-fluorouracil).
- Any treatment with investigational drugs within 30 days before the start of the study.
- Pregnancy or lactation (all women of childbearing potential must have a negative pregnancy test before inclusion in the study; post-menopausal women must be amenorrheic for at least 12 months). Fertile patients must use adequate contraceptive protection.
- History of alcoholism, drug addiction, or any psychiatric or psychological condition which, in the opinion of the investigator, would impair study compliance.
Trial locations and contacts
33 sites in 5 countries.
33 sites in 5 countries
Italy8 sites
Ospedali Ruiniti
Bergamo, I-24128
Ospedale S. Maria Annunzialata
Florence, I-50011
Ospedale Morgagni-Pierantoni
Forlì, I-47100
IST Istituto nazionale per la Ricerca
Genova, I-16132
Palilinico Universitano
Palermo, I-90127
Azienda Ospedaliera Pisana
Pisa, I-56126
A.O. Arciospedate S. Maria Nuova
Reggio Emilia, I-42100
Ospedale San Filippo Neri
Roma, I-00135
Russia8 sites
Arkhangelsk Regional Clinical Oncology Center
Arkhangelsk, 163045
Chelyabinsk Regional Oncology Center
Chelyabinsk, 454087
Krasnodar City Oncology Center
Krasnodar, 350040
Leningrad Regional Oncology Center
Kuzmolovo, 188663
Hertzen Research Institute of Oncology
Moscow, 125284
Semashko Central Clinical Hospital
Moscow, 129128
Rostov Oncology Research Institute
Rostov-on-Don, 344037
Petrov Research Institute of Oncology
Saint Petersburg, 197758
Spain7 sites
Centro Oncologico Regional de Galicia
A Coruña, E-15009
Hospital Universiatio de Guadalajara
Guadalajara, I-19002
Hospital Unicersaitario de La Princesa
Madrid, E-28006
Centro Oncologico Anderson Internacional
Madrid, E-28033
Hospital Clinico U. Virgen de la Victoria
Málaga, E-29010
Hospital Clinico Universitario Lozano Blesa
Zaragoza, E-50009
Hospital Clinico Universitario Lozano Blesa
Zaragoza, I-19002
Germany5 sites
Charite Universitatsmedizin Berlin
Berlin, D-12200
Stadt Kliniken Frankfurt-Hochst
Frankfurt, D-65929
IORC Gmbh
Hamburg, D-22081
Medizinische Klinik und Poliklinik
Mainz, D-55101
Zentrum fur Innere Medizin Hamatologie / Onkologie
Stuttgart, D-70376
United Kingdom5 sites
Cookridge Hospital
Leeds, LS16 6QB
St Bartholomew's Hospital
London, EC1A 7BE
Christie Hospital NHS Trust
Manchester, M20 4GJ
Mount Vernon Cancer Centre
Northwood, HA1 2RN
South West Wales Cancer Institute
Swansea, SA2 8QA
About this study
Official title: An Open-label, Randomized, Phase II Study of the Efficacy and Safety of Indisulam (E7070) in Combination With Capecitabine Versus Capecitabine Monotherapy for the Treatment of Metastatic Breast Cancer Patients Following Prior Anthracycline and Taxane Therapy
The overall purpose of this study is to compare the efficacy, safety and tolerability of indisulam in combination with capecitabine (IC) versus capecitabine (C) monotherapy in patients with metastatic breast cancer who have previously been treated with an anthracycline and a taxane.
- Conditions
- Metastatic Breast Cancer
- Being tested
- E7070
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
E7070Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Tumor measurements to be done by CT/MRI or photography in accordance with the RECIST criteria and radiography protocol provided. Six month and median overall survival, pain and analgesia score.
Secondary outcomes (1)
Clinical examination, adverse events, laboratory screens and electrocardiograms. Also, independent radiological review using RECIST criteria.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2005 (estimated)
- Study startDec 2004
- Study completionSep 2007
Why it stopped: This study was stopped prematurely due to lack of efficacy.
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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eisai Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Jantien Wanders, Study director, Eisai Limited
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00165880
- Sponsor's protocol ID
- E7070-E044-213
- Other IDs
- 2004-000774-31, 2004
- Status last verified
- Mar 2008
- First submitted
- 13 Sep 2005
- Last updated
- 1 Jul 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Randomized, Phase II Study of the Efficacy and Safety of Indisulam (E7070) in Combination With Capecitabine Versus Capecitabine Monotherapy for the Treatment of Metastatic Breast Cancer Patients Following Prior Anthracycline and Taxane Therapy
- ClinicalTrials.gov ID
- NCT00165880
- Acronym / sponsor ID
- E7070-E044-213
- Conditions
- Metastatic Breast Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: This study was stopped prematurely due to lack of efficacy.
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Eisai LimitedIndustry (pharma, biotech, devices)
- Study start
- Dec 2004
- Study completion
- Sep 2007 (actual)
- First posted
- 14 Sep 2005 (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.
The overall purpose of this study is to compare the efficacy, safety and tolerability of indisulam in combination with capecitabine (IC) versus capecitabine (C) monotherapy in patients with metastatic breast cancer who have previously been treated with an anthracycline and a taxane.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Ambulant female patients with metastatic breast cancer who have been treated previously with an anthracycline and a taxane will be enrolled.
- Patients must fulfill the following criteria to be included in the study:
- Histologically or cytologically confirmed breast cancer with at least one --- metastatic uni-dimensionally measurable lesion according to RECIST criteria (the following do not qualify as measurable lesions: bone, leptomeningeal disease, ascites, pleural/pericardial effusion, lymphangitis cutis/pulmonis, abdominal masses that are not confirmed and followed by imaging techniques, and cystic lesions).
- Prior treatment with an anthracycline and a taxane.
- All previous treatment (including surgery and radiotherapy) must have been completed at least 4 weeks prior to study entry and any acute toxicities must have resolved.
Key exclusion criteria (22 listed)
- Previously received greater than two prior chemotherapy regimens for metastatic breast cancer.
- Previously received greater than three prior chemotherapy regimens in total (including neo-adjuvant and adjuvant regimens) for breast cancer.
- Primary diagnosis of inflammatory breast cancer, confirmed by histology or cytology.
- Untreated brain metastases (patients who have been treated for CNS metastases must be asymptomatic and radiologically stable for 3 months prior to entry). Patients must not have clinical symptoms from brain metastases and must not be taking corticosteroids for the treatment of brain metastases. Patients must not have leptomeningeal metastases.
- Concurrent or previous malignancy of a different tumor type within five years of starting the study except for adequately treated non-melanoma skin cancer or cervical intraepithelial neoplasia.
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 |
|---|---|---|
| E7070 | Drug | – |
Primary outcome
Tumor measurements to be done by CT/MRI or photography in accordance with the RECIST criteria and radiography protocol provided. Six month and median overall survival, pain and analgesia score.
1 secondary outcome
Clinical examination, adverse events, laboratory screens and electrocardiograms. Also, independent radiological review using RECIST criteria.
Results and safety
The study was stopped early (reason given: This study was stopped prematurely due to lack of efficacy.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 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.
Jantien Wanders study director
Eisai Limited
33 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 E7070 in people with Metastatic Breast Cancer, run by Eisai Limited at 33 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 8 inclusion and 22 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: stopped early, as of the sponsor's last update on 1 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 33 sites in Italy, Russia, Spain, Germany, United Kingdom. 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 was stopped early (reason given: This study was stopped prematurely due to lack of efficacy.). Results are not available in the source record.
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?
Tumor measurements to be done by CT/MRI or photography in accordance with the RECIST criteria and radiography protocol provided. Six month and median overall survival, pain and analgesia score.. 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 1 Jul 2014.